Bezatol

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Bezafibrate

Bezafibrate is reported as an ingredient of Bezatol in the following countries:

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Mebensole

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Mebendazole

Mebendazole is reported as an ingredient of Mebensole in the following countries:

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Toplexil

Toplexil may be available in the countries listed below.

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Guaifenesin

Guaifenesin is reported as an ingredient of Toplexil in the following countries:

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Oxomemazine

Oxomemazine is reported as an ingredient of Toplexil in the following countries:

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Co-Micardis

Co-Micardis may be available in the countries listed below.

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Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Co-Micardis in the following countries:

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Telmisartan

Telmisartan is reported as an ingredient of Co-Micardis in the following countries:

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Tilidura

Tilidura may be available in the countries listed below.

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Naloxone

Naloxone hydrochloride (a derivative of Naloxone) is reported as an ingredient of Tilidura in the following countries:

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Tilidine

Tilidine hydrochloride hemihydrate (a derivative of Tilidine) is reported as an ingredient of Tilidura in the following countries:

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Efedrina Cloridrato Salf

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Ephedrine

Ephedrine hydrochloride (a derivative of Ephedrine) is reported as an ingredient of Efedrina Cloridrato Salf in the following countries:

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Togal ASS

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Aspirin

Acetylsalicylic Acid is reported as an ingredient of Togal ASS in the following countries:

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brompheniramine and phenylpropanolamine

Generic Name: brompheniramine and phenylpropanolamine (brome feh NEER a meen/fen ill proe pa NO la meen)

Brand names: Altatapp, Dibrom, Dibromm, Dimaphen, Dimetapp, Myphetapp, ...show all 13 brand names.E.N.T., Dimaphen(obsolete), Dimetapp Extentabs, Dibromm (obsolete), Dimetapp (obsolete), Dimetapp Cold & Cough (obsolete), Dimetapp Cold and Allergy (obsolete)

What is brompheniramine and phenylpropanolamine?

Brompheniramine is an antihistamine. It works against the naturally occurring chemical histamine in your body. Brompheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

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

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

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

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

What is the most important information I should know about brompheniramine and phenylpropanolamine?

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

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

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

What should I discuss with my healthcare provider before taking brompheniramine and phenylpropanolamine?

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

Before taking this medication, tell your doctor if you have

• kidney disease,


• liver disease,


• 
  

  diabetes,

  
  


• 
  

  glaucoma,

  
  


• 
  

  any type of heart disease or high blood pressure,

  
  


• 
  

  thyroid disease,

  
  


• 
  

  emphysema or chronic bronchitis, or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

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

Brompheniramine and phenylpropanolamine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from brompheniramine and phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take brompheniramine and phenylpropanolamine?

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

Take each dose with a full glass of water. Do not crush, chew, or break the long-acting or sustained-release forms of this medication. Swallow them whole. If you are unsure about the formulation of the medicine, ask your pharmacist for help.

If you cannot swallow the tablets or capsules, look for a liquid form of the medication.

To ensure that you get a correct dose, measure the liquid form of brompheniramine and phenylpropanolamine 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 recommended. An overdose of this medication can cause serious harm.

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

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

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention.

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

What should I avoid while taking brompheniramine and phenylpropanolamine?

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

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

Brompheniramine and phenylpropanolamine side effects

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

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

• 
  

  dryness of the eyes, nose, and mouth;

  
  


• 
  

  drowsiness or dizziness;

  
  


• 
  

  blurred vision;

  
  


• 
  

  difficulty urinating; or

  
  


• 
  

  excitation in children.

  
  

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

What other drugs will affect brompheniramine and phenylpropanolamine?

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

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

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

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

More brompheniramine and phenylpropanolamine resources

• Brompheniramine and phenylpropanolamine Drug Interactions
• Brompheniramine and phenylpropanolamine Support Group
• 0 Reviews for Brompheniramine and phenylpropanolamine - Add your own review/rating

Compare brompheniramine and phenylpropanolamine with other medications

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Where can I get more information?

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

What does my medication look like?

Many formulations of brompheniramine and phenylpropanolamine are available both over-the-counter and with a prescription. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Polovital C

Polovital C may be available in the countries listed below.

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Ascorbic Acid

Ascorbic Acid is reported as an ingredient of Polovital C in the following countries:

• Poland

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Hico

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Heparin

Heparin sodium salt (a derivative of Heparin) is reported as an ingredient of Hico in the following countries:

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Ketamine Panpharma

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Ketamine

Ketamine hydrochloride (a derivative of Ketamine) is reported as an ingredient of Ketamine Panpharma in the following countries:

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Bromocriptine

Dosage Form: tablets
Bromocriptine Mesylate Tablets, USP

Bromocriptine Description

Bromocriptine mesylate is an ergot derivative with potent dopamine receptor agonist activity. Each Bromocriptine mesylate tablet for oral administration contains 2.5 mg Bromocriptine (as the mesylate). Bromocriptine mesylate is chemically designated as Ergotaman-3',6',18-trione, 2-bromo-12'-hydroxy-2'-(1-methylethyl)-5'-(2-methylpropyl)-,(5'α)-monomethanesulfonate (salt).

The structural formula is:

Active Ingredient: Bromocriptine mesylate, USP

Inactive Ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, maleic acid, povidone and pregelatinized starch.

Bromocriptine mesylate tablets USP, 2.5 mg meet USP Dissolution Test 1.

Bromocriptine - Clinical Pharmacology

Bromocriptine is a dopamine receptor agonist, which activates postsynaptic dopamine receptors. The dopaminergic neurons in the tuberoinfundibular process modulate the secretion of prolactin from the anterior pituitary by secreting a prolactin inhibitory factor (thought to be dopamine); in the corpus striatum the dopaminergic neurons are involved in the control of motor function. Clinically, Bromocriptine significantly reduces plasma levels of prolactin in patients with physiologically elevated prolactin as well as in patients with hyperprolactinemia. The inhibition of physiological lactation as well as galactorrhea in pathological hyperprolactinemic states is obtained at dose levels that do not affect secretion of other tropic hormones from the anterior pituitary. Experiments have demonstrated that Bromocriptine induces long lasting stereotyped behavior in rodents and turning behavior in rats having unilateral lesions in the substantia nigra. These actions, characteristic of those produced by dopamine, are inhibited by dopamine antagonists and suggest a direct action of Bromocriptine on striatal dopamine receptors.

