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Tuesday, 17 April 2012

Ibukey

Ibukey may be available in the countries listed below.

Ingredient matches for Ibukey

Ibuprofen

Ibuprofen is reported as an ingredient of Ibukey in the following countries:

Spain

International Drug Name Search

Monday, 16 April 2012

Novamoxin

Generic Name: penicillin (Oral route, Injection route, Intravenous route, Intramuscular route)

Commonly used brand name(s)

In the U.S.

Amoxil

Bactocill

Bicillin L-A

Cloxapen

Crysticillin

Dynapen

Geocillin

Nafcil

Pfizerpen

Pipracil

Principen

Staphcillin

Ticar

Veetids

In Canada

Amoxil Pediatric

Ampicillin Sodium

Apo-Amoxi

Apo-Amoxi Sugar-Free

Apo-Cloxi

Apo-Pen-Vk

Gen-Amoxicillin

Med Amoxicillin

Nadopen V 200

Nadopen V 400

Novamoxin

Available Dosage Forms:

Powder for Suspension

Tablet

Tablet, Chewable

Tablet for Suspension

Tablet, Extended Release

Capsule

Powder for Solution

Suspension

Solution

Syrup

Uses For Novamoxin

Penicillins are used to treat infections caused by bacteria. They work by killing the bacteria or preventing their growth.

There are several different kinds of penicillins. Each is used to treat different kinds of infections. One kind of penicillin usually may not be used in place of another. In addition, penicillins are used to treat bacterial infections in many different parts of the body. They are sometimes given with other antibacterial medicines (antibiotics). Some of the penicillins may also be used for other problems as determined by your doctor. However, none of the penicillins will work for colds, flu, or other virus infections.

Penicillins are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, penicillins are used in certain patients with the following medical conditions:

Chlamydia infections in pregnant women—Amoxicillin and ampicillin

Gas gangrene—Penicillin G

Helicobacter pylori-associated gastritis or peptic ulcer disease—Amoxicillin

Leptospirosis—Ampicillin and penicillin G

Lyme disease—Amoxicillin and penicillin V

Typhoid fever—Amoxicillin and ampicillin

Before Using Novamoxin

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Many penicillins have been used in children and, in effective doses, are not expected to cause different side effects or problems in children than they do in adults.

Some strengths of the chewable tablets of amoxicillin contain aspartame, which is changed by the body to phenylalanine, a substance that is harmful to patients with phenylketonuria.

Geriatric

Penicillins have been used in the elderly and have not been shown to cause different side effects or problems in older people than they do in younger adults.

Pregnancy

Penicillins have not been studied in pregnant women. However, penicillins have been widely used in pregnant women and have not been shown to cause birth defects or other problems in animal studies.

Breast Feeding

Penicillins pass into the breast milk. Even though only small amounts may pass into breast milk, allergic reactions, diarrhea, fungus infections, and skin rash may occur in nursing babies.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Cyclosporine

Methotrexate

Vecuronium

Venlafaxine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of penicillin

This section provides information on the proper use of a number of products that contain penicillin. It may not be specific to Novamoxin. Please read with care.

Penicillins (except bacampicillin tablets, amoxicillin, penicillin V, pivampicillin, and pivmecillinam) are best taken with a full glass (8 ounces) of water on an empty stomach (either 1 hour before or 2 hours after meals) unless otherwise directed by your doctor.

For patients taking amoxicillin, penicillin V, pivampicillin, and pivmecillinam:

Amoxicillin, penicillin V, pivampicillin, and pivmecillinam may be taken on a full or empty stomach.

The liquid form of amoxicillin may also be taken by itself or mixed with formulas, milk, fruit juice, water, ginger ale, or other cold drinks. If mixed with other liquids, take immediately after mixing. Be sure to drink all the liquid to get the full dose of medicine.

For patients taking bacampicillin:

The liquid form of this medicine is best taken with a full glass (8 ounces) of water on an empty stomach (either 1 hour before or 2 hours after meals) unless otherwise directed by your doctor.

The tablet form of this medicine may be taken on a full or empty stomach.

For patients taking penicillin G by mouth:

Do not drink acidic fruit juices (for example, orange or grapefruit juice) or other acidic beverages within 1 hour of taking penicillin G since this may keep the medicine from working properly.

For patients taking the oral liquid form of penicillins:

This medicine is to be taken by mouth even if it comes in a dropper bottle. If this medicine does not come in a dropper bottle, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

Do not use after the expiration date on the label. The medicine may not work properly after that date. If you have any questions about this, check with your pharmacist.

For patients taking the chewable tablet form of amoxicillin:

Tablets should be chewed or crushed before they are swallowed.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you have a ”strep” infection, you should keep taking this medicine for at least 10 days. This is especially important in ”strep” infections. Serious heart problems could develop later if your infection is not cleared up completely. Also, if you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night . For example, if you are to take four doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

Make certain your health care professional knows if you are on a low-sodium (low-salt) diet. Some of these medicines contain enough sodium to cause problems in some people.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

The number of tablets or teaspoonfuls of suspension that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking a penicillin.

For amoxicillin:
- For bacterial infections:
  - For oral dosage forms (capsules, oral suspension, tablets, and chewable tablets):
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—250 to 500 milligrams (mg) every eight hours or 500 to 875 mg every twelve hours, depending on the type and severity of the infection.
    - Neonates and infants up to 3 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 15 mg per kg (6.8 mg per pound) of body weight or less every twelve hours.
    - Infants 3 months of age and older and children weighing up to 40 kg (88 lbs.)—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.7 to 13.3 mg per kg (3 to 6 mg per pound) of body weight every eight hours or 12.5 to 22.5 mg per kg (5.7 to 10.2 mg per pound) of body weight every twelve hours.
      - For duodenal ulcers (associated with Helicobacter pylori bacterial infection):
        For oral dosage forms (capsules, oral suspension, tablets, and chewable tablets):
        Adults: 1000 mg twice a day every twelve hours for fourteen days, along with the two other medicines, clarithromycin and lansoprazole, as directed by your doctor.
        
        Teenagers and children: Use and dose must be determined by your doctor.
        For dual medicine therapy—
        Adults: 1000 mg three times a day every eight hours for fourteen days, along with the other medicine, lansoprazole, as directed by your doctor.
        
        Teenagers and children: Use and dose must be determined by your doctor.

For ampicillin:
- For bacterial infections:
  - For oral dosage forms (capsules and oral suspension):
    - Adults, teenagers, and children weighing more than 20 kilograms (kg) (44 pounds)—250 to 500 milligrams (mg) every six hours.
    - Infants and children weighing up to 20 kg (44 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight every six hours; or 16.7 to 33.3 mg per kg (7.6 to 15 mg per pound) of body weight every eight hours.
      - For injection dosage form:
        Adults, teenagers, and children weighing more than 20 kg (44 pounds)—250 to 500 mg, injected into a vein or muscle every three to six hours.
        
        Infants and children weighing up to 20 kg (44 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 12.5 mg per kg (5.7 mg per pound) of body weight, injected into a vein or muscle every six hours.

For bacampicillin:
- For bacterial infections:
  - For oral dosage forms (oral suspension and tablets):
    - Adults, teenagers, and children weighing more than 25 kilograms (kg) (55 pounds)—400 to 800 milligrams (mg) every twelve hours.
    - Children weighing up to 25 kg (55 pounds)—Bacampicillin tablets are not recommended for use in children weighing up to 25 kg (55 pounds). The dose of the oral suspension is based on body weight and must be determined by your doctor. The usual dose is 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight every twelve hours.

For carbenicillin:
- For bacterial infections:
  - For oral dosage form (tablets):
    - Adults and teenagers—500 milligrams (mg) to 1 gram every six hours.
    - Children—Dose must be determined by your doctor.
      - For injection dosage form:
        Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The usual dose is 50 to 83.3 mg per kilogram (kg) (22.8 to 37.9 mg per pound) of body weight, injected into a vein or muscle every four hours.
        
        Older infants and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 16.7 to 75 mg per kg (7.6 to 34 mg per pound) of body weight, injected into a vein or muscle every four to six hours.

For cloxacillin:
- For bacterial infections:
  - For oral dosage form (capsules and oral solution):
    - Adults, teenagers, and children weighing more than 20 kilograms (kg) (44 pounds)—250 to 500 milligrams (mg) every six hours.
    - Infants and children weighing up to 20 kg (44 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 to 12.5 mg per kg (2.8 to 5.7 mg per pound) of body weight every six hours.
      - For injection dosage form:
        Adults, teenagers, and children weighing more than 20 kg—250 to 500 mg, injected into a vein every six hours.
        
        Infants and children weighing up to 20 kg (44 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 to 12.5 mg per kg (2.8 to 5.7 mg per pound) of body weight, injected into a vein every six hours.

For dicloxacillin:
- For bacterial infections:
  - For oral dosage form (capsules and oral suspension):
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—125 to 250 milligrams (mg) every six hours.
    - Infants and children weighing up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 3.1 to 6.2 mg per kg (1.4 to 2.8 mg per pound) of body weight every six hours.

