INDICATIONS

ADIPEX-P^® 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 greater than or equal to 30 kg/m², or greater than or equal to 27 kg/m² in 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 ADIPEX-P^®, should be measured against possible risk factors inherent in their use such as those described below.

DOSAGE

Exogenous Obesity

Dosage should be individualized to obtain an adequate response with the lowest effective dose.

The usual adult dose is one capsule (37.5 mg) daily as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast for appetite control.

The usual adult dose is one tablet (37.5 mg) daily as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast. The dosage may be adjusted to the patient’s need. For some patients, half tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give half tablets (18.75 mg) two times a day.

ADIPEX-P^® is not recommended for use in pediatric patients less than or equal to 16 years of age.

Late evening medication should be avoided because of the possibility of resulting insomnia.

Dosage In Patients With Renal Impairment

The recommended maximum dosage of ADIPEX-P^® is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m² ). Avoid use of ADIPEX-P^® in patients with eGFR less than 15 mL/min/1.73 m² or end-stage renal disease requiring dialysis.

Tablets are packaged in bottles of 30 (NDC 57844-009-56); 100 (NDC 57844-009-01); and 1000 (NDC 57844-009-10).

Capsules are packaged in bottles of 100 (NDC 57844-019-01).

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

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

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

SIDE EFFECTS

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

• Primary pulmonary hypertension
• Valvular heart disease
• Effect on the ability to engage in potentially hazardous tasks
• Withdrawal effects following prolonged high dosage administration

The following adverse reactions to phentermine have been identified:

Cardiovascular

Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, the 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, and other gastrointestinal disturbances.

Allergic

Urticaria.

Endocrine

Impotence, changes in libido.

PATIENT INFORMATION

Patients must be informed that ADIPEX-P^® 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.

Patients must be instructed on how much ADIPEX-P^® to take, and when and how to take it.

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:

• Development of primary pulmonary hypertension.
• Development of serious valvular heart disease.
• Effects on the ability to engage in potentially hazardous tasks.
• The risk of an increase in blood pressure
• The risk of interactions.

The patients must also be informed about

• the potential for developing tolerance and actions if they suspect development of tolerance and
• the risk of dependence and the potential consequences of abuse.

Tell patients to keep ADIPEX-P^® in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away ADIPEX-P^® may harm others and is against the law. Buy Adipex-P Online

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