theophylline

thee-OF-i-lin

Commonly used brand name(s)

In the U.S.

• Elixophyllin


• Norphyl


• Phyllocontin


• Quibron-T


• Quibron-T/SR


• Theo-24


• TheoCap


• Theochron


• Theo-Dur


• Theo-Time


• Truxophyllin


• Uniphyl

Available Dosage Forms:

• Solution


• Tablet, Extended Release, 12 HR


• Tablet


• Capsule, Extended Release, 24 HR


• Capsule, Extended Release


• Tablet, Extended Release


• Capsule, Extended Release, 12 HR


• Syrup


• Capsule


• Tablet, Extended Release, 24 HR


• Elixir


• Tablet, Enteric Coated

Therapeutic Class: Bronchodilator

Chemical Class: Methylxanthine

Uses For theophylline

Theophylline is used together with other medicines to treat the symptoms of asthma, bronchitis, emphysema, and other lung diseases.

Theophylline belongs to a group of medicines known as bronchodilators. Bronchodilators are medicines that relax the muscles in the bronchial tubes (air passages) of the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

theophylline is available only with your doctor's prescription.

Before Using theophylline

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For theophylline, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to theophylline 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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of theophylline in children. However, children younger than 1 year of age are more likely to have serious side effects, which may require caution and an adjustment in the dose for patients receiving theophylline.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of theophylline in the elderly. However, elderly patients may be more sensitive to the effects of theophylline than younger adults, and are more likely to have kidney, liver, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving theophylline.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

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 theophylline, 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 theophylline 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.

• Bupropion


• Cimetidine


• Ciprofloxacin


• Deferasirox


• Desogestrel


• Dienogest


• Drospirenone


• Enoxacin


• Erythromycin


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etintidine


• Etonogestrel


• Fluvoxamine


• Halothane


• Idrocilamide


• Imipenem


• Levofloxacin


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mestranol


• Mexiletine


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Pefloxacin


• Peginterferon Alfa-2a


• Rofecoxib


• Thiabendazole


• Troleandomycin


• Vemurafenib


• Zileuton

Using theophylline with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenosine


• Adinazolam


• Alprazolam


• Aminoglutethimide


• Amiodarone


• Azithromycin


• Bromazepam


• Brotizolam


• Cannabis


• Carbamazepine


• Chlordiazepoxide


• Clobazam


• Clonazepam


• Clorazepate


• Diazepam


• Disulfiram


• Estazolam


• Febuxostat


• Flunitrazepam


• Flurazepam


• Fosphenytoin


• Halazepam


• Interferon Alfa-2a


• Ipriflavone


• Isoproterenol


• Ketazolam


• Lorazepam


• Lormetazepam


• Medazepam


• Methotrexate


• Midazolam


• Nilutamide


• Nitrazepam


• Oxazepam


• Pancuronium


• Pentoxifylline


• Phenobarbital


• Phenytoin


• Piperine


• Prazepam


• Propafenone


• Quazepam


• Rifampin


• Rifapentine


• Riluzole


• Ritonavir


• Secobarbital


• St John's Wort


• Tacrine


• Tacrolimus


• Telithromycin


• Temazepam


• Ticlopidine


• Triazolam


• Viloxazine


• Zafirlukast

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using theophylline with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use theophylline, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine


• food

Other Medical Problems

The presence of other medical problems may affect the use of theophylline. Make sure you tell your doctor if you have any other medical problems, especially:

• Congestive heart failure or


• Cor pulmonale (heart condition) or


• Fever of 102 degrees F or higher for 24 hours or more or


• Hypothyroidism (underactive thyroid) or


• Infection, severe (e.g., sepsis) or


• Kidney disease in infants younger than 3 months of age or


• Liver disease (e.g., cirrhosis, hepatitis) or


• Pulmonary edema (lung condition) or


• Shock (serious condition with very little blood flow in the body)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Heart rhythm problems (e.g., arrhythmia) or


• Seizures, or history of or


• Stomach ulcer—Use with caution. May make these conditions worse.

Proper Use of theophylline

Take theophylline exactly as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. theophylline works best if there is a constant amount in the blood. To keep the blood level constant, take theophylline at the same time each day and do not miss any doses.

After you or your child begin taking theophylline, it is very important that your doctor check the level of the medicine in the blood at regular intervals to decide if the dose needs to be changed. Keep all appointments for testing the blood level.

Take the extended-release capsule or tablet every morning at the same time each day. You may take your second dose 10 to 12 hours after the morning dose and before the evening meal, unless your doctor tells you otherwise.

Swallow the extended-release tablet whole. Do not break, crush, or chew it. You may take the extended-release tablet with or without food.

It is best to take the extended-release capsule one hour before a high-fat meal or without food.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of theophylline 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 theophylline. 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.

• To treat symptoms of asthma, bronchitis, and emphysema:
  
  • For oral dosage form (elixir or tablets):
    
    • Adults, teenagers, and children above 1 year of age weighing more than 45 kilograms (kg)—At first, 300 milligrams (mg) per day, divided and given every 6 to 8 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 600 mg per day.
    
    
    • Older adults—The dose must be determined by your doctor. However, the total dose is usually not more than 400 milligrams per day, divided and given every 6 to 8 hours.
    
    
    • Children and teenagers 1 to 15 years of age weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, the dose is 12 to 14 milligrams (mg) per kg of body weight per day, divided and given every 4 to 6 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 20 mg per kg of body weight per day or 600 mg per day.
    
    
    • Infants younger than 1 year of age—Dose is based on body weight and age and must be determined by your doctor.
    
    
  
  
  • For oral dosage form (extended-release capsules):
    
    • Adults, teenagers, and children 12 years of age and older weighing more than 45 kilograms (kg)—At first, 300 to 400 milligrams (mg) as a single dose, usually in the morning, or divided and given two times per day. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 600 mg per day.
    
    
    • Older adults—The dose must be determined by your doctor. However, the total dose is usually not more than 400 milligrams per day as a single dose, usually in the morning, or divided and given two times per day.
    
    
    • Children and teenagers 12 to 15 years of age weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, the dose is 12 to 14 milligrams (mg) per kg of body weight per day as a single dose, usually in the morning, or divided and given two times per day. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 20 mg per kg of body weight per day or 600 mg per day.
    
    
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (extended-release tablets):
    
    • Adults, teenagers, and children 6 years of age and older weighing more than 45 kilograms (kg)—At first, 300 milligrams (mg) per day, divided and given every 12 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 600 mg per day.
    
    
    • Older adults—The dose must be determined by your doctor. However, the total dose is usually not more than 400 milligrams per day, divided and given every 12 hours.
    
    
    • Children and teenagers 6 to 15 years of age weighing less than 45 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, the dose is 12 to 14 milligrams (mg) per kg of body weight per day, divided and given every 12 hours. Your doctor may adjust your dose as needed. However, the total dose is usually not more than 20 mg per kg of body weight per day or 600 mg per day.
    
