国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB)
Preferred Pharmaceuticals Inc.
SERTRALINE HYDROCHLORIDE
SERTRALINE 100 mg
ORAL
PRESCRIPTION DRUG
Sertraline tablets are indicated for the treatment of the following [See Clinical Studies (14)] : Sertraline is contraindicated in patients: Risk Summary Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations. Some studies have reported increases for specific major birth defects; however, these study results are inconclusive [See Data] . There are clinical considerations regarding neonates exposed to SSRIs and SNRIs, including sertraline, during the third trimester of pregnancy [See Clinical Considerations]. Although no teratogenicity was observed in animal reproduction studies, delayed fetal ossification was observed when sertraline was administered during the period of organogenesis at doses less than the maximum recommended human dose (MRHD) in rats and doses 3.1 times the MRHD in rabbits on a mg/m2 basis in adolescen
Sertraline 100 mg Tablets: Light Yellow film coated Modified oval biconvex tablets debossed with I on the left side of bisect and G on the right side of bisect on one side and “214” on other NDC 68788-6919-2 Bottles of 28 NDC 68788-6919-3 Bottles of 30 NDC 68788-6919-6 Bottles of 60 NDC 68788-6919-9 Bottles of 90 NDC 68788-6919-1 Bottles of 100 NDC 68788-6919-8 Bottles of 120 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET Preferred Pharmaceuticals Inc. ---------- MEDICATION GUIDE Sertraline Tablets, USP (SIR-trah-leen) What is the most important information I should know about sertraline tablets? Sertraline 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 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 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: o attempts to commit suicide o acting on dangerous impulses o acting aggressive or violent o thoughts about suicide or dying o new or worse depression o new or worse anxiety or panic attacks o feeling agitated, restless, angry or irritable o trouble sleeping o an increase in activity or talking more than what is normal for you o other unusual changes in behavior or mood 2. Serotonin Syndrome. This condition can be life-threatening and symptoms may include: • agitation, hallucinations, coma, or other changes in mental status • nausea, vomiting, or diarrhea • racing heartbeat, high or low blood pressure • sweating or fever • coordination problem 完全なドキュメントを読む
SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET PREFERRED PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SERTRALINE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SERTRALINE TABLETS. SERTRALINE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1991 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • INDICATIONS AND USAGE Sertraline tablets are selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1): • • • • • • 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 • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • • 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) Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Post-traumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) 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 (2.3) Moderate or severe: Not recommended (2.4) When discontinuing sertraline, reduce dose gradually (2.5, 5.4) Tablets: 25 mg, 50 mg and 100 mg (3) Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOI 完全なドキュメントを読む