Benzphetamine Hydrochloride

Benzphetamine Hydrochloride

Benzphetamine Hydrochloride Recall

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Questions & Answers

Side Effects & Adverse Reactions

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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 CLINICAL PHARMACOLOGY) should be weighed against possible risks inherent in their use such as those described below.

BODY MASS INDEX (BMI), kg/m2
Weight
(pounds)
Height (feet, inches)
5'0"5'3"5'6"5'9"6'0"6'3"
140272523211918
150292724222019
160312826242220
170333028252321
180353229272523
190373431282624
200393632302725
210413734312926
220433936333028
230454137343129
240474339363330
250494440373431

Benzphetamine Hydrochloride Tablets are indicated for use as monotherapy only.

History

There is currently no drug history available for this drug.

Other Information

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:

C:Documents and SettingsavyasDesktopBenzphetamine label draftFinalimage-a.jpg

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.

Benzphetamine Hydrochloride Manufacturers


  • A-s Medication Solutions Llc
    Benzphetamine Hydrochloride Tablet [A-s Medication Solutions Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Benzphetamine Hydrochloride Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Paddock Laboratories, Inc.
    Benzphetamine Hydrochloride Tablet, Coated [Paddock Laboratories, Inc.]
  • Apotheca Inc.
    Benzphetamine Hydrochloride (Benaphetamine) Tablet [Apotheca Inc.]
  • Global Pharmaceuticals, Division Of Impax Laboratories Inc.
    Benzphetamine Hydrochloride Tablet [Global Pharmaceuticals, Division Of Impax Laboratories Inc.]
  • Kvk-tech, Inc
    Benzphetamine Hydrochloride Tablet [Kvk-tech, Inc]
  • Solco Healthcare Us Llc
    Benzphetamine Hydrochloride Tablet [Solco Healthcare Us Llc]
  • C.o. Truxton, Inc.
    Benzphetamine Hydrochloride Tablet [C.o. Truxton, Inc.]
  • Mikart, Inc.
    Benzphetamine Hydrochloride Tablet [Mikart, Inc.]
  • Pd-rx Pharmaceuticals, Inc.
    Benzphetamine Hydrochloride (Benaphetamine) Tablet [Pd-rx Pharmaceuticals, Inc.]
  • Bryant Ranch Prepack
    Benzphetamine Hydrochloride Tablet [Bryant Ranch Prepack]
  • Pd-rx Pharmaceuticals, Inc.
    Benzphetamine Hydrochloride Tablet [Pd-rx Pharmaceuticals, Inc.]
  • A-s Medication Solutions Llc
    Benzphetamine Hydrochloride Tablet [A-s Medication Solutions Llc]
  • Boca Pharmacal, Llc
    Benzphetamine Hydrochloride Tablet [Boca Pharmacal, Llc]
  • Heritage Pharmaceuticals Inc.
    Benzphetamine Hydrochloride (Benzphetamine Hydrochloride Tablets) Tablet, Film Coated [Heritage Pharmaceuticals Inc.]
  • Aidarex Pharmaceuticals Llc
    Benzphetamine Hydrochloride Tablet [Aidarex Pharmaceuticals Llc]

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