TRAZODONE HYDROCHLORIDE tablet, film coated TRAZODONE HYDROCHLORIDE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30)

Verfügbar ab:

Sun Pharmaceutical Industries, Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults. Trazodone hydrochloride tablets are contraindicated in: - Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7.1)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/ pregnancyregistry/antidepressants/ Risk Summary Published prospective cohort studies, case series, and case reports over several decades with DESYREL use in preg

Produktbesonderheiten:

Trazodone hydrochloride tablets, USP are available as follows: Trazodone hydrochloride tablets, USP 50 mg are white, round, convex, bisected, film-coated tablets, debossed 'S/14' on one side and having break-line on other side. Bottles of 100 CRC NDC 57664-514-72 Bottles of 500 NCRC NDC 57664-514-74 Bottles of 1000 NCRC NDC 57664-514-75 Trazodone hydrochloride tablets, USP 100 mg are white, round, convex, bisected, film-coated tablets, debossed 'S/26' on one side and break line on other side Bottles of 100 CRC NDC 57664-026-72 Bottles of 500 NCRC NDC 57664-026-74 Bottles of 1000NCRC NDC-57664-026-75 Trazodone hydrochloride tablets, USP 150 mg are white, round, flat-faced bevelled, quadrisected tablets, debossed "S53" on one side and having 'break-line' on other side (quadrisect). Bottles of 100 CRC NDC 57664-053-72 Bottles of 500 NCRC NDC-57664-053-74 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET, FILM COATED
TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Trazodone ( TRAYZ-oh-dohn) hydrochloride tablets, USP
What is the most important information I should know about trazodone
hydrochloride tablets?
Antidepressant medicines, depression or other serious mental
illnesses, and suicidal thoughts or actions:
Talk to your healthcare provider about:
•
All risks and benefits of treatment with antidepressant medicines
•
All treatment choices for depression or other serious mental illnesses
•
Antidepressant medicines may increase suicidal thoughts or actions in
some children, teenagers,
and young adults within the first few months of treatment.
•
Depression and other serious mental illnesses are the most important
causes of suicidal thoughts
and actions. Some people may have a higher risk of having suicidal
thoughts or actions. These
include people who have or have a family history of bipolar illness
(also called manic-depressive
illness) or suicidal thoughts or actions.
•
How can I watch for and try to prevent suicidal thoughts and actions?
•
Pay close attention to any changes, especially sudden changes in mood,
behaviors, thoughts, or
feelings. This is very important when an antidepressant medicine is
started or when the dose is
changed.
•
Call your healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts or feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare
provider between visits as needed, especially if you are worried about
symptoms.
Call a healthcare provider right away if you have any of the following
symptoms, especially if they are
new, worse, or worry you:
•
Thoughts about suicide or dying
•
Attempts to commit suicide
•
New or worse depression
•
New or worse anxiety
•
Feeling very agitated or restless
•
Panic attacks
•
Trouble sleeping (insomnia)
•
New or worse i

Fachinformation

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET, FILM COATED
TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAZODONE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
TRAZODONE HYDROCHLORIDE TABLETS.
TRAZODONE HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1981
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)
TRAZODONE HYDROCHLORIDE TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS (
8.4)
INDICATIONS AND USAGE
Trazodone hydrochloride tablets are a selective serotonin reuptake
inhibitor indicated for the treatment of
major depressive disorder (MDD) ( 1).
DOSAGE AND ADMINISTRATION
Starting dose: 150 mg in divided doses daily. May be increased by 50
mg per day every three to four
days. Maximum dose: 400 mg per day in divided doses ( 2.1).
Trazodone hydrochloride tablets should be taken shortly after a meal
or light snack ( 2.2).
Tablets should be swallowed whole or broken in half along the score
line ( 2.2).
When discontinued, gradual dose reduction is recommended ( 2.6).
DOSAGE FORMS AND STRENGTHS
Bisectable tablets of 50 mg, 100 mg and 150 mg ( 3).
CONTRAINDICATIONS
Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within
14 days of stopping MAOIs ( 4).
WARNINGS AND PRECAUTIONS
Serotonin Syndrome: Increased risk when co-administered with other
serotonergic agents (e.g., SSRI,
SNRI, triptans), but also when taken alone. If it occurs, discontinue
trazodone hydrochloride tablets and
initiate supportive treatment ( 5.2).
Cardiac Arrhythmias: Increases the QT interval. Avoid use with drugs
that also increase the QT interval
and in