PHENTERMINE SANDOZ

What it is

PHENTERMINE SANDOZ contains phentermine as a hydrochloride in modified release capsules available in strengths of 15 mg, 30 mg and 40 mg. The capsules use an ion-exchange resin that releases phentermine continuously and in a controlled manner over a 10 to 14 hour period. Phentermine is a sympathomimetic amine with appetite suppressant effects generally considered to be exerted through the hypothalamus.

Approved indications

— Management of obesity as a short-term adjunct in a medically monitored comprehensive regimen of weight reduction based on exercise, diet and behaviour modification in obese patients with a body mass index (BMI) of 30 kg/m² or greater. — Treatment may be initiated in overweight patients with a lower BMI (25 to 29.9 kg/m²) which increases the risk of morbidity from a number of disorders.

Dosing overview

One capsule should be swallowed whole daily at breakfast in adults and adolescents over 12 years. The recommended starting dose is 30 mg daily. Larger framed individuals may require 40 mg daily. The recommended maintenance dose, either continuous or intermittent, is 15 to 40 mg daily depending on responsiveness. Evening dosing should be avoided as this agent may induce insomnia. Patients require medical review after a defined course of treatment, which should not exceed three months.

Key safety warnings

Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and tricuspid valves, has been reported in persons who took a combination of fenfluramine or dexfenfluramine with phentermine, but there have been no reported cases of valvular heart disease with phentermine alone. The possibility of an association between primary pulmonary hypertension and phentermine alone cannot be ruled out, with very rare cases reported. The initial symptom is usually dyspnoea, with other early symptoms including angina pectoris, syncope, lower extremity oedema or unexplained onset or aggravation of diminished exercise tolerance. Treatment should be immediately discontinued and the patient referred to a specialist unit for investigation under these circumstances. Cardiovascular and cerebrovascular events have rarely been reported, mainly in association with rapid weight loss. Weight loss should be gradual and controlled in obese patients undergoing treatment with PHENTERMINE SANDOZ. PHENTERMINE SANDOZ may impair the ability to perform activities requiring mental alertness, such as driving and operating machinery.

Contraindications

PHENTERMINE SANDOZ is contraindicated in pulmonary artery hypertension; existing heart valve abnormalities or heart murmurs; moderate to severe arterial hypertension; cerebrovascular disease; severe cardiac disease including arrhythmias and advanced arteriosclerosis; known hypersensitivity to sympathomimetic drugs; hyperthyroidism; agitated states or a history of psychiatric illnesses including anorexia nervosa and depression; glaucoma; history of drug or alcohol abuse or dependence; and concomitant treatment with Monoamine Oxidase Inhibitors or within 14 days following their administration.

Regulatory history

PHENTERMINE SANDOZ in 15 mg, 30 mg and 40 mg sustained release capsule strengths was first listed on the Australian Register of Therapeutic Goods on 11 March 2022.