For flucloxacillin:
- For bacterial infections:
  - For oral dosage form (capsules and oral suspension):
    - Adults, teenagers, and children more than 12 years of age and weighing more than 40 kilograms (kg) (88 pounds)—250 to 500 milligrams (mg) every six hours.
    - Children less than 12 years of age and weighing up to 40 kg (88 pounds)—125 to 250 mg every six hours; or 6.25 to 12.5 mg per kg (2.8 to 5.7 mg per pound) of body weight every six hours.
    - Infants up to 6 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 mg per kg (2.8 mg per pound) of body weight every six hours.

For methicillin:
- For bacterial infections:
  - For injection dosage form:
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—1 gram injected into a muscle every four to six hours; or 1 gram injected into a vein every six hours.
    - Children weighing up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 25 milligrams (mg) per kg (11.4 mg per pound) of body weight, injected into a vein or muscle every six hours.

For mezlocillin:
- For bacterial infections:
  - For injection dosage form:
    - Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The usual dose is 33.3 to 87.5 milligrams (mg) per kilogram (kg) (15.1 to 39.8 mg per pound) of body weight, injected into a vein or muscle every four to six hours; or 3 to 4 grams every four to six hours.
    - Infants over 1 month of age and children up to 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 50 mg per kg (22.7 mg per pound) of body weight, injected into a vein or muscle every four hours.

For nafcillin:
- For bacterial infections:
  - For oral dosage form (capsules and tablets):
    - Adults and teenagers—250 milligrams (mg) to 1 gram every four to six hours.
    - Older infants and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 to 12.5 mg per kilogram (kg) (2.8 to 5.7 mg per pound) of body weight every six hours.
    - Newborns—Dose is based on body weight and must be determined by your doctor. The usual dose is 10 mg per kg (4.5 mg per pound) of body weight every six to eight hours.
      - For injection dosage form:
        Adults and teenagers—500 mg to 2 grams injected into a vein or muscle every four to six hours.
        
        Infants and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 10 to 25 mg per kg (4.5 to 11.4 mg per pound) of body weight, injected into a muscle every twelve hours; or 10 to 40 mg per kg (4.5 to 18.2 mg per pound) of body weight, injected into a vein every four to eight hours.

For oxacillin:
- For bacterial infections:
  - For oral dosage form (capsules and oral solution):
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—500 milligrams (mg) to 1 gram every four to six hours.
    - Children weighing up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight every six hours.
      - For injection dosage form:
        Adults, teenagers, and children weighing more than 40 kg (88 pounds)—250 mg to 1 gram injected into a vein or muscle every four to six hours.
        
        Children weighing up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 12.5 to 25 mg per kg (5.7 to 11.4 mg per pound) of body weight, injected into a vein or muscle every four to six hours.
        
        Premature infants and newborns—Dose is based on body weight and must be determined by your doctor. The usual dose is 6.25 mg per kg (2.8 mg per pound) of body weight, injected into a vein or muscle every six hours.

For penicillin G:
- For bacterial infections:
  - For oral dosage form (oral solution, oral suspension, and tablets):
    - Adults and teenagers—200,000 to 500,000 Units (125 to 312 milligrams [mg]) every four to six hours.
    - Infants and children less than 12 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 4167 to 30,000 Units per kilogram (kg) (189 to 13,636 Units per pound) of body weight every four to eight hours.
      - For benzathine injection dosage form:
        Adults and teenagers—1,200,000 to 2,400,000 Units injected into a muscle as a single dose.
        
        Infants and children—300,000 to 1,200,000 Units injected into a muscle as a single dose; or 50,000 Units per kg (22,727 Units per pound) of body weight injected into a muscle as a single dose.
        For injection dosage forms (potassium and sodium salts):
        Adults and teenagers—1,000,000 to 5,000,000 Units, injected into a vein or muscle every four to six hours.
        
        Older infants and children—Dose is based on body weight and must be determined by your doctor. The usual dose is 8333 to 25,000 Units per kg (3788 to 11,363 Units per pound) of body weight, injected into a vein or muscle every four to six hours.
        
        Premature infants and newborns—Dose is based on body weight and must be determined by your doctor. The usual dose is 30,000 Units per kg (13,636 Units per pound) of body weight, injected into a vein or muscle every twelve hours.
        For procaine injection dosage form:
        Adults and teenagers—600,000 to 1,200,000 Units injected into a muscle once a day.
        
        Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 50,000 Units per kg (22,727 Units per pound) of body weight, injected into a muscle once a day.

For penicillin V:
- For bacterial infections:
  - For the benzathine salt oral dosage form (oral solution):
    - Adults and teenagers—200,000 to 500,000 Units every six to eight hours.
    - Children—100,000 to 250,000 Units every six to eight hours.
      - For the potassium salt oral dosage forms (oral solution, oral suspension, and tablets):
        Adults and teenagers—125 to 500 milligrams (mg) every six to eight hours.
        
        Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2.5 to 16.7 mg per kilogram (kg) (1.1 to 7.6 mg per pound) of body weight every four to eight hours.

For piperacillin:
- For bacterial infections:
  - For injection dosage form:
    - Adults and teenagers—3 to 4 grams, injected into a vein or muscle every four to six hours.
    - Infants and children—Dose must be determined by your doctor.

For pivampicillin:
- For bacterial infections:
  - For oral dosage form (oral suspension):
    - Adults, teenagers, and children 10 years of age and older—525 to 1050 milligrams (mg) two times a day.
    - Children 7 to 10 years of age—350 mg two times a day.
    - Children 4 to 6 years of age—262.5 mg two times a day.
    - Children 1 to 3 years of age—175 mg two times a day.
    - Infants 3 to 12 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 to 30 mg per kilogram (kg) (9.1 to 13.6 mg per pound) of body weight two times a day.
      - For oral dosage form (tablets):
        Adults, teenagers, and children 10 years of age and older—500 mg to 1 gram two times a day.
        
        Children up to 10 years of age—Dose must be determined by your doctor.

For pivmecillinam:
- For bacterial infections:
  - For oral dosage form (tablets):
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—200 milligrams (mg) two to four times a day for three days.
    - Children up to 40 kg (88 pounds)—Dose must be determined by your doctor.

For ticarcillin:
- For bacterial infections:
  - For injection dosage form:
    - Adults, teenagers, and children weighing more than 40 kilograms (kg) (88 pounds)—3 grams injected into a vein every four hours; or 4 grams injected into a vein every six hours.
    - Children up to 40 kg (88 pounds)—Dose is based on body weight and must be determined by your doctor. The usual dose is 33.3 to 75 milligrams (mg) per kg (15 to 34 mg per pound) of body weight, injected into a vein every four to six hours.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Novamoxin

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Penicillins may cause diarrhea in some patients.

Check with your doctor if severe diarrhea occurs. Severe diarrhea may be a sign of a serious side effect. Do not take any diarrhea medicine without first checking with your doctor. Diarrhea medicines may make your diarrhea worse or make it last longer.

For mild diarrhea, diarrhea medicine containing kaolin or attapulgite (e.g., Kaopectate tablets, Diasorb) may be taken. However, other kinds of diarrhea medicine should not be taken. They may make your diarrhea worse or make it last longer.

If you have any questions about this or if mild diarrhea continues or gets worse, check with your health care professional.

Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking ampicillin, amoxicillin, or penicillin V. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking any of these penicillins. If you have any questions about this, check with your health care professional.

For diabetic patients:

Penicillins may cause false test results with some urine sugar tests. Check with your doctor before changing your diet or the dosage of your diabetes medicine.

Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Novamoxin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Less common

Fast or irregular breathing

fever

joint pain

lightheadedness or fainting (sudden)

puffiness or swelling around the face

red, scaly skin

shortness of breath

skin rash, hives, itching

Check with your doctor immediately if any of the following side effects occur:

Rare

Abdominal or stomach cramps and pain (severe)

abdominal tenderness

convulsions (seizures)

decreased amount of urine

diarrhea (watery and severe), which may also be bloody

mental depression

nausea and vomiting

pain at place of injection

sore throat and fever

unusual bleeding or bruising

yellow eyes or skin

Rare - For penicillin G procaine only

Agitation or combativeness

anxiety

confusion

fear of impending death

feeling, hearing, or seeing things that are not real

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea (mild)

headache

sore mouth or tongue

vaginal itching and discharge

white patches in the mouth and/or on the tongue

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Novamoxin side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Novamoxin resources

Novamoxin Side Effects (in more detail)
Novamoxin Use in Pregnancy & Breastfeeding
Drug Images
Novamoxin Drug Interactions
Novamoxin Support Group
11 Reviews for Novamoxin - Add your own review/rating

Compare Novamoxin with other medications

Actinomycosis
Anthrax
Anthrax Prophylaxis
Aspiration Pneumonia
Bacterial Infection
Clostridial Infection
Congenital Syphilis
Cutaneous Bacillus anthracis
Deep Neck Infection
Diphtheria
Endocarditis
Fusospirochetosis, Trench Mouth
Joint Infection
Leptospirosis
Lyme Disease, Arthritis
Lyme Disease, Carditis
Lyme Disease, Erythema Chronicum Migrans
Lyme Disease, Neurologic
Meningitis
Meningitis, Meningococcal
Meningitis, Pneumococcal
Neurosyphilis
Otitis Media
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Rat-bite Fever
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Strep Throat
Syphilis, Early
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Tertiary Syphilis
Tonsillitis/Pharyngitis
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Friday, 13 April 2012

Phenylephrine Orally Disintegrating Strips

Generic Name: Phenylephrine (FEN-il-EF-rin)
Brand Name: Generic only. No brands available.

