SERTRALINE HYDROCHLORIDE tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Zydus Pharmaceuticals (USA) Inc.

INN（国际名称）:

SERTRALINE HYDROCHLORIDE

组成:

SERTRALINE 25 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 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 in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in compar

產品總結:

Sertraline Hydrochloride Tablets equivalent to 25 mg of sertraline base, are light green, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','82' and bisect on one side and plain on the other side and are supplied as follows: NDC 68382-043-06 in bottles of 30 tablets NDC 68382-043-18 in bottles of 50 tablets NDC 68382-043-14 in bottles of 60 tablets NDC 68382-043-16 in bottles of 90 tablets NDC 68382-043-01 in bottles of 100 tablets NDC 68382-043-05 in bottles of 500 tablets NDC 68382-043-10 in bottles of 1,000 tablets Sertraline Hydrochloride Tablets equivalent to 50 mg of sertraline base, are light blue, round, biconvex, beveled, film-coated tablets debossed with the logo of 'Z','81' and bisect on one side and plain on the other side and are supplied as follows: NDC 68382-044-06 in bottles of 30 tablets NDC 68382-044-14 in bottles of 60 tablets NDC 68382-044-16 in bottles of 90 tablets NDC 68382-044-01 in bottles of 100 tablets NDC 68382-044-05 in bottles of 500 tablets NDC 68382-044-10 in bottles of 1,000 tablets Sertraline Hydrochloride Tablets equivalent to 100 mg of sertraline base, are yellow, round, biconvex, beveled, film-coated tablets engraved with 'Z','80' and bisect on one side and the other side is plain and are supplied as follows: NDC 68382-045-06 in bottles of 30 tablets NDC 68382-045-14 in bottles of 60 tablets NDC 68382-045-16 in bottles of 90 tablets NDC 68382-045-01 in bottles of 100 tablets NDC 68382-045-40 in bottles of 5,000 tablets Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. PDR® is registered trademark of Thomson Healthcare.

授权状态:

Abbreviated New Drug Application

资料单张

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
Zydus Pharmaceuticals (USA) Inc.
----------
MEDICATION GUIDE
Sertraline Hydrochloride (ser' tra leen hye'' droe klor' ide) Tablets
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 tabletsand 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 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:
•
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 status
•
racing

产品特点

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
ZYDUS PHARMACEUTICALS (USA) INC.
----------
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 mg per day 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, reduce dose gradually
(2.6, 5.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg and 100 mg (3)
CO