"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(Generic versions may still be available.)
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 trials.
The average magnitude of increased weight loss of drug-treated patients over placebo-treated is only a fraction of a pound a week. The rate of weight loss is 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 average 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 proof 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 clinically limited.
DOSAGE AND ADMINISTRATION
The usual dose is one 20 mg tablet three times daily before meals. Depending on the degree of effectiveness and side effects, the dosage may be increased at weekly intervals by one tablet (20 mg) daily until a maximum dosage of two tablets three times daily is attained. Total dosage of fenfluramine should not exceed 120 mg per day.
Pondimin (fenfluramine - removed from us market) is available in 20 mg orange, scored, compressed tablets monogrammed AHR and 6447, in bottles of 100 and 500.
Tablet, Uncoated - Oral - 20 mg
100's Pondimin, AH Robins 00031-6447-63 500's Pondimin, AH Robins 00031-6447-70
Store at controlled room temperature, between 15°C and 30°C (59°F and 86°F).
Dispense in well-closed container.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Pondimin Information
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