Generic Name and Formulations:
Bupropion HBr 174mg (equiv. to bupropion HCl 150mg), 348mg (equiv. to bupropion HCl 300mg), 522mg (equiv. to bupropion HCl 500mg); ext-rel tabs.
Bausch Health Companies Inc.
Indications for APLENZIN:
Treatment of major depressive disorder (MDD). Prevention of seasonal affective disorder (SAD).
Swallow whole. Take in the AM. MDD: Initially 174mg once daily; after 4 days, may increase to target dose of 348mg once daily. SAD: Individualize. Start therapy in autumn, prior to onset of symptoms; continue through the winter season; taper dose and discontinue early spring. Initially 174mg once daily; after 7 days, may increase to target dose of 348mg once daily. Severe hepatic impairment: max 174mg every other day. Renal or mild-moderate hepatic dysfunction: reduce dose and/or frequency. All: increase dose gradually to reduce seizure risk: max 522mg once daily.
Seizure disorder or conditions that increase seizure risk (eg, arteriovenous malformation, severe head injury, CNS tumor/infection, severe stroke, anorexia nervosa or bulimia, or abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs. Within 14 days of MAOIs (eg, phenelzine).
Suicidal thoughts and behaviors. Neuropsychiatric reactions.
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. Mania/hypomania. Psychosis. Risk of seizures; discontinue if seizure occurs: do not restart. Angle-closure glaucoma. Unstable heart disease. CHF. Recent MI. Monitor BP before initiating and periodically during treatment. Hepatic or renal impairment (monitor closely). Maintain at lowest effective dose. Write ℞ for smallest practical amount. Labor & delivery. Pregnancy (Cat.C). Nursing mothers.
See Contraindications. Avoid alcohol. May be potentiated by CYP2B6 inhibitors (eg, ticlopidine, clopidogrel), paroxetine, sertraline, fluvoxamine, nelfinavir. May be antagonized by CYP2B6 inducers (eg, ritonavir, lopinavir, efavirenz), others (eg, carbamazepine, phenobarbital, phenytoin). Caution with drugs that lower seizure threshold (eg, other bupropion products, antipsychotics, antidepressants, theophylline, systemic corticosteroids, anorectic drugs, benzodiazepines, sedative/hypnotics, opiates, oral hypoglycemics, insulin). Caution with levodopa, amantadine, and with drugs metabolized by CYP2D6 including tricyclic antidepressants, SSRIs, antipsychotics, β-blockers, Class 1C antiarrhythmics; consider dose reduction. May cause false (+) results in urine immunoassay tests for amphetamine.
Dry mouth, nausea, insomnia, dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, anorexia, urinary frequency, rash (may be serious, eg, Stevens-Johnson syndrome); hypertension, neuropsychiatric events.
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