SERTRALINE HYDROCHLORIDE- sertraline hydrochloride tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 hos

Produktbesonderheiten:

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 35356-669-30 Bottles of 30 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 35356-668-30 Bottles of 30 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
----------
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 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

Fachinformation

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
----------
SERTRALINE HYDROCHLORIDE TABLETS
25 MG, 50 MG AND 100 MG
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