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Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder, which is soluble in water and lower alcohols; slightly soluble in chloroform and insoluble in ether. Its molecular weight is 185.7 and the molecular formula is C10H15N•HCl. Chemically, the product is α, α-Dimethylphenethylamine hydrochloride. Phentermine hydrochloride has the following structural formula:

Phentermine hydrochloride, an anorectic agent for oral administration, is available as a capsule containing 30 mg of phentermine hydrochloride (equivalent to 24 mg Phentermine). In addition, each capsule contains the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, gelatin, magnesium stearate, povidone, titanium dioxide, FDA/E 172 Yellow Iron Oxide. The imprinting ink contains FD&C Blue #2, FD&C Red #40. FD&C Blue #1 and D&C Yellow #10 Lake.

CLINICAL PHARMACOLOGY

Phentermine 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 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, for example.

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 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 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 drugs 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.

INDICATIONS AND USAGE

Phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavorial modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia).

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.

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