SERTRALINE HYDROCHLORIDE tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Hikma Pharmaceutical

INN (Kansainvälinen yleisnimi):

SERTRALINE HYDROCHLORIDE

Koostumus:

SERTRALINE HYDROCHLORIDE 25 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Sertraline 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 has not been

Tuoteyhteenveto:

Sertraline hydrochloride tablets capsular-shaped scored 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 tablets scored and imprinted with W58 on one side Bottles of 30's Bottles of 50's Bottles of 100's Bottles of 500's Sertraline hydrochloride 50 mg Tablets: light blue film coated tablets scored and imprinted with W57 on one side Bottles of 30's Bottles of 100's Bottles of 500's Sertraline hydrochloride 100 mg Tablets: light yellow film coated tablets scored and imprinted with W56 on one side Bottles of 30's Bottles of 100's Bottles of 500's Store at 20º- 25ºC (68º- 77ºF) [See USP Controlled Room Temperature].

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

Hikma Pharmaceutical
----------
MEDICATION GUIDE
Antidepressant Medicines, Depression and other Serious Mental
Illnesses, 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 when the medicine is first started.
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?
· Pay close attention to any changes, especially sudden changes, in
mood, behavior, thoughts, or feelings.
This is very important when an antidepressant medicine is first
started or when the dose is changed.
· Call the health care provider right away to report new or sudden
changes in mood, behavior, thoughts, or
feelings.
· Keep all follow-up visits with the healthcare provider as
scheduled. Call the healthcare provider between
visits as needed, especially if you have concerns about symptoms.
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 suici

Valmisteyhteenveto

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
HIKMA PHARMACEUTICAL
----------
SERTRALINE HYDROCHLORIDE TABLETS
RX ONLY
REV. 09/11
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
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 NC ·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 is suppl