SERTRALINE- sertraline tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Exelan Pharmaceuticals, Inc.

INN (שם בינלאומי):

SERTRALINE HYDROCHLORIDE

הרכב:

SERTRALINE 25 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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)]. Pregnancy Exposure Registry  There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2

leaflet_short:

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 NDC 76282-212-30 Bottles of 30 NDC 76282-212-60 Bottles of 60 NDC 76282-212-90 Bottles of 90 NDC 76282-212-01 Bottles of 100 NDC 76282-212-18 Bottles of 180 NDC 76282-212-05 Bottles of 500 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 NDC 76282-213-30 Bottles of 30 NDC 76282-213-60 Bottles of 60 NDC 76282-213-90 Bottles of 90 NDC 76282-213-01 Bottles of 100 NDC 76282-213-18 Bottles of 180 NDC 76282-213-05 Bottles of 500 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 NDC 76282-214-30 Bottles of 30 NDC 76282-214-60 Bottles of 60 NDC 76282-214-90 Bottles of 90 NDC 76282-214-01 Bottles of 100 NDC 76282-214-18 Bottles of 180 NDC 76282-214-05 Bottles of 500 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

עלון מידע

Exelan Pharmaceuticals, Inc.
----------
Medication Guide
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:
o attempts to
commit
suicide
o acting
o acting on dangerous
impulses
o thoughts about suicide or
dying
aggressive or
violent
o new or
worse
depression
o feeling
agitated,
restless, angry
or irritable
o an increase
in activity or
talking more
than what is
normal for you
o new or worse anxiety or
panic attacks
o trouble sleeping
o 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 or
muscle
twitching
(overactive
reflexes)
• nausea, vomiting, or
diarrhea
• sweating or fever
• muscle rigid

מאפייני מוצר

SERTRALINE- SERTRALINE TABLET, FILM COATED
EXELAN PHARMACEUTICALS, INC.
----------
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)
RECENT MAJOR CHANGES
Warnings and Precautions (5.2, 5.3) 8/2023
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, 5.4)
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 us