DailyMed Label: Phentermine Hydrochloride

DailyMed Label: Phentermine Hydrochloride

2010

DailyMed Prescription

Phentermine Hydrochloride

Phentermine Hydrochloride

Keltman Pharmaceuticals Inc.

NDC: 68387-690

NDC: 68387-690

Phentermine hydrochloride USP has the chemical name of α, α-Dimethylphenethylamine hydrochloride. The structural formula is as follows: C 10 H 15 N•HCl                                  M.W. 185.7 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. Phentermine hydrochloride, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride tablets contain the inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, magnesium stearate, povidone, propylene glycol, FD&C Blue #1 Aluminum Lake, shellac glaze, and titanium dioxide. Chemical Structure

Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m 2 , or ≥27 kg/m 2 in the presence of other risk factors (e. g., hypertension, diabetes, hyperlipidemia). 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. BODY MASS INDEX (BMI), kg/m 2 Height (feet, inches) Weight (pounds) 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 The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY ) should be measured against possible risk factors inherent in their use such as those described below.

Exogenous Obesity: Dosage should be individualized to obtain an adequate response with the lowest effective dose. The usual adult dose is one tablet (37.5 mg) daily, administered before breakfast or 1 – 2 hours after breakfast. The dosage may be adjusted to the patient's need. For some patients 1/2 tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give 1/2 tablet (18.75 mg) two times a day. Late evening medication should be avoided because of the possibility of resulting insomnia. Phentermine is not recommended for use in patients sixteen (16) years of age and under.

Advanced arteriosclerosis, cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma. Agitated states. Patients with a history of drug abuse. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).

Caution is to be exercised in prescribing phentermine hydrochloride for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of phentermine hydrochloride and the concomitant dietary regimen. Phentermine hydrochloride may decrease the hypotensive effect of guanethidine. 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: Studies have not been performed with phentermine hydrochloride to determine the potential for carcinogenesis, mutagenesis or impairment of fertility. Pregnancy – Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with phentermine hydrochloride. It is also not known whether phentermine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Phentermine hydrochloride should be given to a pregnant woman only if clearly needed. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Safety and effectiveness in pediatric patients have not been established.

Phentermine hydrochloride tablets USP 37.5 mg (equivalent to 30 mg phentermine base) are white with blue specks, oval shaped, scored on one side and debossed MP 273 on the other side. They are supplied by Keltman Pharmaceuticals Inc. as follows: NDC Strength Quantity/Form Color Source Prod. Code 68387-690-07 37.5 mg 7 Tablets in a Plastic Bottle White with blue specks 53489-406 68387-690-14 37.5 mg 14 Tablets in a Plastic Bottle White with blue specks 53489-406 68387-690-15 37.5 mg 15 Tablets in a Plastic Bottle White with blue specks 53489-406 68387-690-21 37.5 mg 21 Tablets in a Plastic Bottle White with blue specks 53489-406 68387-690-28 37.5 mg 28 Tablets in a Plastic Bottle White with blue specks 53489-406 68387-690-30 37.5 mg 30 Tablets in a Plastic Bottle White with blue specks 53489-406 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Phentermine hydrochloride 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 over placebo-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.

PHENTERMINE HYDROCHLORIDE TABLETS USP 37.5 mg Rx only PRINCIPAL DISPLAY PANEL - 37.5 mg Label