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Safety Information¹

Indications and Clinical use:

CONTRAVE is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:

• ≥30 kg/m² (obese) or
• ≥27 kg/m² (overweight) in the presence of at least one weight-related comorbidity (e.g., controlled hypertension, type 2 diabetes mellitus, or dyslipidemia). The effect on cardiovascular morbidity and mortality has not been established.

The safety and effectiveness in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
Geriatrics (≥65 years of age): Use with caution.
Pediatrics (<18 years of age): Not indicated.

Contraindications:

• Uncontrolled hypertension
• Current seizure disorder or a history of seizures
• Use of other bupropion hydrochloride-containing products
• Current or prior diagnosis of bulimia or anorexia nervosa
• Chronic opioid or opiate agonist or partial agonists use, or acute opiate withdrawal
• Patients undergoing an abrupt discontinuation of alcohol, benzodiazepines or other sedatives and antiepileptic drugs
• Concomitant administration of monoamine oxidase inhibitors (MAOI)
• Concomitant administration of the antipsychotic thioridazine
• Pregnancy
• Severe hepatic impairment
• End-stage renal failure
• Do not use in combination with tamoxifen

Most Serious Warnings and Precautions:

• Potential association with behavioural and emotional changes, including self-harm: Bupropion, a component of CONTRAVE, is used for the treatment of depression. There is an increased risk of self-harm, harm to others, suicidal thinking and behaviour with antidepressant use. Closely monitor all patients for emergence of depression, agitation-type and/or suicidal thoughts and behaviours
• Seizures: In order to minimize the risk of seizures the maximum recommended daily dose should not be exceeded
• Serious drug interactions: Serious drug interactions with CONTRAVE include concomitant medicines that contain bupropion hydrochloride (e.g., WELLBUTRIN^® XL, WELLBUTRIN^® SR, and ZYBAN^®), MAOI, and medicines that contain thioridazine

Relevant Warnings and Precautions:

• Unmasking of Brugada syndrome
• Interference with the action of opioid-containing drug products, vulnerability to opioid overdose, and precipitated opioid withdrawal
• Increase in blood pressure and heart rate; not for use in patients with uncontrolled hypertension and caution in patients with controlled hypertension
• Dependence/tolerance
• Caution about driving and operating machinery
• Contains lactose
• Risk of hypoglycemia in patients with type 2 diabetes on antidiabetic therapy
• Tamoxifen and other drugs metabolized by CYP2D6 may have reduced efficacy
• Monitor patients with mild-to-moderate hepatic impairment or moderate-to-severe renal impairment for adverse effects that could indicate high drug or metabolite levels; dose adjustments required
• Hepatotoxicity; discontinue in the event of symptoms and/or signs of acute hepatitis
• Anaphylactic and hypersensitivity reactions
• Development of cutaneous lupus erythematosus or exacerbation of systemic lupus erythematosus
• Serotonin toxicity, also known as serotonin syndrome
• Angle-closure glaucoma
• Activation of mania and hallucinations
• Not recommended in nursing mothers

For More Information:

Please consult the product monograph for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The product monograph is also available by calling 1-800-361-4261.