Tuberculosis, HIV Negative Medications

There are currently no drugs listed for "Tuberculosis, HIV Negative". See Tuberculosis.

Drug List:

Betnovat med chinoform

Betnovat med chinoform may be available in the countries listed below.

Ingredient matches for Betnovat med chinoform

Betamethasone

Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Betnovat med chinoform in the following countries:

• Norway


• Sweden

Clioquinol

Clioquinol is reported as an ingredient of Betnovat med chinoform in the following countries:

• Norway


• Sweden

International Drug Name Search

Butalbital, Acetaminophen and Caffeine

Butalbital, Acetaminophen and Caffeine TABLETS, USP

50 mg/500 mg/40 mg

Rx only

BOXED WARNING

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.

Butalbital, Acetaminophen and Caffeine Description

Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration.

Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula:

Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula:

Each Butalbital, Acetaminophen and Caffeine Tablet contains:

Butalbital ...................................................................................... 50 mg

Acetaminophen .......................................................................... 500 mg

Caffeine ....................................................................................... 40 mg

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.

Butalbital, Acetaminophen and Caffeine - Clinical Pharmacology

This combination drug product is intended as a treatment for tension headache.

It consists of a fixed combination of Butalbital, Acetaminophen and Caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.

Pharmacokinetics

The behavior of the individual components is described below.

Butalbital

Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.

Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2,3-dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5 (3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% is conjugated.

The in vitro plasma binding of butalbital is 45% over the concentration range of 0.5 to 20 mcg/mL. This falls within the range of plasma protein binding (20% to 45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood concentration ratio was almost unity, indicating that there is no preferential distribution of butalbital into either plasma or blood cells.

See OVERDOSAGE for toxicity information.

Acetaminophen

Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.

See OVERDOSAGE for toxicity information.

Caffeine

Like most xanthines, caffeine is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk.

Caffeine is cleared through metabolism and excretion in the urine. The plasma half-life is about 3 hours. Hepatic biotransformation prior to excretion, results in about equal amounts of 1-methylxanthine and 1-methyluric acid. Of the 70% of the dose that is recovered in the urine, only 3% is unchanged drug.

See OVERDOSAGE for toxicity information.

Indications and Usage for Butalbital, Acetaminophen and Caffeine

Butalbital, Acetaminophen and Caffeine Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

Contraindications

This product is contraindicated under the following conditions:

– Hypersensitivity or intolerance to any component of this product

– Patients with porphyria.

Warnings

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.

Hypersensitivity/anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Butalbital, Acetaminophen and Caffeine Tablets, USP immediately and seek medical care if they experience these symptoms. Do not prescribe Butalbital, Acetaminophen and Caffeine Tablets, USP for patients with acetaminophen allergy.

Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.

Precautions

General

Butalbital, Acetaminophen and Caffeine Tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions.

Information for Patients/Caregivers

• Do not take Butalbital, Acetaminophen and Caffeine Tablets, USP if you are allergic to any of its ingredients.


• If you develop signs of allergy such as a rash or difficulty breathing stop taking Butalbital, Acetaminophen and Caffeine Tablets, USP and contact your healthcare provider immediately.


• Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.

This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.

Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.

Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Laboratory Tests

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Drug Interactions

The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.

Butalbital, Acetaminophen and Caffeine Tablets may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.

Drug/Laboratory Test Interactions

Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C: Animal reproduction studies have not been conducted with this combination product. It is also not known whether Butalbital, Acetaminophen and Caffeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed.

Nonteratogenic Effects

Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last two months of pregnancy. Butalbital was found in the infant's serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.

Nursing Mothers

Caffeine, barbiturates and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from Butalbital, Acetaminophen and Caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 have not been established.

Geriatric Use

Clinical studies of Butalbital, Acetaminophen, and Caffeine Tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or renal drug therapy.

Butalbital is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions

Frequently Observed

The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.

Infrequently Observed

All adverse events tabulated below are classified as infrequent.

Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement, or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.

Autonomic Nervous System: dry mouth, hyperhidrosis.

Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.

Cardiovascular: tachycardia.

Musculoskeletal: leg pain, muscle fatigue.

Genitourinary: diuresis.

Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.

Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.

The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage are listed in the OVERDOSAGE section.

Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.

Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.

Drug Abuse and Dependence

Abuse and Dependence

Butalbital

Barbiturates may be habit-forming:

Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient's regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

Overdosage

Following an acute overdosage of Butalbital, Acetaminophen and Caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.

