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:

DIRECT RX

INN (International Name):

SERTRALINE HYDROCHLORIDE

Composition:

SERTRALINE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 hosp

Product summary:

Sertraline tablets, USP are available with each tablet containing sertraline hydrochloride, USP equivalent to 25 mg, 50 mg and 100 mg of sertraline. Sertraline 25 mg Tablets: Light Green film coated Modified oval biconvex tablets debossed with I on the left Side of bisect and G on the right Side of bisect on one Side and "212" on other Sertraline 50 mg Tablets: Light Blue film coated Modified oval biconvex tablets debossed with I on the left side of bisect and G on the right side of bisect on one side and "213" on other Sertraline 100 mg Tablets: Light Yellow film coated Modified oval biconvex tablets debossed with I on the left side of bisect and G on the right side of bisect on one side and "214" on other Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET
DIRECT RX
----------
Sertraline Tablets, USP
(SIR-trah-leen)
What is the most important information I should know about sertraline
tablets?
Sertraline tablets and other antidepressant medicines may cause
serious side effects. Call your healthcare
provider right away if you have any of the following symptoms, or call
911 if there is an emergency.
1. Suicidal thoughts or actions:
Sertraline tablets and other antidepressant medicines may increase
suicidal thoughts or actions in some
people 24 years of age and younger, especially 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 tablets are
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:
o attempts to commit suicide o acting on dangerous impulses
o acting aggressive or violent o thoughts about suicide or dying
o new or worse depression o new or worse anxiety or panic attacks
o feeling agitated, restless,
angry or irritable o trouble sleeping
o an increase in activity or
talking more than what is
normal for you o other unusual changes in behavior or mood
2. Serotonin Syndrome. This condition can be life-threatening and
symptoms may include:
• agitation, hallucinations, coma, or other changes in mental status
• nausea, vomiting, or diarrhea
• racing heartbeat, high or low blood pressure • sweating or fever
• coordination problems or muscle twitching (overactive reflexes)
• muscle rig

Summary of Product characteristics

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET
DIRECT RX
----------
SERTRALINE
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 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).
Sertraline hydrochloride is a selective serotonin reuptake inhibitor
(SSRI) for oral
administration. It has a molecular weight of 342.7. Sertraline
hydrochloride, USP 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:
[image]
Sertraline hydrochloride, USP is a white crystalline powder that is
slightly soluble in water
and isopropyl alcohol and sparingly soluble in ethanol.
Sertraline tablets, USP are supplied for oral administration as