Phenylephrine Orally Disintegrating Strips are used for:

Relieving congestion due to colds, flu, hay fever, and other allergies. It may also be used for other conditions as determined by your doctor.

Phenylephrine Orally Disintegrating Strips are a decongestant. It works by reducing swelling and constricting blood vessels in the nasal passages, allowing you to breathe more easily.

Do NOT use Phenylephrine Orally Disintegrating Strips if:

you are allergic to any ingredient in Phenylephrine Orally Disintegrating Strips

you have had an unusual reaction (eg, dizziness, weakness, tremors, irregular heartbeat) to another sympathomimetic medicine (eg, pseudoephedrine)

you are taking furazolidone or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) in the last 14 days

you have severe high blood pressure, severe heart blood vessel disease, fast heartbeat, or severe heart problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Phenylephrine Orally Disintegrating Strips:

Some medical conditions may interact with Phenylephrine Orally Disintegrating Strips. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of glaucoma or increased pressure in the eye, enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, or stroke

Some MEDICINES MAY INTERACT with Phenylephrine Orally Disintegrating Strips. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Phenylephrine Orally Disintegrating Strips's side effects

Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

Bromocriptine because the risk of its side effects may be increased by Phenylephrine Orally Disintegrating Strips

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Phenylephrine Orally Disintegrating Strips

This may not be a complete list of all interactions that may occur. Ask your health care provider if Phenylephrine Orally Disintegrating Strips may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Phenylephrine Orally Disintegrating Strips:

Use Phenylephrine Orally Disintegrating Strips as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Phenylephrine Orally Disintegrating Strips by mouth with or without food.

Do not remove the strip from the pouch until you are ready to take Phenylephrine Orally Disintegrating Strips. Be sure that your hands are dry when you touch the strip.

Remove the strip from the pouch and place it onto the tongue. The strip dissolves quickly and can be swallowed with saliva. It may be taken with or without water.

Use the strip right away after you open the pouch. Do not store it for future use.

If you miss a dose of Phenylephrine Orally Disintegrating Strips and are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Phenylephrine Orally Disintegrating Strips.

Important safety information:

Phenylephrine Orally Disintegrating Strips may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Phenylephrine Orally Disintegrating Strips with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

If your symptoms do not get better within 7 days, if they get worse, or if they occur with a fever, check with your doctor.

Phenylephrine Orally Disintegrating Strips has phenylephrine in it. Before you start any new medicine, check the label to see if it has phenylephrine or pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Do not take diet or appetite control medicines while you are taking Phenylephrine Orally Disintegrating Strips.

If you have trouble sleeping, ask your pharmacist or doctor about the best time to take Phenylephrine Orally Disintegrating Strips.

Tell your doctor or dentist that you take Phenylephrine Orally Disintegrating Strips before you receive any medical or dental care, emergency care, or surgery.

Diabetes patients - Phenylephrine Orally Disintegrating Strips may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Use Phenylephrine Orally Disintegrating Strips with caution in the ELDERLY; they may be more sensitive to its effects.

Caution is advised when using Phenylephrine Orally Disintegrating Strips in CHILDREN; they may be more sensitive to its effects.

Different brands of Phenylephrine Orally Disintegrating Strips may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.

Phenylephrine Orally Disintegrating Strips should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Phenylephrine Orally Disintegrating Strips while you are pregnant. Phenylephrine Orally Disintegrating Strips are found in breast milk. Do not breast-feed while taking Phenylephrine Orally Disintegrating Strips.

Possible side effects of Phenylephrine Orally Disintegrating Strips:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; nausea; nervousness; restlessness; sleeplessness; stomach irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; hallucinations; seizures; severe dizziness or headache; severe or persistent nervousness, restlessness, or trouble sleeping; tremor; trouble urinating.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room right away. Symptoms may include confusion; hallucinations; irregular or unusually slow or rapid heartbeat; rapid breathing; seizures.

Proper storage of Phenylephrine Orally Disintegrating Strips:

Store Phenylephrine Orally Disintegrating Strips at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Phenylephrine Orally Disintegrating Strips out of the reach of children and away from pets.

General information:

If you have any questions about Phenylephrine Orally Disintegrating Strips, please talk with your doctor, pharmacist, or other health care provider.

Phenylephrine Orally Disintegrating Strips are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Phenylephrine Orally Disintegrating Strips. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Phenylephrine resources

Phenylephrine Use in Pregnancy & Breastfeeding
Drug Images
Phenylephrine Drug Interactions
Phenylephrine Support Group
3 Reviews for Phenylephrine - Add your own review/rating

Compare Phenylephrine with other medications

Hypotension
Nasal Congestion
Shock
Supraventricular Tachycardia

Thursday, 12 April 2012

Ultrabase (Bayer plc)

1. Name Of The Medicinal Product

Ultrabase®

2. Qualitative And Quantitative Composition

There are no active constituents.

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

For general use as:

- an emollient

- a diluent for dermatological preparations and

- a vehicle for various dermatological medicaments.

Additionally, it may be alternated with topical corticosteroids when the latter are being gradually withdrawn, and may be continued alone after complete withdrawal of the topical corticosteroid.

4.2 Posology And Method Of Administration

For topical administration as required.

4.3 Contraindications

Hypersensitivity to any of the components of Ultrabase.

4.4 Special Warnings And Precautions For Use

None stated.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

None stated.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known.

4.9 Overdose

Not applicable. Ultrabase contains no active ingredients.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ultrabase has no specific active ingredient, but the cream formulation has good emollient properties.

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

There are no preclinical safety data which could be of relevance to the prescriber and which are not already included in other relevant sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Polyoxyl 40 stearate [E431]

White soft paraffin

Liquid paraffin

Stearyl alcohol

Carbomer

Sodium hydroxide

Methyl parahydroxybenzoate (methyl paraben) [E218]

Propyl parahydroxybenzoate (propyl paraben) [E216]

Disodium edentate [E463]

Purified water

Citrus-rose perfume oil

6.2 Incompatibilities

None known.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

Not applicable.

6.5 Nature And Contents Of Container

This product is available in collapsible aluminium tubes (10 g or 50 g) and polypropylene jars (500 g). Also available in polypropylene pump dispensers (500 g).

6.6 Special Precautions For Disposal And Other Handling

Keep out of the reach of children.

7. Marketing Authorisation Holder

Intendis GmbH

Max-Dohrn-Strasse 10

D-10589

Berlin

Germany

8. Marketing Authorisation Number(S)

PL 28428/0002

9. Date Of First Authorisation/Renewal Of The Authorisation

2 June 1972/13 January 2003

10. Date Of Revision Of The Text

29 September 2006

Wednesday, 11 April 2012

Teveten 600mg Film-coated Tablets

1. Name Of The Medicinal Product

Teveten 600mg film-coated tablets.

2. Qualitative And Quantitative Composition

Eprosartan mesilate equivalent to 600mg eprosartan free base.

For excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablets.

Capsule-shaped, biconvex, white film-coated tablet with the inscription '5046'.

4. Clinical Particulars

4.1 Therapeutic Indications

Eprosartan is indicated for the treatment of essential hypertension.

4.2 Posology And Method Of Administration

The recommended dose is 600 mg eprosartan once daily.

The dose may be increased to 800 mg eprosartan once daily if further response is required. Achievement of maximal blood pressure reduction in most patients may take 2 to 3 weeks of treatment.

Eprosartan may be used alone or in combination with other anti-hypertensives, e.g. thiazide-type diuretics, calcium channel blockers, if a greater blood pressure lowering effect is required.

Eprosartan should be taken with food.

Elderly (>75 years): As clinical experience is limited in patients over 75 years, a starting dose of 300 mg once daily is recommended.

Dosage in hepatically impaired patients: There is limited experience in patients with hepatic impairment (see section 4.3 and section 5.2). In patients with mild to moderate hepatic impairment, a starting dose of 300 mg once daily is recommended.

Dosage in renally impaired patients: No dose adjustment is required in patients with creatinine clearance 60-80 ml/min. As clinical experience is limited in patients with creatinine clearance <60 ml/min, a starting dose of 300mg once daily is recommended (see section 4.4).

Children: As safety and efficacy in children have not been established, treatment of children is not recommended.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Second and third trimester of pregnancy (see sections 4.4 and 4.6).

Severe hepatic impairment.

Haemodynamically significant bilateral renovascular disease or severe stenosis of a solitary functioning kidney

4.4 Special Warnings And Precautions For Use

Hepatic impairment

When Eprosartan is used in patients with mild to moderate hepatic impairment, special care should be exercised due to the fact that there is limited experience in this patient population

Renal impairment

No dose adjustment is required in patients with mild to moderate renal insufficiency (creatinine clearance ≥ 30 ml/min). Caution is recommended for use in patients with creatinine clearance < 30 ml/min or in patients undergoing dialysis

Patients at risk of renal impairment

Patients whose renal function is dependent predominantly on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe cardiac insufficiency [NYHA-classification: class IV], bilateral renal artery stenosis, or renal artery stenosis of a solitary kidney) are at increased risk of developing oliguria and/or progressive azotaemia and rarely acute renal failure during therapy with an angiotensin converting enzyme (ACE) inhibitor. These events are more likely to occur in patients treated concomitantly with a diuretic. The possibility of similar effects cannot be excluded with angiotensin II receptor antagonists. When eprosartan is to be used in patients with renal impairment, renal function should be assessed before starting treatment with eprosartan and at intervals during the course of therapy. If worsening of renal function is observed during therapy, treatment with eprosartan should be reassessed.

