sertraline hydrochloride- Sertraline Hydrochloride tablet, film coated

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

sertraline hydrochloride (UNII: UTI8907Y6X) (sertraline - UNII:QUC7NX6WMB)

থেকে পাওয়া:

Cobalt Pharmaceuticals

INN (International Name):

Sertraline Hydrochloride

ফার্মাসিউটিকাল ফর্ম:

TABLET, FILM COATED

রচনা:

25 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Sertraline hydrochloride tablets are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline 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 in hospitalized depressed patients has not been adeq

পণ্য সারাংশ:

Sertraline Hydrochloride Tablets capsular-shaped tablets, containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline, are packaged in bottles and unit dose cartons. Sertraline Hydrochloride Tablets 25 mg: white to off-white film-coated, capsule-shaped, biconvex tablet with “SL” scoreline “25” on one side and “>” on the other side. NDC 68533-055-12 Bottles of 30 NDC 68533-055-25 Bottles of 1000 NDC 68533-055-40 Unit Dose Packages of 100 Sertraline Hydrochloride Tablets 50 mg: white to off-white film-coated, capsule-shaped, biconvex tablet with “SL” scoreline “50” on one side and “>” on the other side. NDC 68533-056-12 Bottles of 30 NDC 68533-056-25 Bottles of 1000 NDC 68533-056-40 Unit Dose Packages of 100 Sertraline Hydrochloride Tablets 100 mg: white to off-white, film-coated, capsule-shaped, biconvex tablet with “SL” scoreline “100” on one side and “>” on the other side. NDC 68533-057-12 Bottles of 30 NDC 68533-057-25 Bottles of 1000 NDC 68533-057-40 Unit Dose Packages of 100 Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

তথ্য লিফলেট

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
Cobalt Pharmaceuticals
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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, behaviors, thoughts, or
feelings. This is very important when an antidepressant medicine is
first 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,

পণ্য বৈশিষ্ট্য

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
COBALT PHARMACEUTICALS
----------
SERTRALINE HYDROCHLORIDE TABLETS
BOXED WARNING
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 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 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 Hydrochlor