TRAZODONE HYDROCHLORIDE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Bryant Ranch Prepack

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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-research-programs/ pregnancyregistry/ antidepressants/ Risk Summary Published prospective cohort studies, case series, and case reports over several decades with trazodone hydrochloride tablets use in pregnant women have not identi

Toote kokkuvõte:

NDC: 63629-8139-1: 30 Tablets in a BOTTLE NDC: 63629-8139-2: 90 Tablets in a BOTTLE

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

Bryant Ranch Prepack
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SPL MEDGUIDE
MEDICATION GUIDE
Trazodone Hydrochloride (traz' oh done hye'' droe klor' ide)
Tablets USP, for oral use
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
1.
Antidepressant medicines may increase suicidal thoughts or actions in
some children,
teenagers, and young adults within the first few months of treatment.
2.
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.
3.
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 irritability
•
Acting aggressive, being angry or violent
•
Acting on dangerous impulses
•
A

Toote omadused

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
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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 IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (8.4)
INDICATIONS AND USAGE
Trazodone is 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).
Trazodone hydrochloride tablets should be taken shortly after a meal
or light snack (2).
Tablets should be swallowed whole or broken in half along the score
line, and should not be chewed or
crushed (2).
When discontinued, gradual dose reduction is recommended (2).
DOSAGE FORMS AND STRENGTHS
Scored tablets of 50mg, 100mg, 150 mg and 300 mg (3).
CONTRAINDICATIONS
None (4).
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 and initiate
supportive treatment (5.2).
CARDIAC ARRHYTHMIAS: Increases the QT interval. Avoid use with drugs
that also increase the QT
interval and in patients with risk factors for prolonged QT interval
(5.3)
ORTHOSTATIC HYPOTENSION AND SYNCOPE: Warn patients of risk and