SERTRALINE tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

RedPharm Drug, Inc.

INN (International Adı):

SERTRALINE HYDROCHLORIDE

Kompozisyon:

SERTRALINE 50 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 birt

Ürün özeti:

Sertraline Hydrochloride Tablets USP, 25 mg Green colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D01' on the other side. NDC 68180-351-06 Bottles of 30 NDC 68180-351-08 Bottles of 50 NDC 68180-351-09 Bottles of 90 NDC 68180-351-01 Bottles of 100 NDC 68180-351-03 Bottles of 1000 Sertraline Hydrochloride Tablets USP, 50 mg Blue colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D02' on the other side. NDC 68180-352-06 Bottles of 30 NDC 68180-352-09 Bottles of 90 NDC 68180-352-01 Bottles of 100 NDC 68180-352-02 Bottles of 500 NDC 68180-352-03 Bottles of 1000 NDC 68180-352-05 Bottles of 5000 NDC 68180-352-11 Box containing 10 x 10's unit dose blisters Sertraline Hydrochloride Tablets USP, 100 mg Yellow colored, capsule shaped, biconvex, film-coated tablets, debossed with 'L' and 'U' on either side of the breakline on one side and 'D03' on the other side. NDC 68180-353-06 Bottles of 30 NDC 68180-353-09 Bottles of 90 NDC 68180-353-01 Bottles of 100 NDC 68180-353-02 Bottles of 500 NDC 68180-353-03 Bottles of 1000 NDC 68180-353-05 Bottles of 5000 NDC 68180-353-11 Box containing 10 x 10's unit dose blisters Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

SERTRALINE- sertraline tablet, film coated
RedPharm Drug, Inc.
----------
MEDICATION GUIDE
Medication Guide
Sertraline Hydrochloride (ser' tra leen hye'' droe klor' ide) Tablets
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.
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 thefirst
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
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 (overactive refl

Ürün özellikleri

SERTRALINE- SERTRALINE TABLET, FILM COATED
REDPHARM DRUG, INC.
----------
BOXED WARNING
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)].
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
sertraline hydrochloride
tablets safely and effectively. See full prescribing information for
sertraline hydrochloride
tablets.
SERTRALINE hydrochloride tablets, for oral use
Initial U.S. Approval: 1991
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Antidepressants increased the risk of suicidal thoughts and behaviors
in pediatric and
young adult patients (5.1)
Closely monitor for clinical worsening and emergence of suicidal
thoughts and behaviors
(5.1)
INDICATIONS AND USAGE
Sertraline hydrochloride tablet is a selective serotonin reuptake
inhibitor (SSRI) indicated
for the treatment of (1):
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Post-traumatic stress disorder (PTSD)
Social anxiety disorder (SAD)
Premenstrual dysphoric disorder (PMDD)
DOSAGE AND ADMINISTRATION
Indication
Starting Dosage
Maximum Dosage
MDD (2.1)
50 mg per day
200 mg per day
OCD (2.1)
25 mg per day (ages 6 to 12)
200 mg per day
50 mg per day (ages ≥ 13)
PD, PTSD, SAD (2.1)
25 mg per day
200 mg per day
PMDD (2.2) continuous dosing
50 mg per day
150 mg per day
PMDD (2.2) intermittent dosing
50 mg per day during luteal phase only
100 mg per day during luteal phase only
If inadequate response to starting dosage, titrate in 25 to 50 mg per
day increments
once weekly in MDD, OCD, PD, PTSD, and SAD (2.1)
See Full Prescribing Information for titration in PMDD (2.2)
Hepatic impairment:
Mild: Recommended starting and maximum dosage i