Hypotension

Symptomatic hypotension may occur in patients with severe sodium depletion and/or volume depletion (e.g. high dose diuretic therapy). These conditions should be corrected before commencing therapy. There is an increased risk of severe hypotension when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medical products that affect the renin-angiotensin-aldosterone system.

Aortic and mitral valve stenosis or obstructive hypertrophic cardiomyopathy.

As with other vasodilators, special caution is indicated in patients suffering from haemodynamically relevant aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.

Primary hyperaldosteronism

Patients with primary hyperaldosteronism will not generally respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin-aldosterone system. Therefore, the use of Teveten is not recommended.

Hyperkalaemia

Although eprosartan has no significant effect on serum potassium there is no experience of concomitant administration with K-sparing diuretics or K-supplements. Consequently, as with other angiotensin II antagonists, the risk of hyperkalaemia when taken with K-sparing diuretics or K-supplements cannot be excluded. Regular monitoring for serum potassium levels is recommended when drugs that may increase potassium are administered with eprosartan in patients with renal impairment.

Pregnancy

Eprosartan should not be initiated during pregnancy. Unless continued Eprosartan therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with Eprosartan should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).

Other conditions

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant drug interactions have been observed. No effect on the pharmacokinetics of digoxin and the pharmacodynamics of warfarin or glyburide (glibenclamide) has been shown with eprosartan. Similarly no effect on eprosartan pharmacokinetics has been shown with ranitidine, ketoconazole or fluconazole.

Eprosartan has been safely used concomitantly with thiazide diuretics (e.g. hydrochlorothiazide) and calcium channel blockers (e.g. sustained-release nifedipine) without evidence of clinically significant adverse interactions. It has been safely co-administered with hypolipidaemic agents (e.g. lovastatin, simvastatin, pravastatin, fenofibrate, gemfibrozil, niacin).

Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors. The possibility of a similar effect can not be excluded and careful monitoring of serum lithium levels is recommended during concomitant use.

Eprosartan has been shown not to inhibit human cytochrome P450 enzymes CYP1A, 2A6, 2C9/8, 2C19, 2D6, 2E and 3A in vitro.

Combination with NSAIDs: When Angiotensin II antagonists are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.

As with ACE inhibitors, concomitant use of Angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function. The combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.

4.6 Pregnancy And Lactation

Pregnancy

The use of Eprosartan is not recommended during the first trimester of pregnancy (see section 4.4). The use of Eprosartan is contraindicated during second and third trimester of pregnancy (see sections 4.3 and 4.4).

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor blockers, similar risks may exist for this class of drugs. Unless continued Eprosartan therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with Eprosartan should be stopped immediately and, if appropriate, alternative therapy should be started.

Exposure to Eprosartan therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).

Should exposure to Eprosartan have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.

Infants whose mothers have taken Eprosartan should be closely observed for hypotension (see sections 4.3 and 4.4).

Lactation

Because no information is available regarding the use of Eprosartan during breast-feeding, Eprosartan is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

4.7 Effects On Ability To Drive And Use Machines

The effect of eprosartan on the ability to drive and use machines has not been studied, but based on its pharmacodynamic properties, eprosartan is unlikely to affect this ability. When driving vehicles or operating machines, it should be taken into account, that occasionally dizziness or weariness may occur during treatment of hypertension.

4.8 Undesirable Effects

Clinical Trials

The most commonly reported adverse drug reactions of patients treated with eprosartan are headache and unspecific gastrointestinal complaints, occurring in approximately 11% and 8%, respectively, of patients.

ADVERSE EVENTS REPORTED DURING CLINICAL TRIALS IN PATIENTS TREATED WITH EPROSARTAN (n = 2316)

MedDRA system organ class	Very common	Common	Uncommon
Immune system disorders			Hypersensitivity
Nervous system disorders	Headache	Dizziness
Vascular disorders			Hypotension
Respiratory, thoracic and mediastinal disorders		Rhinitis
Gastrointestinal disorders		Flatulence and unspecific gastrointestinal complaints (e.g., nausea, diarrhoea, vomiting)
Skin and subcutaneous tissue disorders		Allergic skin reactions (e.g. rash, pruritus)	Angioedema
Musculoskeletal and connective tissue disorders		Arthralgia
General disorders and administration site reactions		Asthenia

Postmarketing experience

In addition to those adverse events reported during clinical trials, the following side effects have been reported spontaneously during postmarketing use of eprosartan. A frequency cannot be estimated from the available data (not known).

Renal and urinary disorders

Impaired renal function including renal failure in patients at risk.

Laboratory Findings

In placebo-controlled clinical studies, significantly elevated serum potassium concentrations were observed in 0.9% of patients treated with eprosartan and 0.3% of patients who received placebo.

Significantly low values of haemoglobin were observed in 0.1% and 0% patients treated with eprosartan and placebo respectively.

In rare cases elevations of BUN values were reported in patients treated with eprosartan. In rare cases increases in liver function values were also observed but were not considered to be causally related to eprosartan treatment.

4.9 Overdose

Limited data are available with regard to overdosage in humans. Eprosartan was well tolerated after oral dosing (maximum unit dose taken to date in humans 1200 mg) with no mortality in rats and mice up to 3000 mg/kg and in dogs up to 1000 mg/kg. The most likely manifestation of overdosage would be hypotension. If symptomatic hypotension occurs, supportive treatment should be instituted.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Eprosartan is a potent, synthetic, orally active non-biphenyl non-tetrazole angiotensin II receptor antagonist, which binds selectively to the AT₁ receptor. Angiotensin II is a potent vasoconstrictor and the primary active hormone of the renin-angiotensin-aldosterone system, playing a major part in the pathophysiology of hypertension. Angiotensin II binds to the AT₁ receptor in many tissues (e.g. smooth vascular musculature, suprarenals, kidney, heart) and produces important biological effects such as vasoconstriction, sodium retention and release of aldosterone. More recently, angiotensin II has been implicated in the genesis of cardiac and vascular hypertrophy through its effect on cardiac and smooth muscle cell growth.

Eprosartan antagonised the effect of angiotensin II on blood pressure, renal blood flow and aldosterone secretion in normal volunteers. In hypertensive patients, comparable blood pressure control is achieved when eprosartan is administered as a single dose or in two divided doses. In placebo-controlled studies, in 299 patients treated receiving 600-800 mg once daily, there was no evidence of first dose postural hypotension. Discontinuation of treatment with eprosartan does not lead to a rapid rebound increase in blood pressure.

Eprosartan was evaluated in mild to moderate hypertensive patients (sitting DBP

A dose of 1200 mg once daily, for 8 weeks, has been shown in 72 patients in clinical trials to be effective. In placebo-controlled studies using doses up to 1200 mg once daily, there is no apparent dose relationship in the incidence of adverse experiences reported.

In patients with hypertension, blood pressure reduction did not produce a change in heart rate.

In hypertensive patients eprosartan does not affect fasting triglycerides, total cholesterol, or LDL (low density lipoprotein) cholesterol levels. In addition, eprosartan has no effect on fasting blood sugar levels.

Eprosartan does not compromise renal autoregulatory mechanisms. In normal adult males eprosartan has been shown to increase mean effective renal plasma flow. Effective renal plasma flow is not altered in patients with essential hypertension and patients with renal insufficiency treated with eprosartan. Eprosartan does not reduce glomerular filtration rate in normal males, in patients with hypertension or in patients with varying degrees of renal insufficiency. Eprosartan has a natriuretic effect in normal subjects on a salt restricted diet.

Eprosartan does not significantly affect the excretion of urinary uric acid.

Eprosartan does not potentiate effects relating to bradykinin (ACE-mediated), e.g. cough. In a study specifically designed to compare the incidence of cough in patients treated with eprosartan and an angiotensin converting enzyme inhibitor, the incidence of dry persistent cough in patients treated with eprosartan (1.5%) was significantly lower (p<0.05) than that observed in patients treated with an angiotensin converting enzyme inhibitor (5.4%). In a further study investigating the incidence of cough in patients who had previously coughed while taking an angiotensin converting enzyme inhibitor, the incidence of dry, persistent cough was 2.6% on eprosartan, 2.7% on placebo, and 25.0% on an angiotensin converting enzyme inhibitor (p<0.01, eprosartan versus angiotensin converting enzyme inhibitor).

5.2 Pharmacokinetic Properties

Absolute bioavailability following a single 300 mg oral dose of eprosartan is about 13%, due to limited oral absorption. Eprosartan plasma concentrations peak at one to two hours after an oral dose in the fasted state. Plasma concentrations are dose proportional from 100 to 200 mg, but less than proportional for 400 and 800 mg doses. The terminal elimination half-life of eprosartan following oral administration is typically five to nine hours. A slight accumulation (14%) is seen with chronic use of eprosartan. Administration of eprosartan with food delays absorption with minor increases (<25%) observed in C_max and AUC.

Plasma protein binding of eprosartan is high (approximately 98%) and constant over the concentration range achieved with therapeutic doses. The extent of plasma protein binding is not influenced by gender, age, hepatic dysfunction or mild-moderate renal impairment but has shown to be decreased in a small number of patients with severe renal impairment.

