SERTRALINE HYDROCHLORIDE tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Direct_Rx

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] : Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) Sertraline hydrochloride tablets are contraindicated in patients: Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [See Warnings and Precautions (5.2), Drug Interactions (7.1)] . Taking pimozide [See Drug Interactions (7.1)] . With known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [See Adverse Reactions (6.1, 6.2)]. 8.1 Pregnancy Risk Summary Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major bir

제품 요약:

Sertraline hydrochloride tablets, USP having functional scoring containing sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline, are supplied as. 25 mg: light green to green colored, round, biconvex, film coated tablets, debossed with “S1” on one side and breakline on other side. Bottles of 30 Bottles of 50 Bottles of 90 N Unit Dose Packages of 100 Bottles of 500 50 mg: light blue to blue colored, round, biconvex, film coated tablets, debossed with “S2” on one side and breakline on other side. Bottles of 30 Bottles of 90 Bottles of 100 Unit Dose Packages of 100 100 mg: yellow colored, round biconvex, film coated tablets, debossed with “S3” on one side and breakline on other side. Bottles of 30 Bottles of 90 Bottles of 100 Bottles of 500 Unit Dose Packages of 100 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
Direct_Rx
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Medication Guide
Sertraline Hydrochloride Tablets
(ser′ tra leen hye″ droe klor′ ide)
What is the most important information I should know about sertraline
hydrochloride tablets?
Sertraline hydrochloride 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 hydrochloride 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 hydrochloride
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:
attempts to commit suicide
acting aggressive or violent
new or worse depression
feeling agitated, restless, angry or irritable
an increase in activity or talking more than what is normal for you
acting on dangerous impulses
thoughts about suicide or dying
new or worse anxiety or panic attacks
trouble sleeping
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
racing heartbeat, high or low blood pressure
coordination problems or muscle twitching (ov

제품 특성 요약

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
DIRECT_RX
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SERTRALINE HCL 50MG
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior
in pediatric and young adult
patients in short-term studies. Closely monitor all
antidepressant-treated patients for clinical
worsening, and for emergence of suicidal thoughts and behaviors [see
Warnings and Precautions
(5.1)].
Sertraline hydrochloride tablets are indicated for the treatment of
the following [See Clinical Studies
(14)] :
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Posttraumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
2.1 Dosage in Patients with MDD, OCD, PD, PTSD, and SAD
The recommended initial dosage and maximum sertraline hydrochloride
tablets dosage in patients with
MDD, OCD, PD, PTSD, and SAD are displayed in Table 1 below. A dosage
of 25 mg or 50 mg per day
is the initial therapeutic dosage.
For adults and pediatric patients, subsequent dosages may be increased
in case of an inadequate
response in 25 mg to 50 mg per day increments once a week, depending
on tolerability, up to a maximum
of 200 mg per day. Given the 24-hour elimination half-life of
sertraline hydrochloride, the
recommended interval between dose changes is one week.
Table 1: Recommended Daily Dosage of Sertraline Hydrochloride Tablets
in Patients with MDD,
OCD, PD, PTSD, and SAD
Indication
Starting Dose
Therapeutic Range
Adults
MDD
50 mg
50 mg to 200 mg
OCD
50 mg
PD, PTSD, SAD
25 mg
Pediatric Patients
OCD (ages 6 to 12 years old)
25 mg
50 mg to 200 mg
OCD (ages 13 to 17 years old)
50 mg
2.2 Dosage in Patients with PMDD
The recommended starting sertraline hydrochloride tablets dosage in
adult women with PMDD is 50 mg
per day. Sertraline hydrochloride tablets may be administered either
continuously (every day throughout
the menstrual cycle) or intermittently (only during the luteal phase
of the menstrual cycle, i.e.,