SERTRALINE HYDROCHLORIDE 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:

Contract Pharmacy Services-PA

INN (International Name):

sertraline hydrochloride

Composition:

sertraline hydrochloride 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 hospitalized depressed patients

Product summary:

Sertraline hydrochloride capsular-shaped scored tablets, equivalent to 25, 50 and 100 mg of sertraline, are packaged in bottles. Sertraline hydrochloride 100 mg Tablets: light yellow capsular-shaped scored tablets engraved on one side with G 4910 and on the side engraved with 100 mg.   NDC 67046-665-30              Blisters of 30    Store at 25°C (77°F); excursions permitted to 15° – 30°C (59° – 86°F)[see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Patient Information leaflet

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
Contract Pharmacy Services-PA
----------
MEDICATION GUIDE
ANTIDEPRESSANT MEDICINES,
DEPRESSION AND OTHER SERIOUS MENTAL
ILLNESS, AND SUICIDAL THOUGHTS OR
ACTIONS
Read the Medication Guide that comes with you or your family member's
antidepressant medicine. This
Medication Guide is only about the risk of suicidal thoughts and
actions with antidepressant medicines.
Talk to your, or your family member's healthcare provider about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression, and
other serious mental illnesses, and suicidal thoughts or actions?
•
1. Antidepressant medicines may increase suicidal thoughts or actions
in some children, teenagers,
and young adults within the first few months of treatment.
•
2. Depression and other serious mental illnesses are the most
important causes of suicidal thoughts
and actions. Some people may have a particularly high risk of having
suicidal thoughts or actions.
These include people who have (or have a family history of) bipolar
illness (also called manic-
depressive illness) or suicidal thoughts or actions.
•
3. How can I watch for and try to prevent suicidal thoughts and
actions in myself or a family
member?
Call a healthcare provider right away if you or your family member has
any of the following symptoms
especially if they are new, worse, or worry you:
•
thoughts about suicide or dying
•
attempts to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling very agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other unusual changes in behavior or mood
Call your doctor for medical advice about side

Summary of Product characteristics

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
CONTRACT PHARMACY SERVICES-PA
----------
SERTRALINE HYDROCHLORIDE
TABLETS AND ORAL CONCENTRATE
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 empirical
formula C
H NCl
•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 et