Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB)
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
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) 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) ]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage patients to enroll by calling the National Pregnancy
Sertraline Hydrochloride Tablets USP, 25 mg are available as light green, film coated, elliptical shaped tablets, scored on one side of tablet and debossed with "757" on the other side, packaged in bottles of 30 (NDC 23155-757-03), 90 (NDC 23155-757-09) and 500 tablets (NDC 23155-757-05). Sertraline Hydrochloride Tablets USP, 50 mg are available as light blue, film coated, elliptical shaped tablets, scored on one side of tablet and debossed with "758" on the other side, packaged in bottles of 30 (NDC 23155-758-03), 90 (NDC 23155-758-09), 500 tablets (NDC 23155-758-05), and 5000 tablets (NDC 23155-758-69). Sertraline Hydrochloride Tablets USP, 100 mg are available as light yellow, film coated, elliptical shaped tablets, scored on one side of tablet and debossed with "759" on the other side, packaged in bottles of 30 (NDC 23155-759-03), 90 (NDC 23155-759-09) and 500 tablets (NDC 23155-759-05). Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
SERTRALINE- SERTRALINE TABLET, FILM COATED Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. ---------- Dispense with Medication Guide available at: www.avetpharma.com/product. Medication Guide Sertraline Hydrochloride Tablets, USP (ser' tra leen hye'' droe klor' ide) What is the most important information I should know about sertraline hydrochloride tablets? Sertraline hydrochloride tablets and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency. 1. Suicidal thoughts or actions: • Sertraline hydrochloride tablets and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. • Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. • Pay particular attention to such changes when sertraline hydrochloride tablets are started or when the dose is changed. • Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: • attempts to commit suicide • acting aggressive or violent • new or worse depression • feeling agitated, restless, angry or irritable • an increase in activity or talking more than what is normal for you • acting on dangerous impulses • thoughts about suicide or dying • new or worse anxiety or panic attacks • trouble sleeping • other unusual changes in behavior or mood 2. Serotonin Syndrome. This condition can be life-threatening and symptoms may include: Soma hati kamili
SERTRALINE- SERTRALINE TABLET, FILM COATED HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SERTRALINE HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SERTRALINE HYDROCHLORIDE TABLETS. SERTRALINE HYDROCHLORIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1991 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients (5.1) • Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors (5.1) RECENT MAJOR CHANGES Warnings and Precautions (5.2, 5.3) 08/2023 INDICATIONS AND USAGE Sertraline hydrochloride tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1): • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD) DOSAGE AND ADMINISTRATION INDICATION STARTING DOSAGE MAXIMUM DOSAGE MDD (2.1) 50 mg per day 200 mg per day OCD (2.1) 25 mg per day (ages 6 to 12) 200 mg per day 50 mg per day (ages ≥ 13) PD, PTSD, SAD (2.1) 25 mg per day 200 mg per day PMDD (2.2) continuous dosing 50 mg per day 150 mg per day PMDD (2.2) intermittent dosing50 mg per day during luteal phase only100 mg per day during luteal phase only • If inadequate response to starting dosage, titrate in 25 to 50 mg per day increments once weekly in MDD,OCD, PD,PTSD,and SAD (2.1) • See Full Prescribing Information for titration in PMDD (2.2) • Hepatic impairment: Mild: Recommended starting and maximum dosage is half recommended dosage (2.4) Moderate or severe: Not recommended (2.4) • When discontinuing sertraline hydrochloride, reduce dose gradually (2.6, 5.4) DOSAGE FORMS AND STRENGTHS Tablets: 25 mg, 50 mg Soma hati kamili