    
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of theophylline, 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using theophylline

It is very important that your doctor check the progress of you or your child at regular visits, especially for the first few weeks after you begin using theophylline. Blood tests may be needed to check for unwanted effects.

A change in your usual behavior or physical well-being may affect the way theophylline works in your body. Tell your doctor if you or your child:

• Have had a fever of 102 degrees F or higher for at least 24 hours or more.


• Have started or stopped smoking tobacco or marijuana in the last few weeks.


• Have started or stopped taking another medicine in the last few weeks.


• Have changed your diet in the last few weeks.

Stop using theophylline and check with your doctor right away if you or your child have the following symptoms while using theophylline: nausea or vomiting that continues, headaches, trouble with sleeping, seizures, or irregular heartbeats.

Do not stop or change the dose of theophylline without checking first with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you or your child are using theophylline. The results of some tests may be affected by theophylline.

theophylline may add to the central nervous system (CNS) stimulant effects of caffeine-containing foods or beverages such as chocolate, cocoa, tea, coffee, and cola drinks. Avoid eating or drinking large amounts of these foods or beverages while using theophylline. If you have questions about this, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal (e.g., St. John's wort) or vitamin supplements.

theophylline 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.

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

Incidence not known

• Chest pain or discomfort


• dizziness


• fainting


• fast, slow, or irregular heartbeat


• increase in urine volume


• lightheadedness


• persistent vomiting


• pounding or rapid pulse


• seizures


• shakiness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Abdominal or stomach pain


• blurred vision


• confusion


• confusion about identity, place, and time


• dark-colored urine


• decrease in frequency of urination


• decreased urine


• diarrhea


• difficulty in passing urine (dribbling)


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• dry mouth


• fast, pounding, or irregular heartbeat or pulse


• fever


• increased thirst


• irregular heartbeat


• loss of appetite


• mood changes


• muscle cramps or spasms


• muscle pain or stiffness


• nausea or vomiting


• nervousness


• numbness or tingling in the hands, feet, or lips


• pain or discomfort in the arms, jaw, back, or neck


• painful urination


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• sweating


• unusual tiredness or weakness


• vomiting of blood or material that looks like coffee grounds

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:

Incidence not known

• Headache


• irritability


• restlessness


• sleeplessness


• trouble sleeping


• unable to sleep

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: theophylline side effects (in more detail)

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More theophylline resources

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

• theophylline Concise Consumer Information (Cerner Multum)


• Theophylline Prescribing Information (FDA)


• Theophylline MedFacts Consumer Leaflet (Wolters Kluwer)


• Theophylline Professional Patient Advice (Wolters Kluwer)


• Elixophyllin Prescribing Information (FDA)


• Elixophyllin Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Quibron-T Prescribing Information (FDA)


• Theo-24 Prescribing Information (FDA)


• TheoCap Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Theochron Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Theolair tablets Prescribing Information (FDA)


• Theophyllines Monograph (AHFS DI)


• Uniphyl Prescribing Information (FDA)

Compare theophylline with other medications

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leuprolide Intramuscular, Subcutaneous, Intradermal, Injection

LOO-proe-lide AS-e-tate

Commonly used brand name(s)

In the U.S.

• Eligard


• Lupron


• Lupron Depot


• Lupron Depot-Ped


• Viadur

Available Dosage Forms:

• Powder for Solution


• Powder for Suspension, 3 Month


• Solution


• Powder for Suspension, 1 Month


• Powder for Suspension, 6 Month


• Kit


• Powder for Suspension, 4 Month


• Powder for Suspension

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Leuprolide

Uses For leuprolide

Leuprolide is a man-made version of a hormone that is similar to the one normally released from the hypothalamus gland in the brain. It is used to treat a number of medical problems. These include:

• Anemia caused by bleeding of uterine leiomyomas (tumors in the uterus).


• Cancer of the prostate, advanced.


• Central precocious puberty (CPP), a condition that causes early puberty in boys (before 9 years of age) and in girls (before 8 years of age).


• Pain due to endometriosis.

When given regularly to men and boys, leuprolide decreases testosterone levels. Reducing the amount of testosterone in the body is one way of treating cancer of the prostate.

When given regularly to women, leuprolide decreases estrogen levels. Reducing the amount of estrogen in the body is one way of treating endometriosis. By shrinking tumors in the uterus, leuprolide helps stop anemia by decreasing the vaginal bleeding from these tumors. Iron supplements should be used to help treat the anemia.

When given to boys and girls experiencing early puberty, leuprolide slows down the development of the genital areas in both sexes and breast development in girls. leuprolide delays puberty in a child only as long as the child continues to receive it.

Suppressing estrogen can cause thinning of the bones or slowing of growth. This is a problem for adult women whose bones are no longer growing like the bones of children. Slowing the growth of bones is a positive effect in girls and boys whose bones grow too fast when puberty begins too early. Boys and girls may benefit by adding inches to their adult height when leuprolide helps their bones grow at the proper and expected rate for children.

leuprolide is 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 this use is not included in product labeling, leuprolide is used in certain patients with the following medical condition:

• Cancer of the breast.

Before Using leuprolide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For leuprolide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to leuprolide 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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of leuprolide pediatric injection in children. However, use is not recommended in children younger than 2 years of age. Leuprolide pediatric injection will stop having an effect on a child treated for central precocious puberty soon after the child stops using it, and puberty will advance normally. It is not known if using leuprolide around the time of puberty causes changes in boys' and girls' future abilities to have babies. Their chances of having children later are thought to be normal. It is especially important that you discuss with the child's doctor the benefit of leuprolide as well as the risk of using it.

Appropriate studies have not been performed on the relationship of age to the effects of Eligard®, Lupron® injection, Lupron Depot®, Lupron Depot®-3 month, Lupron Depot®-4 month, Lupron Depot®-6 month, or Viadur® in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Eligard®, Lupron® injection, Lupron Depot®, Lupron Depot®-3 month, Lupron Depot®-4 month, or Lupron Depot®-6 month in the elderly.

No information is available on the relationship of age to the effects of leuprolide pediatric injection and Viadur® in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Other Medical Problems

The presence of other medical problems may affect the use of leuprolide. Make sure you tell your doctor if you have any other medical problems, especially:

• Benzyl alcohol allergy, history of—Using Lupron® injection (certain brand) may cause a skin reaction.

• Brain problems (e.g., brain tumors), history of or


• Pituitary gland problem or


• Seizures or epilepsy, history of or


• Stroke, history of—Use with caution. May make these conditions worse.

• Changes in vaginal bleeding from an unknown cause (for use for endometriosis or anemia due to tumors of the uterus)—Leuprolide may delay diagnosis or worsen condition. The reason for the bleeding should be determined before leuprolide is used.

• Conditions that increase the chances of developing thinning bones or


• Osteoporosis (thinning of the bones), family history of—It is important that your doctor know if you already have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, alcohol abuse, and a family history of osteoporosis or easily broken bones. Some medicines, such as corticosteroids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones when used for a long time.

