Monday, 30 April 2012

Acarbose


Pronunciation: AY-kar-bose
Generic Name: Acarbose
Brand Name: Precose


Acarbose is used for:

Treating type 2 diabetes. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.


Acarbose is a glucosidase inhibitor. It works by slowing down the enzyme that turns carbohydrates into glucose. This results in a smaller rise in blood sugar levels following a meal.


Do NOT use Acarbose if:


  • you are allergic to any ingredient in Acarbose

  • you have blockage of the stomach or bowel, or you are at risk of these problems

  • you have inflammatory bowel disease, colon ulcers, or long-term (chronic) stomach or bowel problems that interfere with digestion or nutrient absorption

  • you have cirrhosis of the liver

  • you have diabetic ketoacidosis (high ketone levels) or severe kidney problems

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



Before using Acarbose:


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


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

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

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

  • if you have stomach or bowel problems, liver problems or unexplained abnormal liver function tests, or kidney problems

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


  • Anticoagulants (eg, warfarin) because the risk of their side effects, including bleeding, may be increased by Acarbose

  • Calcium channel blockers (eg, verapamil), corticosteroids (eg, prednisone), diuretics (eg, hydrochlorothiazide), estrogen, isoniazid, nicotinic acid, oral contraceptives (birth control pills), phenothiazines (eg, chlorpromazine), phenytoin, sympathomimetics (eg, pseudoephedrine), or thyroid hormones (eg, levothyroxine) because they may increase the risk of high blood sugar levels

  • Insulin or sulfonylureas (eg, glyburide) because they may increase the risk of low blood sugar levels

  • Oral neomycin because it may increase the risk of Acarbose's side effects

  • Digoxin because its effectiveness may be decreased by Acarbose

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


How to use Acarbose:


Use Acarbose as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Acarbose by mouth at the start (with the first bite) of each main meal.

  • If you also take charcoal or digestive enzyme preparations (eg, amylase, pancreatin), ask your doctor or pharmacist how to take them with Acarbose.

  • Temporary insulin therapy may be necessary during stressful periods (such as fever, infection, surgery, or trauma). Talk with your doctor if any of these occur.

  • If you miss a dose of Acarbose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acarbose.



Important safety information:


  • Proper diet and exercise are important in order to lose weight and keep it off. Follow the diet and exercise program given to you by your health care provider.

  • Diabetes patients - Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher than they should be and you take Acarbose exactly as prescribed, tell your doctor.

  • Tell your doctor or dentist that you take Acarbose before you receive any medical or dental care, emergency care, or surgery.

  • Carefully follow the regular testing of urine or blood glucose schedules given to you by your health care provider.

  • When other diabetes medicines are used with Acarbose, low blood sugar levels may occur. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you hungrier. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. This will raise your blood sugar level quickly. Because Acarbose prevents the breakdown of table (cane) sugar, be sure to use glucose (dextrose), not sugar or fruits, to treat symptoms of low blood sugar. Contact your health care provider right away if these symptoms occur.

  • Lab tests, including blood glucose, glycosylated hemoglobin levels, and liver function, may be performed while you use Acarbose. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Acarbose should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Acarbose while you are pregnant. It is not known if Acarbose is found in breast milk. Do not breast-feed while taking Acarbose.


Possible side effects of Acarbose:


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



Bloating; diarrhea; gas; nausea; stomach pain; vomiting.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe stomach pain; symptoms of liver problems (eg, dark urine; pale stools; unusual or severe nausea, tiredness, or loss or appetite; yellowing of the skin or eyes).



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


See also: Acarbose side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; gas; stomach pain or discomfort.


Proper storage of Acarbose:

Store Acarbose below 77 degrees F (25 degrees C) in a tightly sealed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acarbose out of the reach of children and away from pets.


General information:


  • If you have any questions about Acarbose, please talk with your doctor, pharmacist, or other health care provider.

  • Acarbose is to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

  • Check with your pharmacist about how to dispose of unused medicine.

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



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Acarbose resources


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


  • Acarbose Prescribing Information (FDA)

  • Acarbose Monograph (AHFS DI)

  • Acarbose Professional Patient Advice (Wolters Kluwer)

  • acarbose Concise Consumer Information (Cerner Multum)

  • acarbose Advanced Consumer (Micromedex) - Includes Dosage Information

  • Precose Prescribing Information (FDA)



Compare Acarbose with other medications


  • Diabetes, Type 2

Sunday, 29 April 2012

Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets


Pronunciation: a-seet-a-MIN-oh-fen/klor-fen-EER-a-meen/dex-troe-meth-OR-fan/sue-doe-eh-FED-rin
Generic Name: Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine
Brand Name: Examples include Children's Cold Plus Cough and Tylenol Cold Plus Cough


Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets are used for:

Relieving symptoms of pain, sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also used for other conditions as determined by your doctor.


Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets are a decongestant, antihistamine, cough suppressant, and analgesic combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The analgesic and cough suppressant work in the brain to decrease pain and to reduce a dry or unproductive cough.


Do NOT use Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets if:


  • you are allergic to any ingredient in Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets

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

  • you are unable to urinate or are having an asthma attack

  • you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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



Before using Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets:


Some medical conditions may interact with Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, plan to become pregnant, or are breast-feeding

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

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

  • if you have a fast, slow, or irregular heartbeat

  • if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; overactive thyroid; or liver problems; or if you consume more than 3 alcohol-containing drinks per day

  • if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets may be increased

  • Anticoagulants (eg, warfarin), digoxin or droxidopa because risk of bleeding, irregular heartbeat or heart attack may be increased

  • Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets

  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets:


Use Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets may be taken with or without food.

  • Chew thoroughly before swallowing.

  • If you miss a dose of Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets.



Important safety information:


  • Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets. Using Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

  • Do not take diet or appetite control medicines while you are taking Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets without checking with you doctor.

  • Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.

  • Do NOT exceed the recommended dose or take Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets for longer than prescribed without checking with your doctor.

  • If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.

  • Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

  • Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets or other pain relievers/fever reducers. Alcohol use combined with Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets may increase your risk for liver damage.

  • If you are scheduled for allergy skin testing, do not take Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets for several days before the test because it may decrease your response to the skin tests.

  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets.

  • Use Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets with caution in the ELDERLY because they may be more sensitive to its effects.

