HIGHLIGHTS OF PRESCRIBING INFORMATION

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB)

Beszerezhető a:

Torrent Pharmaceuticals Limited

INN (nemzetközi neve):

SERTRALINE HYDROCHLORIDE

Összetétel:

SERTRALINE 25 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Sertraline tablets 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) Sertraline tablets 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)]. Risk Summary Overall, available published epidemiologic studies of pregnant women exposed to sertraline hydrochloride in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in

Termék összefoglaló:

Sertraline 25 mg tablets, USP: White to off white, capsule shaped biconvex film coated tablets with "Torrent logo" debossed on one side and "25" debossed with break line separating 2 and 5 on other side. NDC 13668-004-30            Bottles of 30 NDC 13668-004-50            Bottles of 50 NDC 13668-004-90            Bottles of 90 NDC 13668-004-01            Bottles of 100 NDC 13668-004-05            Bottles of 500 NDC 13668-004-10            Bottles of 1000 NDC 13668-004-09            Bottles of 9990 Sertraline 50 mg tablets, USP: White to off white, capsule shaped biconvex film coated tablets with "Torrent logo" debossed on one side and "50MG" debossed with break line separating 50 and MG on other side. NDC 13668-005-30            Bottles of 30 NDC 13668-005-50            Bottles of 50 NDC 13668-005-90            Bottles of 90 NDC 13668-005-01            Bottles of 100 NDC 13668-005-05            Bottles of 500 NDC 13668-005-10            Bottles of 1000 NDC 13668-005-58            Bottles of 4500 Sertraline 100 mg tablets, USP:  White to off white, capsule shaped biconvex film coated tablets with "Torrent logo" debossed on one side and "100MG" debossed with break line separating 100 and MG on other side. NDC 13668-006-30            Bottles of 30 NDC 13668-006-50            Bottles of 50 NDC 13668-006-90            Bottles of 90 NDC 13668-006-01            Bottles of 100 NDC 13668-006-05            Bottles of 500 NDC 13668-006-10            Bottles of 1000 NDC 13668-006-13            Bottles of 1300 NDC 13668-006-34            Bottles of 2200 NDC 13668-006-74            100 Unit dose Tablets Store sertraline tablets, USP at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F) [See USP Controlled Room Temperature].

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
Torrent Pharmaceuticals Limited
----------
MEDICATION GUIDE
SERTRALINE (SER tra leen) TABLETS, USP
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.
o Pay particular attention to such changes when sertraline tablets is
started or when the dose
is changed.
o 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 o other unusual changes in
behavior
than what is normal for you or mood
2. Serotonin Syndrome. This condition can be life-threatening and
symptoms may include:
• agitation, hallucinations, coma, or other • nausea, vomiting, or
diarrhea
changes in mental status
• racing heartbeat, high or low blood pressure • sweating or fever
• coordination

Termékjellemzők

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
TORRENT PHARMACEUTICALS LIMITED
----------
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_
• 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
Warning and Precautions, QTc Prolongation (5.10) 12/2017
INDICATIONS AND USAGE
Sertraline tablets are a selective serotonin reuptake inhibitor (SSRI)
indicated for the treatment of (1): (1)
• Major depressive disorder (MDD) (1)
• Obsessive-compulsive disorder (OCD) (1)
• Panic disorder (PD) (1)
• Post-traumatic stress disorder (PTSD) (1)
• Social anxiety disorder (SAD) (1)
• Premenstrual dysphoric disorder (PMDD) (1)
DOSAGE AND ADMINISTRATION
• 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) (2)
• See Full Prescribing Information for titration in PMDD (2.2) (2)
• Hepatic impairment: (2)
o Mild: Recommended starting and maximum dosage is half (2)
recommended dosage (2.4) (2)
o Moderate or severe: Not recommended (2.4) (2)
When discontinuing sertraline tablets, reduce dose gradually (2.6,
5.4) (2)
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 to12)
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
Tablets: 25 mg,