• Congestive heart failure or


• Diabetes or


• Electrolyte imbalance or


• Heart or blood vessel disease or


• Heart rhythm problems (e.g., congenital long QT syndrome) or


• Hyperglycemia (high sugar in the blood)—Use with caution. May make these conditions worse in patients treated for prostate cancer.

• Nerve problems caused by bone lesions in the spine (in treatment of cancer of the prostate) or


• Problems in passing urine (in treatment cancer of the prostate)—Conditions may get worse for a short time after leuprolide treatment is started. Your doctor will want to follow your condition carefully.

Proper Use of leuprolide

For leuprolide injections (Eligard®, Lupron® injection, Lupron Depot®, Lupron Depot®-Ped 1-month or 3-month, Lupron Depot®-3 month, Lupron Depot®-4 month, or Lupron Depot®-6 month):

• A nurse or other trained health professional may give you leuprolide. leuprolide is given as a shot under your skin or into a muscle.


• You may be taught how to give leuprolide at home. Make sure you understand all of the instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.


• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.


• Use a new needle and syringe each time you inject your medicine.


• Before each injection, look carefully at the medicine to check for any particles or a change in color. You should not use medicine that has changed color or has particles in it.


• If you have any questions about any of this, check with your doctor.

Each package of leuprolide injection contains patient directions. Read the instructions carefully and make sure you understand:

• How to prepare the injection.


• Proper use of disposable syringes.


• How to give the injection.


• How long the injection is stable.

The long-acting form of leuprolide (depot) may be given once every month or once every 3 to 12 months. Your schedule depends on the reason you are using leuprolide. To stay on the right schedule with the medicine, make sure you keep all appointments.

If you are to receive the leuprolide implant (Viadur®):

• Viadur® is an implant that is surgically placed under the skin of the upper arm. Your doctor will treat the arm with numbing medicine and then cut a small incision to insert the implant with a special tool. The incision will be closed with surgical strips. An adhesive bandage will be placed over the arm and should be left on for 24 hours.


• After the implant is put in place, you should keep the arm clean and dry, and should not swim or bathe for 24 hours. You should avoid any heavy lifting or strenuous exercise for 48 hours after the implant is put into the arm.


• The surgical strips can be removed after at least 3 days or as soon as the incision is healed.


• The implant will be left in place for one year and then removed. If needed, your doctor will then insert a new implant to continue treatment for another year.


• Viadur® comes with patient instructions. Read these instructions carefully.

Use only the brand of leuprolide that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of leuprolide 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 leuprolide. 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.

• For cancer of the prostate:
  
  • The dose varies depending on the specific product used.
  
  


• For central precocious puberty:
  
  • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose for the once daily product is 50 microgram (mcg) per kilogram (kg) of body weight injected under the skin once a day. The starting dose for the once monthly product is 0.3 milligrams (mg) per kg of body weight or 7.5 mg, 11.25 mg, or 15 mg injected into a muscle every 4 weeks. The 3-month product dose is 11.25 mg or 30 mg injected into a muscle as a single injection every 12 weeks. Your doctor may increase your dose as needed.
  
  
  • Children younger than 2 years of age—Use is not recommended.
  
  


• For anemia caused by tumors of the uterus or endometriosis:
  
  • Adults—The dose given depends on the specific product used. Some examples are 3.75 milligrams (mg) injected into a muscle once a month for up to 3 months or 11.25 mg injected into a muscle as a single injection to last for 3 months. .
  
  

Missed Dose

leuprolide needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

The mixed suspension should be discarded if not used right away. Eligard® must be used within 30 minutes after mixing, and Lupron Depot® must be used within 2 hours after mixing.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using leuprolide

It is very important that your doctor check the progress of you or your child at regular visits to make sure that leuprolide is working properly. Blood and urine tests may be needed to check for unwanted effects.

For female patients: You should not receive leuprolide if you are pregnant or may become pregnant. Using leuprolide while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

For patients receiving leuprolide for central precocious puberty (CPP):

• If you are a female patient, you may have occasional bleeding or spotting. If you continue to have heavy bleeding or regular periods after 2 months of using leuprolide, call your doctor.


• If you develop a rash or irritation at the injection site, check with your doctor right away.

For patients receiving leuprolide for endometriosis or for anemia caused by tumors of the uterus:

• For the first few days of treatment, the symptoms of your condition may get worse. This is normal. Do not stop taking leuprolide. Talk with your doctor if you have concerns about this.


• During the time you are receiving leuprolide, your menstrual period may not be regular or you may not have a menstrual period at all. This is to be expected when being treated with leuprolide. If regular menstruation does not begin within 60 to 90 days after you stop receiving leuprolide, check with your doctor.


• During the time you are receiving leuprolide, you should use birth control methods that do not contain hormones. If you have any questions about this, check with your doctor.


• If you suspect you may have become pregnant, stop using leuprolide and check with your doctor. There is a chance that continued use of leuprolide during pregnancy could cause birth defects or a miscarriage.

When you first start using leuprolide for prostate cancer treatment, some of your symptoms might get worse for a short time. You might also have new symptoms. You might have bone pain, back pain, a tingling or numbness in the body, blood in the urine, or trouble urinating. These symptoms should improve within a few weeks. Tell your doctor if you have any new symptoms or your symptoms get worse.

Patients receiving leuprolide for advanced prostate cancer:

• leuprolide may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.


• leuprolide may increase your risk of having a heart attack or stroke. Check with your doctor right away if you are having chest pain or discomfort; pain or discomfort in the arms, jaw, back, or neck; confusion; shortness of breath; nausea or vomiting, or sweating.


• leuprolide can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

leuprolide can cause decreases in bone mineral density, which may lead to osteoporosis or weakened bones. Talk with your doctor about how this risk will affect you.

leuprolide may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using leuprolide.

Do not stop using or changing the dose of Lupron® injection without checking first with your doctor.

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

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

leuprolide 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.

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

For adultsLess common

• Fast or irregular heartbeat

Rare

• Bone, muscle, or joint pain


• fainting


• fast or irregular breathing


• numbness or tingling of the hands or feet


• puffiness or swelling of the eyelids or around the eyes


• shortness of breath


• skin rash, hives, or itching


• sudden, severe decrease in blood pressure and collapse


• tightness in the chest or wheezing


• troubled breathing

For males only (adults)More common

• Arm, back, or jaw pain


• bloody or cloudy urine


• blurred vision


• burning while urinating


• chest pain or discomfort


• chest tightness or heaviness


• difficult or labored breathing


• difficult, burning, or painful urination


• difficulty with moving


• dizziness


• frequent urge to urinate


• headache


• increased urge to urinate during the night


• muscle pain or stiffness


• nausea


• nervousness


• pain in the joints


• pale skin


• pounding in the ears


• slow or fast heartbeat


• sweating


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• waking to urinate at night

Rare

• Pain in the groin or legs (especially in the calves of the legs)