  • Caution is advised when using Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets in CHILDREN because they may be more sensitive to its effects.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets, discuss with your doctor the benefits and risks of using Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets during pregnancy. It is unknown if Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets are excreted in breast milk. Do not breast-feed while taking Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets.


Possible side effects of Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets:


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



Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.



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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; trouble sleeping; vision changes; yellowing of skin or eyes.



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


See also: Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.


Proper storage of Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets:

Store Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets out of the reach of children and away from pets.


General information:


  • If you have any questions about Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.

  • Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine resources


  • Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Side Effects (in more detail)
  • Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Dosage
  • Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Use in Pregnancy & Breastfeeding
  • Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Drug Interactions
  • Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine Support Group
  • 1 Review for Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine - Add your own review/rating


Compare Acetaminophen/Chlorpheniramine/Dextromethorphan/Pseudoephedrine with other medications


  • Cold Symptoms
  • Influenza

Friday, 27 April 2012

Lodrane 12 Hour


Generic Name: brompheniramine (brome feh NEER a meen)

Brand Names: BroveX, BroveX CT, Dimetane, Dimetane Extentab, Dimetapp Allergy, Dimetapp Allergy Liquigel, Lodrane 12 Hour


What is Lodrane 12 Hour (brompheniramine)?

Brompheniramine is an antihistamine. Brompheniramine blocks the effects of the naturally occurring chemical histamine in the body.


Brompheniramine is used to sneezing; runny nose; itching, watery eyes; hives; rashes; itching; and other symptoms of allergies and the common cold.


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


What is the most important information I should know about Lodrane 12 Hour (brompheniramine)?


Use caution when driving, operating machinery, or performing other hazardous activities. Brompheniramine 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 brompheniramine. Do not crush, chew, or break the extended- or timed-release forms of brompheniramine. Swallow them whole. They are specially formulated to release the medication slowly in the body.

What should I discuss with my healthcare provider before taking Lodrane 12 Hour (brompheniramine)?


Do not take brompheniramine 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 brompheniramine, talk to your doctor if you have



  • glaucoma or increased pressure in the eye;




  • a stomach ulcer;




  • an enlarged prostate, bladder problems or difficulty urinating;




  • an overactive thyroid (hyperthyroidism);




  • hypertension or any type of heart problems; or




  • asthma.



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


Brompheniramine is in the FDA pregnancy category C. This means that it is not known whether brompheniramine will be harmful to an unborn baby. Do not take brompheniramine without first talking to your doctor if you are pregnant or could become pregnant during treatment. Brompheniramine passes into breast milk. Infants are especially sensitive to the effects of antihistamines, and serious side effects could occur in a nursing infant. Do not take brompheniramine without first talking to your doctor if you are nursing a baby. If you are over 60 years of age, you may be more likely to experience side effects from brompheniramine. You may require a lower dose of this medication.

How should I take Lodrane 12 Hour (brompheniramine)?


Take brompheniramine exactly as directed on the package or as directed by your doctor. 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.

Brompheniramine can be taken with or without food.


Do not crush, chew, or break the extended- or timed-release forms of brompheniramine. Swallow them whole. They are specially formulated to release the medication slowly in the body.

To ensure that you get a correct dose, measure the liquid form of brompheniramine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.


Do not take more of this medication than is prescribed or is recommended on the package. The maximum amount of brompheniramine that you should take in 1 day is 24 mg. The regular-release tablets and the syrup are usually taken every 4 to 6 hours as needed (four to six times a day). The sustained-release tablets and capsules are usually taken every 8 to 12 hours as needed (two or three times a day). If your symptoms do not improve, or if they worsen, contact your healthcare provider. Store brompheniramine 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 unless otherwise directed by your doctor.


What happens if I overdose?


Seek emergency medical attention if an overdose is suspected.

Symptoms of a brompheniramine overdose may include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.


What should I avoid while taking Lodrane 12 Hour (brompheniramine)?


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


Brompheniramine 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 brompheniramine is taken with any of these medications.


Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking brompheniramine.

Lodrane 12 Hour (brompheniramine) side effects


Stop taking brompheniramine and seek emergency medical attention if you experience a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take brompheniramine and talk to your doctor if you experience



  • sleepiness, fatigue, or dizziness;




  • headache;




  • dry mouth; or




  • difficulty urinating or an enlarged prostate.



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. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Lodrane 12 Hour (brompheniramine)?


Do not take brompheniramine 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, pain, or sleep medications while taking brompheniramine without first talking to your pharmacist or doctor. Other medications may also contain brompheniramine or other similar drugs, and you may accidentally take too much of these medicines.


Brompheniramine 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 brompheniramine is taken with any of these medications.


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



More Lodrane 12 Hour resources


  • Lodrane 12 Hour Side Effects (in more detail)
  • Lodrane 12 Hour Use in Pregnancy & Breastfeeding
  • Lodrane 12 Hour Drug Interactions
  • Lodrane 12 Hour Support Group
  • 0 Reviews for Lodrane2 Hour - Add your own review/rating


  • Lodrane 12 Hour 12-Hour Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Brompheniramine Professional Patient Advice (Wolters Kluwer)

  • Brompheniramine Maleate, Dexbrompheniramine Maleate Monograph (AHFS DI)

  • Brovex Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • Brovex CT Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lodrane 24 24-Hour Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • VaZol Liquid MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Lodrane 12 Hour with other medications


  • Allergic Reactions
  • Cold Symptoms
  • Hay Fever
  • Urticaria


Where can I get more information?


  • Your pharmacist has more information about brompheniramine written for health professionals that you may read.

See also: Lodrane2 Hour side effects (in more detail)


Atarax



Generic Name: hydroxyzine (hye DROX ee zeen)

Brand Names: Vistaril


What is hydroxyzine?

Hydroxyzine reduces activity in the central nervous system. It also acts as an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing and runny nose, or hives on the skin.


Hydroxyzine is used as a sedative to treat anxiety and tension. It is also used together with other medications given for anesthesia. Hydroxyzine may also be used to control nausea and vomiting.


Hydroxyzine is also used to treat allergic skin reactions such as hives or contact dermatitis.


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


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


You should not use this medication if you are allergic to hydroxyzine, or if you are pregnant.

Before you take hydroxyzine, tell your doctor if you have a seizure disorder, liver disease, or kidney disease.


Hydroxyzine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Stop using hydroxyzine and call your doctor at once if you have a serious side effect such as tremors, confusion, seizures, or restless muscle movements in your eyes, tongue, jaw, or neck. Avoid drinking alcohol. It can increase some of the side effects of hydroxyzine.

