Sunday 7 October 2012

Allerhist-D


Generic Name: clemastine and phenylpropanolamine (KLEM as teen/fen ill proe pa NOLE a meen)

Brand Names: Allerhist-D, Dayhist-D, Tavist-D


What is Allerhist-D (clemastine and phenylpropanolamine)?

Clemastine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Clemastine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.


Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal and respiratory (breathing) passages to open up.


Clemastine and phenylpropanolamine is used to treat nasal congestion and sinusitis (inflammation of the sinuses) associated with allergies and hay fever.


Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.


Clemastine and phenylpropanolamine may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Allerhist-D (clemastine and phenylpropanolamine)?


Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.


Use caution when driving, operating machinery, or performing other hazardous activities. Clemastine and phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking clemastine and phenylpropanolamine.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.


Who should not take Allerhist-D (clemastine and phenylpropanolamine)?


Do not take clemastine and phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have


  • kidney disease,

  • liver disease,


  • diabetes,




  • glaucoma,




  • any type of heart disease or high blood pressure,




  • thyroid disease, or




  • difficulty urinating or an enlarged prostate.



You may not be able to take clemastine and phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.


Clemastine and phenylpropanolamine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from clemastine and phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions. Clemastine and phenylpropanolamine is not approved for use by children younger than 12 years of age.

How should I take Allerhist-D (clemastine and phenylpropanolamine)?


Take clemastine and phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.


Take each dose with a full glass of water. Do not crush, chew, or break the tablets. Swallow them whole. They are specially formulated to release slowly over 12 hours. Do not take more than one tablet every 12 hours. If one tablet per day controls your symptoms, use that dosage. Never take more than two tablets in 1 day. Taking too much of this medication could cause severe dizziness, insomnia, and nervousness.

Do not take clemastine and phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.


Store clemastine and phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of a clemastine and phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, and vomiting.


What should I avoid while taking Allerhist-D (clemastine and phenylpropanolamine)?


Use caution when driving, operating machinery, or performing other hazardous activities. Clemastine and phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking clemastine and phenylpropanolamine.

Allerhist-D (clemastine and phenylpropanolamine) side effects


Serious side effects are unlikely to occur. Stop taking clemastine and phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take clemastine and phenylpropanolamine and talk to your doctor or try another similar medication if you experience



  • dryness of the eyes, nose, and mouth;




  • drowsiness or dizziness;




  • blurred vision;




  • difficulty urinating; or




  • excitation in children.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect Allerhist-D (clemastine and phenylpropanolamine)?


Do not take clemastine and phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking clemastine and phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain clemastine, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.


Clemastine and phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if clemastine and phenylpropanolamine is taken with any of these medications.


Drugs other than those listed here may also interact with clemastine and phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.



More Allerhist-D resources


  • Allerhist-D Side Effects (in more detail)
  • Allerhist-D Use in Pregnancy & Breastfeeding
  • Allerhist-D Drug Interactions
  • Allerhist-D Support Group
  • 0 Reviews for Allerhist-D - Add your own review/rating


Compare Allerhist-D with other medications


  • Cold Symptoms


Where can I get more information?


  • Your pharmacist has additional information about clemastine and phenylpropanolamine written for health professionals that you may read.

What does my medication look like?


Clemastine and phenylpropanolamine is available with a prescription under the brand name Tavist-D. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.



  • Tavist-D 1 mg of clemastine and 75 mg of phenylpropanolamine-- round, white tablets



See also: Allerhist-D side effects (in more detail)


Sunday 30 September 2012

sorafenib


Generic Name: sorafenib (sor a FEN ib)

Brand Names: NexAVAR


What is sorafenib?

Sorafenib is a cancer medication that interferes with the growth and spread of cancer cells in the body.


Sorafenib is used to treat a type of kidney cancer called advanced renal cell carcinoma. It is also used to treat liver cancer.


Sorafenib may also be used for purposes not listed in this medication guide.


What is the most important information I should know about sorafenib?


Do not use sorafenib if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medication and for at least 2 weeks after your treatment ends, whether you are a man or a woman. Sorafenib use by either parent may cause birth defects. Do not breast-feed while using this medication. You should not use sorafenib if you are allergic to it, or if you have squamous cell lung cancer and you are being treated with carboplatin (Paraplatin) and paclitaxel (Onxol, Taxol, Abraxane).

Before you take sorafenib, tell your doctor if you have kidney or liver problems (other than cancer), a bleeding or blood clotting disorder, high blood pressure, heart disease, slow heartbeats, congestive heart failure, a personal or family history of Long QT syndrome, a history of stroke or heart attack, or any allergies.


If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are taking sorafenib.

What should I discuss with my health care provider before taking sorafenib?


You should not use sorafenib if you are allergic to it, or if you have squamous cell lung cancer and you are being treated with carboplatin (Paraplatin) and paclitaxel (Onxol, Taxol, Abraxane).

To make sure you can safely take sorafenib, tell your doctor if you have any of these other conditions:



  • kidney or liver problems other than cancer;




  • lung cancer, especially if you are receiving gemcitabine (Gemzar) and cisplatin (Platinol);




  • a bleeding or blood clotting disorder such as hemophilia;




  • high blood pressure (hypertension), heart disease, slow heartbeats, congestive heart failure, chest pain;




  • a personal or family history of Long QT syndrome;




  • a history of stroke or heart attack; or




  • any allergies.




FDA pregnancy category D. Do not use sorafenib if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medication and for at least 2 weeks after your treatment ends, whether you are a man or a woman. Sorafenib use by either parent may cause birth defects. It is not known whether sorafenib passes into breast milk or if it could harm a nursing baby. Do not breast-feed while using this medication.

How should I take sorafenib?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Take sorafenib on an empty stomach, at least 1 hour before or 2 hours after eating. Do not crush, chew, or break a sorafenib tablet. Swallow it whole with water.

To be sure this medication is not causing harmful side effects, your blood pressure will need to be checked often. Visit your doctor regularly.


If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are taking sorafenib. You may need to stop taking the medicine for a short time. Store at room temperature away from moisture and heat.

See also: Sorafenib dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember, but at least 2 hours since your last meal. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include severe diarrhea or severe skin rash.

What should I avoid while taking sorafenib?


Follow your doctor's instructions about any restrictions on food, beverages, or activity.


Sorafenib side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using sorafenib and call your doctor at once if you have a serious side effect such as:

  • rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet;




  • mouth sores;




  • black or bloody stools, coughing up blood or vomit that looks like coffee grounds;




  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;




  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;




  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;




  • dry cough, wheezing;




  • swelling, rapid weight gain, feeling short of breath (even with mild exertion);




  • sudden numbness or weakness, especially on one side of the body;




  • sudden weight loss, increased appetite, trouble sleeping, increased bowel movements, sweating, feeling hot, feeling nervous or anxious, swelling in your neck (goiter);




  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, uneven heartbeats, seizure); or




  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.



