SERTRALINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lupin Pharmaceuticals, Inc.

INN (International Name):

SERTRALINE HYDROCHLORIDE

Composition:

SERTRALINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage pat

Product summary:

Sertraline Hydrochloride Tablets USP, 25 mg Green colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D01' on the other side. NDC 68180-351-06                Bottles of 30 NDC 68180-351-09                Bottles of 90 NDC 68180-351-03                Bottles of 1000 Sertraline Hydrochloride Tablets USP, 50 mg Blue colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D02' on the other side. NDC 68180-352-06                Bottles of 30 NDC 68180-352-09                Bottles of 90 NDC 68180-352-02                Bottles of 500 NDC 68180-352-05                Bottles of 5000 Sertraline Hydrochloride Tablets USP, 100 mg Yellow colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D03' on the other side. NDC 68180-353-06                Bottles of 30 NDC 68180-353-09                Bottles of 90 NDC 68180-353-02                Bottles of 500 NDC 68180-353-05                Bottles of 5000 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

SERTRALINE- SERTRALINE TABLET, FILM COATED
Lupin Pharmaceuticals, 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 tablets and other antidepressant medicines
may increase suicidal thoughts
or actions in some people 24 years of age and younger, especially
within thefirst 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 pr

Summary of Product characteristics

SERTRALINE- SERTRALINE TABLET, FILM COATED
LUPIN 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._
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 (5.2, 5.3) 8/2023
INDICATIONS AND USAGE
Sertraline hydrochloride tablet 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 to 12)
200 mg per day
50 mg per day (ages ≥ 13)
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 dosing50 mg per day during luteal phase
only100 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 (2.4)
Moderate or severe: Not recommended (2.4)
When discontinuing sertraline hydrochloride tablets, reduce dose
gradually (2.6, 5.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg and 100 mg (3)
CONTRAINDICATIONS
Concomitant use of monoamine oxidase in