What should I discuss with my healthcare provider before taking hydroxyzine?


You should not use this medication if you are allergic to hydroxyzine, or if you are pregnant.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take hydroxyzine, tell your doctor if you have:



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  • epilepsy or other seizure disorder;




  • asthma, emphysema, or other breathing problem;




  • glaucoma;




  • heart disease or high blood pressure;




  • stomach ulcer, blockage in your stomach or intestines;




  • thyroid disorder;




  • enlarged prostate or problems with urination;




  • liver disease; or




  • kidney disease.




FDA pregnancy category D. Do not use hydroxyzine without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether hydroxyzine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

How should I take hydroxyzine?


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


Take this medicine with a full glass of water.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


Store hydroxyzine at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include extreme drowsiness, nausea, vomiting, feeling like you might pass out.


What should I avoid while taking hydroxyzine?


Hydroxyzine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of hydroxyzine.

Hydroxyzine 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. Stop using hydroxyzine and call your doctor at once if you have a serious side effect such as:

  • restless muscle movements in your eyes, tongue, jaw, or neck;




  • tremor (uncontrolled shaking);




  • confusion; or




  • seizure (convulsions).



Less serious side effects may include:



  • dizziness, drowsiness;




  • blurred vision, dry mouth; or




  • headache.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect hydroxyzine?


Before using hydroxyzine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by hydroxyzine.

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



More Atarax resources


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


  • Atarax Consumer Overview

  • Atarax MedFacts Consumer Leaflet (Wolters Kluwer)

  • Atarax Prescribing Information (FDA)

  • Hydroxyzine Professional Patient Advice (Wolters Kluwer)

  • Hydroxyzine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Hydroxyzine Prescribing Information (FDA)

  • Hydroxyzine Hydrochloride Monograph (AHFS DI)

  • Vistaril Prescribing Information (FDA)

  • Vistaril Consumer Overview



Compare Atarax with other medications


  • Allergic Urticaria
  • Allergies
  • Anxiety
  • Nausea/Vomiting
  • Pain
  • Pruritus
  • Sedation


Where can I get more information?


  • Your pharmacist can provide more information about hydroxyzine.

See also: Atarax side effects (in more detail)


Hespan


Generic Name: hetastarch (HET a starch)

Brand Names: Hespan, Hextend


What is Hespan (hetastarch)?

Hetastarch (hydroxyethyl) is a plasma volume expander derived from natural sources of starch. It works by restoring blood plasma lost through severe bleeding.


Severe blood loss can decrease oxygen levels, which can lead to organ failure, brain damage, coma, and possibly death. Plasma is needed to circulate red blood cells that deliver oxygen throughout the body.

Hetastarch is used to treat hypovolemia (a decrease in the volume of circulating blood plasma), that can result from severe blood loss after surgery, injury, or other causes of bleeding.


Hetastarch also contains electrolytes (sodium, calcium potassium, magnesium) which are minerals essential for many functions in the body, including the brain and nervous system, heartbeat, and fluid balance.


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


What is the most important information I should know about Hespan (hetastarch)?


You should not be given this medication if you are allergic to hetastarch, or if you have a bleeding or blood clotting disorder, congestive heart failure, urination problems not caused by hypovolemia, or lactic acidosis.

Before you receive hetastarch, tell your doctor if you have kidney or liver disease, heart disease, congestive heart failure, diabetes, or an electrolyte imbalance.


Tell your doctor about all other medications you use, especially a blood thinner such as warfarin (Coumadin), steroid medications, digoxin (digitalis, Lanoxin), or a diuretic (water pill).


Tell your caregivers at once if you have a serious side effect such as chest pain, fast or slow heart rate, wheezing or gasping for breath, feeling like you might pass out, weak pulse, slow breathing (breathing may stop), pale skin, easy bruising, blood in your urine or stools, swelling in your hands or feet, unusual bleeding, or any bleeding that will not stop.

Rare but serious side effects may include unusual headache, vision or speech problems, mental changes, drooping eyelids, loss of feeling in your face, tremors, or trouble swallowing, or fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.


What should I discuss with my health care provider before I receive Hespan (hetastarch)?


You should not be given this medication if you are allergic to hetastarch, or have certain conditions. Be sure your doctor knows if you have:

  • a bleeding or blood clotting disorder;




  • congestive heart failure;




  • urination problems not caused by hypovolemia; or




  • lactic acidosis.



Before you receive hetastarch, tell your doctor if you are allergic to any drugs, or if you have:



  • kidney disease;




  • liver disease;




  • heart disease;




  • congestive heart failure;




  • diabetes;




  • high potassium levels in your blood (hyperkalemia), or any other electrolyte imbalance; or




  • if you are allergic to corn.



If you have any of these conditions, you may need a dose adjustment or special tests to safely receive hetastarch.


FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hetastarch passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is hetastarch given?


Hetastarch is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. A doctor, nurse, or other healthcare professional will give you this medication.


To be sure hetastarch is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with hetastarch.


What happens if I miss a dose?


Since hetastarch is given as needed by a healthcare professional, it is not likely that you will miss a dose.


What happens if I overdose?


Seek emergency medical attention if you think you have received too much of this medicine.

An overdose of hetastarch is not expected to produce life-threatening symptoms.


What should I avoid while receiving Hespan (hetastarch)?


Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are receiving hetastarch.


Hespan (hetastarch) 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. Tell your caregivers at once if you have a serious side effect such as:

  • chest pain, fast or slow heart rate;




  • wheezing or gasping for breath, sweating, and anxiety;




  • feeling like you might pass out;




  • weak pulse, slow breathing (breathing may stop);




  • pale skin, easy bruising, weakness, blood in your urine or stools;




  • unusual bleeding, or any bleeding that will not stop;




  • unusual headache, vision or speech problems, mental changes, drooping eyelids, loss of feeling in your face, tremors, or trouble swallowing;




  • swelling in your hands or feet; or




  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.



Rare but serious side effects may include:



  • unusual headache, vision or speech problems, mental changes;




  • drooping eyelids, loss of feeling in your face, tremors, or trouble swallowing; or




  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.



Less serious side effects may include:



  • mild itching or skin rash;




  • cough or sneezing;




  • warmth, redness, or tingly feeling under your skin;




  • vomiting;




  • swollen glands;




  • headache;




  • muscle pain; or




  • flu symptoms.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Hespan (hetastarch)?


