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Please review full Product Information before prescribing. Product Information available on request from iNova Pharmaceuticals, Toll-free 1800 630 056.
Minimum Product Information.
Minimum Product Information. 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. Precautions: Safety and tolerability should be assessed at regular intervals. Suicidal ideation has been reported in post marketing reports with CONTRAVE and patients should be supervised closely. Use with caution in patients with predisposing factors that increase the risk of seizures. 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. Hypertensive crisis has been reported in post marketing cases during the initial titration phase of CONTRAVE, and it should be used with caution in those with controlled hypertension. Serotonin syndrome has been reported in post marketing cases when bupropion is co-administered with other serotonergic agents and in overdosage so CONTRAVE should be used under careful observation in these cases. Use with caution in patients with a history of psychiatric disorders as panic attacks, particularly in these patients, have been reported with CONTRAVE. Use with caution in patients with a history of mania, reduced renal clearance, underlying liver disease, patients aged greater than 65. 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. CONTRAVE may decrease plasma digoxin levels and digoxin levels may rise on discontinuation of CONTRAVE and the patient should be monitored for possible digoxin toxicity. Adverse Reactions: More common: Nausea, constipation, vomiting, Common: Decreased lymphocyte count, palpitations, tinnitus, vertigo, dry mouth, toothache, upper abdominal pain, feeling jittery, dizziness, tremor, dysgeusia, disturbance in attention, lethargy, hot flush, hyperhidrosis, pruritus, alopecia and hypertension. 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 Last reviewed: 19/09/2022
This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
iNova Pharmaceuticals (Australia) Pty Limited, ABN 13 617 871 539, Level 10, 12 Help St, Chatswood, NSW 2067 Australia, Ph: 1800 630 056, Fax: +61 2 8918 6416
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