PHENTERMINE HYDROCHLORIDE- phentermine hydrochloride tablet, orally disintegrating
Cadila Healthcare Limited
Phentermine hydrochloride orally disintegrating tablets 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 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 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.
Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is one tablet as prescribed by the physician, administered in the morning, with or without food. Phentermine hydrochloride orally disintegrating tablets are 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.
With dry hands, gently remove the phentermine hydrochloride orally disintegrating tablet from the bottle. Immediately place the phentermine hydrochloride orally disintegrating tablet on top of the tongue where it will dissolve, then swallow with or without water.
Phentermine hydrochloride orally disintegrating tablets (ODT) containing 15 mg, 30 mg, or 37.5 mg phentermine hydrochloride (equivalent to 12 mg, 24 mg, or 30 mg phentermine base, respectively). The tablets are not scored.
- The 15 mg orally disintegrating tablet (ODT) is a white to off-white, round, beveled, biconvex, uncoated tablets, debossed with ’703′ on one side and plain on other side.
- The 30 mg orally disintegrating tablet (ODT) is a white to off-white, oval, beveled, biconvex, uncoated tablets, debossed with ’704′ on one side and plain on other side.
- The 37.5 mg orally disintegrating tablet (ODT) is a white to off-white, round, beveled, biconvex, uncoated tablets, debossed with ’670′ on one side and plain on other side.
- 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 orally disintegrating tablets 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 hydrochloride orally disintegrating tablets 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 hydrochloride orally disintegrating tablets and these drug products is not recommended.
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 hydrochloride 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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