Incidence not known

• Altered mental status


• cardiovascular collapse


• double vision


• visual changes


• vomiting

For females only (adults)Rare

• Anxiety


• deepening of voice


• increased hair growth


• mental depression


• mood changes

For childrenRare

• Body pain


• burning, itching, redness, or swelling at the injection site


• skin rash

For females only (children)—expected in first few weeksRare

• Vaginal bleeding (continuing)


• white vaginal discharge (continuing)

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:

For adultsMore common

• Sudden sweating and feelings of warmth (also called hot flashes)

Less common

• Bleeding, bruising, burning, itching, pain, redness, or swelling at the injection site


• decreased interest in sexual intercourse


• swelling of the feet or lower legs


• swelling or increased tenderness of the breasts


• trouble with sleeping


• weight gain

For females only (adults)More common

• Light, irregular vaginal bleeding


• stopping of menstrual periods

Less common

• Burning, dryness, or itching of the vagina


• pelvic pain

For males only (adults)More common

• Back pain


• chills


• constipation


• cough


• diarrhea


• fever


• general feeling of discomfort or illness


• loss of appetite


• pain or discomfort at the injection site


• redness of the face, neck, arms, and occasionally, upper chest


• runny nose


• shivering


• sleeplessness


• sore throat


• sudden sweating


• trouble sleeping


• unable to sleep


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Less common

• Bone pain


• decreased size of the testicles


• inability to have or keep an erection

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: leuprolide Intramuscular, Subcutaneous, Intradermal, Injection 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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More leuprolide Intramuscular, Subcutaneous, Intradermal, Injection resources

• Leuprolide Intramuscular, Subcutaneous, Intradermal, Injection Side Effects (in more detail)
• Leuprolide Intramuscular, Subcutaneous, Intradermal, Injection Use in Pregnancy & Breastfeeding
• Leuprolide Intramuscular, Subcutaneous, Intradermal, Injection Drug Interactions
• Leuprolide Intramuscular, Subcutaneous, Intradermal, Injection Support Group
• 53 Reviews for Leuprolide Intramuscular, Subcutaneous, Intradermal, Injection - Add your own review/rating

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Poly Hist Forte

Generic Name: chlorpheniramine/ pyrilamine/ phenylephrine/ phenylpropanolamine (klor fen IR a meen/pie RILL a meen/fen ill EFF rin/fen ill proe pa NOLE a meen)

Brand Names: Histalet Forte, Poly Hist Forte, Vanex Forte

What is Poly Hist Forte (chlorpheniramine/ pyrilamine/ phenylephrine/ phenylpropanolamine)?

Chlorpheniramine and pyrilamine are antihistamines. They block the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine and pyrilamine prevent sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Phenylephrine and phenylpropanolamine are decongestants. They constrict blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal and respiratory (breathing) passages to open up.

Chlorpheniramine/pyrilamine/phenylephrine/phenylpropanolamine is used to treat nasal congestion and sinusitis (inflammation of the sinuses) associated with allergies, hay fever, and the common cold.

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.

Chlorpheniramine/pyrilamine/phenylephrine/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 Poly Hist Forte (chlorpheniramine/ pyrilamine/ phenylephrine/ 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. Chlorpheniramine/pyrilamine/phenylephrine/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 chlorpheniramine/pyrilamine/phenylephrine/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 Poly Hist Forte (chlorpheniramine/ pyrilamine/ phenylephrine/ phenylpropanolamine)?

Do not take chlorpheniramine/pyrilamine/phenylephrine/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,

  
  


• 
  

  emphysema or chronic bronchitis, or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

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

Chlorpheniramine/pyrilamine/phenylephrine/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 chlorpheniramine/pyrilamine/phenylephrine/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.

How should I take Poly Hist Forte (chlorpheniramine/ pyrilamine/ phenylephrine/ phenylpropanolamine)?

Take chlorpheniramine/pyrilamine/phenylephrine/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 long-acting or sustained-release forms of this medication. Swallow them whole. If you are unsure about the formulation of the medicine, ask your pharmacist for help. If you cannot swallow the tablets or capsules, look for a liquid form of the medication. Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm.

Do not take chlorpheniramine/pyrilamine/phenylephrine/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 chlorpheniramine/pyrilamine/phenylephrine/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 chlorpheniramine/pyrilamine/phenylephrine/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea and vomiting.

What should I avoid while taking Poly Hist Forte (chlorpheniramine/ pyrilamine/ phenylephrine/ phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine/pyrilamine/phenylephrine/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 chlorpheniramine/pyrilamine/phenylephrine/phenylpropanolamine.

Poly Hist Forte (chlorpheniramine/ pyrilamine/ phenylephrine/ phenylpropanolamine) side effects

Serious side effects are unlikely to occur. Stop taking chlorpheniramine/pyrilamine/phenylephrine/ 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 chlorpheniramine/pyrilamine/phenylephrine/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 Poly Hist Forte (chlorpheniramine/ pyrilamine/ phenylephrine/ phenylpropanolamine)?

Do not take chlorpheniramine/pyrilamine/phenylephrine/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 chlorpheniramine/pyrilamine/phenylephrine/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain chlorpheniramine, pyrilamine, phenylephrine, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Chlorpheniramine/pyrilamine/phenylephrine/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 chlorpheniramine/pyrilamine/phenylephrine/phenylpropanolamine is taken with any of these medications.

Drugs other than those listed here may also interact with chlorpheniramine/pyrilamine/phenylephrine/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

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• Cold Symptoms
• Cough and Nasal Congestion
• Hay Fever
• Sinusitis
• Upper Respiratory Tract Infection

Where can I get more information?

• Your pharmacist has additional information about chlorpheniramine/pyrilamine/phenylephrine/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Chlorpheniramine/pyrilamine/phenylephrine and phenylpropanolamine is available with a prescription under the brand names Vanex Forte and Histalet Forte in tablets containing 4 mg of chlorpheniramine, 25 mg of pyrilamine, 10 mg of phenylephrine, and 50 mg of phenylpropanolamine. 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.

Uniphyllin Continus tablets

1. Name Of The Medicinal Product

UNIPHYLLIN^® CONTINUS^® 200, 300 and 400 mg prolonged release tablets

2. Qualitative And Quantitative Composition

Tablets containing 200, 300 or 400 mg of Theophylline.

For excipients, see 6.1

3. Pharmaceutical Form

Prolonged release tablets

200 mg	Capsule shaped, white tablet, plain one side and 'U200' on the other.
300 mg	Capsule shaped, white tablet, plain one side and 'U300' on the other.
400 mg	Capsule shaped, white tablet with 'UNIPHYLLIN' on one side and the 'Napp logo' and 'U400' on the reverse.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment and prophylaxis of bronchospasm associated with asthma, chronic obstructive pulmonary disease and chronic bronchitis. Also indicated for the treatment of left ventricular and congestive cardiac failure.

4.2 Posology And Method Of Administration

Route of Administration

Oral

The tablets should be swallowed whole and not crushed or chewed. Crushing or chewing the tablets may lead to a rapid release of theophylline with the potential for toxicity. Patients vary in their response to xanthines and it may be necessary to titrate the dose on an individual basis.

