WELLBUTRIN XL Extended-release tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US LLC

Λέξεις κλειδιά

0187-0730 0187-0731

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1. Indications and Usage

1.1 Major Depressive Disorder (MDD) Wellbutrin XL (bupropion hydrochloride extended-release) tablets is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and ...

2. Dosage and Administration

2.1 General Instructions for Use 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, ...

3. Dosage Forms and Strengths

Wellbutrin XL extended-release tablets, 150 mg of bupropion hydrochloride, are creamy-white to pale yellow, round tablets printed with Wellbutrin XL 150. Wellbutrin XL extended-release tablets, 300 mg ...

4. Contraindications

Wellbutrin XL is contraindicated in patients with seizure disorder. Wellbutrin XL is contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of ...

5. Warnings and Precautions

5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal thoughts and behaviors in children, adolescents, and young adults [see Warnings and Precautions ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Wellbutrin XL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Potential for Other Drugs to Affect Wellbutrin XL Bupropion is primarily metabolized to hydroxybupropion by CYP2B6. Therefore, the potential exists for drug interactions between Wellbutrin XL and drugs ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register ...

8.2. Lactation

Risk Summary Data from published literature report the presence of bupropion and its metabolites in human milk (see Data). There are no data on the effects of bupropion or its metabolites on milk ...

8.4. Pediatric Use

Safety and effectiveness in the pediatric population have not been established. When considering the use of Wellbutrin XL in a child or adolescent, balance the potential risks with the clinical need ...

8.5. Geriatric Use

Of the approximately 6000 patients who participated in clinical trials with bupropion hydrochloride sustained-release tablets (depression and smoking cessation studies), 275 were ≥65 years old and 47 were ...

8.6. Renal Impairment

Consider a reduced dose and/or dosing frequency of Wellbutrin XL in patients with renal impairment (glomerular filtration rate: <90 mL/min). Bupropion and its metabolites are cleared renally and may accumulate ...

8.7. Hepatic Impairment

In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum Wellbutrin XL dose is 150 mg every other day. In patients with mild hepatic impairment (Child-Pugh score: ...

9.1. Controlled Substance

Bupropion is not a controlled substance.

9.2. Abuse

Humans Controlled clinical studies of bupropion HCl immediate-release conducted in normal volunteers, in subjects with a history of multiple drug abuse, and in depressed patients demonstrated an increase ...

10. Overdosage

10.1 Human Overdose Experience Overdoses of up to 30 grams or more of bupropion have been reported. Seizure was reported in approximately one third of all cases. Other serious reactions reported with overdoses ...

11. Description

Wellbutrin XL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant ...

12.1. Mechanism of Action

The mechanism of action of bupropion is unknown, as is the case with other antidepressants. However, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms. Bupropion ...

12.3. Pharmacokinetics

Bupropion is a racemic mixture. The pharmacologic activity and pharmacokinetics of the individual enantiomers have not been studied. Following chronic dosing, the mean steady-state plasma concentration ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Lifetime carcinogenicity studies were performed in rats and mice at doses up to 300 and 150 mg/kg/day bupropion hydrochloride, respectively. These doses are approximately 7 and 2 times the maximum recommended ...

14. Clinical Studies

14.1 Major Depressive Disorder The efficacy of bupropion in the treatment of major depressive disorder was established with the immediate-release formulation of bupropion hydrochloride in two 4-week, placebo-controlled ...

16.1. How Supplied

Wellbutrin XL extended-release tablets are supplied as: NDC Strength Quantity Description 0187‑0730‑30 150 mg bottle of 30 tablets Creamy white to pale yellow round tablets imprinted with Wellbutrin ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Wellbutrin XL tablets may have an odor.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Wellbutrin ...

BOXED WARNING SECTION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and ...