Bromocriptine is a nonhormonal, nonestrogenic agent that inhibits the secretion of prolactin in humans, with little or no effect on other pituitary hormones, except in patients with acromegaly, where it lowers elevated blood levels of growth hormone in the majority of patients.

In about 75% of cases of amenorrhea and galactorrhea, Bromocriptine therapy suppresses the galactorrhea completely, or almost completely, and reinitiates normal ovulatory menstrual cycles.

Menses are usually reinitiated prior to complete suppression of galactorrhea; the time for this on average is 6-8 weeks. However, some patients respond within a few days, and others may take up to 8 months.

Galactorrhea may take longer to control depending on the degree of stimulation of the mammary tissue prior to therapy. At least a 75% reduction in secretion is usually observed after 8-12 weeks. Some patients may fail to respond even after 12 months of therapy.

In many acromegalic patients, Bromocriptine produces a prompt and sustained reduction in circulating levels of serum growth hormone.

Bromocriptine produces its therapeutic effect in the treatment of Parkinson's disease, a clinical condition characterized by a progressive deficiency in dopamine synthesis in the substantia nigra, by directly stimulating the dopamine receptors in the corpus striatum. In contrast, levodopa exerts its therapeutic effect only after conversion to dopamine by the neurons of the substantia nigra, which are known to be numerically diminished in this patient population.

Pharmacokinetics

The pharmacokinetics and metabolism of Bromocriptine in human subjects were studied with the help of radioactively labeled drug. Twenty-eight percent of an oral dose was absorbed from the gastrointestinal tract. The blood levels following a 2.5 mg dose were in the range of 2-3 ng equivalents/mL. Plasma levels were in the range of 4-6 ng equivalents/mL indicating that the red blood cells did not contain appreciable amounts of drug and/or metabolites. In vitro experiments showed that the drug was 90%-96% bound to serum albumin.

Bromocriptine was completely metabolized prior to excretion. The major route of excretion of absorbed drug was via the bile. Only 2.5%-5.5% of the dose was excreted in the urine. Almost all (84.6%) of the administered dose was excreted in the feces in 120 hours.

Indications and Usage for Bromocriptine

Hyperprolactinemia-Associated Dysfunctions

Bromocriptine mesylate tablets are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine mesylate tablets treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of Bromocriptine mesylate tablets therapy may be used to reduce the tumor mass prior to surgery.

Acromegaly

Bromocriptine mesylate tablets therapy is indicated in the treatment of acromegaly. Bromocriptine mesylate tablets therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately ½ of patients treated, although not usually to normal levels.

Since the effects of external pituitary radiation may not become maximal for several years, adjunctive therapy with Bromocriptine mesylate tablets offers potential benefit before the effects of irradiation are manifested.

Parkinson's Disease

Bromocriptine mesylate tablets are indicated in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson's disease. As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor), Bromocriptine mesylate tablets therapy may provide additional therapeutic benefits in those patients who are currently maintained on optimal dosages of levodopa, those who are beginning to deteriorate (develop tolerance) to levodopa therapy, and those who are experiencing "end of dose failure" on levodopa therapy. Bromocriptine mesylate tablets therapy may permit a reduction of the maintenance dose of levodopa and, thus may ameliorate the occurrence and/or severity of adverse reactions associated with long-term levodopa therapy such as abnormal involuntary movements (e.g., dyskinesias) and the marked swings in motor function ("on-off" phenomenon). Continued efficacy of Bromocriptine mesylate tablets therapy during treatment of more than 2 years has not been established.

Data are insufficient to evaluate potential benefit from treating newly diagnosed Parkinson's disease with Bromocriptine mesylate tablets. Studies have shown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in Bromocriptine mesylate treated patients than in levodopa/carbidopa treated patients. Patients unresponsive to levodopa are poor candidates for Bromocriptine mesylate tablets therapy.

Contraindications

Uncontrolled hypertension and sensitivity to any ergot alkaloids. In patients being treated for hyperprolactinemia Bromocriptine mesylate tablets should be withdrawn when pregnancy is diagnosed (see PRECAUTIONS, Hyperprolactinemic States). In the event that Bromocriptine is reinstituted to control a rapidly expanding macroadenoma (see PRECAUTIONS, Hyperprolactinemic States) and a patient experiences a hypertensive disorder of pregnancy, the benefit of continuing Bromocriptine must be weighed against the possible risk of its use during a hypertensive disorder of pregnancy. When Bromocriptine is being used to treat acromegaly, prolactinoma, or Parkinson's disease in patients who subsequently become pregnant, a decision should be made as to whether the therapy continues to be medically necessary or can be withdrawn. If it is continued, the drug should be withdrawn in those who may experience hypertensive disorders of pregnancy (including eclampsia, preeclampsia, or pregnancy-induced hypertension) unless withdrawal of Bromocriptine is considered to be medically contraindicated.

The drug should not be used during the post-partum period in women with a history of coronary artery disease and other severe cardiovascular conditions unless withdrawal is considered medically contraindicated. If the drug is used in the post-partum period the patient should be observed with caution.

Warnings

Since hyperprolactinemia with amenorrhea/galactorrhea and infertility has been found in patients with pituitary tumors, a complete evaluation of the pituitary is indicated before treatment with Bromocriptine.

If pregnancy occurs during Bromocriptine administration, careful observation of these patients is mandatory. Prolactin-secreting adenomas may expand and compression of the optic or other cranial nerves may occur, emergency pituitary surgery becoming necessary. In most cases, the compression resolves following delivery. Reinitiation of Bromocriptine treatment has been reported to produce improvement in the visual fields of patients in whom nerve compression has occurred during pregnancy. The safety of Bromocriptine treatment during pregnancy to the mother and fetus has not been established.

Symptomatic hypotension can occur in patients treated with Bromocriptine for any indication. In postpartum studies with Bromocriptine, decreases in supine systolic and diastolic pressures of greater than 20 mm and 10 mm Hg, respectively, have been observed in almost 30% of patients receiving Bromocriptine. On occasion, the drop in supine systolic pressure was as much as 50-59 mm of Hg. While hypotension during the start of therapy with Bromocriptine occurs in some patients, in postmarketing experience in the U.S. in postpartum patients 89 cases of hypertension have been reported, sometimes at the initiation of therapy, but often developing in the second week of therapy; seizures have been reported in 72 cases (including 4 cases of status epilepticus), both with and without the prior development of hypertension; 30 cases of stroke have been reported mostly in postpartum patients whose prenatal and obstetric courses had been uncomplicated. Many of these patients experiencing seizures and/or strokes reported developing a constant and often progressively severe headache hours to days prior to the acute event. Some cases of strokes and seizures were also preceded by visual disturbances (blurred vision, and transient cortical blindness). Nine cases of acute myocardial infarction have been reported.

