SERTRALINE- sertraline tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

SERTRALINE HYDROCHLORIDE

Composition:

SERTRALINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 action of sertraline hydrochloride tablets U

Product summary:

Sertraline capsule-shaped, film-coated tablets, containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline, are packaged in bottles as well as unit dose blisters. Sertraline Hydrochloride Tablets USP, 25 mg: green colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D01' on the other side. 55700-222-30 Sertraline Hydrochloride Tablets USP, 50 mg: blue colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D02' on the other side. Sertraline Hydrochloride Tablets USP, 100 mg: yellow colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D03' on the other side. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States MADE IN INDIA Revised: December 2014                                                                                    ID#: 239380

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

SERTRALINE- SERTRALINE TABLET, FILM COATED
Lake Erie Medical DBA Quality Care Products LLC
----------
Medication Guide
SERTRALINE HYDROCHLORIDE TABLETS USP (ser′ tra leen)
25 mg, 50 mg and 100 mg
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
hydrochloridetablets?
Sertraline hydrochloride tablets and other antidepressant medicines
may cause serious side effects,
including:
1. Suicidal thoughts or actions:
•
Sertraline 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 increase in activ

Summary of Product characteristics

SERTRALINE- SERTRALINE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
SERTRALINE HYDROCHLORIDE 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 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 C
H NCl
•HCl is represented by the following structural formula:
Sertraline hydrochloride is a white to off white crystalline powder
that is sparingly soluble in methanol
and dimethyl formamide.
Sertraline hydrochloride is