SERTRALINE HYDROCHLORIDE solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Marlex Pharmaceuticals Inc

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Sertraline Hydrochloride Oral Concentrate is 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 be

Bidhaa muhtasari:

Sertraline Hydrochloride Oral Concentrate is a clear, colorless solution containing sertraline hydrochloride equivalent to 20 mg of sertraline per mL. It is supplied as a 60 mL bottle with an accompanying calibrated dropper. NDC 10135-0694-61 - Bottle of 60 mL Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Manufactured for & Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev. 3/20 IT

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE SOLUTION
Marlex Pharmaceuticals Inc
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Medication Guide
Sertraline (ser’ tra leen) Hydrochloride Oral Concentrate
Read the Medication Guide that comes with sertraline before you start
taking it and each time you get a
refill. There may be new information. This Medication Guide does not
take the place of talking to your
healthcare provider about your medical condition or treatment. Talk
with your healthcare provider if there
is something you do not understand or want to learn more about.
What is the most important information I should know about sertraline?
Sertraline and other antidepressant medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
•
Sertraline and other antidepressant medicines may increase suicidal
thoughts or actions in some
children, teenagers, or young adults within the first few months of
treatment or when the dose is
changed.
•
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
•
Watch for these changes and call your healthcare provider right away
if you notice:
•
New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if
severe.
•
Pay particular attention to such changes when sertraline is started or
when the dose is
changed.
Keep all follow-up visits with your healthcare provider and call
between visits if you are worried about
symptoms.
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 if an
emergency, especially if they are new, worse, or worry you:
•
attempts to commit suicide
•
acting on dangerous impulses
•
acting aggressive or violent
•
thoughts about suicide or dying
•
new or worse depression
•
new or worse anxiety or panic attacks
•
feeling agitated, restless, angry or irritable
•
trouble sleeping
•
an increase in activity or talking more than what is normal for you
•
other unusual changes in behavior or mood
Call your healthcare prov

Tabia za bidhaa

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE SOLUTION
MARLEX PHARMACEUTICALS INC
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SERTRALINE HYDROCHLORIDE ORAL SOLUTION, USP
SERTRALINE HYDROCHLORIDE
ORAL CONCENTRATE
RX ONLY
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 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 ethan