SERTRALINE HYDROCHLORIDE 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:

Bryant Ranch Prepack

INN (International Name):

SERTRALINE HYDROCHLORIDE

Composition:

SERTRALINE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sertraline hydrochloride 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 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)]. In addition to the contraindications for all sertraline hydrochloride formulations listed above, sertraline hydrochloride oral solution is contraindicated in patients: - Taking disulfiram. Sertraline hydrochloride oral solution contains alcohol, and concomitant use of s

Product summary:

Product: 63629-6755 NDC: 63629-6755-1 90 TABLET, FILM COATED in a BOTTLE NDC: 63629-6755-2 60 TABLET, FILM COATED in a BOTTLE

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

Bryant Ranch Prepack
----------
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 status
•
racing heartbeat, high or low blood
pressure
•
coordinat

Summary of Product characteristics

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
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)
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
INDIC ATIO N
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 solution: Must be diluted before administration (2.7)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg and 100 mg (3)
Oral solution (new name, same p