Although a causal relationship between Bromocriptine administration and hypertension, seizures, strokes, and myocardial infarction in postpartum women has not been established, use of the drug for prevention of physiological lactation, or in patients with uncontrolled hypertension is not recommended. In patients being treated for hyperprolactinemia Bromocriptine should be withdrawn when pregnancy is diagnosed (see PRECAUTIONS, Hyperprolactinemic States). In the event that Bromocriptine is reinstituted to control a rapidly expanding macroadenoma (see PRECAUTIONS, Hyperprolactinemic States) and a patient experiences a hypertensive disorder of pregnancy, the benefit of continuing Bromocriptine must be weighed against the possible risk of its use during a hypertensive disorder of pregnancy. When Bromocriptine is being used to treat acromegaly or Parkinson's disease in patients who subsequently become pregnant, a decision should be made as to whether the therapy continues to be medically necessary or can be withdrawn. If it is continued, the drug should be withdrawn in those who may experience hypertensive disorders of pregnancy (including eclampsia, preeclampsia, or pregnancy-induced hypertension) unless withdrawal of Bromocriptine is considered to be medically contraindicated. Because of the possibility of an interaction between Bromocriptine and other ergot alkaloids, the concomitant use of these medications is not recommended. Particular attention should be paid to patients who have recently received other drugs that can alter the blood pressure. Periodic monitoring of the blood pressure, particularly during the first weeks of therapy is prudent. If hypertension, severe, progressive, or unremitting headache (with or without visual disturbance), or evidence of CNS toxicity develops, drug therapy should be discontinued and the patient should be evaluated promptly.

Long-term treatment (6-36 months) with Bromocriptine mesylate in doses ranging from 20-100 mg/day has been associated with pulmonary infiltrates, pleural effusion and thickening of the pleura in a few patients. In those instances in which Bromocriptine mesylate treatment was terminated, the changes slowly reverted towards normal.

Precautions

General

Safety and efficacy of Bromocriptine have not been established in patients with renal or hepatic disease. Care should be exercised when administering Bromocriptine therapy concomitantly with other medications known to lower blood pressure.

The drug should be used with caution in patients with a history of psychosis or cardiovascular disease. If acromegalic patients or patients with prolactinoma or Parkinson's disease are being treated with Bromocriptine during pregnancy, they should be cautiously observed, particularly during the post-partum period if they have a history of cardiovascular disease.

Hyperprolactinemic States

Visual field impairment is a known complication of macroprolactinoma. Effective treatment with Bromocriptine leads to a reduction in hyperprolactinaemia and often to a resolution of the visual impairment. In some patients, however, a secondary deterioration of visual fields may subsequently develop despite normalized prolactin levels and tumor shrinkage, which may result from traction on the optic chiasm which is pulled down into the now partially empty sella. In these cases the visual field defect may improve on reduction of Bromocriptine dosage while there is some elevation of prolactin and some tumor re-expansion. Monitoring of visual fields in patients with macroprolactinoma is therefore recommended for an early recognition of secondary field loss due to chiasmal herniation and adaptation of drug dosage.

The relative efficacy of Bromocriptine versus surgery in preserving visual fields is not known. Patients with rapidly progressive visual field loss should be evaluated by a neurosurgeon to help decide on the most appropriate therapy.

Since pregnancy is often the therapeutic objective in many hyperprolactinemic patients presenting with amenorrhea/galactorrhea and hypogonadism (infertility), a careful assessment of the pituitary is essential to detect the presence of a prolactin-secreting adenoma. Patients not seeking pregnancy, or those harboring large adenomas, should be advised to use contraceptive measures, other than oral contraceptives, during treatment with Bromocriptine. Since pregnancy may occur prior to reinitiation of menses, a pregnancy test is recommended at least every 4 weeks during the amenorrheic period, and, once menses are reinitiated, every time a patient misses a menstrual period. Treatment with Bromocriptine should be discontinued as soon as pregnancy has been established. Patients must be monitored closely throughout pregnancy for signs and symptoms that may signal the enlargement of a previously undetected or existing prolactin-secreting tumor. Discontinuation of Bromocriptine treatment in patients with known macroadenomas has been associated with rapid regrowth of tumor and increase in serum prolactin in most cases.

Acromegaly

Cold sensitive digital vasospasm has been observed in some acromegalic patients treated with Bromocriptine. The response, should it occur, can be reversed by reducing the dose of Bromocriptine and may be prevented by keeping the fingers warm. Cases of severe gastrointestinal bleeding from peptic ulcers have been reported, some fatal. Although there is no evidence that Bromocriptine increases the incidence of peptic ulcers in acromegalic patients, symptoms suggestive of peptic ulcer should be investigated thoroughly and treated appropriately. Patients with a history of peptic ulcer or gastrointestinal bleeding should be observed carefully during treatment with Bromocriptine.

Possible tumor expansion while receiving Bromocriptine therapy has been reported in a few patients. Since the natural history of growth hormone secreting tumors is unknown, all patients should be carefully monitored and, if evidence of tumor expansion develops, discontinuation of treatment and alternative procedures considered.

Parkinson's Disease

Safety during long-term use for more than 2 years at the doses required for parkinsonism has not been established.

As with any chronic therapy, periodic evaluation of hepatic, hematopoietic, cardiovascular, and renal function is recommended. Symptomatic hypotension can occur and, therefore, caution should be exercised when treating patients receiving antihypertensive drugs.

High doses of Bromocriptine may be associated with confusion and mental disturbances. Since parkinsonian patients may manifest mild degrees of dementia, caution should be used when treating such patients.

Bromocriptine administered alone or concomitantly with levodopa may cause hallucinations (visual or auditory). Hallucinations usually resolve with dosage reduction; occasionally, discontinuation of Bromocriptine is required. Rarely, after high doses, hallucinations have persisted for several weeks following discontinuation of Bromocriptine.

