SERTRALINE HYDROCHLORIDE tablet, coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Ranbaxy Pharmaceuticals Inc.

INN (International Name):

SERTRALINE HYDROCHLORIDE

Sammensetning:

SERTRALINE 25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Major Depressive Disorder– Sertraline hydrochloride tablets are 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 hydrochlor

Produkt oppsummering:

Sertraline hydrochloride tablets containing sertraline hydrochloride equivalent to 25, 50, 100, 150 and 200 mg of sertraline. They are supplied as follows. 25 mg White, coated, capsule-shaped tablets with ‘RE16’ debossed on one side and scoreline on the other side. NDC 63304-164-03 Bottles of 10 NDC 63304-164-30 Bottles of 30 NDC 63304-164-50 Bottles of 50 NDC 63304-164-52 Bottles of 2500 50 mg White, coated, capsule-shaped tablets with ‘RX165’ debossed on one side and scoreline on the other side. NDC 63304-165-03 Bottles of 10 NDC 63304-165-30 Bottles of 30 NDC 63304-165-01 Bottles of 100 NDC 63304-165-05 Bottles of 500 NDC 63304-165-52 Bottles of 2500 100 mg White, coated, capsule-shaped tablets with ‘RX166’ debossed on one side and scoreline on the other side. NDC 63304-166-03 Bottles of 10 NDC 63304-166-30 Bottles of 30 NDC 63304-166-01 Bottles of 100 NDC 63304-166-05 Bottles of 500 NDC 63304-166-52 Bottles of 2500 150 mg White, coated, capsule-shaped tablets with ‘RX167’ debossed on one side and scoreline on the other side. NDC 63304-167-03 Bottles of 10 NDC 63304-167-10 Bottles of 1000 200 mg White, coated, oval-shaped tablets with ‘RX168’ debossed on one side and plain on the other side. NDC 63304-168-03 Bottles of 10 NDC 63304-168-10 Bottles of 1000 Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, COATED
Ranbaxy Pharmaceuticals Inc.
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MEDICATION GUIDE
SERTRALINE HYDROCHLORIDE (ser′ tra leen hye" droe klor' ide) TABLETS
Rx only
Read the Medication Guide that comes with sertraline hydrochloride
tablets 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
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.
•
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
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

Preparatomtale

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, COATED
RANBAXY PHARMACEUTICALS INC.
----------
SERTRALINE HYDROCHLORIDE TABLETS
RX 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 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 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 molecular
formula C
H NCl
•HCl is represented by the following molecular structure:
Sertraline hydrochloride is a white to off-white crystalline powder
that is slightly soluble in water and
isopropyl alcohol, and sparingly soluble in ethanol