DOSAGE AND ADMINISTRATION
General Dosing Considerations
It is particularly important to administer WELLBUTRIN in a manner most likely to minimize the risk of seizure (see WARNINGS). Increases in dose should not exceed 100 mg/day in a 3-day period. 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.
No single dose of WELLBUTRIN should exceed 150 mg. WELLBUTRIN should be administered 3 times daily, preferably with at least 6 hours between successive doses.
Usual Dosage for Adults
The usual adult dose is 300 mg/day, given 3 times daily. Dosing should begin at 200 mg/day, given as 100 mg twice daily. Based on clinical response, this dose may be increased to 300 mg/day, given as 100 mg 3 times daily, no sooner than 3 days after beginning therapy (see Table 3).
Table 3. Dosing Regimen | | |
Number of Tablets
|
|
Treatment Day
|
Total Daily Dose
|
Tablet Strength
|
Morning
|
Midday
|
Evening
|
|
1
|
200 mg
|
100 mg
|
1
|
0
|
1
|
|
4
|
300 mg
|
100 mg
|
1
|
1
|
1
|
Increasing the Dosage Above 300 mg/Day
As with other antidepressants, the full antidepressant effect of WELLBUTRIN may not be evident until 4 weeks of treatment or longer. An increase in dosage, up to a maximum of 450 mg/day, given in divided doses of not more than 150 mg each, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 300 mg/day. Dosing above 300 mg/day may be accomplished using the 75- or 100-mg tablets. The 100-mg tablet must be administered 4 times daily with at least 4 hours between successive doses, in order not to exceed the limit of 150 mg in a single dose. WELLBUTRIN should be discontinued in patients who do not demonstrate an adequate response after an appropriate period of treatment at 450 mg/day.
Maintenance Treatment
The lowest dose that maintains remission is recommended. Although it is not known how long the patient should remain on WELLBUTRIN, it is generally recognized that acute episodes of depression require several months or longer of antidepressant drug treatment.
Dosage Adjustment for Patients with Impaired Hepatic Function
WELLBUTRIN should be used with extreme caution in patients with severe hepatic cirrhosis. The dose should not exceed 75 mg once a day in these patients. WELLBUTRIN 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 CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS).
Dosage Adjustment for Patients with Impaired Renal Function
WELLBUTRIN should be used with caution in patients with renal impairment and a reduced frequency and/or dose should be considered (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
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