As with levodopa, caution should be exercised when administering Bromocriptine to patients with a history of myocardial infarction who have a residual atrial, nodal, or ventricular arrhythmia.

Retroperitoneal fibrosis has been reported in a few patients receiving long-term therapy (2-10 years) with Bromocriptine mesylate tablets in doses ranging from 30-140 mg daily.

Information for Patients

During clinical trials, dizziness, drowsiness, faintness, fainting, and syncope have been reported early in the course of Bromocriptine therapy. In post-marketing reports, Bromocriptine has been associated with somnolence, and episodes of sudden sleep onset, particularly in patients with Parkinson's disease. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. All patients receiving Bromocriptine should be cautioned with regard to engaging in activities requiring rapid and precise responses, such as driving an automobile or operating machinery.

Patients receiving Bromocriptine for hyperprolactinemic states associated with macroadenoma or those who have had previous transsphenoidal surgery, should be told to report any persistent watery nasal discharge to their physician. Patients receiving Bromocriptine for treatment of a macroadenoma should be told that discontinuation of drug may be associated with rapid regrowth of the tumor and recurrence of their original symptoms.

Drug Interactions

The risk of using Bromocriptine in combination with other drugs has not been systematically evaluated, but alcohol may potentiate the side effects of Bromocriptine. Bromocriptine may interact with dopamine antagonists, butyrophenones, and certain other agents. Compounds in these categories result in a decreased efficacy of Bromocriptine: phenothiazines, haloperidol, metoclopramide, pimozide. Concomitant use of Bromocriptine with other ergot alkaloids is not recommended.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A 74-week study was conducted in mice using dietary levels of Bromocriptine mesylate equivalent to oral doses of 10 and 50 mg/kg/day. A 100-week study in rats was conducted using dietary levels equivalent to oral doses of 1.7, 9.8, and 44 mg/kg/day. The highest doses tested in mice and rats were approximately 2.5 and 4.4 times, respectively, the maximum human dose administered in controlled clinical trials (100 mg/day) based on body surface area. Malignant uterine tumors, endometrial and myometrial, were found in rats as follows: 0/50 control females, 2/50 females given 1.7 mg/kg daily, 7/49 females given 9.8 mg/kg daily, and 9/50 females given 44 mg/kg daily. The occurrence of these neoplasms is probably attributable to the high estrogen/progesterone ratio which occurs in rats as a result of the prolactin-inhibiting action of Bromocriptine mesylate. The endocrine mechanisms believed to be involved in the rats are not present in humans. There is no known correlation between uterine malignancies occurring in Bromocriptine-treated rats and human risk. In contrast to the findings in rats, the uteri from mice killed after 74 weeks treatment did not exhibit evidence of drug related changes.

Bromocriptine mesylate was evaluated for mutagenic potential in the battery of tests that included Ames bacterial mutation assay, mutagenic activity in vitro on V79 Chinese hamster fibroblasts, cytogenetic analysis of Chinese hamster bone marrow cells following in vivo treatment, and an in vivo micronucleus test for mutagenic potential in mice.

No mutagenic effects were obtained in any of these tests.

Fertility and reproductive performance in female rats were not influenced adversely by treatment with Bromocriptine beyond the predicted decrease in the weight of pups due to suppression of lactation. In males treated with 50 mg/kg of this drug, mating and fertility were within the normal range. Increased perinatal loss was produced in the subgroups of dams, sacrificed on day 21 postpartum (p.p.) after mating with males treated with the highest dose (50 mg/kg).

Pregnancy

Category B:

Administration of 10-30 mg/kg of Bromocriptine to 2 strains of rats on days 6-15 post coitum (p.c.) as well as a single dose of 10 mg/kg on day 5 p.c. interfered with nidation. Three mg/kg given on days 6-15 were without effect on nidation, and did not produce any anomalies. In animals treated from day 8-15 p.c., i.e., after implantation, 30 mg/kg produced increased prenatal mortality in the form of increased incidence of embryonic resorption. One anomaly, aplasia of spinal vertebrae and ribs, was found in the group of 262 fetuses derived from the dams treated with 30 mg/kg Bromocriptine. No fetotoxic effects were found in offspring of dams treated during the peri- or post-natal period.

Two studies were conducted in rabbits (2 strains) to determine the potential to interfere with nidation. Dose levels of 100 or 300 mg/kg/day from day 1 to day 6 p.c. did not adversely affect nidation. The high dose was approximately 63 times the maximum human dose administered in controlled clinical trials (100 mg/day), based on body surface area. In New Zealand white rabbits some embryo mortality occurred at 300 mg/kg which was a reflection of overt maternal toxicity. Three studies were conducted in 2 strains of rabbits to determine the teratological potential of Bromocriptine at dose levels of 3, 10, 30, 100, and 300 mg/kg given from day 6 to day 18 p.c. In 2 studies with the Yellow-silver strain, cleft palate was found in 3 and 2 fetuses at maternally toxic doses of 100 and 300 mg/kg, respectively. One control fetus also exhibited this anomaly. In the third study conducted with New Zealand white rabbits using an identical protocol, no cleft palates were produced.

No teratological or embryo-toxic effects of Bromocriptine were produced in any of 6 offspring from 6 monkeys at a dose level of 2 mg/kg.

Information concerning 1276 pregnancies in women taking Bromocriptine has been collected. In the majority of cases, Bromocriptine was discontinued within 8 weeks into pregnancy (mean 28.7 days), however, 8 patients received the drug continuously throughout pregnancy. The mean daily dose for all patients was 5.8 mg (range 1-40 mg).

Of these 1276 pregnancies, there were 1088 full term deliveries (4 stillborn), 145 spontaneous abortions (11.4%), and 28 induced abortions (2.2%). Moreover, 12 extrauterine gravidities and 3 hydatidiform moles (twice in the same patient) caused early termination of pregnancy. These data compare favorably with the abortion rate (11%-25%) cited for pregnancies induced by clomiphene citrate, menopausal gonadotropin, and chorionic gonadotropin.

Although spontaneous abortions often go unreported, especially prior to 20 weeks of gestation, their frequency has been estimated to be 15%.

The incidence of birth defects in the population at large ranges from 2%-4.5%. The incidence in 1109 live births from patients receiving Bromocriptine is 3.3%.