Signs and Symptoms

Toxicity from barbiturate poisoning includes drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.

In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium, tachycardia and extrasystoles.

Treatment

A single or multiple drug overdose with this combination product is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.

Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

Butalbital, Acetaminophen and Caffeine Dosage and Administration

One tablet every 4 hours. Total daily dosage should not exceed 6 tablets.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.

How is Butalbital, Acetaminophen and Caffeine Supplied

Butalbital, Acetaminophen and Caffeine Tablets, USP

Containing butalbital 50 mg, acetaminophen 500 mg and caffeine 40 mg, are white, caplet-shaped tablets, bisected, debossed "23/57" on one side, and debossed "V" on the reverse side.

• Bottles of 10: NDC 0603-2545-10


• Bottles of 100: NDC 0603-2545-21


• Bottles of 500: NDC 0603-2545-28


• Bottles of 1000: NDC 0603-2545-32

Storage

Store at 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container with a child-resistant closure.

Manufactured for:

QUALITEST PHARMACEUTICALS

Huntsville, AL 35811

8181519

R11/11-R4

PRINCIPAL DISPLAY PANEL

Butalbital, Acetaminophen and Caffeine  butalbital, acetaminophen, and caffeine  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0603-2545 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUTALBITAL (BUTALBITAL) BUTALBITAL 50 mg ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg CAFFEINE (CAFFEINE) CAFFEINE 40 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE   CROSCARMELLOSE SODIUM   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   STEARIC ACID   CROSPOVIDONE   POVIDONE   STARCH, CORN

Product Characteristics Color WHITE Score 2 pieces Shape OVAL (caplet-shaped) Size 20mm Flavor Imprint Code 23;57;V Contains

Packaging # NDC Package Description Multilevel Packaging 1 0603-2545-10 10 TABLET In 1 BOTTLE, PLASTIC None 2 0603-2545-21 100 TABLET In 1 BOTTLE, PLASTIC None 3 0603-2545-28 500 TABLET In 1 BOTTLE, PLASTIC None 4 0603-2545-32 1000 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040513	08/25/2003

Labeler - Qualitest Pharmaceuticals (011103059)

Establishment
Name	Address	ID/FEI	Operations
Vintage Pharmaceuticals-Charlotte		151228897	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Vintage Pharmaceuticals-Huntsville		825839835	MANUFACTURE

Revised: 12/2011Qualitest Pharmaceuticals

Sinacort

Sinacort may be available in the countries listed below.

Ingredient matches for Sinacort

Betamethasone

Betamethasone 17α,21-dipropionate (a derivative of Betamethasone) is reported as an ingredient of Sinacort in the following countries:

• Bangladesh

International Drug Name Search

Adrenalina Salf

Adrenalina Salf may be available in the countries listed below.

Ingredient matches for Adrenalina Salf

Epinephrine

Epinephrine is reported as an ingredient of Adrenalina Salf in the following countries:

• Italy

International Drug Name Search

Oxazepam A

Oxazepam A may be available in the countries listed below.

Ingredient matches for Oxazepam A

Oxazepam

Oxazepam is reported as an ingredient of Oxazepam A in the following countries:

• Netherlands

International Drug Name Search

Delgott

Delgott may be available in the countries listed below.

Ingredient matches for Delgott

Dihydroergotamine

Dihydroergotamine mesilate (a derivative of Dihydroergotamine) is reported as an ingredient of Delgott in the following countries:

• Japan

International Drug Name Search

Phenamin

Phenamin may be available in the countries listed below.

Ingredient matches for Phenamin

Dexchlorpheniramine

Dexchlorpheniramine maleate (a derivative of Dexchlorpheniramine) is reported as an ingredient of Phenamin in the following countries:

• Norway

International Drug Name Search

BAL In Oil

Generic Name: dimercaprol (DYE mer KAP rol)

Brand Names: BAL In Oil

What is BAL In Oil (dimercaprol)?

Dimercaprol is a chelating (KEE-late-ing) agent. A chelating agent is capable of removing a heavy metal, such as lead or mercury, from the blood.

Dimercaprol is used to treat poisoning with arsenic, gold, or mercury. It is also used together with another medication called edetate disodium (EDTA) to treat lead poisoning.

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

What is the most important information I should know about BAL In Oil (dimercaprol)?

If possible, before you receive dimercaprol, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease.

Dimercaprol may contain peanut oil. Tell your caregivers if you have a peanut allergy.

In a poisoning situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you have received this medication.

