CONTRAVE® is a prescription medicine. Please review the full Data Sheet before prescribing, available on the Medsafe website www.medsafe.govt.nz. CONTRAVE® 8/90 (naltrexone hydrochloride and bupropion hydrochloride extended release tablets). Indications: CONTRAVE is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of ≥30 kg/m2 (obese) or ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension). Treatment with CONTRAVE should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight. Contraindications: Hypersensitivity to bupropion, naltrexone or any of the excipients, uncontrolled hypertension, seizure disorder or a history of seizures, patients with a known central nervous system tumour, patients undergoing acute alcohol or benzodiazepine withdrawal, patients with a history of bipolar disorder, use of concomitant treatment containing bupropion or naltrexone, current or previous diagnosis of bulimia or anorexia nervosa, patients currently dependent on chronic opioids or opiate agonists, or patients in acute opiate withdrawal, pregnancy, patients with severe hepatic impairment, patients with end-stage renal failure, and in concomitant administration with monoamine oxidase inhibitors (MAOI). At least 14 days should elapse between discontinuation of MAOI and initiation of treatment with CONTRAVE. Starting CONTRAVE in a patient treated with reversible MAOIs is also contraindicated. Warnings and Precautions: Safety and tolerability should be assessed at regular intervals. Safety and efficacy of CONTRAVE for longer than a year has not been established. Suicidal ideation has been reported in post marketing reports with CONTRAVE and patients should be supervised closely. There is a small increase in the risk of seizure. In patients requiring intermittent opiate treatment, CONTRAVE should be temporarily discontinued and lower doses of opioids may be needed. A patient should stop taking CONTRAVE and consult a doctor if experiencing any allergic symptoms during treatment. Use with caution in those with controlled hypertension, predisposing factors that increase the likelihood of seizing, reduced renal clearance, underlying liver disease, history of mania and patients aged greater than 65. Caution in performing activities requiring mental alertness e.g. driving and operating machinery. Pregnancy and lactation: Category B2. Safe use of orphenadrine has not been established with respect to adverse effects on foetal development. Adverse Effects: Decreased lymphocyte count, palpitations, tinnitus, vertigo, nausea, constipation, vomiting, dry mouth, toothache, upper abdominal pain, feeling jittery, dizziness, tremor, dysgeusia, disturbance in attention, lethargy, hot flush, hyperhidrosis, pruritus and alopecia. Interactions: Contraindicated in use with MAOIs, drugs containing bupropion, chronic opioid use or opiate agonist therapy. CONTRAVE may increase the availability of other medicines metabolised by CYP2D6 substrate. Medicines metabolised by the CYP2B6 isozyme may interact with CONTRAVE. Use with caution with drugs that lower the seizure threshold and dopaminergic drugs. Avoid or minimise the use of alcohol. Dosage and Administration: Swallow tablets whole with water, and preferably with food. Dose should be escalated over a 4-week period from initiation. The recommended starting dose is 1 tablet in the morning for 1 week, increasing to 1 tablet in the morning and 1 at night in the second week, 2 tablets in the morning and 1 tablet at night in the third week. The maintenance dose from week 4 onward is 2 tablets in the morning and 2 at night.
© 2021 Radiant Health, an iNova Pharmaceuticals company. Norflex is a registered trademark of iNova Pharmaceuticals. Distributed in New Zealand by Radiant Health Ltd, c/- Supply Chain Solutions, 74 Westney Road, Airport Oaks, Auckland. For all product enquiries: New Zealand Toll Free: 0508 375 394. TAPS NA 13056. Updated June 2021.