Following oral and intravenous dosing with [¹⁴C] eprosartan in human subjects, eprosartan was the only drug-related compound found in the plasma and faeces. In the urine, approximately 20% of the radioactivity excreted was an acyl glucuronide of eprosartan with the remaining 80% being unchanged eprosartan.

The volume of distribution of eprosartan is about 13 litres. Total plasma clearance is about 130 ml/min. Biliary and renal excretion contribute to the elimination of eprosartan. Following intravenous [¹⁴C] eprosartan, about 61% of radioactivity is recovered in the faeces and about 37% in the urine. Following an oral dose of [¹⁴C] eprosartan, about 90% of radioactivity is recovered in the faeces and about 7% in the urine.

Both AUC and C_max values of eprosartan are increased in the elderly (on average, approximately two-fold).

Following administration of a single 100 mg dose of eprosartan, AUC values of eprosartan (but not C_max) are increased, on average, by approximately 40% in patients with hepatic impairment. Since an intravenous dose of eprosartan was not administered to patients with hepatic impairment, the plasma clearance of eprosartan could not be measured.

Compared to subjects with normal renal function (n=7), mean AUC and C_max values were approximately 30% higher in patients with creatinine clearance 30-59 ml/min (n=11) and approximately 50% higher in patients with creatinine clearance 5-29 ml/min (n=3).

In a separate investigation, mean AUC was approximately 60% higher in patients undergoing dialysis (n=9) compared to subjects with normal renal function (n=10).

There is no difference in the pharmacokinetics of eprosartan between males and females.

5.3 Preclinical Safety Data

General toxicology

Eprosartan given orally at dosages up to 1000 mg/kg per day for up to six months in rats and up to one year in dogs did not result in any significant drug-related toxicity.

Reprotoxicity

In pregnant rabbits, eprosartan has been shown to produce maternal and foetal mortality at 10 mg/kg per day during late pregnancy only. This is most likely due to effects on the renin angiotensin aldosterone system. Maternal toxicity but no foetal effects were observed at 3 mg/kg per day.

Genotoxicity

Genotoxicity was not observed in a battery of in vitro and in vivo tests.

Carcinogenicity

Carcinogenicity was not observed in rats and mice given up to 600 or 2000 mg/kg per day respectively for two years.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet cores

Lactose

Microcrystalline cellulose

Pregelatinised starch

Magnesium stearate

Crospovidone

Film-coat

Hypromellose

Titanium dioxide (E171)

Macrogol 400

Polysorbate 80

6.2 Incompatibilities

None known.

6.3 Shelf Life

PVC/Aclar blister packs:	36 months
HDPE bottles:	36 months

6.4 Special Precautions For Storage

Do not store above 25°C.

Keep container in the outer carton.

6.5 Nature And Contents Of Container

Opaque PVC/Aclar blister packs containing 28 tablets or 56 tablets.

HDPE bottles containing 100 tablets.

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

Abbott Healthcare Products Limited

Mansbridge Road

West End

Southampton

SO18 3JD

8. Marketing Authorisation Number(S)

PL 00512/0165

9. Date Of First Authorisation/Renewal Of The Authorisation

29 November 1999/17 April 2003

10. Date Of Revision Of The Text

09/09/2011

LEGAL CATEGORY

POM

Tuesday, 10 April 2012

norfloxacin ophthalmic

Generic Name: norfloxacin ophthalmic (nor FLOX a sin off THAL mik)

Brand Names: Chibroxin

What is norfloxacin ophthalmic?

Norfloxacin ophthalmic is an antibiotic.

Norfloxacin ophthalmic is used to treat bacterial infections of the eyes.

Norfloxacin ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about norfloxacin ophthalmic?

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear ducts.

If you wear contact lenses, ask your doctor if you should wear them during treatment. Norfloxacin ophthalmic can cause the development of crystals on contact lenses. After applying this medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.

Who should not use norfloxacin ophthalmic?

Do not use norfloxacin ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only. It is not known whether norfloxacin ophthalmic will harm an unborn baby. Do not use norfloxacin ophthalmic without first talking to your doctor if you are pregnant. It is also not known whether norfloxacin ophthalmic passes into breast milk. Do not use norfloxacin ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use norfloxacin ophthalmic?

Use norfloxacin ophthalmic eye drops exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using the eye drops.

To apply the eye drops:

Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

If you are using norfloxacin ophthalmic to treat a corneal ulcer, you may notice a whitish buildup on the ulcer. This means that the medication is working; it is not a harmful development.

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eye drop that is discolored or has particles in it. Store norfloxacin ophthalmic at room temperature away from moisture and heat. Keep the bottle properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using norfloxacin ophthalmic?

Use caution when driving, operating machinery, or performing other hazardous activities. Norfloxacin ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Do not use other eye drops or medications during treatment with norfloxacin ophthalmic unless otherwise directed by your doctor.

Norfloxacin ophthalmic side effects

Serious side effects are not expected with this medication.

If you are using norfloxacin ophthalmic to treat a corneal ulcer, you may notice a whitish buildup on the ulcer. This means that the medication is working; it is not a harmful development.

Commonly, some eye burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling or crusting, a bad taste in your mouth, tearing, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Norfloxacin ophthalmic Dosing Information

Usual Adult Dose for Conjunctivitis:

Instill 1 or 2 drops to the affected eye(s) 4 times daily for up to 7 days. For severe infections, instill 1 or 2 drops to the affected eye(s) every 2 hours while awake on the first day.

Usual Pediatric Dose for Conjunctivitis:

1 year to 18 years: Instill 1 or 2 drops to the affected eye(s) 4 times daily for up to 7 days. For severe infections, instill 1 or 2 drops to the affected eye(s) every 2 hours while awake on the first day.

What other drugs will affect norfloxacin ophthalmic?

Do not use other eye drops or medications during treatment with norfloxacin ophthalmic unless otherwise directed by your doctor.

Drugs other than those listed here may also interact with norfloxacin ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More norfloxacin ophthalmic resources

Norfloxacin ophthalmic Dosage
Norfloxacin ophthalmic Use in Pregnancy & Breastfeeding
Norfloxacin ophthalmic Support Group
0 Reviews for Norfloxacin - Add your own review/rating

Compare norfloxacin ophthalmic with other medications

Conjunctivitis
Ophthalmic Surgery

Where can I get more information?

Your pharmacist has additional information about norfloxacin ophthalmic written for health professionals that you may read.

Coversyl Arginine Plus

1. Name Of The Medicinal Product

COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablets

2. Qualitative And Quantitative Composition

One film-coated tablet contains 3.395 mg perindopril corresponding to 5 mg perindopril arginine and 1.25 mg indapamide.

Excipient : 71.33 mg lactose monohydrate

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

White, rod-shaped film-coated tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of essential hypertension, COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablet is indicated in patients whose blood pressure is not adequately controlled on perindopril alone.

4.2 Posology And Method Of Administration

Oral route

One COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablet per day as a single dose, preferably to be taken in the morning, and before a meal.

When possible individual dose titration with the components is recommended. COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablet should be used when blood pressure is not adequately controlled on COVERSYL ARGININE PLUS 2.5mg/0.625mg film-coated tablet (where available). When clinically appropriate, direct change from monotherapy to COVERSYL ARGININE PLUS 5mg/1.25mg film-coated tablet may be considered.

Elderly (see section 4.4)

Treatment should be initiated after considering blood pressure response and renal function.

Patients with renal impairment (see section 4.4)

In severe renal impairment (creatinine clearance below 30 ml/min), treatment is contra-indicated.

In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), it is recommended to start treatment with the adequate dosage of the free combination.

In patients with creatinine clearance greater than or equal to 60 ml/min, no dose modification is required. Usual medical follow-up will include frequent monitoring of creatinine and potassium.

Patients with hepatic impairment (see sections 4.3, 4.4 and 5.2)

In severe hepatic impairment, treatment is contra-indicated.

In patients with moderate hepatic impairment, no dose modification is required.

Children and adolescents

COVERSYL ARGININE PLUS 5mg/1.25mg should not be used in children and adolescents as the efficacy and tolerability of perindopril in children and adolescents, alone or in combination, have not been established.

4.3 Contraindications

Linked to perindopril:

-	Hypersensitivity to perindopril or any other ACE inhibitor
-	History of angioedema (Quincke's oedema) associated with previous ACE inhibitor therapy
-	Hereditary/idiopathic angioedema
-	Second and third trimesters of pregnancy (see sections 4.4 and 4.6)

Linked to indapamide:

-	Hypersensitivity to indapamide or to any other sulphonamides
-	Severe renal impairment (creatinine clearance below 30 ml/min)
-	Hepatic encephalopathy
-	Severe hepatic impairment
-	Hypokalaemia
-	As a general rule, this medicine is inadvisable in combination with non antiarrhythmic agents causing torsades de pointes (see section 4.5)
-	Lactation (see section 4.6).

Linked to COVERSYL ARGININE PLUS 5mg/1.25mg:

-	Hypersensitivity to any of the excipients

Due to the lack of sufficient therapeutic experience, COVERSYL ARGININE PLUS 5mg/1.25mg should not be used in:

-	Dialysis patients
-	Patients with untreated decompensated heart failure.