Less serious side effects may include:



  • tired feeling;




  • nausea, vomiting, diarrhea, stomach pain, loss of appetite;




  • peeling or itchy skin, mild rash;




  • weight loss; or




  • thinning hair.



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.


Sorafenib Dosing Information


Usual Adult Dose for Renal Cell Carcinoma:

Initial dose: 400 mg twice a day at least one hour before or two hours after eating

Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.

Usual Adult Dose for Hepatocellular Carcinoma:

Initial dose: 400 mg twice a day at least one hour before or two hours after eating

Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.


What other drugs will affect sorafenib?


Tell your doctor about all other cancer medicines you use, especially cyclophosphamide (Cytoxan, Neosar), docetaxel (Taxotere), doxorubicin (Adriamycin, Rubex), fluorouracil (Adrucil, Carac, Efudex, Fluoroplex), irinotecan (Camptosar), paclitaxel (Taxol) or tamoxifen (Soltamox).


The following drugs can interact with sorafenib. Tell your doctor if you are using any of these:



  • arsenic trioxide (Trisenox);




  • bosentan (Tracleer);




  • dexamethasone (Decadron, Hexadrol);




  • montelukast (Singulair) or zafirlukast (Accolate);




  • promethazine (Phenergan, Adgan, Anergan, Antinaus, Pentazine);




  • selegiline (Eldepryl, Emsam, Zelapar);




  • St. John's wort;




  • tacrolimus (Prograf);




  • voriconazole (Vfend);




  • an antibiotic such as clarithromycin (Biaxin), levofloxacin (Levaquin), neomycin (Mycifradin, Neo Fradin, Neo Tab), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), and others;




  • an antidepressant;




  • anti-malaria medications such as chloroquine (Aralen) or mefloquine (Lariam);




  • a barbiturate such as pentobarbital (Nembutal) and others;




  • a blood thinner such as warfarin (Coumadin, Jantoven);




  • heart or blood pressure medications;




  • HIV medication;




  • medicine to prevent or treat nausea and vomiting such as dolasetron (Anzemet), droperidol (Inapsine), or ondansetron (Zofran);




  • medicines to treat narcolepsy;




  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), and others;




  • migraine headache medicine such as sumatriptan (Imitrex, Treximet) and others;




  • narcotic medication such as methadone (Methadose, Diskets, Dolophine);




  • seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), and others;




  • sulfa drugs (Bactrim, Gantanol, Gantrisin, Septra, SMX-TMP, and others); or




  • type 2 diabetes medications such as glimepiride (Amaryl), glipizide (Glucotrol), nateglinide (Starlix), pioglitazone (Actos, Actoplus Met), repaglinide (Prandin), rosiglitazone (Avandia, Avandamet), or tolbutamide (Orinase).



This list is not complete and other drugs may interact with sorafenib. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More sorafenib resources


  • Sorafenib Side Effects (in more detail)
  • Sorafenib Dosage
  • Sorafenib Use in Pregnancy & Breastfeeding
  • Sorafenib Drug Interactions
  • Sorafenib Support Group
  • 3 Reviews for Sorafenib - Add your own review/rating


  • sorafenib Advanced Consumer (Micromedex) - Includes Dosage Information

  • Nexavar Prescribing Information (FDA)

  • Nexavar Monograph (AHFS DI)

  • Nexavar Consumer Overview

  • Sorafenib Professional Patient Advice (Wolters Kluwer)

  • Sorafenib MedFacts Consumer Leaflet (Wolters Kluwer)



Compare sorafenib with other medications


  • Hepatic Tumor
  • Hepatocellular Carcinoma
  • Renal Cell Carcinoma
  • Thyroid Cancer


Where can I get more information?


  • Your pharmacist can provide more information about sorafenib.

See also: sorafenib side effects (in more detail)


Saturday 29 September 2012

Acetic Acid




Acetic Acid OTIC SOLUTION, USP

Rx only



Acetic Acid Description


Acetic Acid Otic Solution, USP is a solution of Acetic Acid (2%), in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), sodium acetate (0.015%), and citric acid. The empirical formula for Acetic Acid is CH3COOH, with a molecular weight of 60.05. The structural formula is:



Acetic Acid Otic Solution is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.



Acetic Acid - Clinical Pharmacology


Acetic Acid is antibacterial and antifungal; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues.



Indications and Usage for Acetic Acid


For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.



Contraindications


Hypersensitivity to Acetic Acid Otic Solution or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.



Warnings


Discontinue promptly if sensitization or irritation occurs.



Precautions


Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.



PEDIATRIC USE


Safety and effectiveness in pediatric patients below the age of 3 years have not been established.



Adverse Reactions


Stinging or burning may be noted occasionally; local irritation has occurred very rarely.



Acetic Acid Dosage and Administration


Carefully remove all cerumen and debris to allow Acetic Acid Otic Solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with Acetic Acid Otic Solution into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of Acetic Acid Otic Solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of Acetic Acid Otic Solution 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.



How is Acetic Acid Supplied


Acetic Acid Otic Solution, USP, containing 2% Acetic Acid, is available in 15 mL and 30 mL measured-drop, safety-tip plastic bottles.



STORAGE


Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Keep container tightly closed.



Manufactured for:

QUALITEST PHARMACEUTICALS

Huntsville, AL 35811


8180671

R5/08-R1



PRINCIPAL DISPLAY PANEL



 






Acetic Acid 
Acetic Acid  solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0603-7038
Route of AdministrationAURICULAR (OTIC)DEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetic Acid (Acetic Acid)Acetic Acid0.02 mL  in 1 mL












Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL DIACETATE 
BENZETHONIUM CHLORIDE 
SODIUM ACETATE 
CITRIC ACID 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10603-7038-4115 mL In 1 BOTTLENone
20603-7038-4530 mL In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04060702/24/2005


Labeler - Qualitest Pharmaceuticals (011103059)









Establishment
NameAddressID/FEIOperations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE
Revised: 06/2011Qualitest Pharmaceuticals

More Acetic Acid resources


  • Acetic Acid Use in Pregnancy & Breastfeeding
  • Acetic Acid Support Group
  • 0 Reviews for Acetic Acid - Add your own review/rating


  • Acid Jelly Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Fem pH MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Acetic Acid with other medications


  • Otitis Externa

Quasense extended-cycle


Generic Name: ethinyl estradiol and levonorgestrel (extended-cycle) (ETH in ill ess tra DYE ol and lee voe nor JESS trel)

Brand Names: Jolessa, LoSeasonique, Quasense, Seasonale, Seasonique


What is Quasense (ethinyl estradiol and levonorgestrel (extended-cycle))?

Ethinyl estradiol and levonorgestrel extended-cycle contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.


Ethinyl estradiol and levonorgestrel extended-cycle are used as contraception to prevent pregnancy.


