Nefazodone Hydrochloride

NEFAZODONE HYDROCHLORIDE

Manufacturer: Teva Pharmaceuticals USA, Inc.

Score: 144.0

Quick Summary

Nefazodone hydrochloride is an antidepressant used for the treatment of depression. The recommended starting dose is 200 mg/day, administered in two divided doses, with increments of 100 mg/day to 200 mg/day at intervals of no less than 1 week. Nefazodone has several important safety considerations, including a warning for increased risk of suicidal thinking and behavior in children, adolescents, and young adults, as well as the risk of liver failure. Contraindications include coadministration with terfenadine, astemizole, cisapride, or pimozide, and patients with a history of liver injury. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Treatment of depression
Efficacy established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients

Important Safety Information

Warning

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults, as well as the risk of liver failure

Contraindications

Coadministration with terfenadine, astemizole, cisapride, or pimozide
Patients with a history of liver injury

Adverse Reactions

Somnolence
Dry mouth
Nausea
Dizziness
Constipation
Asthenia
Lightheadedness
Blurred vision
Confusion
Abnormal vision

Dosing Recommendations

General Guidance

Dose adjustments should be made on the basis of clinical response

Depression

Adult Dose

200 mg/day, administered in two divided doses, with increments of 100 mg/day to 200 mg/day at intervals of no less than 1 week

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Category C
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus

Nursing Mothers

Caution should be exercised when nefazodone is administered to a nursing woman

Pediatric Use

Safety and effectiveness in the pediatric population have not been established
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults