SUPREMINE ER

What it is

SUPREMINE ER contains phentermine as an ion-exchange resin complex equivalent to 15, 30 or 40 mg phentermine depending on strength. The capsules are modified release formulations. Phentermine is a sympathomimetic amine with significant anorectic activity. Continuous and controlled ionic release occurs over a 10 to 14 hour period.

Approved indications

— Management of obesity as a short-term adjunct in a medically monitored comprehensive regimen of weight reduction based, for example, on exercise, diet (caloric/kilojoule restriction) and behaviour modification in obese patients with a body mass index (BMI) of 30 kg/m² or greater. — Treatment can 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 daily at breakfast, swallowed whole, is recommended for 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 regurgitate cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of fenfluramine or dexfenfluramine with phentermine for weight loss. There have been no reported cases to date of valvular heart disease occurring with the use of phentermine alone. Cases of severe, sometimes fatal primary pulmonary hypertension have been reported in patients who have received anorectics. The possibility of an association between primary pulmonary hypertension and the use of phentermine alone cannot be ruled out; there have been very rare cases in patients who reportedly have taken phentermine alone. The initial symptom of primary pulmonary hypertension is usually dyspnoea, with other early symptoms including angina pectoris, syncope, lower extremity oedema or the unexplained onset or aggravation of diminished exercise tolerance. Under these circumstances, treatment should be immediately discontinued and the patient referred to a specialist unit for investigation. 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 SUPREMINE ER.

Contraindications

SUPREMINE ER is contraindicated in patients with pulmonary artery hypertension; existing heart valve abnormalities or heart murmurs; moderate to severe arterial hypertension; cerebro-vascular disease; severe cardiac disease including arrhythmias or 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 (MAO) inhibitors or within 14 days following their administration.

Regulatory history

SUPREMINE ER was first approved on 11 August 2021. ARTG registration records show that SUPREMINE ER phentermine 15 mg, 30 mg and 40 mg extended release tablet blister packs were first listed on 2021-10-20. Additional registrations for SUPREMINE ER phentermine 30 mg and 15 mg formulations were listed on 2026-01-12 and 2026-02-24 respectively.