4.4 Special Warnings And Precautions For Use

Special warnings

Common to perindopril and indapamide:

Lithium:

The combination of lithium and the combination of perindopril and indapamide is usually not recommended (see section 4.5).

Linked to perindopril:

Neutropenia/agranulocytosis:

Neutropenia/agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors. In patients with normal renal function and no other complicating factors, neutropenia occurs rarely. Perindopril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function. Some of these patients developed serious infections which in a few instances did not respond to intensive antibiotic therapy. If perindopril is used in such patients, periodical monitoring of white blood cell counts is advised and patients should be instructed to report any sign of infection (e.g. sore throat, fever).

Hypersensitivity/angioedema:

Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported rarely in patients treated with angiotensin converting enzyme inhibitors, including perindopril. This may occur at any time during treatment. In such cases perindopril should be discontinued promptly and appropriate monitoring should be instituted to ensure complete resolution of symptoms prior to dismissing the patient. In those instances where swelling has been confined to the face and lips the condition generally resolved without treatment, although antihistamines have been useful in relieving symptoms.

Angioedema associated with laryngeal oedema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, which may include subcutaneous epinephrine solution 1:1000 (0.3 ml to 0.5 ml) and/or measures to ensure a patent airway, should be administered promptly.

Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks.

Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor (see section 4.3).

Intestinal angioedema has been reported rarely in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan, or ultrasound or at surgery and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.

Anaphylactoid reactions during desensitisation:

There have been isolated reports of patients experiencing sustained, life-threatening anaphylactoid reactions while receiving ACE inhibitors during desensitisation treatment with hymenoptera (bees, wasps) venom. ACE inhibitors should be used with caution in allergic patients treated with desensitisation, and avoided in those undergoing venom immunotherapy. However these reactions could be prevented by temporary withdrawal of ACE inhibitor for at least 24 hours before treatment in patients who require both ACE inhibitors and desensitisation.

Anaphylactoid reactions during LDL apheresis:

Rarely, patients receiving ACE inhibitors during low density lipoprotein (LDL)-apheresis with dextran sulphate have experienced life-threatening anaphylactoid reactions. These reactions were avoided by temporarily withholding ACE-inhibitor therapy prior to each apheresis.

Haemodialysis patients:

Anaphylactoid reactions have been reported in patients dialysed with high-flux membranes (e.g., AN 69®) and treated concomitantly with an ACE inhibitor. In these patients consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.

Potassium-sparing diuretics, potassium salts:

The combination of perindopril and potassium-sparing diuretics, potassium salts is usually not recommended (see section 4.5).

Pregnancy and lactation:

ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).

Use of perindopril is not recommended during breast-feeding.

Linked to indapamide:

When liver function is impaired, thiazide diuretics and thiazide-related diuretics may cause hepatic encephalopathy. Administration of the diuretic should be stopped immediately if this occurs.

Photosensitivity:

Cases of photosensitivity reactions have been reported with thiazides and related thiazides diuretics (see section 4.8). If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment. If a re-administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.

Precautions for use

Common to perindopril and indapamide:

Renal impairment:

In cases of severe renal impairment (creatinine clearance < 30 ml/min), treatment is contra-indicated.

In certain hypertensive patients without pre-existing apparent renal lesions and for whom renal blood tests show functional renal insufficiency, treatment should be stopped and possibly restarted either at a low dose or with one constituent only.

In these patients usual medical follow-up will include frequent monitoring of potassium and creatinine, after two weeks of treatment and then every two months during therapeutic stability period. Renal failure has been reported mainly in patients with severe heart failure or underlying renal failure including renal artery stenosis.

The drug is usually not recommended in case of bilateral renal artery stenosis or a single functioning kidney.

Hypotension and water and electrolyte depletion:

There is a risk of sudden hypotension in the presence of pre-existing sodium depletion (in particular in individuals with renal artery stenosis). Therefore systematic testing should be carried out for clinical signs of water and electrolyte depletion, which may occur with an inter-current episode of diarrhoea or vomiting. Regular monitoring of plasma electrolytes should be carried out in such patients.

Marked hypotension may require the implementation of an intravenous infusion of isotonic saline.

Transient hypotension is not a contra-indication to continuation of treatment. After re-establishment of a satisfactory blood volume and blood pressure, treatment can be started again either at a reduced dose or with only one of the constituents.

Potassium levels:

The combination of perindopril and indapamide does not prevent the onset of hypokalaemia particularly in diabetic patients or in patients with renal failure. As with any antihypertensive agent containing a diuretic, regular monitoring of plasma potassium levels should be carried out.

Excipients:

COVERSYL ARGININE PLUS 5mg/1.25mg should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Linked to perindopril:

Cough:

A dry cough has been reported with the use of angiotensin converting enzyme inhibitors. It is characterised by its persistence and by its disappearance when treatment is withdrawn. An iatrogenic aetiology should be considered in the event of this symptom. If the prescription of an angiotensin converting enzyme inhibitor is still preferred, continuation of treatment may be considered.

Children and adolescents:

The efficacy and tolerability of perindopril in children and adolescents, alone or in combination, have not been established.

Risk of arterial hypotension and/or renal insufficiency (in cases of cardiac insufficiency, water and electrolyte depletion, etc...):

Marked stimulation of the renin-angiotensin-aldosterone system has been observed particularly during marked water and electrolyte depletions (strict sodium-free diet or prolonged diuretic treatment), in patients whose blood pressure was initially low, in cases of renal artery stenosis, congestive heart failure or cirrhosis with oedema and ascites.

The blocking of this system with an angiotensin converting enzyme inhibitor may therefore cause, particularly at the time of the first administration and during the first two weeks of treatment, a sudden drop in blood pressure and/or an increase in plasma levels of creatinine, showing a functional renal insufficiency. Occasionally this can be acute in onset, although rare, and with a variable time to onset.

In such cases, the treatment should then be initiated at a lower dose and increased progressively.

Elderly:

Renal function and potassium levels should be tested before the start of treatment. The initial dose is subsequently adjusted according to blood pressure response, especially in cases of water and electrolyte depletion, in order to avoid sudden onset of hypotension.

Patients with known atherosclerosis:

The risk of hypotension exists in all patients but particular care should be taken in patients with ischaemic heart disease or cerebral circulatory insufficiency, with treatment being started at a low dose.

Renovascular hypertension:

The treatment for renovascular hypertension is revascularisation. Nonetheless, angiotensin converting enzyme inhibitors can be beneficial in patients presenting with renovascular hypertension who are awaiting corrective surgery or when such a surgery is not possible.

If COVERSYL ARGININE PLUS 5mg/1.25mg is prescribed to patients with known or suspected renal artery stenosis, treatment should be started in a hospital setting at a low dose and renal function and potassium levels should be monitored, since some patients have developed a functional renal insufficiency which was reversed when treatment was stopped.

Other populations at risk:

In patients with severe cardiac insufficiency (grade IV) or in patients with insulin dependent diabetes mellitus (spontaneous tendency to increased levels of potassium), treatment should be started under medical supervision with a reduced initial dose. Treatment with beta-blockers in hypertensive patients with coronary insufficiency should not be stopped: the ACE inhibitor should be added to the beta-blocker.

Diabetic patients:

The glycaemia levels should be closely monitored in diabetic patients previously treated with oral antidiabetic drugs or insulin, namely during the first month of treatment with an ACE inhibitor.

Ethnic differences:

As with other angiotensin converting enzyme inhibitors, perindopril is apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of a higher prevalence of low-renin states in the black hypertensive population.

Surgery / anaesthesia:

Angiotensin converting enzyme inhibitors can cause hypotension in cases of anaesthesia, especially when the anaesthetic administered is an agent with hypotensive potential.

It is therefore recommended that treatment with long-acting angiotensin converting enzyme inhibitors such as perindopril should be discontinued where possible one day before surgery.

Aortic or mitral valve stenosis / hypertrophic cardiomyopathy:

ACE inhibitors should be used with caution in patients with an obstruction in the outflow tract of the left ventricle.

Hepatic failure:

Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up (see section 4.8).

Hyperkalaemia:

Elevations in serum potassium have been observed in some patients treated with ACE inhibitors, including perindopril. Risk factors for the development of hyperkalaemia include those with renal insufficiency, worsening of renal function, age (> 70 years), diabetes mellitus, inter-current events, in particular dehydration, acute cardiac decompensation, metabolic acidosis and concomitant use of potassium-sparing diuretics (e.g., spironolactone, eplerenone, triamterene, or amiloride), potassium supplements or potassium-containing salt substitutes; or those patients taking other drugs associated with increases in serum potassium (e.g. heparin). The use of potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes particularly in patients with impaired renal function may lead to a significant increase in serum potassium. Hyperkalaemia can cause serious, sometimes fatal arrhythmias. If concomitant use of the above-mentioned agents is deemed appropriate, they should be used with caution and with frequent monitoring of serum potassium (see section 4.5).

Linked to indapamide:

Water and electrolyte balance:

Sodium levels:

These should be tested before treatment is started, then at regular intervals. All diuretic treatment can cause a reduction in sodium levels, which may have serious consequences. Reduction in sodium levels can be initially asymptomatic and regular testing is therefore essential. Testing should be more frequent in elderly and cirrhotic patients (see sections 4.8 and 4.9).