Ethinyl estradiol and levonorgestrel extended-cycle may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Quasense (ethinyl estradiol and levonorgestrel (extended-cycle))?


Do not use ethinyl estradiol and levonorgestrel extended-cycle if you are pregnant or recently had a baby. Do not use this medication if you have: a history of stroke or blood clot, circulation problems, breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control when you first start using this medication.


Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use.


What should I discuss with my healthcare provider before taking Quasense (ethinyl estradiol and levonorgestrel (extended-cycle))?


This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

  • a history of a stroke or blood clot;




  • circulation problems (especially if caused by diabetes);




  • a hormone-related cancer such as breast or uterine cancer;




  • abnormal vaginal bleeding;




  • liver disease or liver cancer;




  • severe high blood pressure;




  • severe migraine headaches;




  • a heart valve disorder; or




  • a history of jaundice caused by birth control pills.



Before using this medication, tell your doctor if you have any of the following conditions.



  • high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;




  • high cholesterol or if you are overweight;




  • a history of depression;




  • gallbladder disease;




  • diabetes;




  • seizures or epilepsy;




  • a history of irregular menstrual cycles; or




  • a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.




The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Quasense (ethinyl estradiol and levonorgestrel (extended-cycle))?


Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).


You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.


You will not have a menstrual period every month while you are taking an extended-cycle birth control pill. Instead, your period should occur every 12 weeks.


The 91-day birth control pack contains three trays with cards that hold 84 "active" pills and seven "reminder" pills. You must use the pills in a certain order to keep you on a regular cycle. Trays 1 and 2 each hold 28 pills. Tray 3 holds 35 pills, including the 7 reminder pills. Your period should begin while you are using these reminder pills.


Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.


You may have breakthrough bleeding while taking birth control pills. Tell your doctor if this bleeding continues or is very heavy.

If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.


Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments.


Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?


Missing a pill increases your risk of becoming pregnant.


If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.


If you miss two "active" pills in a row, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.


If you miss three "active" pills in a row, do not take the missed pills. Continue taking 1 pill per day on schedule according to the pill package and leave the missed pills in the package. You may have some bleeding or spotting if you miss three pills in a row. Use back-up birth control for at least the next 7 days.


If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill. If your period does not start while you are taking the reminder pills, call your doctor because you might be pregnant.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.


What should I avoid while taking Quasense (ethinyl estradiol and levonorgestrel (extended-cycle))?


Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.


Quasense (ethinyl estradiol and levonorgestrel (extended-cycle)) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;




  • sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;




  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;




  • a change in the pattern or severity of migraine headaches;




  • nausea, stomach pain, low fever, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);




  • swelling in your hands, ankles, or feet; or




  • symptoms of depression (sleep problems, weakness, mood changes).



Less serious side effects may include:



  • mild nausea, vomiting, bloating, stomach cramps;




  • breast pain, tenderness, or swelling;




  • freckles or darkening of facial skin;




  • increased hair growth, loss of scalp hair;




  • changes in weight or appetite;




  • problems with contact lenses;




  • vaginal itching or discharge;




  • changes in your menstrual periods, decreased sex drive; or




  • headache, nervousness, dizziness, tired feeling.



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.


What other drugs will affect Quasense (ethinyl estradiol and levonorgestrel (extended-cycle))?


The following drugs can make birth control pills less effective, which may result in pregnancy:



  • acetaminophen (Tylenol) or ascorbic acid (vitamin C);




  • phenylbutazone (Azolid, Butazolidin);




  • prednisolone (Orapred);




  • theophylline (Respbid, Theo-Dur);




  • cyclosporine (Neoral, Sandimmune, Gengraf);




  • St. John's wort;




  • antibiotics such as amoxicillin (Augmentin), ampicillin (Omnipen), doxycycline (Doryx, Vibramycin), griseofulvin (Grisactin, Grifulvin, Fulvicin), minocycline (Minocin), penicillin (Veetids, Pen Vee K, Bicillin), rifampin (Rifadin), rifabutin (Mycobutin), tetracycline, and others;




  • seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), topiramate (Topamax), or primidone (Mysoline);




  • a barbiturate such as butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or




  • HIV medicines such as indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), or nelfinavir (Viracept), and others.



This list is not complete and there may be other drugs that can interact with birth control pills. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More Quasense resources


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


Compare Quasense with other medications


  • Abnormal Uterine Bleeding
  • Birth Control
  • Endometriosis
  • Gonadotropin Inhibition
  • Ovarian Cysts
  • Polycystic Ovary Syndrome


Where can I get more information?


  • Your pharmacist can provide more information about ethinyl estradiol and levonorgestrel.

See also: Quasense side effects (in more detail)


Monday 24 September 2012

Methylprednisolone



Class: Adrenals
Note: This monograph also contains information on Methylprednisolone Acetate, Methylprednisolone Sodium Succinate
ATC Class: H02AB04
VA Class: HS051
CAS Number: 83-43-2
Brands: A-methaPred, Depo-Medrol, Medrol, Medrol Dosepak, Meprolone Unipak, Solu-Medrol

Introduction

Synthetic glucocorticoid; minimal mineralocorticoid activity.b c d


Uses for Methylprednisolone


Treatment of a wide variety of diseases and conditions principally for glucocorticoid effects as an anti-inflammatory and immunosuppressant agent and for its effects on blood and lymphatic systems in the palliative treatment of various diseases.c d


Usually, inadequate alone for adrenocortical insufficiency because of minimal mineralocorticoid activity.c


Adrenocortical Insufficiency


Corticosteroids are administered in physiologic dosages to replace deficient endogenous hormones in patients with adrenocortical insufficiency.a c


Because production of both mineralocorticoids and glucocorticoids is deficient in adrenocortical insufficiency, hydrocortisone or cortisone (in conjunction with liberal salt intake) usually is the corticosteroid of choice for replacement therapy.a c d m


If methylprednisolone is used, must also administer a mineralocorticoid (fludrocortisone), particularly in infants.a c d


In suspected or known adrenal insufficiency, parenteral therapy may be used preoperatively or during serious trauma, illness, or shock unresponsive to conventional therapy.d e m


In shock unresponsive to conventional therapy, IV therapy in conjunction with other therapy for shock is essential; hydrocortisone is preferred, but a synthetic glucocorticoid like methylprednisolone can be substituted.c e


Adrenogenital Syndrome


Lifelong glucocorticoid treatment of congenital adrenogenital syndrome.a c


In salt-losing forms, cortisone or hydrocortisone is preferred in conjunction with liberal salt intake; a mineralocorticoid may be necessary in conjunction through at least 5–7 years of age.c


A glucocorticoid, usually alone, for long-term therapy after early childhood.c


In hypertensive forms, a “short-acting” glucocorticoid with minimal mineralocorticoid activity (e.g., methylprednisolone, prednisone) is preferred;c avoid long-acting glucocorticoids (e.g., dexamethasone) because of tendency toward overdosage and growth retardation.c


