Contrave

Contrave Dosage/Direction for Use

Manufacturer:

Patheon

Distributor:

Zuellig

Marketer:

iNova
Full Prescribing Info
Dosage/Direction for Use
Posology: Adults: Upon initiating treatment, the dose should be escalated over a 4-week period as follows: Week 1: One tablet in the morning.
Week 2: One tablet in the morning and one tablet in the evening.
Week 3: Two tablets in the morning and one tablet in the evening.
Week 4 and onwards: Two tablets in the morning and two tablets in the evening.
The maximum recommended daily dose of Contrave is two tablets taken twice daily for a total dose of 32 mg naltrexone hydrochloride and 360 mg bupropion hydrochloride.
The need for continued treatment should be evaluated after 16 weeks (see Indications/Uses) and re- evaluated annually.
Missed dose: If a dose is missed, patients should not take an additional dose, but take the prescribed next dose at the usual time.
Special populations: Elderly patients (over 65 years): Naltrexone/bupropion should be used with caution in patients over 65 years of age and is not recommended in patients over 75 years of age (see Precautions, Adverse Reactions and Pharmacology: Pharmacokinetics under Actions).
Patients with renal impairment: Naltrexone/bupropion is contraindicated in patients with end-stage renal failure (see Contraindications). In patients with moderate or severe renal impairment, the maximum recommended daily dose for naltrexone/bupropion is two tablets (one tablet in the morning and one tablet in the evening) (see Precautions, Adverse Reactions and Pharmacology: Pharmacokinetics under Actions). It is recommended that patients with moderate or severe renal impairment initiate treatment with one tablet in the morning for the first week of treatment, and escalate to one tablet in the morning and one tablet in the evening from week 2 onwards. Dose reduction is not necessary in patients with mild renal impairment. For individuals who are at elevated risk for renal impairment, in particular patients with diabetes or elderly individuals, estimated glomerular filtration rate (eGFR) should be assessed prior to initiating therapy with naltrexone/bupropion.
Patients with hepatic impairment: Naltrexone/bupropion is contraindicated in patients with severe hepatic impairment (see Contraindications). Naltrexone/bupropion is not recommended in patients with moderate hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions). In patients with mild hepatic impairment, the maximum recommended daily dose for naltrexone/bupropion is two tablets (one tablet in the morning and one tablet in the evening) (see Precautions and Pharmacology: Pharmacokinetics under Actions). It is recommended that patients with mild hepatic impairment initiate treatment with one tablet in the morning for the first week of treatment, and escalate to one tablet in the morning and one tablet in the evening from week 2 onwards. Degree of hepatic impairment should be assessed using the Child-Pugh score.
Paediatric population: The safety and efficacy of naltrexone/bupropion in children and adolescents below 18 have not yet been established. Therefore, naltrexone/bupropion should not be used in children and adolescents below 18.
Method of administration: Oral use. The tablets should be swallowed whole with some water. The tablets should preferably be taken with food (see Pharmacology: Pharmacokinetics under Actions). The tablets should not be cut, chewed, or crushed.
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