Potassium levels:

Potassium depletion with hypokalaemia is a major risk with thiazide diuretics and thiazide-related diuretics. The risk of onset of lowered potassium levels (< 3.4 mmol/l) should be prevented in some high risk populations such as elderly and/or malnourished subjects, whether or not they are taking multiple medications, cirrhotic patients with oedema and ascites, coronary patients and patients with heart failure.

In such cases hypokalaemia increases the cardiac toxicity of cardiac glycosides and the risk of rhythm disorders.

Subjects presenting with a long QT interval are also at risk, whether the origin is congenital or iatrogenic. Hypokalaemia, as with bradycardia, acts as a factor which favours the onset of severe rhythm disorders, in particular torsades de pointes, which may be fatal.

In all cases more frequent testing of potassium levels is necessary. The first measurement of plasma potassium levels should be carried out during the first week following the start of treatment.

If low potassium levels are detected, correction is required.

Calcium levels:

Thiazide diuretics and thiazide-related diuretics may reduce urinary excretion of calcium and cause a mild and transient increase in plasma calcium levels. Markedly raised levels of calcium may be related to undiagnosed hyperparathyroidism. In such cases the treatment should be stopped before investigating the parathyroid function.

Blood glucose:

Monitoring of blood glucose is important in diabetic patients, particularly when potassium levels are low.

Uric acid:

Tendency to gout attacks may be increased in hyperuricaemic patients.

Renal function and diuretics:

Thiazide diuretics and thiazide-related diuretics are only fully effective when renal function is normal or only slightly impaired (creatinine levels lower than approximately 25 mg/l, i.e. 220 µmol/l for an adult).

In the elderly the value of plasma creatinine levels should be adjusted to take account of the age, weight and sex of the patient, according to the Cockroft formula:

cl_cr = (140 - age) x body weight / 0.814 x plasma creatinine level

with:

age expressed in years

body weight in kg

plasma creatinine level in micromol/l

This formula is suitable for an elderly male and should be adapted for women by multiplying the result by 0.85.

Hypovolaemia, resulting from the loss of water and sodium caused by the diuretic at the start of treatment, causes a reduction in glomerular filtration. It may result in an increase in blood urea and creatinine levels. This transitory functional renal insufficiency is of no adverse consequence in patients with normal renal function but may however worsen a pre-existing renal impairment.

Athletes:

Athletes should note that this product contains an active substance which may cause a positive reaction in doping tests.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Common to perindopril and indapamide:

Concomitant use not recommended:

Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors. Concomitant use of thiazide diuretics may further increase lithium levels and enhance the risk of lithium toxicity with ACE inhibitors. Use of perindopril combined with indapamide with lithium is not recommended, but if the combination proves necessary, careful monitoring of serum lithium levels should be performed (see section 4.4).

Concomitant use which requires special care:

- Baclofen: Potentiation of antihypertensive effect. Monitoring of blood pressure and renal function, and dose adaptation of the antihypertensive if necessary.

- Non-steroidal anti-inflammatory medicinal products (included acetylsalicylic acid at high doses): when ACE-inhibitors are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. Concomitant use of ACE-inhibitors and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function. The combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.

Concomitant use which requires some care:

- Imipramine-like antidepressants (tricyclics), neuroleptics: Increased antihypertensive effect and increased risk of orthostatic hypotension (additive effect).

- Corticosteroids, tetracosactide: Reduction in antihypertensive effect (salt and water retention due to corticosteroids).

- other antihypertensive agents: use of other antihypertensive medicinal products with perindopril/indapamide could result in additional blood pressure lowering effect.

Linked to perindopril:

Concomitant use not recommended:

- Potassium-sparing diuretics (spironolactone, triamterene, alone or in combination), potassium (salts): ACE inhibitors attenuate diuretic induced potassium loss. Potassium sparing diuretics e.g. spironolactone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium (potentially lethal). If concomitant use is indicated because of documented hypokalaemia they should be used with caution and with frequent monitoring of serum potassium and by ECG.

Concomitant use which requires special care:

- Antidiabetic agents (insulin, hypoglycaemic sulphonamides): Reported with captopril and enalapril.

The use of angiotensin converting enzyme inhibitors may increase the hypoglycaemic effect in diabetics receiving treatment with insulin or with hypoglycaemic sulphonamides. The onset of hypoglycaemic episodes is very rare (improvement in glucose tolerance with a resulting reduction in insulin requirements).

Concomitant use which requires some care:

- Allopurinol, cytostatic or immunosuppressive agents, systemic corticosteroids or procainamide: Concomitant administration with ACE inhibitors may lead to an increased risk for leucopenia.

- Anaesthetic drugs: ACE inhibitors may enhance the hypotensive effects of certain anaesthetic drugs.

- Diuretics (thiazide or loop diuretics): Prior treatment with high dose diuretics may result in volume depletion and in a risk of hypotension when initiating therapy with perindopril.

- Gold: Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including perindopril.

Linked to indapamide:

Concomitant use which requires special care:

- Torsades de pointes inducing drugs: Due to the risk of hypokalaemia, indapamide should be administered with caution when associated with medicinal products that induced torsades de pointes such as class IA antiarrhythmic agents (quinidine, hydroquinidine, disopyramide); class III antiarrhythmic agents (amiodarone, dofetilide, ibutilide, bretylium, sotalol); some neuroleptics (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (amisulpride, sulpiride, sultopride, tiapride), butyrophenones (droperidol, haloperidol), other neuroleptics (pimozide); other substances such as bepridil, cisapride, diphemanil, IV erythromycin, halofantrine, mizolastine, moxifloxacin, pentamidine, sparfloxacin, IV vincamine, methadone, astemizole, terfenadine. Prevention of low potassium levels and correction if necessary: monitoring of the QT interval.

- Potassium-lowering drugs: amphotericin B (IV route), glucocorticoids and mineralocorticoids (systemic route), tetracosactide, stimulant laxatives: Increased risk of low potassium levels (additive effect). Monitoring of potassium levels, and correction if necessary; particular consideration required in cases of treatment with cardiac glycosides. Non stimulant laxatives should be used.

- Cardiac glycosides: Low potassium levels favour the toxic effects of cardiac glycosides. Potassium levels and ECG should be monitored and treatment reconsidered if necessary.

Concomitant use which requires some care:

- Metformin: Lactic acidosis due to metformin caused by possible functional renal insufficiency linked to diuretics and in particular to loop diuretics. Do not use metformin when plasma creatinine levels exceed 15 mg/l (135 micromol/l) in men and 12 mg/l (110 micromol/l) in women.

- Iodinated contrast media: In cases of dehydration caused by diuretics, there is an increased risk of acute renal insufficiency, particularly when high doses of iodinated contrast media are used. Rehydration should be carried out before the iodinated compound is administered.

- Calcium (salts): Risk of increased levels of calcium due to reduced elimination of calcium in the urine.

- Ciclosporin: Risk of increased creatinine levels with no change in circulating levels of ciclosporin, even when there is no salt and water depletion.

4.6 Pregnancy And Lactation

Pregnancy:

Linked to perindopril:

The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see section 4.4). The use of ACE inhibitors is contra-indicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.

Exposure to ACE inhibitor therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).

Should exposure to ACE inhibitors have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.

Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension (see sections 4.3 and 4.4).

Linked to indapamide:

Prolonged exposure to thiazide during the third trimester of pregnancy can reduce maternal plasma volume as well as uteroplacental blood flow, which may cause a foeto-placental ischaemia and growth retardation. Moreover, rare cases of hypoglycaemia and thrombocytopenia in neonates have been reported following exposure near term.

Lactation:

COVERSYL ARGININE PLUS 5mg/1.25mg is contra-indicated during lactation.

Use of perindopril is not recommended during breast-feeding.

Indapamide is excreted in human milk. Indapamide is closely related to thiazide diuretics which have been associated, during breast-feeding, with decrease or even suppression of milk lactation. Hypersensitivity to suphonamide-derived drugs, hypokalaemia and nuclear icterus might occur.

As, with both drugs, serious adverse reactions might occur in nursing infants, a decision should be made whether to discontinue nursing or to discontinue therapy taking account the importance of this therapy for the mother.

4.7 Effects On Ability To Drive And Use Machines

Linked to perindopril, indapamide and COVERSYL ARGININE PLUS 5mg/1.25mg:

Neither the two active substances nor COVERSYL ARGININE PLUS 5mg/1.25mg affect alertness but individual reactions related to low blood pressure may occur in some patients, particularly at the start of treatment or in combination with another antihypertensive medication.

As a result the ability to drive or operate machinery may be impaired.

4.8 Undesirable Effects

The administration of perindopril inhibits the renin-angiotensin-aldosterone axis and tends to reduce the potassium loss caused by indapamide. Four percent of the patients on treatment with COVERSYL ARGININE PLUS 5mg/1.25mg experience hypokalaemia (potassium level < 3.4 mmol/l).

The following undesirable effects could be observed during treatment and ranked under the following frequency:

Very common (

Blood and the lymphatic system disorders:

Very rare:

- Thrombocytopenia, leucopenia/neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia.

- Anaemia (see section 4.4) has been reported with angiotensin converting enzyme inhibitors in specific circumstances (patients who have had kidney transplants, patients undergoing haemodialysis).

Psychiatric disorders:

Uncommon: mood or sleep disturbances.

