BENZPHETAMINE HYDROCHLORIDE

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Overview

What is BENZPHETAMINE HYDROCHLORIDE?

Benzphetamine Hydrochloride Tablets contain the anorectic agent benzphetamine hydrochloride. Benzphetamine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benzphetamine hydrochloride is -N,α-Dimethyl-N -(phenylmethyl)-benzeneethanamine hydrochloride and its molecular weight is 275.82.

The structural formula (dextro form) is represented below:

Each Benzphetamine Hydrochloride Tablet, for oral administration, contains 50 mg of benzphetamine hydrochloride.

Inactive Ingredients: carnauba wax powder, colloidal silicon dioxide, FD&C red # 40 aluminum lake, FD&C yellow # 6 aluminum lake, lactose monohydrate, macrogol/polyethylene glycol 3350, magnesium stearate, microcrystalline cellulose 101, polyvinyl alcohol – partially hydrolyzed, sodium starch glycolate, talc and titanium dioxide.

What does BENZPHETAMINE HYDROCHLORIDE look like?

What are the available doses of BENZPHETAMINE HYDROCHLORIDE?

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What should I talk to my health care provider before I take BENZPHETAMINE HYDROCHLORIDE?

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How should I use BENZPHETAMINE HYDROCHLORIDE?

Benzphetamine Hydrochloride Tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷2.2 = kg; inches × 0.0254 = meters. The limited usefulness of agents of this class (See ) should be weighed against possible risks inherent in their use such as those described below.

Benzphetamine Hydrochloride Tablets are indicated for use as monotherapy only.

Dosage should be individualized according to the response of the patient. The suggested dosage ranges from 25 to 50 mg one to three times daily. Treatment should begin with 25 to 50 mg once daily with subsequent increase in individual dose or frequency according to response. A single daily dose is preferably given in mid-morning or mid-afternoon, according to the patient’s eating habits. In an occasional patient it may be desirable to avoid late afternoon administration. Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.

What interacts with BENZPHETAMINE HYDROCHLORIDE?

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What are the warnings of BENZPHETAMINE HYDROCHLORIDE?

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What are the precautions of BENZPHETAMINE HYDROCHLORIDE?

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What are the side effects of BENZPHETAMINE HYDROCHLORIDE?

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What should I look out for while using BENZPHETAMINE HYDROCHLORIDE?

Benzphetamine Hydrochloride Tablets are contraindicated in patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to sympathomimetic amines, and glaucoma. Benzphetamine should not be given to patients who are in an agitated state or who have a history of drug abuse.

Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. Benzphetamine Hydrochloride Tablets should not be used concomitantly with other CNS stimulants.

Benzphetamine Hydrochloride Tablets may cause fetal harm when administered to a pregnant woman. Amphetamines have been shown to be teratogenic and embryotoxic in mammals at high multiples of the human dose. Benzphetamine Hydrochloride Tablets are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Benzphetamine Hydrochloride tablets should not be used in combination with other anorectic agents, including prescribed drugs, over-the-counter preparations and herbal products.

In a case-control epidemiological study, the use of anorectic agents was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. The use of anorectic agents for longer than three months was associated with a 23-fold increase in the risk of developing pulmonary hypertension. Increased risk of pulmonary hypertension with repeated courses of therapy cannot be excluded. It should be noted that benzphetamine was not specifically studied in this case-control study.

The onset or aggravation of exertional dyspnea, or unexplained symptoms of angina pectoris, syncope, or lower extremity edema suggest the possibility of occurrence of pulmonary hypertension. Under these circumstances, Benzphetamine Hydrochloride tablets should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension.

Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported. Possible contributing factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs. However, no cases of this valvulopathy have been reported when benzphetamine has been used alone.

The potential risk of possible serious adverse effects such as valvular heart disease and pulmonary hypertension should be assessed carefully against the potential benefit of weight loss. Baseline cardiac evaluation should be considered to detect pre-existing valvular heart diseases or pulmonary hypertension prior to initiation of benzphetamine treatment. Benzphetamine Hydrochloride tablets are not recommended in patients with known heart murmur or valvular heart disease. Echocardiogram during and after treatment could be useful for detecting any valvular disorders which may occur. To limit unwarranted exposure and risks, treatment with Benzphetamine Hydrochloride tablets should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (i.e., weight loss of at least 4 pounds, or as determined by the physician and patient).

When tolerance to the anorectic effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

Benzphetamine Hydrochloride Tablets are not recommended for severely hypertensive patients or for patients with symptomatic cardiovascular disease including arrhythmias.

Benzphetamine Hydrochloride Tablets are not recommended for patients who used any anorectic agents within the prior year.

What might happen if I take too much BENZPHETAMINE HYDROCHLORIDE?