Dimercaprol is most effective when used within 1 or 2 hours after a poisoning. It may not be as effective in treating long-term poisoning.

What should I discuss with my health care provider before receiving BAL In Oil (dimercaprol)?

If possible, before you receive dimercaprol, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease.

If you have any of these conditions, you may not be able to receive dimercaprol, or you may need a dose or special tests to safely receive this medication.

Dimercaprol may contain peanut oil. Tell your caregivers if you have a peanut allergy.

FDA pregnancy category C. This medication may be harmful to an unborn baby and is not recommended in pregnant women unless clearly needed. It is not known whether dimercaprol passes into breast milk or if it could harm a nursing baby.

In an emergency situation, it may not be possible before you are treated with dimercaprol to tell your caregivers if you are pregnant or breast-feeding. However, make sure any doctor caring for your pregnancy or your baby knows that you have received this medication.

How should I take BAL In Oil (dimercaprol)?

Dimercaprol is given as an injection into a muscle. You will receive this injection in a hospital or emergency setting.

Dimercaprol may be given for several days, depending on the type of poisoning being treated.

Dimercaprol is most effective when used within 1 or 2 hours after a poisoning. It may not be as effective in treating long-term poisoning.

What happens if I miss a dose?

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

What happens if I overdose?

Tell your caregivers right away if you think you have received too much of this medicine.

Overdose symptoms may include nausea, vomiting, extreme drowsiness, or seizure (convulsions).

What should I avoid after receiving BAL In Oil (dimercaprol)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you are treated with dimercaprol.

BAL In Oil (dimercaprol) 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:

• 
  

  fast heart rate, feeling anxious or restless;

  
  


• 
  

  pain or tightness in your throat, chest, or hands;

  
  


• 
  

  burning sensation of your throat, mouth, or lips; or

  
  


• 
  

  burning sensation in your penis.

  
  

Less serious side effects include:

• 
  

  nausea, vomiting, stomach pain;

  
  


• 
  

  numbness or tingling (especially around your mouth);

  
  


• 
  

  headache;

  
  


• 
  

  eye redness, swelling, or watering;

  
  


• 
  

  twitching of your eyelid;

  
  


• 
  

  runny nose;

  
  


• 
  

  increased sweating;

  
  


• 
  

  mild fever; or

  
  


• 
  

  pain, redness, or swelling where the needle is placed.

  
  

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 BAL In Oil (dimercaprol)?

There may be other drugs that can interact with dimercaprol. Tell your doctor about all prescription and over-the-counter medications you have recently used, including vitamins, minerals, herbal products, and drugs prescribed by other doctors.

More BAL In Oil resources

• BAL In Oil Side Effects (in more detail)
• BAL In Oil Drug Interactions
• BAL In Oil Support Group
• 0 Reviews for BAL In - Add your own review/rating

• BAL in Oil Prescribing Information (FDA)


• BAL in Oil Monograph (AHFS DI)

Compare BAL In Oil with other medications

• Arsenic Poisoning
• Gold Poisoning, Severe
• Mercury Poisoning

Where can I get more information?

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

See also: BAL In side effects (in more detail)

Efumin

Efumin may be available in the countries listed below.

Ingredient matches for Efumin

Chlormadinone

Chlormadinone 17α-acetate (a derivative of Chlormadinone) is reported as an ingredient of Efumin in the following countries:

• Japan

International Drug Name Search

bacitracin injection

Generic Name: bacitracin (injection) (BAS i TRAY sin)

Brand names: Baci-IM, Baci-Rx

What is bacitracin?

Bacitracin injection is an antibiotic that treats staph infection caused by a bacteria called staphylococcus (STAF-il-oh-KOK-us).

Bacitracin injection is used in infants to treat pneumonia. It is also used to treat an infection that causes pus to build up between the lungs and the membrane that covers them.

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

What is the most important information I should know about bacitracin injection?

Before your child receives bacitracin injection, tell the doctor if the child has a history of kidney disease.

Many other drugs can damage the kidneys and should not be used together with bacitracin. Tell your doctor if your child is receiving chemotherapy, medicines used to treat a bowel disorder, medications to prevent organ transplant rejection, antiviral medications, or any other injected antibiotics.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.

Serious side effects of bacitracin injection include urinating less than usual or not at all, blood in the urine, lower back pain, or painful urination.

Make sure your child receives this medication for the entire length of time prescribed by the doctor. Your child's symptoms may get better before the infection is completely treated. Bacitracin injection will not treat a viral infection such as the common cold or flu.

