Drug: Didrex

DIDREX 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 DIDREX (benzphetamine) Tablet, for oral administration, contains 50 mg of benzphetamine hydrochloride. Inactive Ingredients: Calcium Stearate, Corn Starch, Erythrosine Sodium. FD & C Yellow No. 6, Lactose, Povidone, Sorbitol.

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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 DIDREX (benzphetamine) 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. Drug Abuse And Dependence Benzphetamine is a controlled substance under the Controlled Substance Act by the Drug Enforcement Administration and has been assigned to Schedule III. Benzphetamine hydrochloride is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of DIDREX (benzphetamine) Tablets should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. Read the Didrex (benzphetamine) Side Effects Center for a complete guide to possible side effectsLearn More »

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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.

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Efficacy of DIDREX (benzphetamine) Tablets in combination with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems. Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. DIDREX (benzphetamine) should not be used concomitantly with other CNS stimulants. Amphetamines may decrease the hypotensive effect of antihypertensives. Amphetamines may enhance the effects of tricyclic antidepressants. Urinary alkalinizing agents increase blood levels and decrease excretion of amphetamines. Urinary acidifying agents decrease blood levels and increase excretion of amphetamines.Read the Didrex Drug Interactions Center for a complete guide to possible interactions Learn More »

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DIDREX (benzphetamine) 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” 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31 DIDREX (benzphetamine) Tablets are indicated for use as monotherapy only.

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DIDREX (benzphetamine) 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. DIDREX (benzphetamine) should not be used concomitantly with other CNS stimulants. DIDREX (benzphetamine) 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. DIDREX (benzphetamine) is 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.Last reviewed on RxList: 2/26/2010
This monograph has been modified to include the generic and brand name in many instances.

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Manifestations of Overdosage Acute overdosage with amphetamines may result in restlessness, tremor, tachypnea, confusion, assaultiveness and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Hyperpyrexia and rhabdomyolysis have been reported and can lead to a number of associated complications. Fatal poisoning is usually preceded by convulsions and coma. Treatment of Overdosage (See WARNINGS)— Information concerning the effects of overdosage with DIDREX (benzphetamine) Tablets is extremely limited. The following is based on experience with other anorexiants. 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 LD50 is 174 mg/kg in mice and 104 mg/kg in rats. The intraperitoneal LD50 in mice is 153 mg/kg.

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DIDREX (benzphetamine) Tablets are supplied as follows: 50 mg (peach, round, imprinted with DIDREX (benzphetamine) 50, scored) Bottles of 100 NDC 0009-0024-01 Bottles of 500 NDC 0009-0024-02 Store at controlled room temperature 20° to 25° C (68° to 77° F). [see USP] Distributed by: Pharmacia & Upjohn Company. Division of Pfizer Inc, NY, NY 10017. Manufactured by: MOVA Pharmaceuticals Manati, PR 00674. August 2009Last reviewed on RxList: 2/26/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General 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. Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility have not been performed by Pharmacia & Upjohn Company. Pregnancy Pregnancy Category X (see CONTRAINDICATIONS section). Nursing Mothers Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age. Geriatric Use Clinical studies of DIDREX (benzphetamine) Tablets did not include sufficient numbers of subjects aged 65 and over to establish safety and efficacy in this population. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.Last reviewed on RxList: 2/26/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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