How should I store and handle BENZPHETAMINE HYDROCHLORIDE?

Store in a dry place at 25°C (77°F); excursions permitted to 15-30°C (59-86° F) [see USP Controlled Room Temperature]. 75 mcg: Protect capsule from light and moisture. Keep out of the reach of children. Store in a dry place at 25°C (77°F); excursions permitted to 15-30°C (59-86° F) [see USP Controlled Room Temperature]. 75 mcg: Protect capsule from light and moisture. Keep out of the reach of children. Store in a dry place at 25°C (77°F); excursions permitted to 15-30°C (59-86° F) [see USP Controlled Room Temperature]. 75 mcg: Protect capsule from light and moisture. Keep out of the reach of children. Benzphetamine Hydrochloride Tablets are available as follows:Benzphetamine Hydrochloride Tablets, 50 mg are supplied as peach, round, biconvex, film coated tablets debossed with “K” on left of the score and the number “40” debossed right of the score and plain on other side.Bottles of 30 NDC 10702-040-03Bottles of 100 NDC 10702-040-01Bottles of 500 NDC 10702-040-50Bottles of 1000 NDC 10702-040-10DispenseStoreRx onlyManufactured by:KVK-Tech, INC.110 Terry Dr. Suite 200Newtown, PA 18940-1850Benzphetamine Hydrochloride Tablets are available as follows:Benzphetamine Hydrochloride Tablets, 50 mg are supplied as peach, round, biconvex, film coated tablets debossed with “K” on left of the score and the number “40” debossed right of the score and plain on other side.Bottles of 30 NDC 10702-040-03Bottles of 100 NDC 10702-040-01Bottles of 500 NDC 10702-040-50Bottles of 1000 NDC 10702-040-10DispenseStoreRx onlyManufactured by:KVK-Tech, INC.110 Terry Dr. Suite 200Newtown, PA 18940-1850Benzphetamine Hydrochloride Tablets are available as follows:Benzphetamine Hydrochloride Tablets, 50 mg are supplied as peach, round, biconvex, film coated tablets debossed with “K” on left of the score and the number “40” debossed right of the score and plain on other side.Bottles of 30 NDC 10702-040-03Bottles of 100 NDC 10702-040-01Bottles of 500 NDC 10702-040-50Bottles of 1000 NDC 10702-040-10DispenseStoreRx onlyManufactured by:KVK-Tech, INC.110 Terry Dr. Suite 200Newtown, PA 18940-1850Benzphetamine Hydrochloride Tablets are available as follows:Benzphetamine Hydrochloride Tablets, 50 mg are supplied as peach, round, biconvex, film coated tablets debossed with “K” on left of the score and the number “40” debossed right of the score and plain on other side.Bottles of 30 NDC 10702-040-03Bottles of 100 NDC 10702-040-01Bottles of 500 NDC 10702-040-50Bottles of 1000 NDC 10702-040-10DispenseStoreRx onlyManufactured by:KVK-Tech, INC.110 Terry Dr. Suite 200Newtown, PA 18940-1850Benzphetamine Hydrochloride Tablets are available as follows:Benzphetamine Hydrochloride Tablets, 50 mg are supplied as peach, round, biconvex, film coated tablets debossed with “K” on left of the score and the number “40” debossed right of the score and plain on other side.Bottles of 30 NDC 10702-040-03Bottles of 100 NDC 10702-040-01Bottles of 500 NDC 10702-040-50Bottles of 1000 NDC 10702-040-10DispenseStoreRx onlyManufactured by:KVK-Tech, INC.110 Terry Dr. Suite 200Newtown, PA 18940-1850Benzphetamine Hydrochloride Tablets are available as follows:Benzphetamine Hydrochloride Tablets, 50 mg are supplied as peach, round, biconvex, film coated tablets debossed with “K” on left of the score and the number “40” debossed right of the score and plain on other side.Bottles of 30 NDC 10702-040-03Bottles of 100 NDC 10702-040-01Bottles of 500 NDC 10702-040-50Bottles of 1000 NDC 10702-040-10DispenseStoreRx onlyManufactured by:KVK-Tech, INC.110 Terry Dr. Suite 200Newtown, PA 18940-1850Benzphetamine Hydrochloride Tablets are available as follows:Benzphetamine Hydrochloride Tablets, 50 mg are supplied as peach, round, biconvex, film coated tablets debossed with “K” on left of the score and the number “40” debossed right of the score and plain on other side.Bottles of 30 NDC 10702-040-03Bottles of 100 NDC 10702-040-01Bottles of 500 NDC 10702-040-50Bottles of 1000 NDC 10702-040-10DispenseStoreRx onlyManufactured by:KVK-Tech, INC.110 Terry Dr. Suite 200Newtown, PA 18940-1850Benzphetamine Hydrochloride Tablets are available as follows:Benzphetamine Hydrochloride Tablets, 50 mg are supplied as peach, round, biconvex, film coated tablets debossed with “K” on left of the score and the number “40” debossed right of the score and plain on other side.Bottles of 30 NDC 10702-040-03Bottles of 100 NDC 10702-040-01Bottles of 500 NDC 10702-040-50Bottles of 1000 NDC 10702-040-10DispenseStoreRx onlyManufactured by:KVK-Tech, INC.110 Terry Dr. Suite 200Newtown, PA 18940-1850Benzphetamine Hydrochloride Tablets are available as follows:Benzphetamine Hydrochloride Tablets, 50 mg are supplied as peach, round, biconvex, film coated tablets debossed with “K” on left of the score and the number “40” debossed right of the score and plain on other side.Bottles of 30 NDC 10702-040-03Bottles of 100 NDC 10702-040-01Bottles of 500 NDC 10702-040-50Bottles of 1000 NDC 10702-040-10DispenseStoreRx onlyManufactured by:KVK-Tech, INC.110 Terry Dr. Suite 200Newtown, PA 18940-1850Benzphetamine Hydrochloride Tablets are available as follows:Benzphetamine Hydrochloride Tablets, 50 mg are supplied as peach, round, biconvex, film coated tablets debossed with “K” on left of the score and the number “40” debossed right of the score and plain on other side.Bottles of 30 NDC 10702-040-03Bottles of 100 NDC 10702-040-01Bottles of 500 NDC 10702-040-50Bottles of 1000 NDC 10702-040-10DispenseStoreRx onlyManufactured by:KVK-Tech, INC.110 Terry Dr. Suite 200Newtown, PA 18940-1850

