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Aplenzin (Bupropion Hydrobromide) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Aplenzin™ (bupropion hydrobromide extended-release tablets) is indicated for the treatment of major depressive disorder.

The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) [see CLINICAL STUDIES ].

A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.

The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion [see CLINICAL STUDIES ]. Nevertheless, the physician who elects to use Aplenzin for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

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.

Initial Treatment

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.

Maintenance Treatment

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 and 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 and 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.

HOW SUPPLIED/STORAGE AND HANDLING

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 (NDC xxxxx-xxx-xx) and 90 tablets (NDC xxxxx-xxx-xx).

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 (NDC xxxxx-xxx-xx) and 90 tablets (NDC xxxxx-xxx-xx).

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 (NDC xxxxx-xxx-xx) and 90 tablets (NDC xxxxx-xxx-xx).

Store at 25C (77F); excursions permitted to 15-30C (59-86F) [see USP Controlled Room Temperature].

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