Sertraline Hcl
Generic Name: sertraline hcl
Brand Names:
Sertraline Hcl
Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride.
Overview
Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride.
Uses
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)
Dosage
2.1 Dosage in Patients with MDD, OCD, PD, PTSD, and SAD The recommended initial dosage and maximum sertraline hydrochloride dosage in patients with MDD, OCD, PD, PTSD, and SAD are displayed in Table 1 below. A dosage of 25 mg or 50 mg per day is the initial therapeutic dosage. For adults and pediatric patients, subsequent dosages may be increased in case of an inadequate response in 25 to 50 mg per day increments once a week, depending on tolerability, up to a maximum of 200 mg per day. Given the 24-hour elimination half-life of sertraline hydrochloride, the recommended interval between dose changes is one week.
Side Effects
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 WA...
Interactions
7.1 Clinically Significant Drug Interactions Table 5 includes clinically significant drug interactions with sertraline hydrochloride [See CLINICAL PHARMACOLOGY (12.3)]. Table 5. Clinically-Significant Drug Interactions with Sertraline Hydrochloride Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of SSRIs including sertraline hydrochloride and MAOIs increases the risk of serotonin syndrome. Intervention: Sertraline hydrochloride is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [See DOSAGE AND ADMINISTRATION (2.5), CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.2)].
Warnings
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS 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)]. 5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 2. No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide. 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)].
Storage
Store Sertraline Hydrochloride Tablets USP at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [See USP Controlled Room Temperature].
Frequently Asked Questions
What is Sertraline Hcl used for?▼
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)
What are the side effects of Sertraline Hcl?▼
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 WA...
What are the important warnings for Sertraline Hcl?▼
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS 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)]. 5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 2. No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide. 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)].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.