What should I discuss with my health care provider before receiving bacitracin injection?

Your child should not receive this medication if he or she is allergic to bacitracin.

Before receiving bacitracin injection, tell your child's doctor if the child is allergic to any drugs, or if your child has a history of kidney disease. If your child has either of these conditions, he or she may not be able to receive bacitracin, or may need dosage adjustments or special tests during treatment.

How is bacitracin injection given?

This medication is given as an injection into a muscle. A doctor, nurse, or other healthcare provider will give your child this injection.

Lung infections in infants are serious conditions, and your child will most likely be kept in the hospital while being treated with bacitracin injection.

To be sure this medication is not causing harmful effects, your child's kidney function may need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Make sure your child receives this medication for the entire length of time prescribed by the doctor. Your child's symptoms may get better before the infection is completely treated. Bacitracin injection will not treat a viral infection such as the common cold or flu.

What happens if I miss a dose?

Since bacitracin injection is usually given in a hospital, it is not likely your child will miss a dose.

What happens if I overdose?

Tell your child's caregivers right away if you think the child has received too much of this medicine.

What should I avoid while receiving bacitracin injection?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while your child is receiving bacitracin injection.

Bacitracin injection side effects

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat. While receiving bacitracin injection, your child will be watched for the following serious side effects:

• 
  

  urinating more than usual or more often;

  
  


• 
  

  urinating less than usual, or not at all (fewer wet diapers);

  
  


• 
  

  blood in the urine;

  
  


• 
  

  lower back pain; or

  
  


• 
  

  painful urination.

  
  

Less serious side effects include:

• 
  

  nausea, vomiting;

  
  


• 
  

  mild skin rash; or

  
  


• 
  

  pain, burning, or swelling where the medicine was injected.

  
  

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 bacitracin injection?

Before your child receives bacitracin, tell the doctor if your child is receiving any of the following drugs:

• 
  

  cancer medications (chemotherapy);

  
  


• 
  

  medicines used to treat a bowel disorder, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

  
  


• 
  

  medicines used to prevent organ transplant rejection, such as sirolimus (Rapamune) or tacrolimus (Prograf);

  
  


• 
  

  any other injected antibiotics such as amikacin (Amikin), amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), or streptomycin; or

  
  


• 
  

  antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir).

  
  

Many of these other drugs can damage the kidneys. If your child is receiving any of these drugs, he or she may not be able to receive bacitracin, or may need dosage adjustments or special tests during treatment.

There may be other drugs that can affect bacitracin injection. Tell your doctor about all your child's 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 child's doctor.

More bacitracin resources

• Bacitracin Drug Interactions
• Bacitracin Support Group
• 0 Reviews for Bacitracin - Add your own review/rating

Compare bacitracin with other medications

• Pneumonia

Where can I get more information?

• Your pharmacist can provide more information about bacitracin injection.

Zinc and Salicylic acid

Zinc and Salicylic acid may be available in the countries listed below.

Ingredient matches for Zinc and Salicylic acid

Salicylic Acid

Salicylic Acid is reported as an ingredient of Zinc and Salicylic acid in the following countries:

• Japan

Zinc Oxide

Zinc Oxide is reported as an ingredient of Zinc and Salicylic acid in the following countries:

• Japan

International Drug Name Search

Tisolon

Tisolon may be available in the countries listed below.

Ingredient matches for Tisolon

Methylprednisolone

Methylprednisolone is reported as an ingredient of Tisolon in the following countries:

• Indonesia

International Drug Name Search

Gluconato de Calcio Biol

Gluconato de Calcio Biol may be available in the countries listed below.

Ingredient matches for Gluconato de Calcio Biol

Calcium Gluconate

Calcium Gluconate is reported as an ingredient of Gluconato de Calcio Biol in the following countries:

• Argentina

International Drug Name Search

Compression Fracture of Vertebral Column Medications

There are currently no drugs listed for "Compression Fracture of Vertebral Column".

Learn more about Compression Fracture of Vertebral Column

Medical Encyclopedia:

• Compression fractures of the back
• Bone fracture repair

Drug List:

Sinu-Med Tablets

Sinu-Med Tablets may be available in the countries listed below.

Ingredient matches for Sinu-Med Tablets

Pseudoephedrine

Pseudoephedrine hydrochloride (a derivative of Pseudoephedrine) is reported as an ingredient of Sinu-Med Tablets in the following countries:

• South Africa

International Drug Name Search

Serolin

Serolin may be available in the countries listed below.

