SERTRALINE- sertraline hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

SERTRALINE HYDROCHLORIDE

Composition:

SERTRALINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Major Depressive Disorder 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 h

Product summary:

Sertraline tablets, USP are available with each containing sertraline hydrochloride, USP equivalent to 25 mg, 50 mg and 100 mg of sertraline. Sertraline 25 mg Tablets: Light Green film coated Modified oval biconvex tablets de-bossed with I on the left Side of bisect and G on the right Side of bisect on one Side and “212” on other. NDC 0615-6558-39 Blistercards of 30 NDC 0615-6558-05 Blistercards of 15 NDC 0615-6558-30 Boxes of 30 tablets for unit dose dispensing Sertraline 50 mg Tablets: Light Blue film coated Modified oval biconvex tablets de-bossed with I on the left side of bisect and G on the right side of bisect on one side and “213” on other. NDC 0615-6559-39 Blistercards of 30 NDC 0615-6559-05 Blistercards of 15 NDC 0615-6559-30 Boxes of 30 tablets for unit dose dispensing Sertraline 100 mg Tablets: Light Yellow film coated Modified oval biconvex tablets de-bossed with I on the left side of bisect and G on the right side of bisect on one side and “214” on other. NDC 0615-6560-39 Blistercards of 30 NDC 0615-6560-05 Blistercards of 15 NDC 0615-6560-30 Boxes of 30 tablets for unit dose dispensing Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Rev: 11/13

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

SERTRALINE- SERTRALINE HYDROCHLORIDE TABLET
NCS HealthCare of KY, Inc dba Vangard Labs
----------
MEDICATION GUIDE
Sertraline Tablets, USP
Read the Medication Guide that comes with sertraline 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
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 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 mood
Call your healthcare pr

Summary of Product characteristics

SERTRALINE- SERTRALINE HYDROCHLORIDE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
SERTRALINE TABLETS, USP
25 MG, 50 MG AND 100 MG
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 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 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 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.
Sertraline tablets, USP are supplied