Before you receive hetastarch, tell your doctor if you are also using:



  • a blood thinner such as warfarin (Coumadin);




  • steroids (prednisolone and others);




  • corticotropin (Acthar, ACTH);




  • digoxin (digitalis, Lanoxin); or




  • a diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), or triamterene (Dyrenium, Dyazide, Maxzide).



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



More Hespan resources


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


  • Hespan Prescribing Information (FDA)

  • Hespan MedFacts Consumer Leaflet (Wolters Kluwer)

  • Hetastarch Prescribing Information (FDA)

  • Hetastarch Monograph (AHFS DI)



Compare Hespan with other medications


  • Blood Disorders


Where can I get more information?


  • Your doctor or pharmacist can provide more information about hetastarch.

See also: Hespan side effects (in more detail)


Friday, 13 April 2012

Anestacaine


Generic Name: lidocaine injection (LYE doe kane)

Brand Names: Anestacaine, UAD Caine, Xylocaine HCl, Xylocaine-MPF


What is Anestacaine (lidocaine injection)?

Lidocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.


Lidocaine injection is used to numb an area of your body to help reduce pain or discomfort caused by invasive medical procedures such as surgery, needle punctures, or insertion of a catheter or breathing tube.


Lidocaine injection is also given in an epidural (spinal block) to reduce the discomfort of contractions during labor.


Lidocaine injection is sometimes used to treat irregular heart rhythms that may signal a possible heart attack.


Lidocaine injection may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Anestacaine (lidocaine injection)?


You should not receive this medication if you are allergic to lidocaine or any other type of numbing medicine.

Before you receive lidocaine injection, tell your doctor if you have liver or kidney disease, heart disease, coronary artery disease, circulation problems, or a history of malignant hyperthermia.


To treat irregular heart rhythms, your doctor may prescribe a LidoPen auto-injector. This is a prefilled automatic injection device to be used in an emergency. Keep the device with you at all times.


Your doctor will describe the signs and symptoms to watch for when deciding when it's time to use lidocaine injection at home. Never use the LidoPen auto-injector without first calling your doctor.

With the LidoPen auto-injector you will also receive a CardioBeeper to transmit your heart rate and rhythm to your doctor over a telephone. Read all provided instructions and practice using the CardioBeeper.


Lidocaine can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after using this medication

What should I discuss with my healthcare provider before receiving Anestacaine (lidocaine injection)?


You should not receive this medication if you are allergic to lidocaine or any other type of numbing medicine.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use lidocaine injection:


  • liver disease;

  • kidney disease;


  • heart disease;




  • coronary artery disease, circulation problems; or




  • a history of malignant hyperthermia.




FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether lidocaine injection passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is lidocaine injection given?


Lidocaine is given as an injection through a needle placed into a vein or directly into the body area to be numbed. Your doctor, nurse, or other healthcare provider will give you this injection.


Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving lidocaine injection in a hospital setting.

To treat irregular heart rhythms, you may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.


The LidoPen auto-injector is a prefilled automatic injection device to be used in an emergency. Keep the device with you at all times. Your doctor will describe the signs and symptoms to watch for when deciding when it's time to use the injection.


Never use the LidoPen auto-injector without first calling your doctor.

Do not use the auto-injector in or near a vein or into your buttocks. Inject the medication only in your upper thigh or upper arm.


With the LidoPen auto-injector you will also receive a CardioBeeper. This device is used to transmit your heart rate and rhythm to your doctor over a telephone. Read all provided instructions and practice using the CardioBeeper so you will be able to quickly use it in an emergency.


Store the LidoPen auto-injector at room temperature away from moisture and extreme hot or cold.

What happens if I miss a dose?


Since lidocaine injection is used only when needed, you are not likely to be on a dosing schedule.


Never use the LidoPen auto-injector without first calling your doctor.


What happens if I overdose?


Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include drowsiness, confusion, nervousness, ringing in your ears, blurred vision, feeling hot or cold, numbness, muscle twitches, uneven heartbeats, seizure (convulsions), slowed breathing, or respiratory failure (breathing stops).


What should I avoid while receiving Anestacaine (lidocaine injection)?


Lidocaine can cause side effects that may impair your thinking or reactions. Unless absolutely necessary, do not drive after using this medication

Avoid eating or chewing within 1 hour after lidocaine injection is used to numb your mouth or throat. You may have trouble swallowing which could lead to choking. You may also accidentally bite the inside of your mouth if you are still numb an hour after treatment with lidocaine injection.


Anestacaine (lidocaine injection) 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. Tell your caregivers at once if you have any of these serious side effects:

  • feeling anxious, shaky, dizzy, restless, or depressed;




  • drowsiness, vomiting, ringing in your ears, blurred vision;




  • confusion, twitching, seizure (convulsions);




  • fast heart rate, rapid breathing, feeling hot or cold;




  • weak or shallow breathing, slow heart rate, weak pulse; or




  • feeling like you might pass out.



Less serious side effects include:



  • mild bruising, redness, itching, or swelling where the medication was injected;




  • mild dizziness;




  • nausea;




  • numbness in places where the medicine is accidentally applied.



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 Anestacaine (lidocaine injection)?


There may be other drugs that can interact with lidocaine injection. 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 Anestacaine resources


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


  • Lidocaine Aerosol MedFacts Consumer Leaflet (Wolters Kluwer)

  • lidocaine Intradermal Advanced Consumer (Micromedex) - Includes Dosage Information

  • Lidocaine Prescribing Information (FDA)

  • Lidocaine Hydrochloride Monograph (AHFS DI)

  • Lidocaine Hydrochloride (Local Anesthetic) Monograph (AHFS DI)



Compare Anestacaine with other medications


  • Anesthesia
  • Arrhythmia
  • Ventricular Fibrillation
  • Ventricular Tachycardia


Where can I get more information?


  • Your doctor or pharmacist can provide more information about lidocaine injection.

See also: Anestacaine side effects (in more detail)


Wednesday, 11 April 2012

Sodium Sulfacetamide/Sulfur Foam


Pronunciation: SO-dee-um SUL-fa-SEET-a-mide/SUL-fur
Generic Name: Sodium Sulfacetamide/Sulfur
Brand Name: Clarifoam EF


Sodium Sulfacetamide/Sulfur Foam is used for:

Treating acne, rosacea, and seborrhea. It may also be used for other conditions as determined by your doctor.


