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:

Aurolife Pharma LLC

INN (International Name):

SERTRALINE HYDROCHLORIDE

Composition:

SERTRALINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Major Depressive Disorder Sertraline hydrochloride tablets are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride tablets 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 hy

Product summary:

Sertraline hydrochloride tablets, contains sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline. Sertraline hydrochloride tablets are supplied as : 25 mg Tablets: Green colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘6’ on the other side. NDC 13107-011-30                            Bottles of 30 NDC 13107-011-50                            Bottles of 50 NDC 13107-011-60                            Bottles of 60 NDC 13107-011-90                            Bottles of 90 NDC 13107-011-01                            Bottles of 100 NDC 13107-011-05                            Bottles of 500 NDC 13107-011-51                            Bottles of 5000 50 mg Tablets:  Blue colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘7’ on the other side. NDC 13107-012-30                            Bottles of 30 NDC 13107-012-50                            Bottles of 50 NDC 13107-012-60                            Bottles of 60 NDC 13107-012-90                            Bottles of 90 NDC 13107-012-01                            Bottles of 100 NDC 13107-012-05                            Bottles of 500 NDC 13107-012-51                            Bottles of 5000 100 mg Tablets: Yellow colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘8’ on the other side. NDC 13107-013-30                            Bottles of 30 NDC 13107-013-50                            Bottles of 50 NDC 13107-013-60                            Bottles of 60 NDC 13107-013-90                            Bottles of 90 NDC 13107-013-01                            Bottles of 100 NDC 13107-013-05                            Bottles of 500 NDC 13107-013-25                            Bottles of 2500 Store at 20º to 25 ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured by: Dayton, NJ08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ08810 Revised: 02/2011

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

SERTRALINE HYDROCHLORIDE - SERTRALINE HYDROCHLORIDE TABLET
Aurolife Pharma LLC
----------
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?
· Pay close attention to any changes, especially sudden changes, in
mood, behaviors, thoughts, or
feelings. This is very important when an antidepressant medicine is
started or when the dose is changed.
· Call the healthcare 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:
·

Summary of Product characteristics

SERTRALINE HYDROCHLORIDE - SERTRALINE HYDROCHLORIDE TABLET
AUROLIFE PHARMA LLC
----------
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 tablets are 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 molecular 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 ethanol.
Sertraline hydrochloride tablets are supplied for oral admin