Wellbutrin XL NDA 21-515

698 tolerated, an increase to the 300-mg/day target dose, given as once daily, may be made as early

699 as day 4 of dosing. There should be an interval of at least 24 hours between successive doses.

700 Increasing the Dosage Above 300 mg/day: As with other antidepressants, the full

701 antidepressant effect of WELLBUTRIN XL Tablets may not be evident until 4 weeks

702 of treatment of longer. An increase in dosage to the maximum of 450 mg/day, given as a single

703 dose, may be considered for patients in whom no clinical improvement is noted after several

704 weeks of treatment at 300 mg/day.

705 Switching Patients From WELLBUTRIN Tablets or from WELLBUTRIN SR

706 Sustained-Release Tablets: When switching patients from WELLBUTRIN Tablets to

707 WELLBUTRIN XL or from WELLBUTRIN SR Sustained-Release Tablets to

708 WELLBUTRIN XL, give the same total daily dose when possible. Patients who are currently

709 being treated with WELLBUTRIN Tablets at 300 mg/day (for example, 100 mg 3 times a day)

710 may be switched to WELLBUTRIN XL 300 mg once daily. Patients who are currently being

711 treated with WELLBUTRIN SR Sustained-Released Tablets at 300 mg/day (for example 150 mg

712 twice daily) may be switched to WELLBUTRIN XL 300 mg once daily.

713 Maintenance Treatment: It is generally agreed that acute episodes of depression require

714 several months or longer of sustained pharmacological therapy beyond response to the acute

715 episode. It is unknown whether or not the dose of WELLBUTRIN XL needed for maintenance.

716 Treatment is identical to the dose needed to achieve an initial response. Patients should be

717 Periodically reassessed to determine the need for maintenance treatment and the appropriate dose

718 For such treatment.

719 Dosage Adjustment for Patients With Impaired Hepatic Function:

720 WELLBUTRIN XL should be used with extreme caution in patients with severe hepatic

721 cirrhosis. The dose should not exceed 150 mg every other day in these patients.

722 WELLBUTRIN XL should be used with caution in patients with hepatic impairment (including

723 mild to moderate hepatic cirrhosis) and a reduced frequency and/or dose should be considered in

724 patients with mild to moderate hepatic cirrhosis (see CLINICAL PHARMACOLOGY,

725 WARNING, and PRECAUTIONS).

726 Dosage Adjustment For Patients With Impaired Renal Function: WELLBUTRIN XL

727 should be used with caution in patients with renal impairment and a reduced frequency and/or

728 dose should be considered (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

729 HOW SUPPLIED

730 WELLBUTRIN XL Extended-Release Tablets, 150 mg of bupropion hydrochloride, are

731 creamy-white to pale yellow, round, tablets printed with “WELLBUTRIN XL 150” in bottles

732 30 tablets (NDC 0173-0730-01).

733 WELLBUTRIN XL Extended-Release Tablets, 300 mg of bupropion hydrochloride, are

734 creamy-white to pale yellow, round, tablets printed with “WELLBUTRIN XL 300” in bottles of

735 30 tablets (NDC 0173-0731-01).