SERTRALINE- sertraline hydrochloride tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

ReadyMeds

INN (International Name):

SERTRALINE HYDROCHLORIDE

Sammensetning:

SERTRALINE 50 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Sertraline Tablets, USP are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline 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 sertraline in hospitalized depressed patients has not been adequately st

Produkt oppsummering:

Sertraline tablets are modified oval biconvex tablets, containing sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline, are packaged in bottles. Sertraline Tablets, USP 25 mg: 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 the other side. Bottles of 30 Bottles of 90 Bottles of 500 Sertraline Tablets, USP 50 mg: 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 the other side. Bottles of 30 Bottles of 90 Bottles of 500 Sertraline Tablets, USP 100 mg: 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 the other side. Bottles of 30 Bottles of 90 Bottles of 500 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

SERTRALINE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
ReadyMeds
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MEDICATION GUIDE
Sertraline Tablets, USP
Read the Medication Guide that comes with Sertraline Tablets before
you start taking them 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 sertraline
tablets?Sertraline tablets and other
antidepressant medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
•
Sertraline tablets and other antidepressant medicines may increase
suicidal thoughts or actions in
some children, teenagers, or 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 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 unusu

Preparatomtale

SERTRALINE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
READYMEDS
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SERTRALINE TABLETS, USP50 MGISS. 09/12RX ONLY
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
SERTRALINE 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.
SERTRALINE 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
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-Nmethyl- 1-naphthalenamine
hydrochloride. The empirical
formula C17H17NCl2•HCl is represented by the following structural
formula:
Sertraline Hydrochloride, USP is a white crystalline powder that is
slightly soluble in water and
isopropyl alcohol, and sparingly soluble in ethanol.
Sertraline Tablets, USP are supplied for oral administra