Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB)
Aphena Pharma Solutions - Tennessee, LLC
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 defect risk compared to the background rate for major birth defects in comparator
Sertraline Hydrochloride Tablets USP, 25 mg are green colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘6’ on the other side. NDC 16714-611-01 Bottles of 30 NDC 16714-611-02 Bottles of 60 NDC 16714-611-03 Bottles of 90 NDC 16714-611-04 Bottles of 100 NDC 16714-611-05 Bottles of 500 NDC 16714-611-06 Bottles of 1,000 Sertraline Hydrochloride Tablets USP, 50 mg are blue colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘7’ on the other side. NDC 16714-612-01 Bottles of 30 NDC 16714-612-02 Bottles of 60 NDC 16714-612-03 Bottles of 90 NDC 16714-612-04 Bottles of 100 NDC 16714-612-05 Bottles of 500 NDC 16714-612-06 Bottles of 1,000 Sertraline Hydrochloride Tablets USP, 100 mg are yellow colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘8’ on the other side. NDC 16714-613-01 Bottles of 30 NDC 16714-613-02 Bottles of 60 NDC 16714-613-03 Bottles of 90 NDC 16714-613-04 Bottles of 100 NDC 16714-613-05 Bottles of 500 NDC 16714-613-06 Bottles of 1,000 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
SERTRALINE HYDROCHLORIDE - SERTRALINE HYDROCHLORIDE TABLET, FILM COATED Aphena Pharma Solutions - Tennessee, LLC ---------- 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 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 2. Serotonin Syndrome. This condition can be life-threatening and symptoms may include: • agitation, hallucinations, coma, or other changes in mental sta Baca dokumen lengkap
SERTRALINE HYDROCHLORIDE - SERTRALINE HYDROCHLORIDE TABLET, FILM COATED APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- 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, QTc Prolongation (5.10) 12/2017 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) 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 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 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 Baca dokumen lengkap