WELLBUTRINXL XL

WELLBUTRINXL XL- bupropion hydrochloride tablet, extended release
REMEDYREPACK INC.

SPL UNCLASSIFIED

WELLBUTRIN XL® (bupropion hydrobromide) Extended-Release Tablets

Boxed Warning section

SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressants use in subjects aged 65 and older [see Warnings and Precautions ( 5.1 ) ].

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions ( 5.1 ) ].

NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION

Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation [see Warnings and Precautions ( 5.2 ) ]. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although WELLBUTRIN XL is not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur [see Warnings and Precautions ( 5.2 ) ].

INDICATIONS & USAGE

WELLBUTRIN XL is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. (1)

WELLBUTRIN XL® (bupropion hydrochloride extended-release tablets) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).

The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14.1)].

WELLBUTRIN XL is indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD).

The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see Clinical Studies (14.2)].

DOSAGE & ADMINISTRATION

General:

•Increase dose gradually to reduce seizure risk. (2.1, 5.3)

•Periodically reassess the dose and need for maintenance treatment. (2.2)

Major Depressive Disorder

•Starting dose: 150 mg/day once daily. Usual target dose: 300 mg once daily (2.2)

•After 4 days, may increase the dose to 300 mg once daily. (2.2)

Seasonal Affective Disorder

•Initiative treatment in the autumn prior to onset of seasonal depressive symptoms. (2.3)

•Starting dose: 150 mg once daily. Usual target dose: 300 mg once daily. (2.3)

•After one week, may increase the dose to 300 mg once daily. (2.3)

•Continue treatment through the winter season. (2.3)

Hepatic Impairment

•Moderate to severe hepatic impairment: 150 mg every other day (2.6)

•Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. (2.6, 8.7)

Renal Impairment

•Consider reducing the dose and/or frequency of dosing. (2.7, 8.6)

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

WELLBUTRIN XL should be swallowed whole and not crushed, divided, or chewed.

WELLBUTRIN XL should be administered in the morning and may be taken with or without food.

The recommended starting dose for MDD is 150 mg once daily in the morning. After 4 days of dosing, the dose may be increased to the target dose of 300 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 WELLBUTRIN XL 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.

The recommended starting dose for SAD is 150 mg once daily. After 7 days of dosing, the dose may be increased to the target dose of 300 mg once daily in the morning. Doses above 300 mg of bupropion HCl extended-release were not assessed in the SAD trials.

For the prevention of seasonal MDD episodes associated with SAD, initiate WELLBUTRIN XL in the autumn, prior to the onset of depressive symptoms. Continue treatment through the winter season. Taper and discontinue WELLBUTRIN XL in early spring. For patients treated with 300 mg per day, decrease the dose to 150 mg once daily before discontinuing WELLBUTRIN XL. Individualize the timing of initiation and duration of treatment should be individualized, based on the patient’s historical pattern of seasonal MDD episodes.

When switching patients from WELLBUTRIN Tablets to WELLBUTRIN XL or from WELLBUTRIN SR Sustained-Release Tablets to WELLBUTRIN XL, give the same total daily dose when possible.

When discontinuing treatment in patients treated with WELLBUTRIN XL 300 mg once daily, decrease the dose to 150 mg once daily prior to discontinuation.

In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose is 150 mg every other day. In patients with mild hepatic impairment (Child-Pugh score: 5 to 6), consider reducing the dose and/or frequency of dosing [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ].

Consider reducing the dose and/or frequency of WELLBUTRIN in patients with renal impairment (Glomerular Filtration Rate <90 mL/min) [see Use in Specific Populations (8.6)and Clinical Pharmacology (12.3)].

At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with WELLBUTRIN XL. Conversely, at least 14 days should be allowed after stopping WELLBUTRIN XL before starting an MAOI antidepressant [see Contraindications (4) and Drug Interactions (7.6) ].

Do not start WELLBUTRIN XL in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue. Drug interactions can increase risk of hypertensive reactions. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered [see Contraindications (4) ].

In some cases, a patient already receiving therapy with WELLBUTRIN XL may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of hypertensive reactions in a particular patient, WELLBUTRIN XL should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with WELLBUTRIN XL may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue.

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with WELLBUTRIN XL is unclear. The clinician should, nevertheless, be aware of the possibility of a drug interaction with such use [see Contraindications (4) and Drug Interactions (7.6) ].

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