SERTRALINE HYDROCHLORIDE tablet, film coated

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

DIRECT RX

INN（国際名）:

SERTRALINE HYDROCHLORIDE

構図:

SERTRALINE 50 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 b

製品概要:

Sertraline Hydrochloride Tablets USP, 25 mg are green colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘6’ on the other side. 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. Sertraline Hydrochloride Tablets USP, 100 mg are yellow colored, biconvex, capsule shaped film coated tablets debossed with ‘A’ on one side and with a score line in between ‘1’ and ‘8’ on the other side. Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59° to 86°F) [See USP Controlled Room Temperature].

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
DIRECT RX
----------
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 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 (overactive reflexes)

製品の特徴

SERTRALINE HYDROCHLORIDE- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
DIRECT RX
----------
SERTRALINE HCL
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
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 intermittently (only during the luteal phase of
the menstrual cycle, i.e., starting the
daily dosage 14 days prior to the anticipated onset of menstruation
and continuing through the onset of
menses). Intermittent dosing would be repeated with each new cycle.
When dosing continuously, patients not responding to a 50 mg dosage
may benefit from dosage
increases at 50 mg increments per menstrual cycle up to 150 mg per
day.
When dosing intermittently, patient