Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB)
Greenstone LLC
SERTRALINE HYDROCHLORIDE
SERTRALINE 25 mg
ORAL
PRESCRIPTION DRUG
Sertraline hydrochloride is indicated for the treatment of the following [See Clinical Studies (14)] : Sertraline hydrochloride is contraindicated in patients: In addition to the contraindications for all sertraline hydrochloride formulations listed above, sertraline hydrochloride oral solution 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 hydrochloride, during the third trimester of pregnancy [See Clinical Considerations]. Although no teratogenicity was observed in animal reproduction studies, delayed fetal ossification was observed when se
Sertraline hydrochloride 25 mg tablets: light green, film-coated, capsular-shaped tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "25 mg" NDC 59762-6347-1 Bottles of 30 Sertraline hydrochloride 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" NDC 59762-6443-1 Bottles of 30 NDC 59762-6443-2 Bottles of 100 NDC 59762-6443-3 Bottles of 500 Sertraline hydrochloride 100 mg tablets: light yellow, film-coated, capsular-shaped, tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "100 mg" NDC 59762-5160-1 Bottles of 30 NDC 59762-5160-2 Bottles of 100 NDC 59762-5160-3 Bottles of 500 Sertraline hydrochloride oral solution: clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol NDC 59762-0067-1 Bottles containing 60 mL, each with an accompanying calibrated dropper that has 25 mg and 50 mg graduation marks. 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].
New Drug Application Authorized Generic
SERTRALINE HYDROCHLORIDE- sertraline hydrochloride tablet, film coated Greenstone LLC ---------- Medication Guide SERTRALINE HYDROCHLORIDE Tablets and Oral Solution This Medication Guide has been approved by the U.S. Food and Drug Administration What is the most important information I should know about sertraline hydrochloride? Sertraline hydrochloride 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 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 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 stat Lees het volledige document
SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED GREENSTONE LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SERTRALINE HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SERTRALINE HYDROCHLORIDE. SERTRALINE HYDROCHLORIDE TABLETS, FOR ORAL USE SERTRALINE HYDROCHLORIDE ORAL SOLUTION 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 Sertraline hydrochloride 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 sertraline hydrochloride, reduce dose gradually (2.6, 5.4) Oral solu Lees het volledige document