Ingredient matches for Serolin

Nicergoline

Nicergoline is reported as an ingredient of Serolin in the following countries:

• Indonesia

International Drug Name Search

Perivax R

Perivax R may be available in the countries listed below.

Ingredient matches for Perivax R

Pentoxifylline

Pentoxifylline is reported as an ingredient of Perivax R in the following countries:

• Peru

International Drug Name Search

Cotibin Compuesto

Cotibin Compuesto may be available in the countries listed below.

Ingredient matches for Cotibin Compuesto

Paracetamol

Paracetamol is reported as an ingredient of Cotibin Compuesto in the following countries:

• Chile

International Drug Name Search

Kesium

Kesium may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Kesium

Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Kesium in the following countries:

• France

Clavulanate

Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Kesium in the following countries:

• France

International Drug Name Search

Quest

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Quest

Moxidectin

Moxidectin is reported as an ingredient of Quest in the following countries:

• United States

Praziquantel

Praziquantel is reported as an ingredient of Quest in the following countries:

• United States

International Drug Name Search

Fenformina

Fenformina may be available in the countries listed below.

Ingredient matches for Fenformina

Phenformin

Fenformina (DCIT) is also known as Phenformin (Prop.INN)

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana
Prop.INN	Proposed International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Celay

Celay may be available in the countries listed below.

Ingredient matches for Celay

Cetirizine

Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Celay in the following countries:

• Venezuela

International Drug Name Search

Mefinter

Mefinter may be available in the countries listed below.

Ingredient matches for Mefinter

Mefenamic Acid

Mefenamic Acid is reported as an ingredient of Mefinter in the following countries:

• Indonesia

International Drug Name Search

Somatuline retard

Somatuline retard may be available in the countries listed below.

Ingredient matches for Somatuline retard

Lanreotide

Lanreotide acetate (a derivative of Lanreotide) is reported as an ingredient of Somatuline retard in the following countries:

• Austria

International Drug Name Search

Avage

Avage is a brand name of tazarotene topical, approved by the FDA in the following formulation(s):

AVAGE (tazarotene - cream; topical)

• 
  Manufacturer: ALLERGAN
  
  Approval date: September 30, 2002
  
  Strength(s): 0.1% ^[RLD]

Has a generic version of Avage been approved?

No. There is currently no therapeutically equivalent version of Avage available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Avage. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

There are no current U.S. patents associated with Avage.

See also...

• Avage Cream Consumer Information (Wolters Kluwer)
• Avage Consumer Information (Cerner Multum)
• Avage Topical Advanced Consumer Information (Micromedex)
• Tazarotene Cream Consumer Information (Wolters Kluwer)
• Tazarotene Gel Consumer Information (Wolters Kluwer)
• Tazarotene topical Consumer Information (Cerner Multum)
• Tazarotene Topical Advanced Consumer Information (Micromedex)
• Tazarotene AHFS DI Monographs (ASHP)

Fungocamt

Fungocamt may be available in the countries listed below.

Ingredient matches for Fungocamt

Isoconazole

Isoconazole is reported as an ingredient of Fungocamt in the following countries:

• Peru

International Drug Name Search

Mirtazapine Sandoz

Mirtazapine Sandoz may be available in the countries listed below.

Ingredient matches for Mirtazapine Sandoz

Mirtazapine

Mirtazapine is reported as an ingredient of Mirtazapine Sandoz in the following countries:

• Australia


• Belgium


• France


• Lithuania


• Netherlands

International Drug Name Search

Voltex

Voltex may be available in the countries listed below.

Ingredient matches for Voltex

Diclofenac

Diclofenac diethylamine (a derivative of Diclofenac) is reported as an ingredient of Voltex in the following countries:

• Myanmar

Methyl Salicylate

Methyl Salicylate is reported as an ingredient of Voltex in the following countries:

• Myanmar

International Drug Name Search

ATP Sanwa Kagaku

ATP Sanwa Kagaku may be available in the countries listed below.

Ingredient matches for ATP Sanwa Kagaku

Adenosine Triphosphate

Adenosine Triphosphate disodium salt (a derivative of Adenosine Triphosphate) is reported as an ingredient of ATP Sanwa Kagaku in the following countries:

• Japan

International Drug Name Search

Rowasa

Generic Name: mesalamine (Rectal route)

me-SAL-a-meen

Commonly used brand name(s)

In the U.S.

