Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in the presence of other risk factors (e.g., controlled 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 x 0.0254 = meters.

The limited usefulness of agents of this class, including Phentermine hydrochloride, [see CLINICAL PHARMACOLOGY ( 12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described below.

Capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base).

Tablets containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base).

• History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension)
• During or within 14 days following the administration of monoamine oxidase inhibitors
• Hyperthyroidism
• Glaucoma
• Agitated states
• History of drug abuse
• Pregnancy [see Use in Specific Populations ( 8.1) ]
• Nursing [see Use in Specific Populations ( 8.3) ]
• Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines

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

• Primary pulmonary hypertension [ see Warnings and Precautions ( 5.2) ]
• Valvular heart disease [ see Warnings and Precautions ( 5.3) ]
• Effect on the ability to engage in potentially hazardous tasks [ see Warnings and Precautions ( 5.5) ]
• Withdrawal effects following prolonged high dosage administration [ seeDrug Abuse and Dependence ( 9.3) ]

The following adverse reactions to phentermine have been identified:

Cardiovascular:

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

Central Nervous System:

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

Gastrointestinal:

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

Allergic:

Urticaria.

Endocrine:

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 is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows:

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 is available as a capsule and tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base).

Phentermine hydrochloride capsules, USP contain the inactive ingredients: corn starch, D&C Red #33, FD&C Blue #1, gelatin, lactose monohydrate, magnesium stearate and titanium dioxide.

Phentermine hydrochloride tablets, USP contain the inactive ingredients: corn starch, colloidal silicon dioxide, FD&C blue #1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, stearic acid, and sucrose.

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.

Available in tablets and capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg Phentermine base).

Phentermine hydrochloride tablets, USP 37.5 mg (equivalent to 30 mg phentermine base), are supplied as blue and white mottled oval tablets debossed “K” left to bisect “25” on one side and plain on the other side.

Bottles of 1000, NDC 68071-3819-1

Storeat 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

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

Keep out of the reach of children

Patients must be informed that phentermine hydrochloride is 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, and that coadministration of Phentermine with other drugs for weight loss is not recommended [ see Indications and Usage ( 1) and Warnings and Precautions ( 5) ].

Patients must be instructed on how much phentermine to take, and when and how to take it [ see Dosage and Administration ( 2) ].

Advice pregnant women and nursing mothers not to use phentermine [ see Use in Specific Populations ( 8.1, 8.3) ].

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:

• Development of primary pulmonary hypertension [ see Warnings and Precautions ( 5.2) ]
• Development of serious valvular heart disease [ see Warnings and Precautions ( 5.3) ]
• Effects on the ability to engage in potentially hazardous tasks [ see Warnings and Precautions ( 5.5) ]
• The risk of an increase in blood pressure [ see Warnings and Precautions ( 5.8) and Adverse Reactions ( 6) ]
• The risk of interactions [ see Contraindications ( 4), Warnings and Precautions ( 5) and Drug Interactions ( 7) ]

See also, for example, Adverse Reactions ( 6) and Use in Specific Populations ( 8) .

The patients must also be informed about

• the potential for developing tolerance and actions if they suspect development of tolerance [ see Warnings and Precautions ( 5.4) ] and
• th risk of dependence and the potential consequences of abuse [ see Warnings and Precautions ( 5.6), Drug Abuse and Dependence ( 9), and Overdosage ( 10)].

Tell patients to keep phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away Phentermine may harm others and is against the law.

Regitine ®is a registered trademark of CIBA PHARMACEUTICAL PRODUCTS, INC.

Manufactured by:

KVK-TECH INC.

110 Terry Drive

Newtown, PA 18940

Item ID # 6071/07 05/2021

Manufacturer’s Code: 10702