ZOLOFT- 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:

Aphena Pharma Solutions - Tennessee, LLC

Designación común internacional (DCI):

SERTRALINE HYDROCHLORIDE

Composición:

SERTRALINE 50 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

ZOLOFT (sertraline hydrochloride) is indicated for the treatment of major depressive disorder in adults. The efficacy of ZOLOFT in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of ZOLOFT in hospitalized depressed patients has not been adequately st

Resumen del producto:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. ZOLOFT (sertraline hydrochloride) capsular-shaped scored tablets, containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline, are packaged in bottles. ZOLOFT 25 mg Tablets: light green film coated tablets engraved on one side with ZOLOFT and on the other side scored and engraved with 25 mg. ZOLOFT 50 mg Tablets: light blue film coated tablets engraved on one side with ZOLOFT and on the other side scored and engraved with 50 mg. ZOLOFT 100 mg Tablets: light yellow film coated tablets engraved on one side with ZOLOFT and on the other side scored and engraved with 100 mg. Store at 25°C (77°F); excursions permitted to 15° – 30°C (59° – 86°F)[see USP Controlled Room Temperature]. ZOLOFT Oral Concentrate: ZOLOFT Oral Concentrate is a clear, colorless solution with a menthol scent containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL and 12% alcohol. It is supplied as a 60 mL bottle with an accompanying calibrated dropper. Store at 25°C (77°F); excursions permitted to 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature].

Estado de Autorización:

New Drug Application

Información para el usuario

ZOLOFT- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
ZOLOFT (ZOH-loft)
(sertraline hydrochloride)
(Tablets and Oral Concentrate (solution))
Read the Medication Guide that comes with ZOLOFT before you start
taking it and each time you get a
refill. There may be new information. This Medication Guide does not
take the place of talking to your
healthcare provider about your medical condition or treatment. Talk
with your healthcare provider if there
is something you do not understand or want to learn more about.
What is the most important information I should know about ZOLOFT?
ZOLOFT and other antidepressant medicines may cause serious side
effects, including:
1.
Suicidal thoughts or actions:
•
ZOLOFT and other antidepressant medicines may increase suicidal
thoughts or actions in
some children, teenagers, or young adults 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 ZOLOFT 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 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
Call your h

Ficha técnica

ZOLOFT- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
ZOLOFT
(SERTRALINE HYDROCHLORIDE)
TABLETS AND ORAL CONCENTRATE
SUICIDALITY AND ANTIDEPRESSANT DRUGS
ANTIDEPRESSANTS INCREASED THE RISK COMPARED TO PLACEBO OF SUICIDAL
THINKING AND BEHAVIOR
(SUICIDALITY) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM
STUDIES OF MAJOR
DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS. ANYONE
CONSIDERING THE USE OF
ZOLOFT OR ANY OTHER ANTIDEPRESSANT IN A CHILD, ADOLESCENT, OR YOUNG
ADULT MUST BALANCE
THIS RISK WITH THE CLINICAL NEED. SHORT-TERM STUDIES DID NOT SHOW AN
INCREASE IN THE RISK OF
SUICIDALITY WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS BEYOND
AGE 24; THERE WAS A
REDUCTION IN RISK WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS
AGED 65 AND OLDER.
DEPRESSION AND CERTAIN OTHER PSYCHIATRIC DISORDERS ARE THEMSELVES
ASSOCIATED WITH
INCREASES IN THE RISK OF SUICIDE. PATIENTS OF ALL AGES WHO ARE STARTED
ON ANTIDEPRESSANT
THERAPY SHOULD BE MONITORED APPROPRIATELY AND OBSERVED CLOSELY FOR
CLINICAL WORSENING,
SUICIDALITY, OR UNUSUAL CHANGES IN BEHAVIOR. FAMILIES AND CAREGIVERS
SHOULD BE ADVISED OF
THE NEED FOR CLOSE OBSERVATION AND COMMUNICATION WITH THE PRESCRIBER.
ZOLOFT IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS EXCEPT FOR PATIENTS WITH
OBSESSIVE COMPULSIVE
DISORDER (OCD). (SEE WARNINGS: CLINICAL WORSENING AND SUICIDE RISK,
PRECAUTIONS:
INFORMATION FOR PATIENTS, AND PRECAUTIONS: PEDIATRIC USE)
DESCRIPTION
ZOLOFT (sertraline hydrochloride) is a selective serotonin reuptake
inhibitor (SSRI) for oral
administration. It has a molecular weight of 342.7. Sertraline
hydrochloride has the following chemical
name:
(1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine
hydrochloride.
The empirical formula C
H NCl
•HCl is represented by the following structural formula:
Sertraline hydrochloride is a white crystalline powder that is
slightly soluble in water and isopropyl
alcohol, and sparingly soluble in ethanol.
®
®
17
17
2
ZOLOF