Hypercalcemia


Treatment of hypercalcemia associated with malignancy.a c d m


Usually ameliorates hypercalcemia associated with bone involvement in multiple myeloma.c


Most effective long-term treatment for hypercalcemia associated with breast cancer in postmenopausal women.c


Efficacy varies in other malignancies.c


Treatment of hypercalcemia associated with sarcoidosis.c


Treatment of hypercalcemia associated with vitamin D intoxication.c


Not effective for hypercalcemia caused by hyperparathyroidism.c


Thyroiditis


Treatment of granulomatous (subacute, nonsuppurative) thyroiditis.a c d m


Anti-inflammatory actions relieves fever, acute thyroid pain, and swelling.c


May reduce orbital edema in endocrine exophthalmos (thyroid ophthalmopathy).c


Usually reserved for palliative therapy in severely ill patients unresponsive to salicylates and thyroid hormones.c


Rheumatic Disorders and Collagen Diseases


Short-term palliative treatment of acute episodes or exacerbations and systemic complications of rheumatic disorders (e.g., rheumatoid arthritis, juvenile arthritis, psoriatic arthritis, acute gouty arthritis, posttraumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis, ankylosing spondylitis, Reiter syndrome, rheumatic fever [especially with carditis]) and collagen diseases (e.g., acute rheumatic carditis, systemic lupus erythematosus, dermatomyositis [polymyositis], polyarteritis nodosa, vasculitis) refractory to more conservative measures.a c d l m


Relieves inflammation and suppresses symptoms but not disease progression.c


Rarely indicated as maintenance therapy.c


May be used as maintenance therapy (e.g., in rheumatoid arthritis, acute gouty arthritis, systemic lupus erythematosus, acute rheumatic carditis) as part of a total treatment program in selected patients when more conservative therapies have proven ineffective.a b c d


Glucocorticoid withdrawal is extremely difficult if used for maintenance; relapse and recurrence usually occur with drug discontinuance.c


Local injection can provide dramatic relief initially for articular manifestations of rheumatic disorders (e.g., rheumatoid arthritis) that involve only a few persistently inflamed joints or for inflammation of tendons or bursae;c inflammation tends to recur and sometimes is more intense after drug cessation.c


Local injection used for the management of cystic tumors of an aponeurosis or tendon (ganglia).d


Local injection can prevent invalidism by facilitating movement of joints that might otherwise become immobile.c


Controls acute manifestations of rheumatic carditis more rapidly than salicylates and may be life-saving; cannot prevent valvular damage and no better than salicylates for long-term treatment.c


Adjunctively for severe systemic complications of Wegener’s granulomatosis, but cytotoxic therapy is the treatment of choice.c


Primary treatment to control symptoms and prevent severe, often life-threatening complications in patients with dermatomyositis and polymyositis, polyarteritis nodosa, relapsing polychondritis, polymyalgia rheumatica and giant-cell (temporal) arteritis, or mixed connective tissue disease syndrome.a c High dosage may be required for acute situations; after a response has been obtained, drug must often be continued for long periods at low dosage.c


Polymyositis associated with malignancy and childhood dermatomyositis may not respond well.c


Rarely indicated in psoriatic arthritis, diffuse scleroderma (progressive systemic sclerosis), acute and subacute bursitis, or osteoarthritis; risks outweigh benefits.a c d m


In osteoarthritis, intra-articular injections may be beneficial but should be limited in number as joint damage may occur.c d


Dermatologic Diseases


Treatment of pemphigus and pemphigoid, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, uncontrollable eczema, cutaneous sarcoidosis, mycosis fungoides, lichen planus, lichen simplex chronicus (neurodermatitis), severe psoriasis, and severe seborrheic dermatitis.a c d e


Usually reserved for acute exacerbations unresponsive to conservative therapy.c


Early initiation of systemic glucocorticoid therapy may be life-saving in pemphigus vulgaris and pemphigoid, and high or massive doses may be required.c


For control of severe or incapacitating allergic conditions (e.g., contact dermatitis, atopic dermatitis) intractable to adequate trials of conventional treatment.a d e f m


Chronic skin disorders seldom an indication for systemic glucocorticoids.c


Intralesional or sublesional injections occasionally indicated for localized chronic skin disorders, keloids, psoriatic plaques, alopecia areata, discoid lupus erythematosus, necrobiosis lipoidica diabeticorum, granuloma annulared m unresponsive to topical therapy.c


Rarely indicated for psoriasis;c if used, exacerbation may occur when the drug is withdrawn or dosage is decreased.c


Rarely indicated systemically for alopecia (areata, totalis, or universalis).c May stimulate hair growth, but hair loss returns when the drug is discontinued.c


Allergic Conditions


For control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment and control of acute manifestations, including anaphylactic and anaphylactoid reactions, angioedema, acute noninfectious laryngeal edema, serum sickness, allergic symptoms of trichinosis, asthma, urticarial transfusion reactions, drug hypersensitivity reactions, and severe seasonal or perennial rhinitis.a c d e f m


Systemic therapy usually reserved for acute conditions and severe exacerbations.c


For acute conditions, usually used in high dosage and with other therapies (e.g., antihistamines, sympathomimetics).c


Reserve prolonged treatment of chronic allergic conditions for disabling conditions unresponsive to more conservative therapy and when risks of long-term glucocorticoid therapy are justified.c


Ocular Disorders


To suppress a variety of allergic and nonpyogenic ocular inflammations.c


To reduce scarring in ocular injuries.c


For the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and adnexa (e.g., allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, diffuse posterior uveitis and choroiditis, anterior segment inflammation, optic neuritis, sympathetic ophthalmia, temporal arteritis).a c d e f m


Acute optic neuritis optimally treated with initial high-dose IV therapy followed by chronic oral therapy. Assists in recovery of vision and slows progression to clinically definite multiple sclerosis.


Less severe allergic and inflammatory allergic conditions of the eye are treated with topical (to the eye) corticosteroids.g


Topically applied glucocorticoids appear to be as effective as systemic steroids for the treatment of most anterior ocular inflammations.c


Systemically in stubborn cases of anterior segment eye disease and when deeper ocular structures are involved.c


Asthma


Adjunctively for moderate to severe exacerbations of asthma and for maintenance in persistent asthma.c g


Systemically (oral or IV) for treatment of moderate to severe acute exacerbations of asthma (oral prednisone usually preferred); speeds resolution of airflow obstruction and reduces rate of relapse.g


Because onset of effects is delayed, do not use alone for emergency treatment.c


Early systemic glucocorticoid therapy particularly important for asthma exacerbations in infants and children.g


In hospital management of an acute asthma exacerbation, may give systemic adjunctive glucocorticoids if response to oral inhalation therapy is not immediate, if oral corticosteroids were used as self-medication prior to hospitalization, or if the episode is severe.c


For severe persistent asthma once initial control is achieved, high dosages of inhaled corticosteroids are preferable to oral glucocorticoids for maintenance because inhaled corticosteroids have fewer systemic effects.