The usual maintenance dose for adults and elderly patients is 200 mg 12 hourly. This may be titrated to either 300 mg or 400 mg dependent on the therapeutic response. Plasma theophylline concentrations should ideally be maintained between 5 and 15 mg/l. A plasma level of 5 mg/l probably represents the lower level of clinical effectiveness. Significant adverse reactions are usually seen at plasma theophylline levels greater than 20 mg/l. Patients may require monitoring of plasma theophylline levels when higher dosages are prescribed or when co-administered with medication that reduces theophylline clearance.

Children: The maintenance dose is 9 mg/kg twice daily. Some children with chronic asthma require and tolerate much higher doses (10-16 mg/kg twice daily). Lower dosages (based on usual adult dose) may be required for adolescents.

It may be appropriate to administer a larger evening or morning dose in some patients, in order to achieve optimum therapeutic effect when symptoms are most severe e.g. at the time of the 'morning dip' in lung function.

In patients whose night time or day time symptoms persist despite other therapy and who are not currently receiving theophylline, then the total daily requirement of UNIPHYLLIN CONTINUS tablets (as specified above) may be added to their treatment regimen as either a single evening or morning dose.

4.3 Contraindications

Porphyria; hypersensitivity to xanthines or any of the tablet constituents; concomitant administration with ephedrine in children.

4.4 Special Warnings And Precautions For Use

The patient's response to therapy should be carefully monitored – worsening of asthma symptoms requires medical attention.

Use with caution in patients with cardiac disease, peptic ulcer, hyperthyroidism, severe hypertension, hepatic dysfunction, chronic alcoholism or acute febrile illness.

Caution should be exercised in elderly males with pre-existing partial outflow obstruction, such as prostatic enlargement, due to risk of urinary retention.

The half-life of theophylline may be prolonged in the elderly and in patients with heart failure, hepatic impairment or viral infections. Toxic accumulation may occur (see Section 4.9 Overdose). A reduction of dosage may be necessary in the elderly patient.

The hypokalaemia resulting from beta agonist therapy, steroids, diuretics and hypoxia may be potentiated by xanthines. Particular care is advised in patients suffering from severe asthma who require hospitalisation. It is recommended that serum potassium levels are monitored in such situations.

Severe side effects (hypertonia, convulsions, supraventricular tachycardia) may indicate serum concentrations of theophylline above therapeutic levels. Serum concentrations should be checked urgently and a decrease in the dose of theophylline may be required.

Alternative treatment is advised for patients with a history of seizure activity.

It is not possible to ensure bioequivalence between different prolonged release theophylline products. Therefore patients, once titrated to an effective dose, should not be changed from one prolonged release theophylline preparation to a different prolonged release preparation without re-titration and clinical assessment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The following increase clearance and it may therefore be necessary to increase dosage to ensure a therapeutic effect: aminoglutethimide, carbamazepine, isoprenaline, moracizine, phenytoin, rifampicin, ritonavir, sulphinpyrazone, barbiturates and hypericum perforatum. Plasma concentrations of theophylline can be reduced by concomitant use of the herbal remedy St John's Wort (hypericum perforatum). Smoking and alcohol consumption can also increase clearance of theophylline.

The following reduce clearance and a reduced dosage may therefore be necessary to avoid side-effects: allopurinol, carbimazole, cimetidine, ciprofloxacin, clarithromycin, diltiazem, disulfiram, erythromycin, fluconazole, interferon, isoniazid, methotrexate, mexiletine, nizatidine, norfloxacin, oxpentifylline, propafenone, propranolol, ofloxacin, thiabendazole, verapamil, viloxazine hydrochloride and oral contraceptives (see Section 4.9 Overdose). The concomitant use of theophylline and fluvoxamine should usually be avoided. Where this is not possible, patients should have their theophylline dose halved and plasma theophylline should be monitored closely.

Factors such as viral infections, liver disease and heart failure also reduce theophylline clearance (see Section 4.9 Overdose). There are conflicting reports concerning the potentiation of theophylline by influenza vaccine and physicians should be aware that interaction may occur. A reduction in dosage may be necessary in elderly patients. Thyroid disease or associated treatment may alter theophylline plasma levels. There is also a pharmacological interaction with adenosine, benzodiazepines, halothane, lomustine and lithium and these drugs should be used with caution.

Theophylline may decrease steady state phenytoin levels.

Xanthines can potentiate hypokalaemia resulting from beta₂ agonist therapy, steroids, diuretics and hypoxia. Particular caution is advised in severe asthma. It is recommended that serum potassium levels are monitored in such situations.

Co-administration with β-blockers may cause antagonism of bronchodilation; with ketamine may cause reduced convulsive threshold; with doxapram may cause increased CNS stimulation.

4.6 Pregnancy And Lactation

There are no adequate data from well controlled studies of the use of theophylline in pregnant women. Theophylline has been reported to give rise to teratogenic effects in mice, rats and rabbits (See section 5.3). The potential risk for humans is unknown. Theophylline should not be administered during pregnancy unless clearly necessary. Theophylline is secreted in breast milk, and may be associated with irritability in the infant, therefore it should only be given to breast feeding women when the anticipated benefits outweigh the risk to the child.

4.7 Effects On Ability To Drive And Use Machines

No known effects.

4.8 Undesirable Effects

The following adverse drug reactions have been reported in the post-marketing setting for theophylline. Frequencies of “not known” have been assigned as accurate frequencies cannot be estimated from the available clinical trial data.

Immune system disorders	Anaphylactic reaction
	Anaphylactoid reaction
	Hypersensitivity
Metabolism and nutrition disorders	Hyperuricaemia
Psychiatric disorders	Agitation
	Anxiety
	Insomnia
Nervous system disorders	Convulsions
	Dizziness
	Headache
	Tremor
Cardiac disorders	Atrial tachycardia
	Palpitations
	Sinus tachycardia
Gastrointestinal disorders	Abdominal pain
	Diarrhoea
	Gastric irritation
	Gastro-oesophageal reflux
	Nausea
	Vomiting
Skin and subcutaneous tissue disorders	Pruritus
	Rash
Renal and urinary disorders	Diuresis
	Urinary retention*

* Please refer to section 4.4 as theophylline may induce urinary retention in elderly males with pre-existing partial outflow obstruction.

4.9 Overdose

Over 3 g could be serious in an adult (40 mg/kg in a child). The fatal dose may be as little as 4.5 g in an adult (60 mg/kg in a child), but is generally higher.

Symptoms

Warning: Serious features may develop as long as 12 hours after overdosage with prolonged release formulations.

Alimentary features: Nausea, vomiting (which is often severe), epigastric pain and haematemesis. Consider pancreatitis if abdominal pain persists.

Neurological features: Restlessness, hypertonia, exaggerated limb reflexes and convulsions. Coma may develop in very severe cases.

Cardiovascular features: Sinus tachycardia is common. Ectopic beats and supraventricular and ventricular tachycardia may follow.