Sodium Sulfacetamide/Sulfur Foam is an antibacterial and keratolytic combination. The antibacterial works by killing sensitive bacteria. The keratolytic helps to loosen and shed hard, scaly skin.


Do NOT use Sodium Sulfacetamide/Sulfur Foam if:


  • you are allergic to any ingredient in Sodium Sulfacetamide/Sulfur Foam or to sulfonamides (eg, sulfamethoxazole)

  • you have kidney problems

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



Before using Sodium Sulfacetamide/Sulfur Foam:


Some medical conditions may interact with Sodium Sulfacetamide/Sulfur Foam. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


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

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

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

  • if you have eczema

  • if the skin at the application site is scraped, cut, or damaged

Some MEDICINES MAY INTERACT with Sodium Sulfacetamide/Sulfur Foam. Because little, if any, of Sodium Sulfacetamide/Sulfur Foam is absorbed into the blood, the risk of it interacting with another medicine is low.


Ask your health care provider if Sodium Sulfacetamide/Sulfur Foam may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Sodium Sulfacetamide/Sulfur Foam:


Use Sodium Sulfacetamide/Sulfur Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Before the first use of a new container, you will need to prime the container. Hold the can upright and point it away from yourself and others. Press the spray button down for 3 to 5 seconds or until foam begins to appear.

  • Wash the affected skin and gently pat dry with a clean towel before each use of Sodium Sulfacetamide/Sulfur Foam.

  • Shake well before each use.

  • Hold the container upright. Dispense a small amount of the medicine onto your fingertips. Gently massage the foam into the affected area.

  • If your doctor has told you to leave Sodium Sulfacetamide/Sulfur Foam on, be sure to wipe off any excess medicine after you apply it.

  • If your doctor has told you to wash Sodium Sulfacetamide/Sulfur Foam off, wait 10 minutes after you apply it, then rinse with water and pat dry.

  • Wash your hands immediately after using Sodium Sulfacetamide/Sulfur Foam, unless your hands are part of the affected area.

  • Use Sodium Sulfacetamide/Sulfur Foam on a regular schedule to get the most benefit from it.

  • Continue to use Sodium Sulfacetamide/Sulfur Foam even if your condition improves. Do not miss any doses

  • If you miss a dose of Sodium Sulfacetamide/Sulfur Foam, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Sodium Sulfacetamide/Sulfur Foam.



Important safety information:


  • Sodium Sulfacetamide/Sulfur Foam is for external use only. Do not get it in your eyes or on the inside of your nose or mouth. If you get Sodium Sulfacetamide/Sulfur Foam in any of these areas, rinse them immediately with cool water.

  • Talk with your doctor before you use any other medicines or cleansers on your skin.

  • Do not apply Sodium Sulfacetamide/Sulfur Foam over large areas of the body or to open wounds or scraped, infected, or burned skin without first checking with your doctor.

  • Do not use Sodium Sulfacetamide/Sulfur Foam for other skin conditions at a later time.

  • Sodium Sulfacetamide/Sulfur Foam may be harmful if swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.

  • Sodium Sulfacetamide/Sulfur Foam should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: It is not known if Sodium Sulfacetamide/Sulfur Foam can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sodium Sulfacetamide/Sulfur Foam while you are pregnant. It is not known if Sodium Sulfacetamide/Sulfur Foam is found in breast milk after topical use. If you are or will be breast-feeding while you use Sodium Sulfacetamide/Sulfur Foam, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Sodium Sulfacetamide/Sulfur Foam:


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



Mild redness or peeling of the skin.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever, chills, or sore throat; red, swollen, blistered, or peeling skin; severe or persistent skin irritation; unusual tiredness or weakness; yellowing of the skin or eyes.



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


See also: Sodium Sulfacetamide/Sulfur side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Sodium Sulfacetamide/Sulfur Foam may be harmful if swallowed. Symptoms of ingestion may include change in the amount of urine; nausea; vomiting.


Proper storage of Sodium Sulfacetamide/Sulfur Foam:

Store Sodium Sulfacetamide/Sulfur Foam at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not freeze. Avoid temperatures above 120 degrees F (49 degrees C). Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Sodium Sulfacetamide/Sulfur Foam out of the reach of children and away from pets.


General information:


  • If you have any questions about Sodium Sulfacetamide/Sulfur Foam, please talk with your doctor, pharmacist, or other health care provider.

  • Sodium Sulfacetamide/Sulfur Foam is to be used only by the patient for whom it is prescribed. Do not share it with other people.

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

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Sodium Sulfacetamide/Sulfur Foam. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Sodium Sulfacetamide/Sulfur resources


  • Sodium Sulfacetamide/Sulfur Side Effects (in more detail)
  • Sodium Sulfacetamide/Sulfur Use in Pregnancy & Breastfeeding
  • Sodium Sulfacetamide/Sulfur Drug Interactions
  • Sodium Sulfacetamide/Sulfur Support Group
  • 18 Reviews for Sodium Sulfacetamide/Sulfur - Add your own review/rating


Compare Sodium Sulfacetamide/Sulfur with other medications


  • Acne
  • Rosacea
  • Seborrheic Dermatitis

Tuesday, 10 April 2012

Flulaval


Generic Name: influenza virus vaccine (Intradermal route, Intramuscular route)


in-floo-EN-za VYE-rus VAX-een (sub-VEER-ee-on)


Commonly used brand name(s)

In the U.S.


  • Afluria

  • Fluarix

  • Flulaval

  • Fluvirin

  • Fluzone

  • Fluzone High-Dose

  • Fluzone Pediatric

Available Dosage Forms:


  • Suspension

  • Solution

Therapeutic Class: Vaccine


Uses For Flulaval


Influenza virus vaccine is used to prevent infection by the influenza viruses. The vaccine works by causing your body to produce its own protection (antibodies) against the disease. It is also known as a “flu shot”.


There are many kinds of influenza viruses, but not all will cause problems in any given year. Therefore, before the influenza vaccine is produced each year, the World Health Organization (WHO) and the U.S. and Canadian Public Health Services decide which viruses will most likely cause influenza infections for that year. The antigens, which are substances that cause protective antibodies to be formed, for these viruses are included in the influenza vaccine. Usually, the U.S. and Canada use the same influenza vaccine; however, they are not required to do so.


It is necessary to receive an influenza vaccine injection each year, since influenza infections are usually caused by different kinds of viruses and the protection gained by the vaccine lasts less than a year.


