WELLBUTRIN SR Sustained‑release tablet (2020)

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GlaxoSmithKline LLC

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1. Indications and Usage

WELLBUTRIN SR (bupropion hydrochloride) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment ...

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 SR tablets should be swallowed whole and not crushed, ...

3. Dosage Forms and Strengths

100 mg – blue, round, biconvex, film‑coated, sustained-release tablets printed with WELLBUTRIN SR 100. 150 mg – purple, round, biconvex, film‑coated, sustained-release tablets printed with WELLBUTRIN SR ...

4. Contraindications

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

5. Warnings and Precautions

5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Patients with MDD, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal thoughts and behaviors in adolescents and young adults [see Boxed Warning, 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 with rates in the clinical trials of ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of WELLBUTRIN SR and are not described elsewhere in the label. Because these reactions are reported voluntarily from a population ...

7. Drug Interactions

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

8.1. Pregnancy

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

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 [see Boxed Warning, Warnings and Precautions (5.1)].

8.5. Geriatric Use

Of the approximately 6,000 subjects who participated in clinical trials with bupropion sustained-release tablets (depression and smoking cessation trials), 275 were aged ≥65 years and 47 were aged ≥75 ...

8.6. Renal Impairment

Consider a reduced dose and/or dosing frequency of WELLBUTRIN SR in patients with renal impairment (Glomerular Filtration Rate: less than 90 mL/min). Bupropion and its metabolites are cleared renally and ...

8.7. Hepatic Impairment

In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose of WELLBUTRIN SR is 100 mg/day or 150 mg every other day. In patients with mild hepatic impairment (Child-Pugh ...

9.1. Controlled Substance

Bupropion is not a controlled substance.

9.2. Abuse

Humans Controlled clinical trials conducted in normal volunteers, in subjects with a history of multiple drug abuse, and in depressed subjects showed some increase in motor activity and agitation/excitement, ...

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 SR (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re‑uptake inhibitor, or other known antidepressant ...

12.1. Mechanism of Action

The exact mechanism of the antidepressant action of bupropion is not known but is presumed to be related to noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the ...

12.3. Pharmacokinetics

Bupropion is a racemic mixture. The pharmacological activity and pharmacokinetics of the individual enantiomers have not been studied. The mean elimination half‑life (±SD) of bupropion after chronic dosing ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Lifetime carcinogenicity studies were performed in rats and mice at bupropion doses up to 300 and 150 mg/kg/day, respectively. These doses are approximately 7 and 2 times the MRHD, respectively, on a mg/m² ...

14. Clinical Studies

The efficacy of the immediate‑release formulation of bupropion in the treatment of major depressive disorder was established in two 4‑week, placebo‑controlled trials in adult inpatients with MDD (Trials ...

16.1. How Supplied

WELLBUTRIN SR sustained‑release tablets, 100 mg of bupropion hydrochloride, are blue, round, biconvex, film‑coated tablets printed with WELLBUTRIN SR 100 in bottles of 60 (NDC 0173-0947-55) tablets. WELLBUTRIN ...

16.2. Storage and Handling

Store at room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Instruct patients, their families, and/or their caregivers to be alert to the emergence ...

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 ...