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:

RedPharm Drug, 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 hosp

Product summary:

Sertraline hydrochloride modified oval biconvex tablets, containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline, are packaged in bottles. Sertraline hydrochloride 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 31722-212-30 Bottles of 30 NDC 31722-212-90 Bottles of 90 NDC 31722-212-05 Bottles of 500 Sertraline hydrochloride 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 31722-213-30 Bottles of 30 NDC 31722-213-90 Bottles of 90 NDC 31722-213-05 Bottles of 500 Sertraline hydrochloride 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 31722-214-30 Bottles of 30 NDC 31722-214-90 Bottles of 90 NDC 31722-214-05 Bottles of 500 Store at 25°C (77°F); excursions permitted to 15° - 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET
RedPharm Drug, Inc.
----------
MEDICATION GUIDE
Sertraline hydrochloride
Tablets
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
hydrochloride?
Sertraline hydrochloride and other antidepressant medicines may cause
serious side effects, including:
Suicidal thoughts or actions:
Sertraline hydrochloride 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
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 provider right away if you have a

Summary of Product characteristics

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET
REDPHARM DRUG, INC.
----------
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 has the
following chemical name: (1S-cis)-4-
(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine
hydrochloride. The empirical
formula C17H17NCl2•HCl is represented by the following structural
formula:
Sertraline hydrochloride is a white crystalline powder that is
slightly soluble in water and isopropyl
alcohol and sparingly soluble in ethanol.
Sertraline hydrochloride is supplied for oral administration as scored