Maintenance therapy with low doses of an orally inhaled corticosteroid is preferred treatment for adults and children with mild persistent asthmac (i.e., patients with daytime symptoms of asthma more than twice weekly but less than once daily, and nocturnal symptoms of asthma more than twice per month).b


Orally as an adjunct to other therapy to speed resolution of all but the mildest exacerbations of asthma when response to a short-acting inhaled β2-agonist is not prompt or sustained after 1 hour or in those who have a history of severe exacerbations.c


Oral glucocorticoids with minimal mineralocorticoid activity and relatively short half-life (e.g., prednisone, prednisolone, methylprednisolone) are preferred.


COPD


For severe exacerbations of COPD, a short (e.g., 1–2 weeks) course of oral glucocorticoids can be added to existing therapy.


Effects in stable COPD are much less dramatic than in asthma, and role of glucocorticoids in the management of stable COPD is limited to very specific indications.


Croup


Adjunctive treatment of croup in pediatric patients.g


Decreases edema in laryngeal mucosa.g


Reduces need for hospitalization, shorter duration of hospitalization, and reduces need for subsequent interventions (e.g., epinephrine).g


Sarcoidosis


Management of symptomatic sarcoidosis.a c d e f m


Systemic glucocorticoids are indicated for hypercalcemia; ocular, CNS, glandular, myocardial, or severe pulmonary involvement; or severe skin lesions unresponsive to intralesional injections of glucocorticoids.c


Advanced Pulmonary and Extrapulmonary Tuberculosis


Systemically as adjunctive therapy with effective antimycobacterial agents (e.g., streptomycin, isoniazid) to suppress manifestations related to the host’s inflammatory response to the bacillus (Mycobacterium tuberculosis) and ameliorate complications in severe pulmonary or extrapulmonary tuberculosis.a m


Adjunctive glucocorticoid therapy may enhance short-term resolution of disease manifestations (e.g., clinical and radiographic abnormalities) in advanced pulmonary tuberculosis and also may reduce mortality associated with certain forms of extrapulmonary disease (e.g., meningitis, pericarditis).


Systemic adjunctive glucocorticoids may reduce sequelae (e.g., intellectual impairment) and/or improve survival in moderate to severe tuberculous meningitis; used in the treatment of tuberculous meningitis with subarachnoid block or impending block concurrently with appropriate antituberculous chemotherapy.a d e f m


Systemic adjunctive glucocorticoid therapy rapidly reduces the size of pericardial effusions and the need for drainage procedures and decreases mortality (probably through control of hemodynamically threatening effusion) in acute tuberculous pericarditis.


Hastens the resolution of pain, dyspnea, and fever associated with tuberculous pleurisy.c


Lipid Pneumonitis


Promotes the breakdown or dissolution of pulmonary lesions and eliminates sputum lipids in lipid pneumonitis.c


Pneumocystis jiroveci Pneumonia


Systemic adjunctive glucocorticoids decrease the likelihood of deterioration of oxygenation, respiratory failure, and/or death in moderate to severe Pneumocystis jiroveci (formerly Pneumocystis carinii) pneumonia in AIDS.


Prevents early deterioration in oxygenation associated with antipneumocystis therapy; initiate adjunctive glucocorticoid therapy as early as possible in moderate to severe pneumocystis pneumonia.


Not known whether patients with mild pneumocystis pneumonia (arterial oxygen pressure >70 mm Hg or arterial-alveolar gradient <35 mm Hg on room air) will have clinically important benefit with adjunctive glucocorticoid therapy.


Oral prednisone or parenteral methylprednisolone generally is preferred.


Loeffler’s Syndrome


Symptomatic relief of acute manifestations of symptomatic Loeffler’s syndrome not manageable by other means.a f


Berylliosis


Symptomatic relief of acute manifestations of berylliosis.a d f m


Aspiration Pneumonitis


Symptomatic relief of acute manifestations of aspiration pneumonitis.a d f


Anthrax


Adjunct to anti-infective therapy in the treatment of anthrax in an attempt to ameliorate toxin-mediated effects associated with Bacillus anthracis infections.


For cutaneous anthrax if there are signs of systemic involvement or extensive edema involving the neck and thoracic region, anthrax meningitis, and inhalational anthrax that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism if extensive edema, respiratory compromise, or meningitis is present.


Hematologic Disorders


Management of acquired (autoimmune) hemolytic anemia, pure red cell aplasia, idiopathic thrombocytopenic purpura (ITP), secondary thrombocytopenia, erythroblastopenia, or congenital (erythroid) hypoplastic anemia.a d e f m


High or even massive dosages decrease bleeding tendencies and normalize blood counts; does not affect the course or duration of hematologic disorders.c


Glucocorticoids, immune globulin IV (IGIV), or splenectomy are first-line therapies for moderate to severe ITP, depending on the extent of bleeding involved.


May not affect or prevent renal complications in Henoch-Schoenlein purpura.c


Insufficient evidence of effectiveness in aplastic anemia in children, but widely used.c


Shock


Although IV glucocorticoids may be life-saving in shock secondary to adrenocortical insufficiency (see Adrenocortical Insufficiency under Uses), the value of the drugs in the treatment of shock resulting from other causes is controversial.c


Management of shock should be based on specific treatment of the primary cause and secondary abnormalities, and glucocorticoids, if used, should be regarded only as adjunctive supportive treatment.c


Value in adjunctive treatment of septic shock is particularly controversial. Conflicting evidence regarding effects of high-dose regimens on morbidity and mortality in septic shock. In a clinical study, methylprednisolone was ineffective in the treatment of sepsis syndrome and septic shock, and may increase the risk of mortality in certain patients (i.e., patients with increased Scr or those who develop secondary infections after treatment).e


Pericarditis


To reduce the pain, fever, and inflammation of pericarditis, including that associated with MI.c


Glucocorticoids can provide effective symptomatic relief, but aspirin considered the treatment of choice for post-MI pericarditis because of greater evidence establishing benefit.


Important to distinguish between pain caused by pericarditis and that caused by ischemia since management will differ.


Consider possibility that cardiac rupture may account for recurrent pain since use of glucocorticoids may be a risk factor in its development.


Glucocorticoids may cause thinning of developing scar and myocardial rupture.


Management of tuberculous pericarditis. (See Advanced Pulmonary and Extrapulmonary Tuberculosis under Uses.)


GI Diseases


Short-term palliative therapy for acute exacerbations and systemic complications of ulcerative colitis, regional enteritis (Crohn's disease), and celiac disease.a c d e f m


Do not use if a probability of impending perforation, abscess, or other pyogenic infection.e


Rarely indicated for maintenance therapy in chronic GI diseases (e.g., ulcerative colitis, celiac disease) since does not prevent relapses and may produce severe adverse reactions with long-term administration.c


Occasionally, low dosages, in conjunction with other supportive therapy, may be useful for disease unresponsive to the usual therapy indicated for chronic conditions.c


Management of mildly to moderately active and moderately to severely active Crohn's disease .


