Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB)
QPharma Inc
SERTRALINE HYDROCHLORIDE
SERTRALINE 50 mg
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)]. Risk Summary Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth d
Sertraline hydrochloride tablets, USP having functional scoring containing sertraline hydrochloride equivalent to 50 mg of sertraline, are supplied as. 50 mg: light blue to blue colored, round, biconvex, film coated tablets, debossed with “S2” on one side and breakline on other side. NDC 42708-092-30 Bottles of 30’s count with child-resistant closure Store sertraline hydrochloride 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].
Abbreviated New Drug Application
QPharma Inc ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 5/2023 Dispense with Medication Guide available at www.accordhealthcare.us/medication-guides Medication Guide Sertraline Hydrochloride Tablets (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 actionsin 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 inc Leggi il documento completo
SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED QPHARMA 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) INDICATIONS AND USAGE Sertraline is 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) 50 mg per day (ages ≥ 13) 200 mg per day 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 dosing 50 mg per day during luteal phase only 100 mg per day during luteal phase only If inadequate response to starting dosage, titrate in 25 mg 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 tablets, reduce dose gradually ( 2.6, 5.4) DOSAGE FORMS AND STRENGTHS Tablets: 25 mg, 50 mg and 100 mg ( 3) CONTRAINDICATIONS Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs Leggi il documento completo