SERTRALINE HYDROCHLORIDE tablet, film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

MedVantx, Inc.

INN (Isem Internazzjonali):

SERTRALINE HYDROCHLORIDE

Kompożizzjoni:

SERTRALINE 100 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Major Depressive Disorder Sertraline hydrochloride tablets USP are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride tablets USP 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

Sommarju tal-prodott:

Sertraline hydrochloride tablets USP, contains sertraline hydrochloride USP equivalent to 25 mg, 50 mg and 100 mg of sertraline. Sertraline hydrochloride tablets USP are supplied as : 25 mg Tablets: Green colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘6’ on the other side.             NDC 16714-611-01                Bottles of 30             NDC 16714-611-02                Bottles of 60             NDC 16714-611-03                Bottles of 90             NDC 16714-611-04                Bottles of 100             NDC 16714-611-05                Bottles of 500             NDC 16714-611-06                Bottles of 1000 50 mg Tablets:  Blue colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘7’ on the other side.             NDC 16714-612-01                Bottles of 30             NDC 16714-612-02                Bottles of 60             NDC 16714-612-03                Bottles of 90             NDC 16714-612-04                Bottles of 100             NDC 16714-612-05                Bottles of 500             NDC 16714-612-06                Bottles of 1000 100 mg Tablets: Yellow colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘8’ on the other side.               NDC 16714-613-01                Bottles of 30               NDC 16714-613-02                Bottles of 60               NDC 16714-613-03                Bottles of 90               NDC 16714-613-04                Bottles of 100               NDC 16714-613-05                Bottles of 500               NDC 16714-613-06                Bottles of 1000 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured for: Northstar Rx LLC Memphis, TN 38141 Toll Free: 1-800-206-7821 Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahaboob Nagar (Dt) AP-509302, INDIA M.L.No.: 22/MN/AP/2009/F/G Revised: 01/2013

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
MedVantx, Inc.
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MEDICATION GUIDE
Sertraline Hydrochloride Tablets USP
Read the Medication Guide that comes with sertraline hydrochloride
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
hydrochloride tablets?
Sertraline hydrochloride tablets and other antidepressant medicines
may cause serious side effects,
including:
1. Suicidal thoughts or actions:
•
Sertraline hydrochloride 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.
∘
New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
∘
Pay particular attention to such changes when sertraline hydrochloride
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 unusual changes in behavior or mood
Call your healthcare pro

Karatteristiċi tal-prodott

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
MEDVANTX, INC.
----------
SERTRALINE HYDROCHLORIDE TABLETS USP
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 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 tablets USP are 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 molecular formula C
H NCl
•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.
Sertrali