Parenteral glucocorticoids recommended for patients with severe fulminant Crohn's disease. Once patients respond to parenteral therapy, they should gradually be switched to an equivalent regimen of an oral glucocorticoid.


Some experts state that glucocorticoids should not be used for the management of mildly to moderately active Crohn's disease because of the high incidence of adverse effects and their use should be reserved for patients with moderately to severely active disease.


Glucocorticoids should not be used for maintenance therapy of chronic GI diseases (e.g., ulcerative colitis, Crohn's disease) because they usually do not prevent relapses and the drugs may produce severe adverse effects with long-term administration.a c


Glucocorticoids have been used in the management of moderately to severely active Crohn’s disease and in mild esophageal or gastroduodenal Crohn's disease in pediatric patients.


Neoplastic Diseases


Alone or as a component of various chemotherapeutic regimens in the palliative treatment of neoplastic diseases of the lymphatic system (e.g., leukemias and lymphomas in adults and acute leukemias in children).a d e f m


Treatment of breast cancer; glucocorticoids alone not as effective as other agents (e.g., cytotoxic agents, hormones, antiestrogens) and should be reserved for unresponsive disease.c


Glucocorticoids alone or as a component of various combination chemotherapeutic regimens for palliative treatment of advanced, symptomatic (i.e., painful) hormone-refractory prostate cancer.


Cancer Chemotherapy-induced Nausea and Vomiting


Prevention of nausea and vomiting associated with emetogenic cancer chemotherapy.


Cerebral Edema


To decrease cerebral edema associated with brain tumors and neurosurgery.c d m


Cerebral edema associated with pseudotumor cerebri may also benefit, but efficacy of glucocorticoids is controversial and remains to be established.c


Edema resulting from brain abscesses is less responsive than that resulting from brain tumors.c


Pharmacologic management of cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy.c d f


Head Injury


Efficacy of glucocorticoid therapy is not established in patients with head injury; such therapy can be detrimental and is associated with a substantial increase in risk of death. Use to improve outcome or reduce intracranial pressure not recommended in patients with head injury.


Cerebral Malaria


Glucocorticoids are not effective and can have detrimental effects in the management of cerebral malaria caused by Plasmodium falciparum; no longer recommended for this condition.c


Acute Spinal Cord Injury


Some evidence indicates that large IV doses of glucocorticoids (i.e., methylprednisolone) can improve motor and sensory function in patients with acute spinal cord injury when treatment is initiated promptly following injury (within 8 hours). It is not known whether improvement in neurologic function with such therapy will routinely lead to specific improvements in disability.


Low Back Pain


Has been used epidurally (alone or combined with a local anesthetic and/or an opiate analgesic) for symptomatic relief of low back pain; although use remains controversial and convincing evidence of efficacy is lacking, most experts consider such therapy an option for short-term relief of acute, subacute, or chronic radicular pain in patients with low back pain and radiculopathy associated with disk disease or herniation or spinal stenosis when more conservative therapies (e.g., rest, analgesics, physical therapy) fail and as a means of potentially avoiding surgery.


Limited evidence suggests that therapeutic facet joint and intradiscal glucocorticoid injections are minimally effective or ineffective in the treatment of low back pain, although facet joint injections may be useful in some patients with facet arthropathy. Inclusion of a glucocorticoid in trigger point injections does not appear to be beneficial.


Sacroiliac joint injections performed using fluoroscopic guidance may provide temporary pain relief in some patients when the principal source of spinal pain is the sacroiliac joint.


Oral glucocorticoids have been used; however, they do not appear to be effective and evidence supporting such use is lacking.


Bacterial Meningitis


Limited data in animals suggest that dexamethasone may be superior to methylprednisolone in reversing certain CSF abnormalities (e.g., intracranial hypertension, elevated lactate concentrations) associated with bacterial meningitis, and experience is insufficient to allow recommendation of glucocorticoids other than dexamethasone for adjunctive therapy in bacterial meningitis.


Short-term IV adjunctive therapy with dexamethasone is preferred.


Multiple Sclerosis


Glucocorticoids are drugs of choice for the management of acute relapses of multiple sclerosisa d m and have replaced corticotropin as the therapy of choice because of a more rapid onset of action, more consistent effects, and fewer adverse effects.


Anti-inflammatory and immunomodulating effects accelerate neurologic recovery by restoring the blood-brain barrier, reducing edema, and possibly improving axonal conduction.


Shortens the duration of relapse and accelerates recovery; remains to be established whether the overall degree of recovery improves or the long-term course is altered.


Myasthenia Gravis


Management of myasthenia gravis, usually when there is an inadequate response to anticholinesterase therapy.


Parenterally for the treatment of myasthenic crisis.


Organ Transplants


In massive dosage, used concomitantly with other immunosuppressive drugs to prevent rejection of transplanted organs.c


Incidence of secondary infections is high with immunosuppressive drugs; limit to clinicians experienced in their use.c


Trichinosis


Treatment of trichinosis with neurologic or myocardial involvement.a d e f


Nephrotic Syndrome and Lupus Nephritis


Treatment of idiopathic nephrotic syndrome without uremia.a d e f


Can induce diuresis and remission of proteinuria in nephrotic syndromea c d e f m secondary to lupus erythematosus or primary renal disease, especially when there is minimal renal histologic change.b d m


Treatment of lupus nephritis.a d e


Carpal Tunnel Syndrome


Local injection of glucocorticoids (e.g., methylprednisolone, betamethasone) into the tissue near the carpal tunnel has been used in a limited number of patients to relieve symptoms (e.g., pain, edema, sensory deficit) of carpal tunnel syndrome.


Methylprednisolone Dosage and Administration


General



  • Route of administration and dosage depend on the condition being treated and the patient response.a



Alternate-day Therapy



  • Alternate-day therapy in which a single dose (twice the usual daily dosage) is administered every other morning is the dosage regimen of choice for long-term oral glucocorticoid treatment of most conditions.a c This regimen provides relief of symptoms while minimizing adrenal suppression, protein catabolism, and other adverse effects.a c




  • If alternate-day therapy is preferred, only use a “short-acting” glucocorticoid that suppresses the HPA axis <1.5 days after a single oral dose (e.g., methylprednisolone, prednisone, prednisolone).c




  • Some conditions (e.g., rheumatoid arthritis, ulcerative colitis) require daily glucocorticoid therapy because symptoms of the underlying disease cannot be controlled by alternate-day therapy.c



Discontinuance of Therapy



  • A steroid withdrawal syndrome consisting of lethargy, fever, and myalgia can develop following abrupt discontinuance.c Symptoms often occur without evidence of adrenal insufficiency (while plasma glucocorticoid concentrations were still high but were falling rapidly).c




  • If used for only brief periods (a few days) in emergency situations, may reduce and discontinue dosage quite rapidly.c




  • Very gradually withdraw systemic glucocorticoids until recovery of HPA-axis function occurs following long-term therapy with pharmacologic dosages.c d e m (See Adrenocortical Insufficiency under Warnings.)




