SERTRALINE HYDROCHLORIDE solution, concentrate SERTRALINE HYDROCHLORIDE tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Greenstone LLC

Designación común internacional (DCI):

SERTRALINE HYDROCHLORIDE

Composición:

SERTRALINE 25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Sertraline hydrochloride is indicated for the treatment of the following [See Clinical Studies (14)] : Sertraline hydrochloride is contraindicated in patients: In addition to the contraindications for all sertraline hydrochloride formulations listed above, sertraline hydrochloride oral solution is 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 se

Resumen del producto:

Sertraline hydrochloride 25 mg tablets: light green, film-coated, capsular-shaped tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "25 mg" NDC 59762-6347-1 Bottles of 30 Sertraline hydrochloride 50 mg tablets: light blue, film-coated, capsular-shaped tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "50 mg" NDC 59762-6443-1 Bottles of 30 NDC 59762-6443-2 Bottles of 100 NDC 59762-6443-3 Bottles of 500 Sertraline hydrochloride 100 mg tablets: light yellow, film-coated, capsular-shaped, tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "100 mg" NDC 59762-5160-1 Bottles of 30 NDC 59762-5160-2 Bottles of 100 NDC 59762-5160-3 Bottles of 500 Sertraline hydrochloride oral solution: clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol NDC 59762-0067-1 Bottles containing 60 mL, each with an accompanying calibrated dropper that has 25 mg and 50 mg graduation marks. Store sertraline hydrochloride at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Estado de Autorización:

New Drug Application Authorized Generic

Información para el usuario

SERTRALINE HYDROCHLORIDE- sertraline hydrochloride tablet, film coated
Greenstone LLC
----------
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 stat

Ficha técnica

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE SOLUTION,
CONCENTRATE
SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
GREENSTONE LLC
----------
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)
RECENT MAJOR CHANGES
Warnings and Precautions, Sexual Dysfunction (5.11)
9/2021
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
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 hydrochloride, reduce dose gradually
(2.6, 5.4)
Oral solu