Influenza is a virus infection of the throat, bronchial tubes, and lungs. Influenza infection causes fever, chills, cough, headache, muscle aches, and pains in your back, arms, and legs. In addition, adults and children weakened by other diseases or medical conditions, and persons 50 years of age and over, even if they are healthy, may get a much more serious illness that may have to be treated in a hospital. Each year thousands of people die as a result of an influenza infection.


The best way to help prevent influenza infections is to get an influenza vaccination each year, usually in early November. Immunization (getting a vaccine) against influenza is approved for infants 6 months of age and older, all children, and all adults (including 65 years of age and older).


This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.


Before Using Flulaval


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


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 have not been performed on the relationship of age to the effects of Agriflu®, Flulaval™, Fluzone® High-Dose, or Fluzone® Intradermal in the pediatric population. Safety and efficacy have not been established.


Afluria® is not indicated in children younger than 5 years of age. Safety and efficacy have not been established.


Appropriate studies have not been performed on the relationship of age to the effects of Fluvirin® in children younger than 4 years of age. Safety and efficacy have not been established.


Appropriate studies have not been performed on the relationship of age to the effects of Fluarix® in children younger than 3 years of age. Safety and efficacy have not been established.


Appropriate studies have not been performed on the relationship of age to the effects of Fluzone® in children younger than 6 months of age. 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 influenza virus vaccine in the elderly.


Appropriate studies have not been performed on the relationship of age to the effects of Fluzone® Intradermal in the geriatric population. Safety and efficacy have not been established.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal 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. 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 this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Allergy to eggs, egg products, or chicken proteins, history of—Usually should not be used in patients with this condition.

  • Bleeding problems (e.g., hemophilia, thrombocytopenia)—Use with caution. May have an increased risk of bleeding at the injection site.

  • Guillain-Barré syndrome (GBS, a severe nerve and muscle problem), history of—Use with caution. May cause the symptoms of this condition to return.

  • Illness with fever, moderate or severe—You may need to wait until you feel better before you receive the vaccine.

  • Immune system problems from a disease or medicine—May not work as well in patients with this condition.

  • Kanamycin, neomycin, or polymyxin allergy, history of—Only certain brands of the influenza vaccine can be used. Talk with your doctor about this.

Proper Use of influenza virus vaccine

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


A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of your muscles or into your skin, usually in the shoulder area.


Sometimes there is not enough flu vaccine for everyone. If this happens and you are a healthy adult, you might need to wait until later in the flu season before getting your vaccination.


You need to get the flu vaccine every year to protect you from the flu.


Some children may need a second dose of the vaccine. If your child needs a second dose of this medicine, it is very important for your child to receive the second dose on schedule. If you must cancel the appointment, make another appointment as soon as possible.


Precautions While Using Flulaval


It is very important that your child return to your doctor’s office at the right time if your child needs a second dose of the vaccine. Be sure to notify your doctor of any side effects that occur after you or your child receive this vaccine.


This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or troubled breathing after you get the injection.


Children who have received a certain brand of the influenza vaccine (Afluria®) have developed a fever and in some cases a fever with seizures. Talk with your doctor if you have concerns about this.


If you are very sick and have a high fever, you will probably need to wait until you are well before your receive this vaccine.


Influenza virus vaccine may not protect everyone who receives the vaccine. Also, this vaccine will not treat flu symptoms if you already have the virus.


The tip cap of the prefilled syringe for certain brands of the injection (Agriflu®, Fluarix®, Fluvirin®, Fluzone®, Fluzone® High-Dose) contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you receive this vaccine.


It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients receiving Fluzone® Intradermal vaccine.


Make sure your doctor knows if you or your child are using a medicine or treatment that weakens your immune system, such as a steroid, radiation, or cancer treatment. This vaccine may not work as well if you are also using these medicines. Your doctor may still want you to get the vaccine because it can give you some protection.


Flulaval Side Effects


In 1976, a number of people who received the “swine flu” influenza vaccine developed Guillain-Barré syndrome (GBS), which is a disease that may cause paralysis. Most of these people were over 25 years of age. Although only 10 out of every one million people who received the vaccine actually developed GBS, this number was 6 times higher than would normally have been expected. Most of the people who got GBS recovered completely.


It is assumed that the “swine flu” virus included in the 1976 vaccine caused the problem, but this has not been proven. Since that time, studies have shown that the risk of acquiring GBS from an influenza vaccine is very low (one out of every million people).


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 or nurse immediately if any of the following side effects occur:


More common
  • Cough

  • diarrhea

  • fever

  • headache

  • irritability

  • loss of appetite

  • muscle aches

  • redness of the eyes

  • sneezing

  • sore throat

  • stuffy or runny nose

  • vomiting

Less common
  • Body aches or pain

  • chills

  • difficulty with breathing

  • earache

  • ear congestion

  • loss of voice

  • shivering

  • swelling or puffiness of the face

  • tightness in the chest

  • unusual tiredness or weakness

Rare
  • Difficulty with swallowing

  • dizziness

  • fast heartbeat

  • hives

  • itching

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • noisy breathing

  • puffiness or swelling of the eyelids or around the eyes, lips, or tongue

  • shortness of breath

  • skin rash

  • wheezing

Incidence not known
  • Agitation

  • back pain, sudden and severe

  • back, leg, or stomach pains

  • black, tarry stools

  • bleeding gums

  • bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, itching, lumps, numbness, scarring, soreness, stinging, tingling, ulceration, or warmth at the injection site

  • blindness

  • blistering, peeling, or loosening of the skin

  • blood in the urine or stools

  • blurred vision

  • bruising, inflammation, rash, redness, swelling, tenderness, or pain at the injection site