Nervous system disorders:

Common: Paraesthesia, headache, asthenia, feelings of dizziness, vertigo.

Very rare: Confusion.

Eye disorders:

Common: Vision disturbance.

Ear and labyrinth disorders:

Common: Tinnitus.

Vascular disorders:

Common: Hypotension whether orthostatic or not (see section 4.4).

Cardiac disorders:

Very rare: Arrhythmia including bradycardia, ventricular tachycardia, atrial fibrillation, angina pectoris and myocardial infarction possibly secondary to excessive hypotension in high-risk patients (see section 4.4).

Respiratory, thoracic and mediastinal disorders:

Common:

- A dry cough has been reported with the use of angiotensin converting enzyme inhibitors. It is characterised by its persistence and by its disappearance when treatment is withdrawn. An iatrogenic aetiology should be considered in the presence of this symptom. Dyspnoea.

Uncommon: Bronchospasm.

Very rare: Eosinophilic pneumonia, rhinitis.

Gastrointestinal disorders:

Common: Constipation, dry mouth, nausea, epigastric pain, anorexia, vomiting, abdominal pain, taste disturbance, dyspepsia, diarrhoea.

Very rare: Pancreatitis.

Hepato-biliary disorders:

Very rare: Hepatitis either cytolytic or cholestatic (see section 4.4).

Not known: In case of hepatic insufficiency, there is a possibility of onset of hepatic encephalopathy (see sections 4.3 and 4.4).

Skin and subcutaneous tissue disorders:

Common: Rash, pruritus, maculopapular eruptions.

Uncommon:

- Angioedema of face, extremities, lips, mucous membranes, tongue, glottis and/or larynx, urticaria (see section 4.4).

- Hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions.

- Purpura.

Possible aggravation of pre-existing acute disseminated lupus erythematosus.

Very rare: erythema multiforme, toxic epidermal necrolysis, Stevens Johnson syndrome.

Cases of photosensitivity reactions have been reported (see section 4.4).

Musculoskeletal, connective tissue and bone disorders:

Common: Cramps.

Renal and urinary disorders:

Uncommon: Renal insufficiency.

Very rare: Acute renal failure.

Reproductive system and breast disorders:

Uncommon: Impotence.

General disorders and administration site conditions:

Common: Asthenia.

Uncommon: Sweating.

Investigations:

- Potassium depletion with particularly serious reduction in levels of potassium in some at risk populations (see section 4.4).

- Reduced sodium levels with hypovolaemia causing dehydration and orthostatic hypotension.

- Increase in uric acid levels and in blood glucose levels during treatment.

- Slight increase in urea and in plasma creatinine levels, reversible when treatment is stopped. This increase is more frequent in cases of renal artery stenosis, arterial hypertension treated with diuretics, renal insufficiency.

- Increased levels of potassium, usually transitory.

Rare: Raised plasma calcium levels.

4.9 Overdose

The most likely adverse reaction in cases of overdose is hypotension, sometimes associated with nausea, vomiting, cramps, dizziness, sleepiness, mental confusion, oliguria which may progress to anuria (due to hypovolaemia). Salt and water disturbances (low sodium levels, low potassium levels) may occur.

The first measures to be taken consist of rapidly eliminating the product(s) ingested by gastric lavage and/or administration of activated charcoal, then restoring fluid and electrolyte balance in a specialised centre until they return to normal.

If marked hypotension occurs, this can be treated by placing the patient in a supine position with the head lowered. If necessary an intravenous infusion of isotonic saline may be given, or any other method of volaemic expansion may be used.

Perindoprilat, the active form of perindopril, can be dialysed (see section 5.2).

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: perindopril and diuretics, ATC code: C09BA04

COVERSYL ARGININE PLUS 5mg/1.25mg is a combination of perindopril arginine salt, an angiotensin converting enzyme inhibitor, and indapamide, a chlorosulphamoyl diuretic. Its pharmacological properties are derived from those of each of the components taken separately, in addition to those due to the additive synergic action of the two products when combined.

Pharmacological mechanism of action

Linked to COVERSYL ARGININE PLUS 5mg/1.25mg:

COVERSYL ARGININE PLUS 5mg/1.25mg produces an additive synergy of the antihypertensive effects of the two components.

Linked to perindopril:

Perindopril is an inhibitor of the angiotensin converting enzyme (ACE inhibitor) which converts angiotensin I to angiotensin II, a vasoconstricting substance; in addition the enzyme stimulates the secretion of aldosterone by the adrenal cortex and stimulates the degradation of bradykinin, a vasodilatory substance, into inactive heptapeptides.

This results in:

- a reduction in aldosterone secretion,

- an increase in plasma renin activity, since aldosterone no longer exercises negative feedback,

- a reduction in total peripheral resistance with a preferential action on the vascular bed in muscle and the kidney, with no accompanying salt and water retention or reflex tachycardia, with chronic treatment.

The antihypertensive action of perindopril also occurs in patients with low or normal renin concentrations.

Perindopril acts through its active metabolite, perindoprilat. The other metabolites are inactive.

Perindopril reduces the work of the heart:

- by a vasodilatory effect on veins, probably caused by changes in the metabolism of prostaglandins : reduction in pre-load,

- by reduction of the total peripheral resistance: reduction in afterload.

Studies carried out on patients with cardiac insufficiency have shown:

- a reduction in left and right ventricular filling pressures,

- a reduction in total peripheral vascular resistance,

- an increase in cardiac output and an improvement in the cardiac index,

- an increase in regional blood flow in muscle.

Exercise test results also showed improvement.

Linked to indapamide:

Indapamide is a sulphonamide derivative with an indole ring, pharmacologically related to the thiazide group of diuretics. Indapamide inhibits the reabsorption of sodium in the cortical dilution segment. It increases the urinary excretion of sodium and chlorides and, to a lesser extent, the excretion of potassium and magnesium, thereby increasing urine output and having an antihypertensive action.

Characteristics of antihypertensive action

Linked to COVERSYL ARGININE PLUS 5mg/1.25mg:

In hypertensive patients regardless of age, COVERSYL ARGININE PLUS 5mg/1.25mg exerts a dose-dependent antihypertensive effect on diastolic and systolic arterial pressure whilst supine or standing. This antihypertensive effect lasts for 24 hours. The reduction in blood pressure is obtained in less than one month without tachyphylaxis; stopping treatment has no rebound effect. During clinical trials, the concomitant administration of perindopril and indapamide produced antihypertensive effects of a synergic nature in relation to each of the products administered alone.

PICXEL, a multicentre, randomised, double blind active controlled study has assessed on echocardiography the effect of perindopril/indapamide combination on LVH versus enalapril monotherapy.

In PICXEL, hypertensive patients with LVH (defined as left ventricular mass index (LVMI) > 120 g/m² in male and > 100 g/m² in female) were randomised either to perindopril tert-butylamine 2 mg (equivalent to 2.5 mg perindopril arginine)/indapamide 0.625 mg or to enalapril 10 mg once a day for a one-year treatment. The dose was adapted according to blood pressure control, up to perindopril tert-butylamine 8 mg (equivalent to 10 mg perindopril arginine) and indapamide 2.5 mg or enalapril 40 mg once a day. Only 34% of the subjects remained treated with perindopril tert-butylamine 2 mg (equivalent to 2.5 mg perindopril arginine)/indapamide 0.625mg (versus 20% with Enalapril 10mg).

At the end of treatment, LVMI had decreased significantly more in the perindopril/indapamide group (-10.1 g/m²) than in the enalapril group (-1.1 g/m²) in the all randomised patients population. The between group difference in LVMI change was -8.3 (95% CI (-11.5,-5.0), p < 0.0001).

A better effect on LVMI was reached with higher perindopril/indapamide doses than those licensed for COVERSYL ARGININE PLUS 2.5mg/0.625mg and COVERSYL ARGININE PLUS 5mg/1.25mg.

Regarding blood pressure, the estimated mean between-group differences in the randomised population were -5.8 mmHg (95% CI (-7.9, -3.7), p < 0.0001) for systolic blood pressure and -2.3 mmHg (95% CI (-3.6,-0.9), p = 0.0004) for diastolic blood pressure respectively, in favour of the perindopril/indapamide group.

Linked to perindopri

Tuesday, 17 April 2012

Ingredient matches for Ibukey

Monday, 16 April 2012

Commonly used brand name(s)

Uses For Novamoxin

Before Using Novamoxin

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of penicillin

Dosing

Missed Dose

Storage

Precautions While Using Novamoxin

Novamoxin Side Effects

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Friday, 13 April 2012

Phenylephrine Orally Disintegrating Strips are used for:

Do NOT use Phenylephrine Orally Disintegrating Strips if:

Before using Phenylephrine Orally Disintegrating Strips:

How to use Phenylephrine Orally Disintegrating Strips:

Important safety information:

Possible side effects of Phenylephrine Orally Disintegrating Strips:

If OVERDOSE is suspected:

General information:

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Thursday, 12 April 2012

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

6.2 Incompatibilities

6.3 Shelf Life

6.4 Special Precautions For Storage

6.5 Nature And Contents Of Container

6.6 Special Precautions For Disposal And Other Handling

7. Marketing Authorisation Holder

8. Marketing Authorisation Number(S)

9. Date Of First Authorisation/Renewal Of The Authorisation

10. Date Of Revision Of The Text

Wednesday, 11 April 2012

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data