SERTRALINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

SERTRALINE HYDROCHLORIDE

Composition:

SERTRALINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sertraline 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 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 comparato

Product summary:

Sertraline 25 mg Tablets: Light Green film coated Modified oval biconvex tablets debossed with I on the left side of bisect and G on the right side of bisect on one side and “212” on other Unit dose packages of 100 (10 x 10) NDC 60687-231-01 Sertraline 50 mg Tablets: Light Blue film coated Modified oval biconvex tablets debossed with I on the left side of bisect and G on the right side of bisect on one side and “213” on other Unit dose packages of 100 (10 x 10) NDC 60687-242-01 Sertraline 100 mg Tablets: Light Yellow film coated Modified oval biconvex tablets debossed with I on the left side of bisect and G on the right side of bisect on one side and “214” on other Unit dose packages of 100 (10 x 10) NDC 60687-253-01 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET
American Health Packaging
----------
MEDICATION GUIDE
8423101/0923
Sertraline Tablets, USP
(SIR-trah-leen)
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.
•
Pay particular attention to such changes when sertraline 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 on dangerous impulses
•
acting aggressive or violent
•
thoughts about suicide or dying
•
new or worse depression
•
new or worse anxiety or panic attacks
•
feeling agitated, restless, angry or irritable
•
trouble sleeping
•
an increase in activity or talking more than what is normal for you
•
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
•
nausea, vomiting, or diarrhea
•
racing heartbeat, high or low blood pressure
•
sweating or fe

Summary of Product characteristics

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET
AMERICAN HEALTH PACKAGING
----------
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)
INDICATIONS AND USAGE
Sertraline tablets are 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 6-12)
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, reduce dose gradually (2.6, 5.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg and 100 mg (3)
CONTRAINDICATIONS
Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within
14 days of stopping MAOIs (4,
7.1)
Concomitant use of pimozide (4, 7.1)
Known hypersensitivity to sertr