WARNINGS
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.
PRECAUTIONS
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.
Information for Patients
Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.
Drug Interactions
Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. DIDREX 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.
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
Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.
Geriatric Use
Clinical studies of DIDREX Tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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.
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