• Canasa


• Rowasa


• sfRowasa

In Canada

• Mesasal


• Pentasa


• Salofalk

Available Dosage Forms:

• Suppository


• Enema

Therapeutic Class: Gastrointestinal Agent

Chemical Class: Salicylate, Non-Aspirin

Uses For Rowasa

Mesalamine is used to treat inflammatory bowel disease, such as ulcerative colitis. This medicine works inside the bowel by helping to reduce inflammation and other symptoms.

Mesalamine 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, mesalamine is used in certain patients with the following medical condition:

• Ulcerative colitis, history of—prevent it from occurring again

Before Using Rowasa

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 this medicine, 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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of mesalamine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of mesalamine in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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. When you are taking this medicine, 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 this medicine 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.

• Varicella Virus Vaccine

Using this medicine 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.

• Ardeparin


• Certoparin


• Dalteparin


• Danaparoid


• Enoxaparin


• Nadroparin


• Parnaparin


• Reviparin


• Tamarind


• Tinzaparin


• Warfarin

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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—The use of mesalamine may make this condition worse.

Proper Use of mesalamine

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

For best results, empty your bowel just before using the rectal enema or suppository.

Keep using this medicine for the full time of treatment even if you begin to feel better after a few days. Do not miss any doses.

For patients using the enema form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Remove the bottles from the protective foil pouch, being careful not to squeeze or puncture them. The enema is an off-white to tan color. Contents of the enemas removed from the foil pouch may darken with time. Slight darkening will not affect the potency of the contents. However, enemas with dark brown contents should be discarded.


• Shake the bottle well to make sure that the medication is thoroughly mixed. Remove the protective cover from the applicator tip. Hold bottle at the neck so that no medicine spills out.


• Lie on your left side with your left leg straight and your right knee bent in front of you for balance. You can also lie in the knee-chest position, on your knees with your chest touching the bed.


• Gently insert the rectal tip of the enema applicator pointed slightly toward your naval to prevent damage to the rectal wall. Tilt the nozzle slightly toward the back and squeeze slowly to cause the enema to flow into your rectum. Steady pressure will discharge most of the medicine. After administering, withdraw and discard the bottle.


• Remain in position for at least 30 minutes to allow the medicine to distribute thoroughly. Retain the medicine all night if possible.

For patients using the suppository form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Detach one suppository from strip of suppositories. Hold suppository upright and carefully remove the foil wrapper.


• Avoid excessive handling of the suppository, which is designed to melt at body temperature.


• Insert suppository (pointed end first) completely into rectum with gentle pressure. Retain the suppository for 3 hours or longer, if possible, to achieve the best result.

Dosing

The dose of this medicine 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 this medicine. 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 inflammatory bowel disease:
  
  • For enema dosage form:
    
    • Adults and teenagers—4 grams (1 unit), used as directed, every night for three to six weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For suppository dosage form:
    
    • Adults and teenagers—500 milligrams (mg), inserted into your rectum, two or three times a day for three to six weeks or 1000 mg, inserted into your rectum, one time a day at bedtime for three to six weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Rowasa

It is important that your doctor check your progress at regular visits.

Contact your doctor if you develop cramping, acute abdominal pain, bloody diarrhea, fever, headache or rash. These may be symptoms of a serious condition.

Tell your doctor right away if you experience chest pain or shortness of breath.

Check with your doctor if you notice rectal bleeding, blistering, pain, burning, itching, or other sign of irritation not present before you started using this medicine.

Mesalamine rectal enema may stain clothing, fabrics, painted surfaces, marble, granite, vinyl, or other surfaces it touches.

Rowasa 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 as soon as possible if any of the following side effects occur:

Less common or rare

• Abdominal or stomach cramps or pain (severe)


• anxiety


• back pain (severe)


• bloody, black, or tarry stools


• blue or pale skin


• bright red blood in the stool


• chest pain, possibly moving to the left arm, neck, or shoulder


• chills


• diarrhea (severe)


• fast heartbeat


• fever


• headache (severe)


• nausea or vomiting


• shortness of breath


• skin rash


• stomach cramps, tenderness, pain


• swelling of the stomach


• unusual tiredness or weakness


• watery or bloody diarrhea


• yellow eyes or skin

Incidence not known

• Blood in urine


• change in frequency of urination or amount of urine


• cough


• difficulty in breathing


• drowsiness


• high fever


• increased thirst


• loss of appetite


• lower back or side pain


• painful or difficult urination


• pale skin


• sore throat


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


• swelling of feet or lower legs


• swollen glands


• troubled breathing


• unexplained or unusual bleeding or bruising


• weakness

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

More common

• Abdominal or stomach cramps or pain (mild)