Metabolic features: Hypokalaemia due to shift of potassium from plasma into cells is common, can develop rapidly and may be severe. Hyperglycaemia, hypomagnesaemia and metabolic acidosis may also occur. Rhabdomyolysis may also occur.

Management

Activated charcoal or gastric lavage should be considered if a significant overdose has been ingested within 1-2 hours. Repeated doses of activated charcoal given by mouth can enhance theophylline elimination. Measure the plasma potassium concentration urgently, repeat frequently and correct hypokalaemia. BEWARE! If large amounts of potassium have been given, serious hyperkalaemia may develop during recovery. If plasma potassium is low, then the plasma magnesium concentration should be measured as soon as possible.

In the treatment of ventricular arrhythmias, proconvulsant antiarrhythmic agents such as lignocaine (lidocaine) should be avoided because of the risk of causing or exacerbating seizures.

Measure the plasma theophylline concentration regularly when severe poisoning is suspected, until concentrations are falling. Vomiting should be treated with an antiemetic such as metoclopramide or ondansetron.

Tachycardia with an adequate cardiac output is best left untreated. Beta-blockers may be given in extreme cases but not if the patient is asthmatic. Control isolated convulsions with intravenous diazepam. Exclude hypokalaemia as a cause.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Theophylline is a bronchodilator. In addition it affects the function of a number of cells involved in the inflammatory processes associated with asthma and chronic obstructive airways disease. Of most importance may be enhanced suppressor, T-lymphocyte activity and reduction of eosinophil and neutrophil function. These actions may contribute to an anti-inflammatory prophylactic activity in asthma and chronic obstructive airways disease. Theophylline stimulates the myocardium and produces a diminution of venous pressure in congestive heart failure leading to marked increase in cardiac output.

5.2 Pharmacokinetic Properties

Theophylline is well absorbed from UNIPHYLLIN CONTINUS tablets and at least 60% may be bound to plasma proteins. The main urinary metabolites are 1,3-dimethyl uric acid and 3-methylxanthine. About 10% is excreted unchanged.

5.3 Preclinical Safety Data

In studies in which mice, rats and rabbits were dosed during the period of organogenesis, theophylline produced teratogenic effects.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Hydroxyethylcellulose

Povidone (K25)

Cetostearyl Alcohol

Macrogol 6000

Talc

Magnesium Stearate

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Blister packs consisting of aluminium foil sealed to 250 μm PVC with a PVdC coating of at least 40 gsm thickness, containing 56 tablets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Napp Pharmaceuticals Ltd

Cambridge Science Park

Milton Road

Cambridge CB4 0GW

8. Marketing Authorisation Number(S)

PL 16950/0066-0068

9. Date Of First Authorisation/Renewal Of The Authorisation

200 mg - 23 August 1979/15 May 2003

300 mg – 22 February 1988/15 May 2003

400 mg – 29 October 1982/15 May 2003

10. Date Of Revision Of The Text

22 March 2011

11 LEGAL CATEGORY

P

® UNIPHYLLIN, CONTINUS, NAPP and the Napp Device (logo) are Registered Trade Marks.

© 2010 – 2011 Napp Pharmaceuticals Ltd .

Miglitol

Class: alpha-Glucosidase Inhibitors
VA Class: HS502
Chemical Name: [2R - (2α,3β,4α,5β] - 1 - (2 - hydroxyethyl) - 2 - (hydroxymethyl) - 3,4,5 - piperidinetriol
Molecular Formula: C₈H₁₇NO₅
CAS Number: 72432-03-2
Brands: Glyset

Introduction

Antidiabetic agent; an α-glucosidase inhibitor.^{1 6 16 38}

Uses for Miglitol

Diabetes Mellitus

Used as monotherapy as an adjunct to diet and exercise for management of type 2 diabetes mellitus in patients whose hyperglycemia cannot be controlled by diet and exercise alone.^{1 2 13 16 38}

Also used as an adjunct to diet and exercise in combination with a sulfonylurea for management of type 2 diabetes mellitus in patients whose hyperglycemia cannot be controlled with miglitol or sulfonylurea monotherapy, diet, and exercise.^{1 6}

Metformin generally recommended over other antidiabetic agents for initial oral antidiabetic therapy because of absence of weight gain or hypoglycemia, relatively lower expense and greater efficacy, and generally low adverse effect profile.⁹²

A consensus group of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes recommends addition of a basal insulin or a sulfonylurea as second-line therapy in patients inadequately controlled on metformin monotherapy.⁹² Alternative but less well-validated second-line agents that can be added to metformin and lifestyle changes are pioglitazone (e.g., for patients in whom hypoglycemia is particularly undesirable) or exenatide (e.g., for patients in whom hypoglycemia is undesirable or to promote weight loss in patients close to target HbA_1c concentration [<8%]).⁹² α-Glucosidase inhibitors (e.g., acarbose, miglitol), amylin agonists (e.g., pramlintide), dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin), or meglitinides (e.g., repaglinide, nateglinide) generally are not recommended as first- or second-line antidiabetic therapy because of relative lesser efficacy, limited clinical data, frequent adverse GI effects, and/or greater cost.⁹²

Miglitol not effective as sole antidiabetic therapy in patients whose diabetes may be complicated by ketoacidosis (e.g., type 1 diabetes mellitus); instead, such patients should receive insulin.^{1 41} (See Contraindications under Cautions.)

Miglitol Dosage and Administration

General

• 
  

  Individualize treatment based on efficacy and tolerance and adjust target blood glucose and glycosylated hemoglobin (HbA_1c) concentrations based on patient’s understanding and adherence to the treatment regimen, the risk of severe hypoglycemia, and other factors that may increase risk or decrease benefit (e.g., very young or old age, comorbid conditions, other diseases that materially shorten life expectancy).^{1 41 91}

  
  


• 
  

  Goal of therapy is to reduce both postprandial blood glucose concentrations and HbA_1c concentrations to normal or near normal (<7%) using lowest effective dosage of miglitol as monotherapy or combined with a sulfonylurea antidiabetic agent.^{1 41} (Plasma glucose concentrations generally 10–15% higher than those in whole blood and may vary according to method and laboratory used.)⁹⁴ During therapy initiation and dosage titration, obtain 1-hour postprandial glucose concentration to determine therapeutic response and minimum effective dosage.¹ Monitor HbA_1c concentrations approximately every 3 months to evaluate long-term glycemic control.^{1 41} Monitor glucose concentrations 1–2 hours after the start of a meal in those who have elevated HbA_1c concentrations despite adequate preprandial glucose concentrations.⁴¹

  
  

Administration

Administer orally.^{1 6 16}

Oral Administration

Administer at the beginning (with the first bite) of each main meal.^{1 38}

Dosage

Adults

Diabetes Mellitus

Monotherapy

Oral

Initially, 25 mg 3 times daily at the beginning of each main meal.¹ To minimize adverse GI effects in patients who may have GI sensitivity to miglitol, initiate therapy with 25 mg once daily and increase gradually (e.g., over 4 weeks) as tolerated to 25 mg 3 times daily.^{1 91 95}