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

  • burning, dry, or itching eyes

  • change in color vision

  • change in walking and balance

  • chest pain

  • clumsiness or unsteadiness

  • cold, clammy skin

  • coma

  • confusion

  • dark urine

  • discharge or excessive tearing

  • drowsiness

  • dryness of the throat

  • eye pain

  • fainting

  • fast, weak pulse

  • feeling hot

  • feeling of constant movement of self or surroundings

  • feeling unusually cold

  • general body swelling

  • general feeling of discomfort or illness

  • hallucinations

  • inability to move the arms and legs

  • increased sensitivity of the eyes to sunlight

  • irritation

  • joint pain, stiffness, or swelling

  • lack or loss of strength

  • large, flat, blue, or purplish patches in the skin

  • lightheadedness

  • mood or mental changes

  • muscle weakness, sudden and progressing

  • nausea

  • nerve pain

  • nosebleeds

  • pain, redness, soreness, swelling, tenderness, or warmth on the skin

  • painful knees and ankles

  • paleness of the skin

  • pinpoint red spots on the skin

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

  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

  • seizures

  • sensation of spinning

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

  • sores, ulcers, or white spots in the mouth or on the lips

  • stabbing pain

  • stiff neck

  • stomach pain, soreness, or discomfort

  • sweating

  • swelling of the face, hands, or feet

  • swelling of the mouth or throat

  • swollen, painful, or tender lymph glands in the neck, armpit, or groin

  • trouble with sleeping

  • troubled breathing or swallowing

  • unusual bleeding or bruising

  • voice changes

  • weakness of the muscles in your face

  • yellowing of the eyes or skin

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
  • Sleepiness or unusual drowsiness

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: Flulaval 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 Flulaval resources


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


  • Flulaval Prescribing Information (FDA)

  • Afluria Prescribing Information (FDA)

  • Afluria Consumer Overview

  • Afluria MedFacts Consumer Leaflet (Wolters Kluwer)

  • Agriflu MedFacts Consumer Leaflet (Wolters Kluwer)

  • Agriflu Consumer Overview

  • FluLaval MedFacts Consumer Leaflet (Wolters Kluwer)

  • FluLaval Consumer Overview

  • Fluarix Prescribing Information (FDA)

  • Fluarix Consumer Overview

  • Fluarix MedFacts Consumer Leaflet (Wolters Kluwer)

  • Fluvirin Prescribing Information (FDA)

  • Fluvirin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Fluzone Prescribing Information (FDA)

  • Fluzone MedFacts Consumer Leaflet (Wolters Kluwer)

  • Influenza Virus Vaccine Inactivated Monograph (AHFS DI)

  • Influenza Virus Vaccine Live Intranasal Monograph (AHFS DI)



Compare Flulaval with other medications


  • Influenza Prophylaxis

Sunday, 8 April 2012

Mesna




Mesna Injection

Mesna Description


Mesna Injection is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide.  The active ingredient Mesna is a synthetic sulfhydryl compound designated as sodium-2-mercaptoethane sulfonate.  Its structural formula is as follows:


 


                        HS-CH2-CH2SO3- Na+



C2H5NaO3S2                                       M.W. 164.18


Mesna Injection is a sterile, nonpyrogenic, aqueous solution of clear and colorless appearance in clear glass multiple dose vials for intravenous administration.  Mesna Injection contains 100 mg/mL Mesna, 0.25 mg/mL edetate disodium, 10.4 mg/mL benzyl alcohol as a preservative and sodium hydroxide for pH adjustment.  The solution has a pH range of 6.5 to 8.5.



Mesna - Clinical Pharmacology


Mesna Injection was developed as a prophylactic agent to prevent the hemorrhagic cystitis induced by ifosfamide.  Analogous to the physiological cysteine-cystine system, following intravenous administration, Mesna is rapidly oxidized to its only metabolite, Mesna disulfide (diMesna).  Mesna disulfide remains in the intravascular compartment and is rapidly eliminated by the kidneys.


In the kidney, the Mesna disulfide is reduced to the free thiol compound, Mesna, which reacts chemically with the urotoxic ifosfamide metabolites (acrolein and 4-hydroxy-ifosfamide) resulting in their detoxification.  The first step in the detoxification process is the binding of Mesna to 4-hydroxy-ifosfamide forming a nonurotoxic 4-sulfoethylthioifosfamide.  Mesna also binds to the double bonds of acrolein and other urotoxic metabolites.


After administration of an 800 mg dose the half-lives of Mesna and diMesna in the blood are 0.36 hours and 1.17 hours respectively.  Approximately 32% and 33% of the administered dose was eliminated in the urine in 24 hours as Mesna and diMesna respectively.  The majority of the dose recovered was eliminated within 4 hours.  Mesna has a volume of distribution of 0.652 L/kg and a plasma clearance of 1.23 L/kg/hour.  Ifosfamide has been shown to have dose dependent pharmacokinetics in humans.  At doses of 2 to 4 g, its terminal elimination half-life is about 7 hours.  As a result, in order to maintain adequate levels of Mesna in the urinary bladder during the course of elimination of the urotoxic ifosfamide metabolites, repeated doses of Mesna Injection are required.


Based on the pharmacokinetic profiles of Mesna and ifosfamide as discussed above, Mesna was given as bolus doses prior to Ifosfamide and at 4 and 8 hours after Ifosfamide administration.  The hemorrhagic cystitis produced by ifosfamide is dose dependent.  At a dose of 1.2 g/m2 ifosfamide administered daily for 5 days, 16 to 26% of the patients who received conventional uroprophylaxis (high fluid intake, alkalinization of the urine and the administration of diuretics) developed hematuria (>50 rbc/hpf or macrohematuria).  In contrast, none of the patients who received Mesna together with this dose of ifosfamide developed hematuria.  Higher doses of ifosfamide from 2 to 4 g/m2 administered for three to five days, produced hematuria in 31 to 100% of the patients.  When Mesna was administered together with these doses of Ifosfamide the incidence of hematuria was less than 7%.



Indications and Usage for Mesna


Mesna Injection has been shown to be effective as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.



Contraindications


Mesna Injection is contraindicated in patients known to be hypersensitive to Mesna or other thiol compounds.



Warnings


Allergic reactions to Mesna were reported in patients with autoimmune disorders.  The majority of the patients received high doses of Mesna orally.  The symptoms ranged from mild hypersensitivity to systemic anaphylactic reactions.


Mesna Injection has been developed as an agent to prevent ifosfamide induced hemorrhagic cystitis.  It will not prevent or alleviate any of the other adverse reactions or toxicities associated with ifosfamide therapy.


Mesna Injection does not prevent hemorrhagic cystitis in all patients. Up to 6% of patients treated with Mesna have developed hematuria (>50 rbc/hpf or WHO grade 2 and above).  As a result, a morning specimen of urine should be examined for the presence of hematuria (red blood cells) each day prior to ifosfamide therapy.  If hematuria develops when Mesna Injection is given with ifosfamide according to the recommended dosage schedule, depending on the severity of the hematuria, dosage reductions or discontinuation of ifosfamide therapy may be initiated.