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Benzphetamine hydrochloride is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics". It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects, may be involved.

Adult obese subjects instructed in dietary management and treated with "anorectic" drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is the greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drug prescribed, such as the physician-investigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered to be clinically limited.

Pharmacokinetic data in humans are not available.

Non-Clinical Toxicology

Benzphetamine Hydrochloride Tablets are contraindicated in patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to sympathomimetic amines, and glaucoma. Benzphetamine should not be given to patients who are in an agitated state or who have a history of drug abuse.

Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. Benzphetamine Hydrochloride Tablets should not be used concomitantly with other CNS stimulants.

Benzphetamine Hydrochloride Tablets may cause fetal harm when administered to a pregnant woman. Amphetamines have been shown to be teratogenic and embryotoxic in mammals at high multiples of the human dose. Benzphetamine Hydrochloride Tablets are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Benzphetamine Hydrochloride tablets should not be used in combination with other anorectic agents, including prescribed drugs, over-the-counter preparations and herbal products.

In a case-control epidemiological study, the use of anorectic agents was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. The use of anorectic agents for longer than three months was associated with a 23-fold increase in the risk of developing pulmonary hypertension. Increased risk of pulmonary hypertension with repeated courses of therapy cannot be excluded. It should be noted that benzphetamine was not specifically studied in this case-control study.

The onset or aggravation of exertional dyspnea, or unexplained symptoms of angina pectoris, syncope, or lower extremity edema suggest the possibility of occurrence of pulmonary hypertension. Under these circumstances, Benzphetamine Hydrochloride tablets should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension.

Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported. Possible contributing factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs. However, no cases of this valvulopathy have been reported when benzphetamine has been used alone.

The potential risk of possible serious adverse effects such as valvular heart disease and pulmonary hypertension should be assessed carefully against the potential benefit of weight loss. Baseline cardiac evaluation should be considered to detect pre-existing valvular heart diseases or pulmonary hypertension prior to initiation of benzphetamine treatment. Benzphetamine Hydrochloride tablets are not recommended in patients with known heart murmur or valvular heart disease. Echocardiogram during and after treatment could be useful for detecting any valvular disorders which may occur. To limit unwarranted exposure and risks, treatment with Benzphetamine Hydrochloride tablets should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (i.e., weight loss of at least 4 pounds, or as determined by the physician and patient).

When tolerance to the anorectic effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

Benzphetamine Hydrochloride Tablets are not recommended for severely hypertensive patients or for patients with symptomatic cardiovascular disease including arrhythmias.

Benzphetamine Hydrochloride Tablets are not recommended for patients who used any anorectic agents within the prior year.

Insulin requirements in diabetes mellitus may be altered in association with use of anorexigenic drugs and the concomitant dietary restrictions.

Psychological disturbances have been reported in patients who receive an anorectic agent together with a restrictive dietary regime.

Caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

The following have been associated with the use of benzphetamine hydrochloride:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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