  • Exercise caution when transferring from systemic glucocorticoid to oral or nasal inhalation corticosteroid therapy.c




  • Many methods of slow withdrawal or “tapering” have been described.c




  • In one suggested regimen, decrease by 2–4 mg every 3–7 days of until the physiologic dose (4 mg) is reached.c




  • Other recommendations state that decrements usually should not exceed 2 mg every 1–2 weeks.c




  • When a physiologic dosage has been reached, single 20-mg oral morning doses of hydrocortisone can be substituted for whatever glucocorticoid the patient has been receiving.c After 2–4 weeks, may decrease hydrocortisone dosage by 2.5 mg every week until a single morning dosage of 10 mg daily is reached.c




  • For certain acute allergic conditions (e.g., contact dermatitis such as poison ivy) or acute exacerbations of chronic allergic conditions, glucocorticoids may be administered short term (e.g., for 6 days).c Administer an initially high dose on the first day of therapy, and then withdraw therapy by tapering the dose over several days.c



Administration


Administer orally, by IV injection or infusion, or IM injection.a d e f m


Administer for local effect by intra-articular, intralesional, intrasynovial, soft-tissue, or epidural injection.c d m


Generally reserve IM or IV therapy for patients who are not able to take the drug orally or for use in an emergency situation.d e After the initial emergency period, a longer-acting injectable corticosteroid preparation or oral administration of a corticosteroid should be considered.b


Methylprednisolone acetate injections (in multiple-dose vials) contain benzyl alcohol; do not administer intrathecally because of reports of severe adverse events with such use.m


Oral Administration


Methylprednisolone

Administer orally as tablets.a


IV Administration


Methylprednisolone Sodium Succinate

Administer by IV injection or infusion.e


Reconstitution of Methylprednisolone Sodium Succinate

Reconstitute by pressing on a plastic activator to force the diluent provided from the manufacturer from an upper compartment of a 2-compartment vial to a lower compartment containing sterile powder.e Alternately, use bacteriostatic water for injection with benzyl alcohol for reconstitution.e


Dilution of Methylprednisolone Sodium Succinate

When administered by IV infusion, the drug can be added to 5% dextrose, or 0.9% sodium chloride, or 5% dextrose in sodium chloride injection.e


Rate of Administration of Methylprednisolone Sodium Succinate

Direct IV injection: Administer over a period of several minutes.e


IM Administration


Do not administer IM for conditions prone to bleeding (e.g., idiopathic thrombocytopenic purpura [ITP]).e


Methylprednisolone Acetate

Administer by IM injection.d m


Because it is slowly absorbed, IM administration is not indicated when an immediate effect of short duration is required.d


Commercially available single-dose vials are for single use only.d m Although initially sterile, multiple use of a single-dose vial may result in contamination, unless strict aseptic technique is observed.m


Methylprednisolone Sodium Succinate

Administer by IM injection.e


Absorption from IM injection sites is rapid.b


Intra-articular, Intralesional, and Soft Tissue Administration


Methylprednisolone Acetate

Administer by intra-articular, intralesional, intrasynovial, or soft tissue injection.b d m (See Dermatologic Effects under Cautions.)


May infiltrate the tissue surrounding the joint with a local anesthetic (e.g., procaine hydrochloride) before administration of methylprednisolone acetate.b d


Examine joint fluid to exclude sepsis and avoid injection into an infected site; if joint sepsis is evident, institute appropriate antibacterial therapy.c d m Symptoms of septic arthritis include local swelling, further restriction of joint motion, fever, or malaise.c d m Do not inject glucocorticoids into unstable joints and caution patients not to overuse joints in which the inflammatory process still is active despite symptomatic improvement.c


Epidural Administration


Long-acting injectable suspension has been administered by epidural injection, although safety of epidural injections using preserved formulations is controversial and epidural administration of these formulations is not recommended by the manufacturer.c Limited evidence suggests that large particles in glucocorticoid suspensions may cause embolic vascular occlusion following inadvertent intra-arterial injection.


Inject into the epidural space near the site where the nerve roots pass before entering the intervertebral foramen.


Epidural injections may be performed by caudal, interlaminar, or transforaminal approaches; the transforaminal approach requires the smallest injection volume and appears to be the most specific and possibly most effective route.


Because of the potential for complications related to improper needle placement or drug administration, many experts state that epidural injections should be performed by an experienced clinician using fluoroscopic guidance and contrast control to ensure that the needle is correctly positioned and that the injection is not performed intravascularly, intrathecally, or into tissues other than the epidural space.


Optimal technique, dosage, timing of initial injection, injection frequency, and maximum number of injections remain to be established.


Dosage


Available as methylprednisolone, methylprednisolone acetate, and methylprednisolone sodium succinate.a b d e m Dosage of methylprednisolone sodium succinate or methylprednisolone acetate is expressed in terms of methylprednisolone or methylprednisolone acetate, respectively.d e m


After a satisfactory response is obtained, decrease dosage in small decrements to the lowest level that maintains an adequate clinical response, and discontinue the drug as soon as possible.a b e


Monitor patients continually for signs that indicate dosage adjustment is necessary, such as remissions or exacerbations of the disease and stress (surgery, infection, trauma).b


High dosages may be required for acute situations of certain rheumatic disorders and collagen diseases; after a response has been obtained, drug often must be continued for long periods at low dosage.c


High or massive dosages may be required in the treatment of pemphigus, exfoliative dermatitis, bullous dermatitis herpetiformis, severe erythema multiforme, or mycosis fungoides.c Early initiation of systemic glucocorticoid therapy may be life-saving in pemphigus vulgaris.c Reduce dosage gradually to the lowest effective level, but discontinuance may not be possible.c d m


Massive dosages may be required for treatment of shock.b


Increase dosage of rapidly acting corticosteroids in patients subjected to any unusual stress before, during, and after the stressful situation.a d e m


Pediatric Patients


Base pediatric dosage on severity of the disease and patient response rather than on strict adherence to dosage indicated by age, body weight, or body surface area.b e


Usual Dosage

Oral

0.117–1.66 mg/kg daily or 3.3–50 mg/m2 daily, administered in 3 or 4 divided doses.b


IM

Methylprednisolone sodium succinate: 0.03–0.2 mg/kg or 1–6.25 mg/m2 IM 1–2 times daily has been used.b


Asthma

Oral

To gain prompt control of asthma in infants and children ≤4 years of age with very poorly controlled, moderate-to-severe asthma (i.e., >3 exacerbations per year requiring oral corticosteroids) and in children 5–11 years of age with asthma of comparable control and severity (i.e., ≥2 exacerbations per year requiring oral corticosteroids): Methylprednisolone 1–2 mg/kg daily (maximum 60 mg daily) may be added to existing asthma therapy.


