Sertraline Hydrochloride (2 brand names, 3 dosage forms, 1 route)
Available dosage forms: CAPSULE, TABLET, CONCENTRATE.
Routes of administration: ORAL.
Brand Names
- SERTRALINE HYDROCHLORIDE
- ZOLOFT
Boxed Warning
Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [See Warnings and Precautions ( 5.1)].
Indications and Usage
Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies ( 14)] : Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD)
Contraindications
Sertraline hydrochloride tablets are contraindicated in patients: Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [See Warnings and Precautions ( 5.2), Drug Interactions ( 7.1)] . Taking pimozide [See Drug Interactions ( 7.1)]. With known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [See Adverse Reactions ( 6.1, 6.2)] .
Adverse Reactions
The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity reactions to sertraline [See Contraindications ( 4)] QTc prolongation and ventricular arrhythmias when taken with pimozide [See Contraindications ( 4) , Clinical Pharmacology ( 12.2)] ] Suicidal thoughts and behaviors [See Warnings and Precautions ( 5.1)] Serotonin syndrome [See Contraindications ( 4), Warnings and Precautions ( 5.2), Drug Interactions ( 7.1)] Increased risk of bleeding [See Warnings and Precautions ( 5.3)] Activation of mania/hypomania [See Warnings and Precautions ( 5.4)] Discontinuation syndrome [See Warnings and Precautions ( 5.5)] Seizures [See Warnings and Precautions ( 5.6)] Angle-closure glaucoma [See Warnings and Precautions ( 5.7)] Hyponatremia [See Warnings and Precautions ( 5.8)] Sexual Dysfunction [See Warnings and Precautions ( 5.11)]
Mechanism of Action
Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT).
Overdosage
The following have been reported with sertraline tablet overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol. Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk). Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a sertraline overdose. Consider contacting a Poison Center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.