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Benzphetamine
Overview
What is Benzphetamine?
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 d-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 25 mg of benzphetamine hydrochloride.
Inactive Ingredients: Calcium Stearate, Polyethylene Glycol, FD&C Yellow No. 6, Lactose Anhydrous, Sorbitol.
What does Benzphetamine look like?
What are the available doses of Benzphetamine?
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What should I talk to my health care provider before I take Benzphetamine?
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How should I use Benzphetamine?
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/m
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 CLINICAL PHARMACOLOGY) 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?
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What are the warnings of Benzphetamine?
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What are the precautions of Benzphetamine?
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What are the side effects of Benzphetamine?
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What should I look out for while using Benzphetamine?
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?
Manifestations of Overdosage
Treatment of Overdosage
Management of acute amphetamine intoxication is largely symptomatic and includes sedation with a barbiturate. If hypertension is marked, the use of a nitrite or rapidly acting alpha receptor blocking agent should be considered. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard.
Acidification of the urine increases amphetamine excretion.
The oral LD
is 174 mg/kg in mice and 104 mg/kg in rats. The intraperitoneal LD
in mice is 153 mg/kg.
How should I store and handle Benzphetamine?
Store between 2° - 30°C (36° - 86°F).Sulfonamide solutions, on long standing, will darken in color and should be discarded.KEEP OUT OF REACH OF CHILDREN.Revised November 2007Bausch & Lomb Incorporated©Bausch & Lomb Incorporated9113200 9113300 Store between 2° - 30°C (36° - 86°F).Sulfonamide solutions, on long standing, will darken in color and should be discarded.KEEP OUT OF REACH OF CHILDREN.Revised November 2007Bausch & Lomb Incorporated©Bausch & Lomb Incorporated9113200 9113300 Store between 2° - 30°C (36° - 86°F).Sulfonamide solutions, on long standing, will darken in color and should be discarded.KEEP OUT OF REACH OF CHILDREN.Revised November 2007Bausch & Lomb Incorporated©Bausch & Lomb Incorporated9113200 9113300 Store between 2° - 30°C (36° - 86°F).Sulfonamide solutions, on long standing, will darken in color and should be discarded.KEEP OUT OF REACH OF CHILDREN.Revised November 2007Bausch & Lomb Incorporated©Bausch & Lomb Incorporated9113200 9113300 Store between 2° - 30°C (36° - 86°F).Sulfonamide solutions, on long standing, will darken in color and should be discarded.KEEP OUT OF REACH OF CHILDREN.Revised November 2007Bausch & Lomb Incorporated©Bausch & Lomb Incorporated9113200 9113300 Store between 2° - 30°C (36° - 86°F).Sulfonamide solutions, on long standing, will darken in color and should be discarded.KEEP OUT OF REACH OF CHILDREN.Revised November 2007Bausch & Lomb Incorporated©Bausch & Lomb Incorporated9113200 9113300 Store between 2° - 30°C (36° - 86°F).Sulfonamide solutions, on long standing, will darken in color and should be discarded.KEEP OUT OF REACH OF CHILDREN.Revised November 2007Bausch & Lomb Incorporated©Bausch & Lomb Incorporated9113200 9113300 Benzphetamine hydrochloride tablets are supplied as follows:25 mg (peach, round tablets imprinted with ) 25 mg:Bottles of 30 NDC 67433-512-03Bottles of 100 NDC 67433-512-01Bottles of 500 NDC 67433-512-05Benzphetamine hydrochloride tablets are supplied as follows:25 mg (peach, round tablets imprinted with ) 25 mg:Bottles of 30 NDC 67433-512-03Bottles of 100 NDC 67433-512-01Bottles of 500 NDC 67433-512-05Benzphetamine hydrochloride tablets are supplied as follows:25 mg (peach, round tablets imprinted with ) 25 mg:Bottles of 30 NDC 67433-512-03Bottles of 100 NDC 67433-512-01Bottles of 500 NDC 67433-512-05Benzphetamine hydrochloride tablets are supplied as follows:25 mg (peach, round tablets imprinted with ) 25 mg:Bottles of 30 NDC 67433-512-03Bottles of 100 NDC 67433-512-01Bottles of 500 NDC 67433-512-05Benzphetamine hydrochloride tablets are supplied as follows:25 mg (peach, round tablets imprinted with ) 25 mg:Bottles of 30 NDC 67433-512-03Bottles of 100 NDC 67433-512-01Bottles of 500 NDC 67433-512-05Benzphetamine hydrochloride tablets are supplied as follows:25 mg (peach, round tablets imprinted with ) 25 mg:Bottles of 30 NDC 67433-512-03Bottles of 100 NDC 67433-512-01Bottles of 500 NDC 67433-512-05
Clinical Information
Chemical Structure
No Image foundClinical 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.
Drug Interactions
Array
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.
Array
Amphetamines may decrease the hypotensive effects of antihypertensives. Amphetamines may enhance the effects of tricyclic antidepressants.
Array
Urinary alkalinizing agents increase blood levels and decrease excretion of amphetamines. Urinary acidifying agents decrease blood levels and increase excretion of amphetamines.
General
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:
Cardiovascular
Palpitation, tachycardia, elevation of blood pressure.
There have been isolated reports of cardiomyopathy and ischemic cardiac events associated with chronic amphetamine use.
Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination with other anorectic drugs, have been reported. However, no cases of this valvulopathy have been reported when Benzphetamine hydrochloride tablets have been used alone.
CNS
Overstimulation, restlessness, dizziness, insomnia, tremor, sweating, headache; rarely, psychotic episodes at recommended doses; depression following withdrawal of the drug.
Gastrointestinal
Dryness of the mouth, unpleasant taste, nausea, diarrhea, other gastrointestinal disturbances.
Allergic
Urticaria and other allergic reactions involving the skin.
Endocrine
Changes in libido.
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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