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Wellbutrin XL

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Wellbutrin XL

Wellbutrin XL

INDICATIONS

Major Depressive Disorder

WELLBUTRIN XL (bupropion hydrochloride extended-release) 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 Trials).

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 Trials). Nevertheless, the physician who elects to use WELLBUTRIN XL (bupropion hydrochloride extended-release) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Seasonal Affective Disorder

WELLBUTRIN XL (bupropion hydrochloride extended-release) is indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder.

The efficacy of WELLBUTRIN XL (bupropion hydrochloride extended-release) for the prevention of seasonal major depressive episodes was established in 3 controlled trials of adult outpatients with a history of major depressive disorder with an autumn-winter seasonal pattern as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (see Clinical Trials).

Seasonal affective disorder is characterized by recurrent major depressive episodes, most commonly occurring during the autumn and/or winter months. Episodes may last up to 6 months in duration, typically beginning in the autumn and remitting in the springtime. Although patients with seasonal affective disorder may have depressive episodes during other times of the year, the diagnosis of seasonal affective disorder requires that the number of seasonal episodes substantially outnumber the number of nonseasonal episodes during the individual's lifetime.

DOSAGE AND ADMINISTRATION

General Dosing Considerations

It is particularly important to administer WELLBUTRIN XL (bupropion hydrochloride extended-release) in a manner most likely to minimize the risk of seizure (see WARNINGS). 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. WELLBUTRIN XL (bupropion hydrochloride extended-release) tablets should be swallowed whole and not crushed, divided, or chewed, as this may lead to an increased risk of adverse effects including seizures. WELLBUTRIN XL (bupropion hydrochloride extended-release) may be taken without regard to meals.

Major Depressive Disorder

Initial Treatment

The usual adult target dose for WELLBUTRIN XL (bupropion hydrochloride extended-release) is 300 mg/day, given once daily in the morning. Dosing with WELLBUTRIN XL (bupropion hydrochloride extended-release) should begin at 150 mg/day given as a single daily dose in the morning. If the 150-mg initial dose is adequately tolerated, an increase to the 300-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 300 mg/day

As with other antidepressants, the full antidepressant effect of WELLBUTRIN XL may not be evident until 4 weeks of treatment or longer. An increase in dosage to the maximum of 450 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 300 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 WELLBUTRIN XL (bupropion hydrochloride extended-release) 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.

Seasonal Affective Disorder

For the prevention of seasonal major depressive episodes associated with seasonal affective disorder, WELLBUTRIN XL (bupropion hydrochloride extended-release) should generally be initiated in the autumn prior to the onset of depressive symptoms. Treatment should continue through the winter season and should be tapered and discontinued in early spring. The timing of initiation and duration of treatment should be individualized based on the patient's historical pattern of seasonal major depressive episodes. Patients whose seasonal depressive episodes are infrequent or not associated with significant impairment should not generally be treated prophylactically.

Dosing with WELLBUTRIN XL (bupropion hydrochloride extended-release) should begin at 150 mg/day given as a single daily dose in the morning. If the 150-mg initial dose is adequately tolerated, the dose of WELLBUTRIN XL (bupropion hydrochloride extended-release) should be increased to the 300-mg/day dose after 1 week. If the 300mg dose is not adequately tolerated, the dose can be reduced to 150 mg/day. The usual adult target dose for WELLBUTRIN XL (bupropion hydrochloride extended-release) is 300 mg/day, given once daily in the morning.

For patients taking 300 mg/day during the autumn-winter season, the dose should be tapered to 150 mg/day for 2 weeks prior to discontinuation.

Doses of WELLBUTRIN XL (bupropion hydrochloride extended-release) above 300 mg/day have not been studied for the prevention of seasonal major depressive episodes.

Switching Patients from WELLBUTRIN Tablets or from WELLBUTRIN SR Sustained-Release Tablets

When switching patients from WELLBUTRIN Tablets to WELLBUTRIN XL (bupropion hydrochloride extended-release) or from WELLBUTRIN SR Sustained-Release Tablets to WELLBUTRIN XL (bupropion hydrochloride extended-release) , give the same total daily dose when possible. 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 WELLBUTRIN XL 300 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 WELLBUTRIN XL (bupropion hydrochloride extended-release) 300 mg once daily.

Dosage Adjustment for Patients With Impaired Hepatic Function

WELLBUTRIN XL (bupropion hydrochloride extended-release) should be used with extreme caution in patients with severe hepatic cirrhosis. The dose should not exceed 150 mg every other day in these patients. WELLBUTRIN XL (bupropion hydrochloride extended-release) 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 XL (bupropion hydrochloride extended-release) 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).

HOW SUPPLIED

WELLBUTRIN XL (bupropion hydrochloride extended-release) Extended-Release Tablets, 150 mg of bupropion hydrochloride, are creamy-white to pale yellow, round, tablets printed with “WELLBUTRIN XL (bupropion hydrochloride extended-release) 150” in bottles of 30 (NDC 64455-730-30) and 90 (NDC 64455-730-90).

WELLBUTRIN XL (bupropion hydrochloride extended-release) Extended-Release Tablets, 300 mg of bupropion hydrochloride, are creamy-white to pale yellow, round, tablets printed with “WELLBUTRIN XL (bupropion hydrochloride extended-release) 300” in bottles of 30 (NDC 64455-731-30).

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

Manufactured by: Biovail Corporation Mississauga, ON L5N 8M5, Canada. For: BTA Pharmaceuticals, Inc. (subsidiary of Biovail Corporation) Bridgewater, NJ 08807. Rev. 02/10.

Last reviewed on RxList: 1/24/2011
This monograph has been modified to include the generic and brand name in many instances.

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