PHENTERMINE HYDROCHLORIDE- phentermine hydrochloride capsule
CALVIN, SCOTT AND COMPANY, INCORPORATED
Phentermine hydrochloride capsules are 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/m2 , or ≥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 × 0.0254 = meters.
|Height (feet, inches)|
The limited usefulness of agents of this class, including phentermine, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.
Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is 15 mg to 30 mg as prescribed by the physician, at approximately 2 hours after breakfast for appetite control. Administration of one 30 mg capsule daily has been found to be adequate in depression of the appetite for 12 to 14 hours. Phentermine is not recommended for use in pediatric patients ≤16 years of age.
Late evening medication should be avoided because of the possibility of resulting insomnia.
The recommended maximum dosage of phentermine is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2). Avoid use of phentermine in patients with eGFR less than 15 mL/min/1.73m2 or end-stage renal disease requiring dialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Capsules containing 15 mg or 30 mg phentermine hydrochloride (equivalent to 12 mg or 24 mg phentermine base, respectively).
15 mg capsules: gray/yellow; imprinted “EL600” in black ink on cap and body, filled with white to off-white powder.
30 mg capsules: yellow; imprinted “EL601” in black ink on cap and body, filled with white to off-white powder.
- 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
- 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
Phentermine hydrochloride capsules are indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with phentermine and any other drug products for weight loss including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of phentermine and these drug products is not recommended.
Primary Pulmonary Hypertension (PPH) — a rare, frequently fatal disease of the lungs — has been reported to occur in patients receiving a combination of phentermine with fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of phentermine alone cannot be ruled out; there have been rare cases of PPH in patients who reportedly have taken phentermine alone. The initial symptom of PPH is usually dyspnea. Other initial symptoms may include angina pectoris, syncope or lower extremity edema. Patients should be advised to report immediately any deterioration in exercise tolerance. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema, and patients should be evaluated for the possible presence of pulmonary hypertension.
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