There is no suggestion that Bromocriptine contributed to the type or incidence of birth defects in this group of infants.

Nursing Mothers

Bromocriptine should not be used during lactation in postpartum women.

Pediatric Use

The safety and effectiveness of Bromocriptine for the treatment of prolactin-secreting pituitary adenomas have been established in patients age 16 to adult. No data are available for Bromocriptine use in pediatric patients under the age of 8 years. A single 8-year old patient treated with Bromocriptine for a prolactin-secreting pituitary macroadenoma has been reported without therapeutic response.

The use of Bromocriptine for the treatment of prolactin-secreting adenomas in pediatric patients in the age group 11 to under 16 years is supported by evidence from well-controlled trials in adults, with additional data in a limited number (n=14) of children and adolescents 11 to 15 years of age with prolactin-secreting pituitary macro- and microadenomas who have been treated with Bromocriptine. Of the 14 reported patients, 9 had successful outcomes, 3 partial responses, and 2 failed to respond to Bromocriptine treatment. Chronic hypopituitarism complicated macroadenoma treatment in 5 of the responders, both in patients receiving Bromocriptine alone and in those who received Bromocriptine in combination with surgical treatment and/or pituitary irradiation.

Safety and effectiveness of Bromocriptine in pediatric patients have not been established for any other indication listed in the INDICATIONS AND USAGE section.

Geriatric Use

Clinical studies for Bromocriptine did not include sufficient numbers of subjects aged 65 and over to determine whether the elderly respond differently from younger subjects. However, other reported clinical experiences, including post-marketing reporting of adverse events, have not identified differences in response or tolerability between elderly and younger patients. Even though no variation in efficacy or adverse reaction profile in geriatric patients taking Bromocriptine has been observed, greater sensitivity of some elderly individuals cannot be categorically ruled out. In general, dose selection for an elderly patient should be cautious, starting at the lower end of the dose range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy in this population.

Adverse Reactions

Hyperprolactinemic Indications

The incidence of adverse effects is quite high (69%) but these are generally mild to moderate in degree. Therapy was discontinued in approximately 5% of patients because of adverse effects. These in decreasing order of frequency are: nausea (49%), headache (19%), dizziness (17%), fatigue (7%), lightheadedness (5%), vomiting (5%), abdominal cramps (4%), nasal congestion (3%), constipation (3%), diarrhea (3%) and drowsiness (3%).

A slight hypotensive effect may accompany Bromocriptine treatment. The occurrence of adverse reactions may be lessened by temporarily reducing dosage to ½ tablet 2 or 3 times daily. A few cases of cerebrospinal fluid rhinorrhea have been reported in patients receiving Bromocriptine for treatment of large prolactinomas. This has occurred rarely, usually only in patients who have received previous transsphenoidal surgery, pituitary radiation, or both, and who were receiving Bromocriptine for tumor recurrence. It may also occur in previously untreated patients whose tumor extends into the sphenoid sinus.

Acromegaly

The most frequent adverse reactions encountered in acromegalic patients treated with Bromocriptine were: nausea (18%), constipation (14%), postural/orthostatic hypotension (6%), anorexia (4%), dry mouth/nasal stuffiness (4%), indigestion/dyspepsia (4%), digital vasospasm (3%), drowsiness/tiredness (3%) and vomiting (2%).

Less frequent adverse reactions (less than 2%) were: gastrointestinal bleeding, dizziness, exacerbation of Raynaud's Syndrome, headache and syncope. Rarely (less than 1%) hair loss, alcohol potentiation, faintness, lightheadedness, arrhythmia, ventricular tachycardia, decreased sleep requirement, visual hallucinations, lassitude, shortness of breath, bradycardia, vertigo, paresthesia, sluggishness, vasovagal attack, delusional psychosis, paranoia, insomnia, heavy headedness, reduced tolerance to cold, tingling of ears, facial pallor and muscle cramps have been reported.

Parkinson's Disease

In clinical trials in which Bromocriptine was administered with concomitant reduction in the dose of levodopa/carbidopa, the most common newly appearing adverse reactions were: nausea, abnormal involuntary movements, hallucinations, confusion, "on-off" phenomenon, dizziness, drowsiness, faintness/fainting, vomiting, asthenia, abdominal discomfort, visual disturbance, ataxia, insomnia, depression, hypotension, shortness of breath, constipation, and vertigo.

Less common adverse reactions which may be encountered include: anorexia, anxiety, blepharospasm, dry mouth, dysphagia, edema of the feet and ankles, erythromelalgia, epileptiform seizure, fatigue, headache, lethargy, mottling of skin, nasal stuffiness, nervousness, nightmares, paresthesia, skin rash, urinary frequency, urinary incontinence, urinary retention, and rarely, signs and symptoms of ergotism such as tingling of fingers, cold feet, numbness, muscle cramps of feet and legs or exacerbation of Raynaud's Syndrome.

Pleural and pericardial effusions, pleural, and pulmonary fibrosis or retroperitoneal fibrosis and constrictive pericarditis have been reported rarely in patients treated with Bromocriptine.

Very rarely, a syndrome resembling Neuroleptic Malignant Syndrome has been reported on abrupt withdrawal of Bromocriptine.

Abnormalities in laboratory tests may include elevations in blood urea nitrogen, SGOT, SGPT, GGPT, CPK, alkaline phosphatase and uric acid, which are usually transient and not of clinical significance.

Adverse Events Observed in Other Conditions

Postpartum Patients

In postpartum studies with Bromocriptine 23 percent of postpartum patients treated had at least 1 side effect, but they were generally mild to moderate in degree. Therapy was discontinued in approximately 3% of patients. The most frequently occurring adverse reactions were: headache (10%), dizziness (8%), nausea (7%), vomiting (3%), fatigue (1.0%), syncope (0.7%), diarrhea (0.4%) and cramps (0.4%). Decreases in blood pressure (≥ 20 mm Hg systolic and ≥10 mm Hg diastolic) occurred in 28% of patients at least once during the first 3 postpartum days; these were usually of a transient nature. Reports of fainting in the puerperium may possibly be related to this effect. In postmarketing experience in the U.S. serious adverse reactions reported include 72 cases of seizures (including 4 cases of status epilepticus), 30 cases of stroke, and 9 cases of myocardial infarction among postpartum patients. Seizure cases were not necessarily accompanied by the development of hypertension. An unremitting and often progressively severe headache, sometimes accompanied by visual disturbance, often preceded by hours to days many cases of seizure and/or stroke. Most patients had shown no evidence of any of the hypertensive disorders of pregnancy including eclampsia, preeclampsia or pregnancy induced hypertension. One stroke case was associated with sagittal sinus thrombosis, and another was associated with cerebral and cerebellar vasculitis. One case of myocardial infarction was associated with unexplained disseminated intravascular coagulation and a second occurred in conjunction with use of another ergot alkaloid. The relationship of these adverse reactions to Bromocriptine administration has not been established.

