SERTRALINE HYDROCHLORIDE- sertraline hydrochloride tablet, film coated

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Preferred Pharmaceuticals Inc.

INN (International Name):

SERTRALINE HYDROCHLORIDE

রচনা:

SERTRALINE 50 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] : Sertraline hydrochloride tablets are 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 sertraline was administered during the period of organogenesis at doses less than the maximum recommended human dose (MRHD) in rats and doses 3.1 times

পণ্য সারাংশ:

50 mg: light blue to blue colored, round, biconvex, film coated tablets, debossed with “S2” on one side and breakline on other side. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

Preferred Pharmaceuticals Inc.
----------
Medication
Guide
Sertraline
Hydrochloride Tablets
(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 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 heartbeat, high or
low blood pressure
•
coordination problems o

পণ্য বৈশিষ্ট্য

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS 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._
•
•
RECENT MAJOR CHANGES
Warnings and Precautions, QTc Prolongation ( 5.10) 12/2017
INDICATIONS AND USAGE
Sertraline is a selective serotonin reuptake inhibitor (SSRI)
indicated for the treatment of ( 1):
•
•
•
•
•
•
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
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
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)
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Post-traumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
If inadequate response to starting dosage, titrate in 25 mg 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 do