Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
CAPSULE
**DOSAGE AND ADMINISTRATION** _Adults and children over 12 years:_ One capsule daily at breakfast, swallowed whole. Evening dosing should be avoided, as this agent may induce insomnia. It is recommended that treatment should be initiated under the care of physicians experienced in the treatment of obesity. The recommended starting dose is 30mg daily. The recommended maintenance dose, either continuous or intermittent is 15 to 30 mg daily depending on responsiveness. The recommended dose of Duromine should not be exceeded to increase the effect. Duromine should not be combined with other appetite suppressants. Patients require medical review after a defined course of treatment, which should not exceed three months. _Children under 12 years:_ Duromine is not recommended for children under the age of twelve. _Elderly:_ Duromine is not recommended for the elderly.
ORAL
Medical Information
**INDICATIONS** Duromine is an anorectic agent indicated in the 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. The treatment with Duromine 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. Secondary organic causes of obesity should be excluded by diagnosis before prescribing this agent.
**CONTRAINDICATIONS** Pulmonary artery hypertension; existing heart valve abnormalities or heart murmurs; moderate to severe arterial hypertension; cerebro-vascular disease; severe cardiac disease including arrhythmias, 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/ alcohol abuse or dependence; concomitant treatment with Monoamine Oxidase (MAO) Inhibitors or within 14 days following their administration.
A08AA01
phentermine
Manufacturer Information
INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED
Douglas Manuafacturing Ltd
Active Ingredients
Documents
Package Inserts
Duromine 15mg_PI_Clean.pdf
Approved: September 12, 2018