Overdosage

The most commonly reported signs and symptoms associated with acute Bromocriptine overdose are: nausea, vomiting, constipation, diaphoresis, dizziness, pallor, severe hypotension, malaise, confusion, lethargy, drowsiness, delusions, hallucinations, and repetitive yawning. The lethal dose has not been established and the drug has a very wide margin of safety. However, one death occurred in a patient who committed suicide with an unknown quantity of Bromocriptine and chloroquine.

Treatment of overdose consists of removal of the drug by emesis (if conscious), gastric lavage, activated charcoal, or saline catharsis. Careful supervision and recording of fluid intake and output is essential. Hypotension should be treated by placing the patient in the Trendelenburg position and administering I.V. fluids. If satisfactory relief of hypotension cannot be achieved by using the above measures to their fullest extent, vasopressors should be considered.

Bromocriptine Dosage and Administration

General

It is recommended that Bromocriptine mesylate tablets be taken with food. Patients should be evaluated frequently during dose escalation to determine the lowest dosage that produces a therapeutic response.

Hyperprolactinemic Indications

The initial dosage of Bromocriptine mesylate tablets in adults is ½ to one 2.5 mg scored tablet daily. An additional 2.5 mg tablet may be added to the treatment regimen as tolerated every 2-7 days until an optimal therapeutic response is achieved. The therapeutic dosage ranged from 2.5-15 mg daily in adults studied clinically.

Based on limited data in children of age 11 to 15, (see Pediatric Use subsection) the initial dose is ½ to one 2.5 mg scored tablet daily.

Dosing may need to be increased as tolerated until a therapeutic response is achieved. The therapeutic dosage ranged from 2.5-10 mg daily in children with prolactin-secreting pituitary adenomas.

In order to reduce the likelihood of prolonged exposure to Bromocriptine mesylate tablets should an unsuspected pregnancy occur, a mechanical contraceptive should be used in conjunction with Bromocriptine mesylate tablets therapy until normal ovulatory menstrual cycles have been restored. Contraception may then be discontinued in patients desiring pregnancy.

Thereafter, if menstruation does not occur within 3 days of the expected date, Bromocriptine mesylate therapy should be discontinued and a pregnancy test performed.

Acromegaly

Virtually all acromegalic patients receiving therapeutic benefit from Bromocriptine mesylate tablets also have reductions in circulating levels of growth hormone. Therefore, periodic assessment of circulating levels of growth hormone will, in most cases, serve as a guide in determining the therapeutic potential of Bromocriptine mesylate tablets. If, after a brief trial with Bromocriptine mesylate tablets therapy, no significant reduction in growth hormone levels has taken place, careful assessment of the clinical features of the disease should be made, and if no change has occurred, dosage adjustment or discontinuation of therapy should be considered.

The initial recommended dosage is ½ to one 2.5 mg Bromocriptine mesylate tablet on retiring (with food) for 3 days. An additional ½ to 1 tablet should be added to the treatment regimen as tolerated every 3-7 days until the patient obtains optimal therapeutic benefit. Patients should be reevaluated monthly and the dosage adjusted based on reductions of growth hormone or clinical response. The usual optimal therapeutic dosage range of Bromocriptine mesylate tablets varies from 20-30 mg/day in most patients. The maximal dosage should not exceed 100 mg/day.

Patients treated with pituitary irradiation should be withdrawn from Bromocriptine mesylate tablets therapy on a yearly basis to assess both the clinical effects of radiation on the disease process as well as the effects of Bromocriptine mesylate tablets therapy. Usually a 4-8 week withdrawal period is adequate for this purpose. Recurrence of the signs/symptoms or increases in growth hormone indicate the disease process is still active and further courses of Bromocriptine mesylate tablets should be considered.

Parkinson's Disease

The basic principle of Bromocriptine mesylate tablets therapy is to initiate treatment at a low dosage and, on an individual basis, increase the daily dosage slowly until a maximum therapeutic response is achieved. The dosage of levodopa during this introductory period should be maintained, if possible. The initial dose of Bromocriptine mesylate tablets is ½ of a 2.5 mg tablet twice daily with meals. Assessments are advised at 2-week intervals during dosage titration to ensure that the lowest dosage producing an optimal therapeutic response is not exceeded. If necessary, the dosage may be increased every 14-28 days by 2.5 mg/day with meals. Should it be advisable to reduce the dosage of levodopa because of adverse reactions, the daily dosage of Bromocriptine mesylate tablets, if increased, should be accomplished gradually in small (2.5 mg) increments.

The safety of Bromocriptine mesylate tablets has not been demonstrated in dosages exceeding 100 mg/day.

How is Bromocriptine Supplied

Bromocriptine mesylate tablets, USP are available containing 2.5 mg of Bromocriptine (as the mesylate). The 2.5 mg tablets are white to off-white, round, bevel edged snap tablets, debossed with "PAD" over "0106" on one side and scored on the other side.

Bottles of 30.........NDC 0574-0106-03

Bottles of 100.......NDC 0574-0106-01

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

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Paddock Laboratories, Inc.

Minneapolis, MN 55427

(05-08)

PRINCIPAL DISPLAY PANEL - 30 Tablets

Bromocriptine

MESYLATE TABLETS, USP

NDC 0574-0106-03

2.5 mg*     Rx ONLY

STORAGE: Store at 20° to 25°C (68° to 77°F)

[see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container

as defined in the USP using a child-resistant

closure.

NET CONTENTS 30 TABLETS

Paddock

Laboratories, Inc.

PRINCIPAL DISPLAY PANEL - 100 Tablets

Bromocriptine

MESYLATE TABLETS, USP

NDC 0574-0106-01

2.5 mg*     Rx ONLY

STORAGE: Store at 20° to 25°C (68° to 77°F)

[see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container

as defined in the USP using a child-resistant

closure.

