Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB)
PD-Rx Pharmaceuticals, Inc.
SERTRALINE HYDROCHLORIDE
SERTRALINE 50 mg
ORAL
PRESCRIPTION DRUG
ZOLOFT is 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) ZOLOFT is 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)]. In addition to the contraindications for all ZOLOFT formulations listed above, ZOLOFT ora
ZOLOFT 50 mg tablets: light blue, film-coated, capsular-shaped tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "50 mg" 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].
New Drug Application
PD-Rx Pharmaceuticals, Inc. ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration Medication Guide ZOLOFT (ZOH-loft) (sertraline hydrochloride) Tablets and Oral Solution What is the most important information I should know about ZOLOFT? ZOLOFT 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. • Suicidal thoughts or actions: • ZOLOFT 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 ZOLOFT is 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 • Serotonin Syndrome. This condition can be life-threatening and symptoms may include: • agitation, hallucinations, coma, or other changes in mental status • racing heartbeat, high or low blood pressure • coordination problems or muscle twitching (overa Leggi il documento completo
ZOLOFT- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED PD-RX PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZOLOFT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLOFT. ZOLOFT (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, Sexual Dysfunction ( 5.11) 9/2021 INDICATIONS AND USAGE ZOLOFT is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1): Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Post-traumatic 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 6–12) 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 25–50 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 ZOLOFT, reduce dose gradually ( 2.6, 5.4) Oral solution: Must be diluted before administration ( 2.7) DOSAGE FORMS AND STRENGTHS Tablets: 25 mg, 50 mg and 100 mg ( 3) Oral solution: 20 mg/mL ( 3) CONTRAINDICATIONS Con Leggi il documento completo