SERTRALINE HYDROCHLORIDE tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Advanced Rx Pharmacy of Tennessee, LLC

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 birth defects i

產品總結:

Sertraline Hydrochloride Tablets USP, 50 mg are blue colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘7’ on the other side. Bottles of 30 Tablets NDC: 80425-0200-01 Bottles of 60 Tablets NDC: 80425-0200-02 Bottles of 90 Tablets NDC: 80425-0200-03 Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [See USP Controlled Room Temperature].

授权状态:

Abbreviated New Drug Application

资料单张

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
Advanced Rx Pharmacy of Tennessee, LLC
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MEDGUIDE
Sertraline Hydrochloride Tablets USP
(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 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
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 m

产品特点

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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SERTRALINE HCL 50MG TABLETS
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)].
1. INDICATIONS AND USAGE
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. DOSAGE AND ADMINISTRATION
2.1 Dosage in Patients with MDD, OCD, PD, PTSD, and SAD
The recommended initial dosage and maximum sertraline hydrochloride
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 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 in
Patients with MDD,
OCD, PD, PTSD, and SAD
Indication
Starting Dose
Therapeutic Range
Adults
MDD
50 mg
50 to 200 mg
OCD
50 mg
PD, PTSD, SAD
25 mg
Pediatric Patients
OCD (ages 6 to 12 years old)
25 mg
50 to 200 mg
<>OCD (ages 13 to 17 years old)
50 mg
2.2 Dosage in Patients with PMDD
The recommended starting sertraline hydrochloride dosage in adult
women with PMDD is
50 mg per day. Sertraline hydrochloride may be administered either
continuously (every
day throughout the menstrual cycle) or intermit