Generic Name and Formulations:
Bupropion HCl 150mg; sust-rel tabs.
Indications for ZYBAN:
Aid in smoking cessation.
Provide patients with counseling and educational support. Set a target "quit date" within the first 2 weeks of treatment. Swallow whole. Begin therapy before quit day while patient is still smoking. Avoid bedtime dosing. ≥18yrs: initially 150mg once daily for 3 days, then 150mg twice daily at least 8hrs apart; max 300mg/day in divided doses. Treat for 7–12 weeks; if patient is unable to quit during this attempt, discontinue and reassess treatment plan. Patients who successfully quit after 12 weeks but do not feel ready to discontinue treatment should be considered for ongoing therapy. Moderate-to-severe hepatic impairment: max 150mg every other day. Mild hepatic or renal impairment: consider reducing dose and/or frequency.
<18yrs: not established.
Seizure disorders. Bulimia. Anorexia nervosa. During or within 14 days of MAOIs. Abrupt withdrawal of alcohol, benzodiazepines, barbiturates, antiepileptic drugs. Concomitant linezolid or IV methylene blue.
Suicidal thoughts and behaviors.
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor all patients for clinical worsening or unusual behavioral changes. Monitor for neuropsychiatric adverse events (eg, behavioral changes, agitation, depression, suicidal ideation); evaluate and consider treatment continuation under closer monitoring, or discontinuation if occur. Pre-existing psychiatric disorders. Bipolar disorder. Psychosis. History or risk of seizures; discontinue if seizure occurs: do not restart. CHF. Unstable heart disease. Recent MI. Monitor BP prior to initiation and periodically during treatment. Angle-closure glaucoma. Hepatic or renal impairment (monitor closely). Elderly. Pregnancy (Cat.C); attempt nondrug treatment first. Nursing mothers.
See Contraindications. Avoid alcohol. May use with transdermal nicotine (monitor for hypertension). Concomitant levodopa, amantadine may increase CNS toxicity. Caution with drugs that lower seizure threshold (eg, other bupropion products, antipsychotics, antidepressants, theophylline, systemic steroids), or other factors that increase the risk of seizures (eg, cocaine addiction, abuse of CNS stimulants, antidiabetics, anorectics, excessive alcohol, benzodiazepines, sedatives, hypnotics, or opiates). May potentiate CYP2D6 substrates including antidepressants (eg, venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (eg, haloperidol, risperidone, thioridazine), β-blockers (eg, metoprolol), Class 1C antiarrhythmics (eg, propafenone, flecainide); consider reducing dose of these. May be potentiated by CYP2B6 inhibitors (eg, ticlopidine, clopidogrel); adjust bupropion dose. May be antagonized by CYP2B6 inducers (eg, ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, phenytoin); may need to increase bupropion dose. May lower efficacy of drugs metabolized by CYP2D6 (eg, tamoxifen); increase dose of these. May antagonize digoxin; monitor. Smoking cessation may affect theophylline, warfarin, insulin; dose adjustment may be needed. May cause false (+) urine immunoassay screening test for amphetamines.
Insomnia, rhinitis, dry mouth, dizziness, nervous disturbance, anxiety, nausea, constipation, arthralgia; hypertension, neuropsychiatric symptoms (may be serious), hypersensitivity or severe skin reactions (discontinue if occur).
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