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Phentermine Juno ER Minimum PI: Phentermine Juno ER extended release tablet contains phentermine hydrochloride. Bioequivalence has been established with phentermine extended release ion exchange resin capsules on which the clinical data is based. Indications: management of obesity as a short-term adjunct in a medically monitored comprehensive regimen of weight reduction in obese patients with a body mass index (BMI) of 30 kg/m2 or greater. 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. Precautions: coadministration of drug products for weight loss; mild hypertension; diabetes; rapid weight loss; established coronary artery disease; epilepsy. Interactions: selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, paroxetine), ergot-like drugs and clomipramine; fenfluramine/dexfenfluramine; psychotropic drugs, including sedatives; sympathomimetic agents; anti-hypertensive agents; adrenergic neurone blocking drugs such as clonidine, methyldopa and guanethidine; monoamine oxidase inhibitors; thyroid hormones; alcohol. Adverse effects: Cardiovascular: Valvular Heart Disease and Primary Pulmonary Hypertension; palpitations, tachycardia, elevation of blood pressure, precordial pain. stroke, angina, myocardial infarction, cardiac failure, cardiac arrest. Central Nervous System: Overstimulation, restlessness, nervousness, insomnia, tremor, dizziness and headache. euphoria followed by fatigue and depression, psychotic episodes and hallucinations. Gastrointestinal: Nausea, vomiting, dry mouth, abdominal cramps, unpleasant taste, diarrhoea, constipation. Other: Micturition disturbances, rash, impotence, changes in libido, facial oedema. Dosage and administration: Adults and adolescents over 12 years. One tablet daily at breakfast, swallowed whole. Evening dosing should be avoided, as this agent may induce insomnia. The recommended starting dose is 30mg daily. Larger framed individuals may require 40mg daily. The recommended maintenance dose, either continuous or intermittent is 15 to 40 mg daily depending on responsiveness. The recommended dose of phentermine should not be exceeded to increase the effect. Phentermine should not be combined with other appetite suppressants. Patients require medical review after a defined course of treatment, which should not exceed three months. Med308. Prepared May 2020.