• gas or flatulence


• headache (mild)


• nausea

Less common or rare

• Acne


• diarrhea


• dizziness


• leg or joint pain


• loss of hair


• rectal pain or irritation

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: Rowasa 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 Rowasa resources

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

• Rowasa Prescribing Information (FDA)


• Rowasa Enema MedFacts Consumer Leaflet (Wolters Kluwer)


• Mesalamine Prescribing Information (FDA)


• Mesalamine Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Mesalamine Monograph (AHFS DI)


• Apriso Prescribing Information (FDA)


• Apriso Consumer Overview


• Apriso Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Asacol Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Asacol Consumer Overview


• Asacol Prescribing Information (FDA)


• Asacol HD Prescribing Information (FDA)


• Asacol HD Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Canasa Prescribing Information (FDA)


• Canasa Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)


• Lialda Prescribing Information (FDA)


• Lialda Consumer Overview


• Pentasa Prescribing Information (FDA)


• Pentasa Consumer Overview


• sfRowasa Prescribing Information (FDA)

Compare Rowasa with other medications

• Crohn's Disease
• Inflammatory Bowel Disease
• Ulcerative Colitis
• Ulcerative Colitis, Active
• Ulcerative Proctitis

Perskindol

In the US, Perskindol is a member of the drug class topical anesthetics and is used to treat Cough and Pain.

Ingredient matches for Perskindol

Levomenthol

Levomenthol is reported as an ingredient of Perskindol in the following countries:

• Switzerland

International Drug Name Search

Amikacin Injection Meiji

Amikacin Injection Meiji may be available in the countries listed below.

Ingredient matches for Amikacin Injection Meiji

Amikacin

Amikacin sulfate (a derivative of Amikacin) is reported as an ingredient of Amikacin Injection Meiji in the following countries:

• Thailand

International Drug Name Search

Sandoz Co-Tenidone

Sandoz Co-Tenidone may be available in the countries listed below.

Ingredient matches for Sandoz Co-Tenidone

Atenolol

Atenolol is reported as an ingredient of Sandoz Co-Tenidone in the following countries:

• South Africa

Chlortalidone

Chlortalidone is reported as an ingredient of Sandoz Co-Tenidone in the following countries:

• South Africa

International Drug Name Search

Aurene

Aurene may be available in the countries listed below.

Ingredient matches for Aurene

Oxcarbazepine

Oxcarbazepine is reported as an ingredient of Aurene in the following countries:

• Argentina

International Drug Name Search

deferasirox

dee-FER-a-sir-ox

Oral route(Tablet for Suspension)

May cause renal impairment (including failure), hepatic impairment (including failure), and gastrointestinal hemorrhage. In some reported cases, these reactions were fatal. These reactions were more frequently observed in patients with advanced age, high risk myelodysplastic syndromes (MDS), underlying renal or hepatic impairment or low platelet counts (less than 50 x 10(9)/L). Therapy requires close patient monitoring, including laboratory tests of renal and hepatic function .

Commonly used brand name(s)

In the U.S.

• Exjade

Available Dosage Forms:

• Tablet for Suspension

Therapeutic Class: Heavy Metal Chelator

Uses For deferasirox

Deferasirox is used to remove excess iron from the body after a person has had too many blood transfusions.

Deferasirox combines with iron in the blood. The combination of iron and deferasirox is then removed from the body by the kidneys. If you have too much iron in the body, it can damage various organs and tissues.

deferasirox is available only with your doctor's prescription.

Before Using deferasirox

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 deferasirox, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to deferasirox 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 deferasirox in children up to 2 years 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 deferasirox in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving deferasirox.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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. When you are taking deferasirox, 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 deferasirox 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.

• Paclitaxel


• Theophylline

Using deferasirox 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.

• Cholestyramine


• Midazolam


• Repaglinide


• Rifampin

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.

Other Medical Problems

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

• Blood or bone marrow disorders (e.g., agranulocytosis, neutropenia) or


• Eye problems (e.g., cataracts, glaucoma) or


• Hearing problems or


• Kidney disease or


• Stomach ulcers or bleeding problems—Use with caution. May make these conditions worse.

• Bone marrow problems (e.g., myelodysplastic syndrome) or


• Cancer or


• Kidney disease, severe or


• Liver disease, severe or


• Thrombocytopenia (low platelet count in the blood)—Should not be used in patients with these conditions.

