DOSAGE AND ADMINISTRATION
General Dosing Considerations
It is particularly important to administer Aplenzin Tablets in a manner most likely to minimize the risk of seizure [see
WARNINGS AND PRECAUTIONS: Seizures
]. Gradual escalation in dosage is also important if agitation, motor restlessness, and insomnia, often seen during the initial days of treatment, are to be minimized. If necessary, these effects may be managed by temporary reduction of dose or the short-term administration of an intermediate to long-acting sedative hypnotic. A sedative hypnotic usually is not required beyond the first week of treatment. Insomnia may also be minimized by avoiding bedtime doses. If distressing, untoward effects supervene, dose escalation should be stopped. Aplenzin should be swallowed whole and not crushed, divided, or chewed. Aplenzin may be taken without regard to meals.
The usual adult target dose for Aplenzin Tablets is 348 mg/day (equivalent to 300 mg/day bupropion HCl), given once daily in the morning. Dosing with Aplenzin Tablets should begin at 174 mg/day (equivalent to 150 mg/day bupropion HCl) given as a single daily dose in the morning. If the 174 mg initial dose is adequately tolerated, an increase to the 348 mg/day target dose, given as once daily, may be made as early as day 4 of dosing. There should be an interval of at least 24 hours between successive doses.
Increasing the Dosage Above 348 mg/day: As with other antidepressants, the full antidepressant effect of Aplenzin Tablets may not be evident until 4 weeks of treatment or longer. An increase in dosage to the maximum of 522 mg/day, given as a single dose, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 348 mg/day.
It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. It is unknown whether or not the dose of Aplenzin needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.
Switching Patients from WELLBUTRIN, WELLBUTRIN SR or WELLBUTRIN XL
When switching patients from WELLBUTRIN®, WELLBUTRIN SR® or WELLBUTRIN XL® Tablets to Aplenzin, give the equivalent total daily dose when possible (522 mg bupropion HBr are equivalent to 450 mg bupropion HCl; 348 mg bupropion HBr are equivalent to 300 mg bupropion HCl; 174 mg bupropion HBr are equivalent to 150 mg bupropion HCl). Patients who are currently being treated with WELLBUTRIN Tablets at 300 mg/day (for example, 100 mg 3 times a day) may be switched to Aplenzin 348 mg once daily. Patients who are currently being treated with WELLBUTRIN SR Sustained-Release Tablets at 300 mg/day (for example, 150 mg twice daily) may be switched to Aplenzin 348 mg once daily.
Dosage Adjustment for Patients With Impaired Hepatic Function
Aplenzin should be used with extreme caution in patients with severe hepatic cirrhosis. The dose should not exceed 174 mg every other day in these patients. Aplenzin should be used with caution in patients with hepatic impairment (including mild to moderate hepatic cirrhosis) and a reduced frequency and/or dose should be considered in patients with mild to moderate hepatic cirrhosis [see
WARNINGS AND PRECAUTIONS: Hepatic Impairment, USE IN SPECIFIC POPULATIONS: Hepatic Impairment
CLINICAL PHARMACOLOGY: Pharmacokinetics
Dosage Adjustment for Patients With Impaired Renal Function
Aplenzin should be used with caution in patients with renal impairment and a reduced frequency and/or dose should be considered [see
USE IN SPECIFIC POPULATIONS: Renal Impairment
CLINICAL PHARMACOLOGY: Pharmacokinetics
DOSAGE FORMS AND STRENGTHS
Aplenzin Extended-Release Tablets, 174 mg of bupropion hydrobromide, are white to off white, round tablets printed with "BR" over "174" in bottles of 30 tablets and 90 tablets.
Aplenzin Extended-Release Tablets, 348 mg of bupropion hydrobromide, are white to off white, round tablets printed with "BR" over "348" in bottles of 30 tablets and 90 tablets.
Aplenzin Extended-Release Tablets, 522 mg of bupropion hydrobromide, are white to off white, round tablets printed with "BR" over "522" in bottles of 30 tablets and 90 tablets.