Aplenzin Dosage

Generic name: bupropion hydrobromide
Dosage form: tablet, extended release

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Administration Instructions

To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions (5.3)].

APLENZIN should be swallowed whole and not crushed, divided, or chewed. APLENZIN should be administered in the morning and may be taken with or without regard to meals.

Equivalent Daily Doses of APLENZIN (Bupropion hydrobromide) and Bupropion hydrochloride

See Table 1 for equivalent daily doses of APLENZIN (bupropion hydrobromide) and bupropion hydrochloride.

Table 1: Equivalent Daily Doses of APLENZIN (Bupropion hydrobromide) and Bupropion hydrochloride
APLENZIN (bupropion hydrobromide) Bupropion hydrochloride

522 mg

450 mg

348 mg

300 mg

174 mg

150 mg

Dosage for Major Depressive Disorder (MDD)

The recommended starting dose for MDD is 174 mg once daily in the morning. After 4 days of dosing, the dose may be increased to the target dose of 348 mg once daily in the morning.

It is generally agreed that acute episodes of depression require several months or longer of antidepressant treatment beyond the response in the acute episode. It is unknown whether the APLENZIN dose needed for maintenance treatment is identical to the dose that provided an initial response. Periodically reassess the need for maintenance treatment and the appropriate dose for such treatment.

Dosage for Seasonal Affective Disorder (SAD)

The recommended starting dose for SAD is 174 mg once daily. After 7 days of dosing, the dose may be increased to the target dose of 348 mg once daily in the morning. Doses above 300 mg of bupropion HCl extended-release (equivalent to APLENZIN 348 mg) were not assessed in the SAD trials.

For the prevention of seasonal MDD episodes associated with SAD, initiate APLENZIN in the autumn, prior to the onset of depressive symptoms. Continue treatment through the winter season. Taper and discontinue APLENZIN in early spring. For patients treated with 348 mg per day, decrease the dose to 150 mg once daily before discontinuing APLENZIN. Individualize the timing of initiation and duration of treatment should be individualized, based on the patient’s historical pattern of seasonal MDD episodes.

To Discontinue APLENZIN, Taper the Dose

When discontinuing treatment in patients treated with APLENZIN 348 mg once daily, decrease the dose to 174 mg once daily prior to discontinuation.

Dosage Adjustment for Patients with Impaired Hepatic Function

For patients with severe hepatic impairment, the recommended initial and maximum dose is 174 mg every other day [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

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