Sertraline Hydrochloride

SERTRALINE HYDROCHLORIDE

Manufacturer: Northwind Pharmaceuticals

Score: 144.0

Quick Summary

Sertraline hydrochloride is an SSRI used for the treatment of major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder (PD), posttraumatic stress disorder (PTSD), social anxiety disorder (SAD), and premenstrual dysphoric disorder (PMDD). Key clinical findings indicate its efficacy in these conditions, but important safety information includes warnings about suicidal thoughts and behaviors, serotonin syndrome, and increased risk of bleeding. The initial dosing and titration for adults vary by condition, and dose adjustments may be necessary for patients with hepatic impairment. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use, with specific recommendations and precautions for each group.

Key Clinical Findings and Indications

Treatment of major depressive disorder (MDD)
Treatment of obsessive-compulsive disorder (OCD)
Treatment of panic disorder (PD)
Treatment of posttraumatic stress disorder (PTSD)
Treatment of social anxiety disorder (SAD)
Treatment of premenstrual dysphoric disorder (PMDD)

Important Safety Information

Warning

Suicidal thoughts and behaviors, serotonin syndrome, and increased risk of bleeding

Contraindications

Concomitant use of MAOIs
Concomitant use of pimozide
Known hypersensitivity to sertraline

Adverse Reactions

Nausea
Diarrhea
Tremor
Dyspepsia
Decreased appetite
Hyperhidrosis
Ejaculation failure
Decreased libido

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for patients with hepatic impairment

MDD, OCD, PD, PTSD, SAD

Adult Dose

50 mg per day, with increases of 25-50 mg per day as needed

Pediatric Dose

25 mg per day for OCD (ages 6-12), 50 mg per day for OCD (ages 13-17)

PMDD

Adult Dose

50 mg per day, with increases of 50 mg per day as needed

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Use during pregnancy may increase risk of persistent pulmonary hypertension of the newborn
Use during pregnancy may increase risk of neonatal complications

Nursing Mothers

Sertraline is excreted in human breast milk
Caution should be exercised when administering sertraline to nursing women

Pediatric Use

Safety and efficacy established for OCD in pediatric patients aged 6-17
Not established for other indications in pediatric patients

Geriatric Use

No overall differences in safety or effectiveness observed between geriatric and younger patients
Dose selection should be conservative, starting at the low end of the dosing range

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