NET CONTENTS 100 TABLETS

Paddock

Laboratories, Inc.

Bromocriptine MESYLATE  Bromocriptine mesylate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0574-0106 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bromocriptine mesylate (Bromocriptine) Bromocriptine 2.5 mg

Inactive Ingredients Ingredient Name Strength anhydrous lactose   silicon dioxide   magnesium stearate   maleic acid   povidone

Product Characteristics Color WHITE (White to off-white) Score 2 pieces Shape ROUND (bevel edged) Size 8mm Flavor Imprint Code PAD;0106 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0574-0106-03 24 BOTTLE In 1 CARTON contains a BOTTLE 1 30 TABLET In 1 BOTTLE This package is contained within the CARTON (0574-0106-03) 2 0574-0106-01 24 BOTTLE In 1 CARTON contains a BOTTLE 2 100 TABLET In 1 BOTTLE This package is contained within the CARTON (0574-0106-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077646	10/01/2008

Labeler - Paddock Laboratories, Inc. (086116803)

Establishment
Name	Address	ID/FEI	Operations
Paddock Laboratories, Inc.		086116803	MANUFACTURE

Revised: 06/2009Paddock Laboratories, Inc.

More Bromocriptine resources

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

• Bromocriptine MedFacts Consumer Leaflet (Wolters Kluwer)


• bromocriptine Advanced Consumer (Micromedex) - Includes Dosage Information


• Bromocriptine Mesylate Monograph (AHFS DI)


• Cycloset MedFacts Consumer Leaflet (Wolters Kluwer)


• Cycloset Consumer Overview

Compare Bromocriptine with other medications

• Acromegaly
• Diabetes, Type 2
• Hyperprolactinemia
• Parkinson's Disease
• Tardive Dyskinesia

Nitroprus

Nitroprus may be available in the countries listed below.

Ingredient matches for Nitroprus

Nitroprusside

Sodium Nitroprusside is reported as an ingredient of Nitroprus in the following countries:

• Argentina

International Drug Name Search

Betac

Pronunciation: ASS-kor-bik ASS-id
Generic Name: Ascorbic Acid
Brand Name: Examples include Ascor L 500 and Betac

Betac is used for:

Treating and preventing low levels of vitamin C. It may also be used for other conditions as determined by your doctor.

Betac is a vitamin. It works by supplementing vitamin C, which is used in many functions in the body.

Do NOT use Betac if:

• you are allergic to any ingredient in Betac

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

Before using Betac:

Some medical conditions may interact with Betac. 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 diabetes, glucose-6-phosphate dehydrogenase deficiency, a high iron level in the blood, anemia (eg, sickle cell, sideroblastic, thalassemia), or kidney stones

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

• Anticoagulants (eg, warfarin) because side effects may be increased by Betac

This may not be a complete list of all interactions that may occur. Ask your health care provider if Betac 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 Betac:

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

• Betac is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Betac at home, carefully follow the injection procedures taught to you by your health care provider.


• If Betac contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Betac, 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 Betac.

Important safety information:

• Do not take large doses of vitamins (megadoses or megavitamin therapy) while taking Betac unless directed to by your doctor.


• Betac may cause incorrect results with some in-home cholesterol test kits. Check with your doctor or pharmacist if you are taking Betac and need to check your cholesterol at home.


• Diabetes patients - Betac may cause incorrect test results with some urine glucose tests. Check with your doctor before you adjust the dose of your diabetes medicine or change your diet.


• Betac may cause incorrect test results with kits used to check for blood in the stool. Check with your doctor if you are taking Betac when using the test kit.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Betac, discuss with your doctor the benefits and risks of using Betac during pregnancy. Betac is excreted in breast milk. If you are or will be breast-feeding while you are using Betac, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Betac:

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:

Burning, stinging, or swelling at the injection site.

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).

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: Betac 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.

Proper storage of Betac:

Store Betac in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store away from heat, moisture, and light. Keep Betac out of the reach of children and away from pets.

General information:

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


• Betac 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 Betac. 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 Betac resources

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

Compare Betac with other medications

• Dietary Supplementation
• Scurvy
• Urinary Acidification

Karnachol

Karnachol may be available in the countries listed below.

Ingredient matches for Karnachol

Trapidil

Trapidil is reported as an ingredient of Karnachol in the following countries:

• Japan

International Drug Name Search

Rinosol

Rinosol may be available in the countries listed below.

Ingredient matches for Rinosol

Beclometasone

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

• Argentina


• Greece

International Drug Name Search

Marviclar

Marviclar may be available in the countries listed below.

Ingredient matches for Marviclar

Clarithromycin

Clarithromycin is reported as an ingredient of Marviclar in the following countries:

• Peru

International Drug Name Search

Brevicon

Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)

Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Brevicon (ethinyl estradiol and norethindrone)?

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

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Brevicon (ethinyl estradiol and norethindrone)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

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

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

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Brevicon (ethinyl estradiol and norethindrone)?

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

• 
  

  coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

  
  


• 
  

  a history of a stroke, blood clot, or circulation problems;

  
  


• 
  

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

  
  


• 
  

  unusual vaginal bleeding that has not been checked by a doctor;

  
  


• 
  

  liver disease or liver cancer;

  
  


• 
  

  severe migraine headaches; or

  
  


• 
  

  a history of jaundice caused by pregnancy or birth control pills.

  
  

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

• 
  

  high blood pressure or a history of heart disease;

  
  


• 
  

  high cholesterol, gallbladder disease, or diabetes;

  
  


• 
  

  migraine headaches or a history of depression; or

  
  


• 
  

  a history of breast cancer or an abnormal mammogram.

  
  

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

How should I take Brevicon (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

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

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

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

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

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

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

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

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Brevicon (ethinyl estradiol and norethindrone)?

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

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

Brevicon (ethinyl estradiol and norethindrone) 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 this medication and call your doctor at once if you have any of these serious side effects:

• 
  

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

  
  


• 
  

  sudden severe headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  sudden cough, wheezing, rapid breathing, coughing up blood;

  
  


• 
  

  pain, swelling, warmth, or redness in one or both legs;

  
  


• 
  

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

  
  


• 
  

  a change in the pattern or severity of migraine headaches;

  
  


• 
  

  pain in your upper stomach, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  a lump in your breast;

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  mild nausea or vomiting, appetite or weight changes;

  
  


• 
  

  breast swelling or tenderness;

  
  


• 
  

  headache, nervousness, dizziness;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  freckles or darkening of facial skin, loss of scalp hair; or

  
  


• 
  

  vaginal itching or discharge.

  
  

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 Brevicon (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

• 
  

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

  
  


• 
  

  bosentan (Tracleer);

  
  


• 
  

  prednisolone (Orapred);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl);

  
  


• 
  

  an antibiotic;

  
  


• 
  

  HIV or AIDS medications;

  
  


• 
  

  phenobarbital (Solfoton) and other barbiturates; or

  
  


• 
  

  seizure medication.

  
  

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

More Brevicon resources

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

• Brevicon Prescribing Information (FDA)


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• Briellyn Prescribing Information (FDA)


• Cyclafem 1/35 Prescribing Information (FDA)


• Cyclafem 7/7/7 Prescribing Information (FDA)


• Estrostep Fe Prescribing Information (FDA)


• Femcon FE Prescribing Information (FDA)


• Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Femhrt Consumer Overview


• Femhrt Prescribing Information (FDA)


• Femhrt MedFacts Consumer Leaflet (Wolters Kluwer)


• Jevantique Prescribing Information (FDA)


• Jinteli Prescribing Information (FDA)


• Leena Prescribing Information (FDA)


• Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer)


• Lo Loestrin Fe Consumer Overview


• Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information


• Lo Loestrin Fe Prescribing Information (FDA)


• Loestrin 24 FE Prescribing Information (FDA)


• Loestrin 24 Fe Consumer Overview


• Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer)


• Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer)


• Tilia FE Prescribing Information (FDA)


• Tri-Norinyl Prescribing Information (FDA)


• Zenchent FE Prescribing Information (FDA)


• Zeosa Prescribing Information (FDA)

Compare Brevicon with other medications

• Abnormal Uterine Bleeding
• Acne
• Birth Control
• Endometriosis
• Gonadotropin Inhibition
• Menstrual Disorders
• Polycystic Ovary Syndrome

Where can I get more information?

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

See also: Brevicon side effects (in more detail)

Citalopram Orifarm

Citalopram Orifarm may be available in the countries listed below.

Ingredient matches for Citalopram Orifarm

Citalopram

Citalopram hydrobromide (a derivative of Citalopram) is reported as an ingredient of Citalopram Orifarm in the following countries:

• Germany


• Sweden


• Switzerland

International Drug Name Search

Blenoxane

Generic Name: bleomycin (Injection route)

blee-oh-MYE-sin

Injection route(Powder for Solution)

Pulmonary fibrosis is the most severe toxicity and its most frequent presentation is pneumonitis occasionally progressing to pulmonary fibrosis. Its occurrence is higher in elderly patients and in those receiving greater than 400 units total dose, but pulmonary toxicity has been observed in young patients and those treated with low doses. A severe idiosyncratic reaction consisting of hypotension, mental confusion, fever, chills, and wheezing has been reported in lymphoma patients treated with bleomycin for injection .

Commonly used brand name(s)

In the U.S.

• Blenoxane

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibiotic

Uses For Blenoxane

Bleomycin belongs to the general group of medicines called antineoplastics. It is used to treat several types of cancer, including cervix and uterus cancer, head and neck cancer, testicle and penile cancer, and certain types of lymphoma. Bleomycin also may used for other conditions, as determined by your doctor.

Bleomycin seems to act by interfering with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by bleomycin, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like darkening of skin or hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with bleomycin, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Bleomycin is to be administered only by or under the immediate supervision of your doctor.

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, bleomycin is used in certain patients with the following medical conditions:

• Bone cancer


• Kaposi's sarcoma


• Malignant melanoma


• Mycosis fungoides (a type of lymphoma)


• Skin cancer


• Thyroid cancer


• Verruca vulgaris (warts)

For patients being treated with bleomycin for warts:

• Bleomycin is used to treat severe cases of warts when other treatments have not worked.


• Before using bleomycin, tell your doctor if you have problems with circulation. Bleomycin can cause paleness or coldness in fingers treated for warts.


• Bleomycin is injected directly into the wart. Because it is not absorbed into the body, it does not cause loss of hair, lung problems, or other unwanted effects described above. However, it may cause burning or pain at the place of injection. Skin rash or itching, nail loss, and pain or coldness in the finger where bleomycin was injected have also been reported.

Before Using Blenoxane

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

Although there is no specific information comparing use of bleomycin in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Lung problems are more likely to occur in elderly patients (over 70 years of age), who are usually more sensitive to the effects of bleomycin.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Brentuximab Vedotin


• Rotavirus Vaccine, Live

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.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever 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.

• Phenytoin

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—Effects of bleomycin may be increased because of slower removal from the body

• Liver disease—Bleomycin can cause liver problems

• Lung disease—Bleomycin may worsen the condition

Proper Use of Blenoxane

Bleomycin is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each medicine at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.

Bleomycin often causes nausea, vomiting, and loss of appetite. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

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.

Precautions While Using Blenoxane

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are receiving or have received this medicine.

Tell your doctor if you smoke. The risk of lung problems is increased in people who smoke.

Blenoxane 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

• Fever and chills (occurring within 3 to 6 hours after a dose)

Less common

• Confusion


• faintness


• wheezing

Rare

• Chest pain (sudden severe)


• weakness in arms or legs (sudden)

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Cough


• shortness of breath


• sores in mouth and on lips

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

• Darkening or thickening of skin


• dark stripes on skin


• itching of skin


• skin rash or colored bumps on fingertips, elbows, or palms


• skin redness or tenderness


• swelling of fingers


• vomiting and loss of appetite

Less common

• Changes in fingernails or toenails


• weight loss

Bleomycin may cause a temporary loss of hair in some people. After treatment has ended, normal hair growth should return, although it may take several months.

Side effects that affect your lungs (for example, cough and shortness of breath) may be more likely to occur if you smoke.

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Cough


• shortness of breath

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: Blenoxane side effects (in more detail)

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More Blenoxane resources

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

• Blenoxane Prescribing Information (FDA)


• Blenoxane MedFacts Consumer Leaflet (Wolters Kluwer)


• Blenoxane Concise Consumer Information (Cerner Multum)


• Blenoxane Monograph (AHFS DI)


• Bleomycin Prescribing Information (FDA)

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