Recommended Topic Related To:

Budeprion XL

"The U.S. Food and Drug Administration today approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.

Aurobindo Pharma Ltd., Dr. Reddy's La"...

Budeprion XL

Indications
Dosage
How Supplied

INDICATIONS

Major Depressive Disorder

BUDEPRION XL™ (bupropion hydrochloride 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 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 BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) 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 BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) 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. BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) should be swallowed whole and not crushed, divided, or chewed. BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) may be taken without regard to meals.

Major Depressive Disorder

Initial Treatment

The usual adult target dose for BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) is 300 mg/day, given once daily in the morning. Dosing with BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) 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 BUDEPRION 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 BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) 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 Bupropion Hydrochloride Tablets or from Bupropion Hydrochloride Sustained-Release Tablets

When switching patients from bupropion hydrochloride tablets to BUDEPRION XL™ or from bupropion hydrochloride sustained-release tablets to BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) , give the same total daily dose when possible. Patients who are currently being treated with bupropion hydrochloride tablets at 300 mg/day (for example, 100 mg 3 times a day) may be switched to BUDEPRION XL (bupropion hydrochloride extended-release tablets) ™ 300 mg once daily. Patients who are currently being treated with bupropion hydrochloride sustained-release tablets at 300 mg/day (for example, 150 mg twice daily) may be switched to BUDEPRION XL™ 300 mg once daily.

Dosage Adjustment for Patients With Impaired Hepatic Function

BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) 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. BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) 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

BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) 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

BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) 150 mg, are white to off-white, round, tablets printed with “A101”. They are supplied as follows:

Bottles of  30 NDC # 0093-5350-56
Bottles of 500 NDC # 0093-5350-05

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

* The following are registered trademarks of their respective manufacturers: ZYBAN® , WELLBUTRIN® , and WELLBUTRIN SR® /GlaxoSmithKline.
Manufactured by: Anchen Pharmaceuticals Inc., Irvine, CA 92618. Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960. Rev. B 8/2007. FDA revision date: n/a

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Emotional Wellness

Get tips on therapy and treatment.