SERTRALINE HYDROCHLORIDE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

NuCare Pharmaceuticals,Inc.

INN (International Name):

SERTRALINE HYDROCHLORIDE

Sammensætning:

SERTRALINE 50 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Major Depressive Disorder – Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride 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 hydroch

Produkt oversigt:

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 68071-1317-0 Bottles of 30 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Revised: 07/2016

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

SERTRALINE HYDROCHLORIDE- sertraline hydrochloride tablet
NuCare Pharmaceuticals,Inc.
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MEDICATION GUIDE
Sertraline Tablets, USP
(SIR-trah-leen)
Read the Medication Guide that comes with Sertraline hydrochloride
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 Sertraline
tablets?
Sertraline hydrochloride 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 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 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 mo

Produktets egenskaber

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET
NUCARE PHARMACEUTICALS,INC.
----------
SERTRALINE TABLETS, USP
25MG, 50MG AND 100 MG
BOXED WARNING
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
HYDROCHLORIDE 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 HYDROCHLORIDE TABLETS
ARE
NOT APPROVED FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER IN
PEDIATRIC
PATIENTS. (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, USP 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
NC
•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.
Sertralin