After 4–8 weeks at 25 mg 3 times daily, increase dosage as tolerated to 50 mg 3 times daily,¹ the usual maintenance dosage.^{1 93} If response (i.e., as determined by HbA_1c concentrations ) is not adequate after 3 months, increase dosage to 100 mg 3 times daily, the maximum recommended daily dosage.^{1 95} If no further therapeutic benefit occurs (i.e., as determined by postprandial glucose or HbA_1c concentrations) at the maximum recommended dosage, consider lowering dosage.¹ Once an effective and tolerated dosage is reached, maintain that dosage.¹

Combination Therapy with a Sulfonylurea

Oral

Initially, 25 mg 3 times daily at the beginning of each main meal.¹ To minimize adverse GI effects in patients who may have GI sensitivity to miglitol, initiate therapy with 25 mg once daily and increase gradually (e.g., over 4 weeks) as tolerated to 25 mg 3 times daily.^{1 91 95}

After 4–8 weeks at 25 mg 3 times daily, increase dosage as tolerated to 50 mg 3 times daily,¹ the usual maintenance dosage.^{1 93} If response (i.e., as determined by HbA_1c concentrations) is not adequate after 3 months, increase dosage to 100 mg 3 times daily, the maximum recommended daily dosage.^{1 95} If no further therapeutic benefit occurs (i.e., as determined by postprandial glucose or HbA_1c concentrations) at the maximum recommended dosage, consider lowering dosage.¹ Once an effective and tolerated dosage is reached, maintain that dosage.¹

Reduce dosage of concomitant sulfonylurea and/or miglitol if hypoglycemia occurs.^{1 93 95} (See Hypoglycemia under Cautions.)

Prescribing Limits

Adults

Diabetes Mellitus

Oral

Miglitol monotherapy: Maximum 100 mg 3 times daily.¹

Combination therapy with a sulfonylurea: Maximum 100 mg 3 times daily.¹

Special Populations

Hepatic Impairment

Not metabolized; dosage adjustments not required.^{1 38 91}

Renal Impairment

Accumulation of miglitol expected in patients with renal impairment.^{1 10 91 95} However, as miglitol acts locally in the small intestine, reduction of elevated plasma concentrations through dosage adjustments in such patients is not feasible.^{1 5 10 38 91 95} (See Renal Impairment under Cautions.)

Geriatric Patients

No dosage adjustment required based solely on age.^{1 93}

Cautions for Miglitol

Contraindications

• 
  

  Known hypersensitivity to the drug.¹

  
  


• 
  

  Diabetic ketoacidosis.^{1 93}

  
  


• 
  

  Inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or predisposition to this condition.¹

  
  


• 
  

  Chronic intestinal diseases associated with marked disorders of digestion or absorption.¹

  
  


• 
  

  Co-existing conditions that may deteriorate as a result of increased intestinal gas formation.¹

  
  

Warnings/Precautions

General Precautions

Hypoglycemia

Miglitol should not cause hypoglycemia when administered alone in the fasting or postprandial state.^{1 2 16 91 93 95} Increased risk of hypoglycemia when used concomitantly with insulin† or a sulfonylurea.^{1 93 95} If hypoglycemia occurs, adjust dosage of these agents appropriately.^{1 95} (See Combination Therapy with a Sulfonylurea under Dosage and Administration.)

Use oral glucose (dextrose) for the treatment of mild to moderate hypoglycemia instead of sucrose (table sugar, a disaccharide);^{1 91 93} absorption of oral glucose (a monosaccharide) is not delayed by miglitol.^{1 93 95} (See Actions.) Severe hypoglycemia may require the use of either IV glucose infusion or parenteral glucagon.^{1 91 95}

Loss of Glycemic Control

Possible loss of glycemic control during periods of stress (e.g., fever, trauma, infection, surgery); temporary administration of insulin may be required.^{1 95}

Specific Populations

Pregnancy

Category B.¹

Lactation

Distributed into milk in low concentrations; use not recommended in nursing women.^{1 91 93}

Pediatric Use

Safety and efficacy not established in pediatric patients.¹

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.^{1 93}

Renal Impairment

Not recommended for use in patients with substantial renal impairment (S_cr >2 mg/dL or Cl_cr <25 mL/minute); safety and efficacy not established.^{1 93 95}

Common Adverse Effects

Flatulence, ^{1 2 13 16 93} soft stools/¹ diarrhea,^{1 2 13 16 93} abdominal discomfort/pain.^{1 93}

Interactions for Miglitol

Carbohydrate-Splitting Digestive Enzyme Supplements

Possible reduction in glycemic effects of miglitol.^{1 91} Avoid concomitant use.^{1 91}

Intestinal Adsorbents

Possible reduction in glycemic effects of miglitol.^{1 91} Avoid concomitant use.^{1 91}

Specific Drugs

Drug	Interaction	Comments
Amylase (digestive enzyme preparation)	Possible reduction in glycemic effects1 91	Avoid concomitant use1 91 93
Antacids	Pharmacokinetic interaction unlikely1 91
Charcoal (intestinal adsorbent)	Possible reduction in glycemic effects1 91	Avoid concomitant use1 91 93
Digoxin	Variable effects on plasma digoxin concentrations, depending on population subgroup1 91 93
Glyburide (Also see entry for Sulfonylureas)	Possible decreased peak blood concentrations and AUC of glyburide1 91 93	Drug interaction not established, clinical importance unknown1 91 93
Insulin	Increased risk of hypoglycemia1 91 93	If hypoglycemia occurs, reduce dosage of insulin 1 91 93
Metformin	Minimal decrease in peak blood concentrations and AUC of metformin; no clinical effect on glycemic control1 38 91 93
Nifedipine	Pharmacokinetic or pharmacodynamic interaction unlikely1 91
Pancreatin (digestive enzyme preparation)	Possible reduction in glycemic effects1 91	Avoid concomitant use1
Pramlintide	Pramlintide-induced slowing of gastric emptying may influence drug effects89	Concomitant use not recommended89
Propranolol	Reduction in bioavailability of propranolol1 91 Pharmacodynamic interaction unlikely93	Adjustment of propranolol dosage may be necessary93 95
Ranitidine	Reduction in bioavailability of ranitidine1 91	Adjustment of ranitidine dosage may be necessary93
Sulfonylureas	Increased risk of hypoglycemia1 95 Reduction in the insulinotropic and weight-increasing effects of sulfonylureas1 6 Additive glycemic effects1 6 7 16	If hypoglycemia occurs, reduce dosage of sulfonylurea and/or miglitol1 91 93 95 Used to therapeutic advantage1 6
Warfarin	Pharmacokinetic or pharmacodynamic interaction unlikely1 91 93

Miglitol Pharmacokinetics

Absorption

Bioavailability

Absorbed via an active transport system that is saturable at high dosages.^{1 7 8 38 91 93 95} Bioavailability 100 or 50–70% following administration of 25- or 100-mg dose, respectively.^{1 91}

Peak plasma concentrations attained within 2–3 hours.^{1 8 91 93}

Therapeutic effects principally result from local actions on small intestine; no evidence that systemic absorption contributes to therapeutic response.^{1 16 38 91}

Duration

Reduction in postprandial blood glucose concentrations persists for 3–4 hours following single dose in healthy individuals.⁹³

Special Populations

Since miglitol excreted principally by kidneys, accumulation expected in patients with renal impairment.^{1 10 91 95} (See Renal Impairment under Cautions.)