In order to obtain adequate protection, Mesna Injection must be administered with each dose of ifosfamide as outlined in DOSAGE AND ADMINISTRATION.  Mesna Injection is not effective in preventing hematuria due to other pathological conditions such as thrombocytopenia.


Because of the benzyl alcohol content, the multiple dose vial should not be used in neonates or infants and should be used with caution in older pediatric patients.



Precautions



Laboratory Tests


A false positive test for urinary ketones may arise in patients treated with Mesna Injection.  In this test, a red-violet color develops which, with the addition of glacial acetic acid, will return to violet.



Pediatrics


Because of the benzyl alcohol content, the multiple dose vial should not be used in neonates or infants and should be used with caution in older pediatric patients.



Drug Interactions


In vitro and in vivo animal tumor models have shown that Mesna does not have any effect on the antitumor efficacy of concomitantly-administered cytotoxic agents.



Carcinogenesis, Mutagenesis, Impairment of Fertility


No long term animal studies have been performed to evaluate the carcinogenic potential of Mesna.  The Ames Salmonella typhimurium test, mouse micronucleus assay and frequency of sister chromatid exchange and chromosomal aberrations in PHA-stimulated lymphocytes in vitro assays revealed no mutagenic activity.



Pregnancy


Pregnancy Category B


Reproduction studies in rats and rabbits with oral doses up to 1000 mg/kg have revealed no harm to the fetus due to Mesna.  It is not known whether Mesna Injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.  Mesna Injection should be given to a pregnant woman only if the benefits clearly outweigh any possible risks.


Teratology studies in rats and rabbits have shown no effects.



Nursing Mothers


It is not known whether Mesna or diMesna is excreted in human milk.  Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from Mesna, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.



Adverse Reactions


Because Mesna is used in combination with Ifosfamide and other chemotherapeutic agents with documented toxicities, it is difficult to distinguish the adverse reactions which may be due to Mesna from those caused by the concomitantly administered cytostatic agents.  As a result, the adverse reaction profile of Mesna was determined in three Phase 1 studies (16 subjects) utilizing intravenous and oral administration and two controlled studies in which ifosfamide and Mesna were compared to ifosfamide and standard prophylaxis.


In Phase 1 studies in which IV bolus doses of 0.8 to 1.6 g/m2 Mesna were administered as single or three repeated doses to a total of 10 patients, a bad taste in the mouth (100%) and soft stools (70%) were reported.  At intravenous and oral bolus doses of 2.4 g/m2 which are approximately 10 times the recommended clinical doses (0.24 g/m2) headache (50%), fatigue (33%), nausea (33%), diarrhea (83%), limb pain (50%), hypotension (17%) and allergy (17%) have also been reported in the 6 patients who participated in this study.


In controlled clinical studies, adverse reactions which can be reasonably associated with Mesna were vomiting, diarrhea and nausea.



Overdosage


There is no known antidote for Mesna Injection.



Mesna Dosage and Administration


For the prophylaxis of ifosfamide induced hemorrhagic cystitis, Mesna Injection may be given on a fractionated dosing schedule of bolus intravenous injections as outlined below.


Mesna Injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage (w/w) at the time of ifosfamide administration and 4 and 8 hours after each dose of ifosfamide.  The total daily dose of Mesna is 60% of the ifosfamide dose. 


The recommended dosing schedule is outlined below:
















0 Hours



4 Hours



8 Hours



Ifosfamide



   1.2 g/m2



—



—



Mesna Injection



240 mg/m2



240 mg/m2



240 mg/m2


In order to maintain adequate protection, the dosing schedule should be repeated on each day that ifosfamide is administered.  When the dosage of ifosfamide is adjusted (either increased or decreased), the dose of Mesna Injection should be modified accordingly.  When exposed to oxygen, Mesna is oxidized to the disulfide, diMesna.  The Mesna Injection multiple dose vials may be stored and used for up to 8 days.



PREPARATION OF INTRAVENOUS SOLUTIONS/STABILITY


For IV administration the drug can be diluted by adding the Mesna Injection solution to any of the following fluids obtaining final concentrations of 20 mg Mesna/mL fluid:


     5% Dextrose Injection, USP


     5% Dextrose and 0.2% Sodium Chloride Injection, USP


     5% Dextrose and 0.33% Sodium Chloride Injection, USP


     5% Dextrose and 0.45% Sodium Chloride Injection, USP


     0.92% Sodium Chloride Injection, USP


     Lactated Ringer’s Injection, USP


For example:


One mL of Mesna Injection multiple dose vial 100 mg/mL may be added to 4 mL of any of the solutions listed above to create a final concentration of 20 mg Mesna/mL fluid.


Diluted solutions are chemically and physically stable for 24 hours at 25° C (77° F).


Mesna is not compatible with cisplatin.


Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.



How is Mesna Supplied












Product


No.



NDC


No.




730310   



63323-733-10   



Mesna Injection, 1 gram in a 10 mL multiple dose vial, in packages of 10.



730311



63323-733-11



Mesna Injection, 1 gram in a 10 mL multiple dose vial, packaged individually.


Vial stopper does not contain natural rubber latex.


Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature].




 


45888D


Revised: January 2008


PACKAGE LABEL - PRINCIPAL DISPLAY - Mesna 10 mL Multiple Dose Vial Label

NDC 63323-733-10


Mesna Injection


1 gram


For Intravenous Use


10 mL Multiple Dose Vial


Rx only










Mesna 
Mesna  injection, solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)63323-733
Route of AdministrationINTRAVENOUSDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Mesna (Mesna)Mesna100 mg  in 1 mL










Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM0.25 mg  in 1 mL
BENZYL ALCOHOL10.4 mg  in 1 mL
SODIUM HYDROXIDE 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
163323-733-1010 VIAL In 1 TRAYcontains a VIAL, MULTI-DOSE
110 mL In 1 VIAL, MULTI-DOSEThis package is contained within the TRAY (63323-733-10)
263323-733-111 VIAL In 1 BOXcontains a VIAL, MULTI-DOSE
210 mL In 1 VIAL, MULTI-DOSEThis package is contained within the BOX (63323-733-11)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07581109/05/2001


Labeler - APP Pharmaceuticals, LLC (608775388)









Establishment
NameAddressID/FEIOperations
APP Pharmaceuticals, LLC023648251MANUFACTURE
Revised: 01/2012APP Pharmaceuticals, LLC