SERTRALINE HYDROCHLORIDE- 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:

NuCare Pharmaceuticals, Inc.

INN (International Name):

SERTRALINE HYDROCHLORIDE

Composition:

SERTRALINE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 hydrochloride in hos

Product summary:

Sertraline 100 mg Tablets: 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 other NDC 68071-1976-3 Bottles of 30 NDC 68071-1976-9 Bottles of 90 NDC 68071-1976-6 Bottles of 60 NDC 68071--1976-2 Bottles of 20 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Revised: 07/2016

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET
NuCare Pharmaceuticals, Inc.
----------
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 m

Summary of Product characteristics

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.
Sertrali