In children ≤11 years of age undergoing emergency department treatment for moderate-to-severe acute asthma exacerbations not controlled with an inhaled β2-adrenergic agonist: May add methylprednisolone 1–2 mg/kg daily in 2 divided doses (maximum 60 mg daily). Continue treatment until patient achieves a PEF of 70% of predicted or personal best.


Allergic Conditions

IM

Methylprednisolone acetate: For control of severe or incapacitating allergic conditions (e.g., bronchial asthma, seasonal or perennial allergic rhinitis) intractable to adequate trials of conventional therapy, initially, 1–2 mg/kg.


To gain prompt control of asthma in infants and children ≤4 years of age or children ≥5 years of age with very poorly-controlled, moderate-to-severe asthma (as an alternative to a short course of an oral corticosteroid) who are vomiting or noncompliant with oral corticosteroid therapy: 7.5 mg/kg or 240 mg as a single dose of methylprednisolone acetate, respectively. Relief of asthma symptoms should occur within 6–48 hours and persist for several days to 2 weeks.d


Relief of coryzal symptoms of allergic rhinitis should occur within 6 hours and persist for several days to 3 weeks.d


IV

Methylprednisolone sodium succinate: For control of severe or incapacitating allergic conditions (e.g., bronchial asthma) intractable to adequate trials of conventional therapy, initially, 1–2 mg/kg.


Croup

IV

Methylprednisolone sodium succinate: Initialy, 1–2 mg/kg.


Pneumocystis jiroveci Pneumonia

IV

Methylprednisolone sodium succinate in children >13 years of age with AIDS and moderate to severe Pneumocystis jiroveci pneumonia: 30 mg twice daily for 5 days, followed by 30 mg once daily for 5 days, and then 15 mg once daily for 11 days (or until completion of the anti-infective regimen). Initiate within 24–72 hours of initial antipneumocystis therapy.


Acute Spinal Cord Injury

IV

Methylprednisolone sodium s

Sunday 23 September 2012

Ipecacuanha and Morphine Mixture BP 1980





1. Name Of The Medicinal Product



Ipecacuanha and Morphine Mixture BP 1980


2. Qualitative And Quantitative Composition










Morphine Hydrochloride BP




0.458mg per 5ml.




Ipecacuanha Tincture BP 1999




0.1ml per 5ml.




Liquorice Liquid Extract BP




0.525ml per 5ml.



3. Pharmaceutical Form



Mixture



4. Clinical Particulars



4.1 Therapeutic Indications



For the symptomatic relief of coughs.



4.2 Posology And Method Of Administration



Oral.



Recommended doses and dosage schedule



Adults, the elderly and children over 12 years: 10ml.



This dose can he repeated up to 4 times in any 24 hours.



Children under 12 years: Not recommended.



4.3 Contraindications



Due to the presence of morphine this product is contraindicated in respiratory depression. It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.



4.4 Special Warnings And Precautions For Use



Caution is advised in patients with asthma, hepatic and renal disease, and a history of drug abuse.






Labels state:




Do not exceed the stated dose.



If symptoms persist consult your doctor.



Keep all medicines away from children.



Shake the bottle.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Concomitant administration of other central nervous system depressants eg. alcohol, hypnotics, sedatives, may result in an enhancement of effects.



It may antagonise the effect of metoclopramide.



4.6 Pregnancy And Lactation



As with all medicines use should be avoided during pregnancy, especially in the first trimester, and in lactation unless recommended by a doctor.



4.7 Effects On Ability To Drive And Use Machines



Although morphine may cause drowsiness, it is not expected that the quantities present in this product will have an effect on the ability to drive etc.



4.8 Undesirable Effects



Adverse effects would not be expected to occur when this preparation is taken at the recommended dose. However, a number of effects are known to arise from administration of morphine, the commonest of these being nausea, vomiting, constipation, drowsiness and confusion.



4.9 Overdose



Overdose with this preparation is unlikely to occur due to the low concentrations of the active ingredients present.



Large doses of ipecacuanha irritate the gastro-intestinal tract and may give rise to bloody vomiting and diarrhoea. Absorption of emetine may have adverse effects on the heart, such as conduction abnormalities or myocardial infarction.



Respiratory depression, nausea and vomiting may occur due to the morphine.



After acute overdosage of ipecacuanha, activated charcoal should be given to delay absorption, followed by gastric lavage if necessary. Excessive vomiting should be controlled by administration of an ant-emetic, and fluid and electrolyte imbalance corrected if necessary.



In acute opiold poisoning the stomach should be emptied by aspiration and lavage, intensive supportive therapy may be required to correct respiratory failure and shock.



Severe respiratory depression and coma produced by excessive doses of opioids can be counteracted by the administration of naloxone given intravenously at a dose of 0.4 to 2mg, repeated at 2-3 minute intervals if necessary, up to 10mg.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Ipecacuanha is an expectorant, and in larger doses an emetic.



Morphine is an opioid analgesic acting mainly on the central nervous system and smooth muscle. It is used for relief of moderate to severe pain and is also effective as a cough suppressant.



5.2 Pharmacokinetic Properties



Emetine one of the major alkaloids of ipecacuanha is excreted or metabolised slowly, it has been detected in urine 40-60 days after discontinuation of treatment.



Morphine salts are absorbed from the gastro-intestinal tract. Morphine is distributed throughout the body. It crosses the placenta and traces have been found in milk and sweat.



Conjugation to morphine 3- and 6- glucuronides occurs in the liver. About 10% of a dose is excreted through the bile into the faeces, the remainder being excreted in the urine in the form of conjugates. About 90% of total morphine is excreted in 24 hours with traces up to 48 hours.



5.3 Preclinical Safety Data



None.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Treacle Black Commercial, Peppermint Oil BP, Ethanol (96%) BP, Diethyl Ether (Peroxide Free), Chloroform BP, Syrup BP and Purified Water BP.



6.2 Incompatibilities



None known.



6.3 Shelf Life



18 months unopened, 8 weeks after first opening.



6.4 Special Precautions For Storage



Store below 25°C.



6.5 Nature And Contents Of Container



200ml: Amber glass bottle with plastic screw cap and liner or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner.



6.6 Special Precautions For Disposal And Other Handling



None.



7. Marketing Authorisation Holder



Thornton & Ross Limited



Linthwaith Laboratories



Huddersfield



HD7 5QH



8. Marketing Authorisation Number(S)



PL 00240/6491R



9. Date Of First Authorisation/Renewal Of The Authorisation



05/03/2009



10. Date Of Revision Of The Text



30/10/2009