ADIPEX-P

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 x 0.0254 = meters.

The limited usefulness of agents of this class, including ADIPEX-P

Tablets: 37.5 mg phentermine hydrochloride, USP (equivalent to 30 mg phentermine base).

The following adverse reactions are described, or described in greater detail, in other sections:

The following adverse reactions to phentermine have been identified:

Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events.

Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis.

Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.

Urticaria.

Impotence, changes in libido.

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Phentermine hydrochloride, USP is a sympathomimetic amine anorectic. It has the chemical name of α,α,-Dimethylphenethylamine hydrochloride. The structural formula is as follows:

Phentermine hydrochloride, USP is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.

ADIPEX-P

ADIPEX-P

No clinical studies have been conducted with ADIPEX-P

In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with “anorectic” drugs lost more weight on the average than those treated with placebo and diet.

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 over several 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.

ADIPEX-P

Each white, oblong, scored tablet is debossed with “ADIPEX-P” and “9”-“9”. Tablets are packaged in bottles of 30 (NDC 72789-175-30) .

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Keep this and all medications out of the reach of children.

Patients must be informed that ADIPEX-P

Patients must be instructed on how much ADIPEX-P

Advise pregnant women and nursing mothers not to use ADIPEX-P

Patients must be informed about the risks of use of phentermine (including the risks discussed in Warnings and Precautions), about the symptoms of potential adverse reactions and when to contact a physician and/or take other action. The risks include, but are not limited to:

See also, for example,

The patients must also be informed about

Tell patients to keep ADIPEX-P

Brands listed are the trademarks of their respective owners.

Manufactured In Croatia By:

Manufactured For:

Rev. AC 3/2024

CIV

ADIPEX-P

37.5 mg

Rx only