Distribution

Extent

Distributed principally into extracellular fluid ^{1 8 91 93} and concentrated in enterocytes of small intestine.^{8 38}

Crosses placenta and is distributed into milk in low concentrations (0.02% of a 100-mg dose).^{1 8 93}

Very low permeation of blood-brain barrier in animals.^{8 91 93}

Plasma Protein Binding

<4%.^{1 91}

Elimination

Metabolism

Not metabolized.^{1 8 38 91}

Elimination Route

Following oral administration of 25 mg, excreted principally in urine (95%) as unchanged drug.^{1 8 91 93}

Half-life

Approximately 2–3 hours in healthy individuals over therapeutic dosage range.^{8 91 93}

Special Populations

Pharmacokinetics not altered in patients with cirrhosis;^{1 91} miglitol not metabolized.^{1 8}

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

ActionsActions

• 
  

  Inhibits α-glucosidase enzymes (e.g., sucrase, glucoamylase, maltase, isomaltase) that hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in small intestinal brush-border.^{1 5 10 38 91} Little or no inhibitory effect on trehalase, lactase, or pancreatic α-amylase; not expected to produce lactose intolerance.^{1 10 38 91 93}

  
  


• 
  

  Delays carbohydrate breakdown and glucose absorption and reduces postprandial hyperglycemia in diabetic patients.^{1 6 7 38 91 93}

  
  


• 
  

  Fasting blood glucose concentrations mildly decreased.^{1 2 7 13 38 88 93}

  
  


• 
  

  In contrast to sulfonylurea antidiabetic agents, miglitol does not enhance insulin secretion.^{1 2 13 16 91 93} Does not produce hypoglycemia when given as monotherapy in fasted or postprandial state.^{1 2 16}

  
  


• 
  

  When used in combination with sulfonylurea antidiabetic agents, miglitol reduces the insulinotropic and weight-increasing effects of sulfonylureas.^{1 6} Does not produce clinically important weight loss.⁶

  
  

Advice to Patients

• 
  

  Importance of adherence to diet and exercise regimen.^{1 91 93}

  
  


• 
  

  Importance of regular monitoring of blood glucose concentrations.^{1 91 93}

  
  


• 
  

  Provide instruction on the management of hypoglycemia.^{1 41} Advise of risk of hypoglycemia, its symptoms, and conditions that predispose to the development of hypoglycemia.¹ Importance of keeping a readily available source of glucose (dextrose) to treat symptoms of hypoglycemia when used in combination with insulin or a sulfonylurea agent.^{1 91}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Miglitol

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	25 mg	Glyset	Pfizer
		50 mg	Glyset	Pfizer
		100 mg	Glyset	Pfizer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 05/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Glyset 100MG Tablets (PFIZER U.S.): 90/$119.99 or 270/$335.95

Glyset 25MG Tablets (PFIZER U.S.): 90/$107.99 or 270/$301.96

Glyset 50MG Tablets (PFIZER U.S.): 90/$112.99 or 270/$307.98

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 13, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Pfizer. Glyset (miglitol) tablets prescribing information. New York, NY; 2008 May.

2. Johnston PS, Lebovitz HE, Coniff RF et al. Advantages of α-glucosidase inhibition as monotherapy in elderly type 2 diabetic patients. J Clin Endocrinol Metab. 1998; 83:1515-22. [PubMed 9589648]

5. Taylor RH, Barker HM, Bowey EA et al. Regulation of the absorption of dietary carbohydrate in man by two new glycosidase inhibitors. Gut. 1986; 27:1471-8. [PubMed 3804023]

6. Johnston PS, Santiago JV, Coniff RF et al. Effects of the carbohydrase inhibitor miglitol in sulfonylurea-treated NIDDM patients. Diabetes Care. 1994; 17:20-9. [PubMed 8112185]

7. Lebovitz HE. Oral antidiabetic agents: the emergence of α-glucosidase inhibitors. Drugs. 1992; 44 (Suppl 3):21-8. [PubMed 1280574]

8. Hans-Jurgen A, Boberg M, Brendel E et al. Pharmacokinetics of miglitol: absorption, distribution, metabolism, and excretion following administration to rats, dogs, and man. Arzneimittlforschung. 1997; 47:734-45.

10. Reuser AJJ, Wisselaar HA. An evaluation of the potential side-effects of α-glucosidase inhibitors used for the management of diabetes mellitus. Eur J Clin Invest. 1994; 24 (Suppl 3):19-24. [PubMed 8001622]

13. Pagano G, Marena S, Corgiat-Mansin L et al. Comparison of miglitol and glibenclamide in diet-treated type 2 diabetic patients. Diabete Metabol. 1995; 21:162-7.

16. Segal P, Feig PU, Schernthaner G et al. The efficacy and safety of miglitol therapy compared with glibenclamide in patients with NIDDM inadequately controlled by diet alone. Diabetes Care. 1997; 20:687-91. ( [PubMed 9135927]

38. Lebovitz HE. α-Glucosidase inhibitors as agents in the treatment of diabetes. Diabetes Reviews. 1998; 6:132-45.

41. American Diabetes Association. Standards of medical care in diabetes--2009. Diabetes Care. 2009; 32 Suppl 1:S13-61.

88. Van De Laar F, Lucassen PL, Akkermans RP et al. α-Glucosidase inhibitors for patients with type 2 diabetes: results from a Cochrane systematic review and meta-analysis. Diabetes Care. 2005; 28:154-63. [PubMed 15616251]

89. Amylin Pharmaceuticals. Symlin (pramlintide acetate) injection prescribing information. San Diego, CA; 2007 Dec.

91. Campbell LK, Baker DE, Campbell RK. Miglitol: assessment of its role in the treatment of patients with diabetes mellitus. Ann Pharmacother. 2000; 34:1291-301. [PubMed 11098345]

92. Nathan DM, Buse JB, Davidson MB et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009; 32:193-203. [PubMed 18945920]

93. Scott LJ, Spencer CM. Miglitol: a review of its therapeutic potential in type 2 diabetes mellitus. Drugs. 2000; 59:521-49. [PubMed 10776834]

94. Knudson PE, Weinstock RS, Henry JB. Carbohydrates. In: Henry JB, ed. Clinical diagnosis and management by laboratory methods. 20th ed. Philadelphia: WB Saunders; 2001:214.

95. Pfizer, New York, NY: Personal communication.

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