• Liver disease (e.g., hepatitis)—You may need a lower dose of deferasirox.

Proper Use of deferasirox

It is best to take deferasirox at the same time each day on an empty stomach, at least 30 minutes before you eat.

Dissolve the tablet in water, orange juice, or apple juice, mix well, then drink the mixture right away. To make sure you get all of the medicine, add some more liquid to the drinking glass, then drink all of this liquid too. Do not chew or swallow the tablet whole, and do not use it without mixing it in a liquid first.

Dosing

The dose of deferasirox 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 deferasirox. 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 oral dosage form (tablet for suspension):
  
  • For chronic iron overload:
    
    • Adults and children over 2 years of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 20 milligrams (mg) per kilogram (kg) of body weight per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per kg per day.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of deferasirox, 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 deferasirox

It is very important that your doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Deferasirox may cause some people to have hearing and vision problems within a few weeks after they start taking it. If you or your child notice any problems with your hearing or vision, such as blurred vision, difficulty with night vision, or difficulty with seeing colors, check with your doctor as soon as possible.

deferasirox 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 or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using deferasirox.

Deferasirox will lower the number of some types of blood cells in your body. Because of this, you or your child may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Stop using deferasirox and check with your doctor right away if you or your child have the following symptoms: agitation, confusion, decreased urine output, lethargy, muscle twitching, rapid weight gain, seizures, or swelling of the face, ankles, or hands. These may be symptoms of a serious kidney problem.

Liver problems may occur while you are using deferasirox. Stop using deferasirox and check with your doctor right away if you or your child are having more than one of these symptoms: abdominal or stomach pain or tenderness; clay-colored stools; dark urine; fever; nausea and vomiting; skin rash; or yellow eyes or skin.

Check with your doctor right away if you or your child have these symptoms: abdominal or stomach pain, cramping, or burning; black, tarry stools; constipation; diarrhea; heartburn; indigestion; nausea; or vomiting of blood or material that looks like coffee grounds. These may be symptoms of a serious stomach or bowel problem.

Serious skin reactions can occur with deferasirox. Stop using deferasirox and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; sores or ulcers on the skin; or fever or chills while you or your child are using deferasirox.

If you or your child have diarrhea or vomiting, drink plenty of water or fluids to keep your body hydrated.

deferasirox may cause some people to become dizzy. Do not drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

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. Do not take deferasirox with aluminum-containing antacids (Mylanta®, Maalox®).

deferasirox 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:

More common

• Body aches or pain


• chills


• congestion


• cough or cough producing mucus


• diarrhea


• difficulty with breathing


• difficulty with moving


• dryness or soreness of the throat


• earache or pain in the ear


• ear drainage


• fever with or without chills


• general feeling of discomfort or illness


• headache


• hoarseness


• joint pain


• loss of appetite


• muscle aches and pains


• nausea


• shivering


• shortness of breath


• stuffy or runny nose


• tender, swollen glands in the neck


• tightness in the chest


• trouble with sleeping


• trouble with swallowing


• unusual tiredness or weakness


• voice changes


• vomiting


• wheezing

Rare

• Blindness


• blurred vision


• change in hearing


• change in vision


• decreased hearing


• decreased vision


• high-frequency hearing loss


• loss of vision


• pain or discomfort in the eye


• white area over the eye

Incidence not known

• Agitation


• black, tarry stools


• bleeding gums


• blood in the urine or stools


• confusion


• decrease in urine amount


• depression


• difficulty with swallowing


• dizziness


• fast heartbeat


• hives or welts


• hostility


• irritability


• itching


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


• lethargy


• lower back or side pain


• muscle twitching


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


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


• rapid weight gain


• redness, soreness or itching of the skin


• seizures


• skin rash


• sore throat


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


• sores, welting, or blisters


• stupor


• swelling of face, ankles, or hands


• unusual bleeding or bruising

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

More common

• Abdominal or stomach pain


• back pain


• muscle stiffness

Incidence not known

• Hair loss or thinning of the hair

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: deferasirox side effects (in more detail)

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More deferasirox resources

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

• Deferasirox Professional Patient Advice (Wolters Kluwer)


• Deferasirox Monograph (AHFS DI)


• Deferasirox MedFacts Consumer Leaflet (Wolters Kluwer)


• Exjade Prescribing Information (FDA)


• Exjade Consumer Overview

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