Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB)
St. Mary's Medical Park Pharmacy
SERTRALINE HYDROCHLORIDE
SERTRALINE 25 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
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 60760-611-30 BOTTLES OF 30 Store at 20º to 25 ºC (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 St. Mary's Medical Park Pharmacy ---------- 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 on dangerous impulses • acting aggressive or violent • thoughts about suicide or dying • new or worse depression • new or worse anxiety or panic attacks • feeling agitated, restless, angry or irritable • trouble sleeping • an increase in activity or talking more than what is normal for you • 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 • r Prečítajte si celý dokument
SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED ST. MARY'S MEDICAL PARK PHARMACY ---------- 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 Setraline 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 ( 2.3) Moderate or severe: Not recommended ( 2.4) When discontinuing sertraline hydrochloride tablets, reduce dose gradually ( 2.5, 5.4) DOSAGE FORMS AND STRENGTHS Tablets: 25 mg, 50 mg and 100 mg ( 3) CONTRAINDICATIONS Concomitant use of monoamine oxidase inhibitors (MAOI Prečítajte si celý dokument