TRAZODONE HYDROCHLORIDE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Proficient Rx LP

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Trazodone hydrochloride tablets, USP are indicated for the treatment of major depressive disorder (MDD) in adults. Trazodone hydrochloride tablets are contraindicated in: 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 use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels app

Ringkasan produk:

Trazodone Hydrochloride Tablets, USP 50 mg are available for oral administration as white to off white, round, biconvex, uncoated tablets debossed with "13" bisect "30" on one side and plain on other side. Bottles of 30                         NDC 71205-505-30 Bottles of 60                         NDC 71205-505-60 Bottles of 90                         NDC 71205-505-90     Directions for using the correct score when breaking the tablet, please refer to the following:  - For 50 mg, break the score on either the left or right side of the tablet (one-third of a tablet). Store at 20° to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] . Dispense with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
Proficient Rx LP
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MEDICATION GUIDE
Trazodone hydrochloride tablets, USP, for oral use
(traz' oh done hye" droe klor' ide)
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

Karakteristik produk

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAZODONE HYDROCHLORIDE
TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR TRAZODONE
HYDROCHLORIDE TABLETS, USP.
TRAZODONE HYDROCHLORIDE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1981
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
INDICATIONS AND USAGE
Trazodone hydrochloride tablets, USP are a selective serotonin
reuptake inhibitor indicated for the
treatment of major depressive disorder (MDD) ( 1).
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ANTIDEPRESANTS 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)
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).
Scored tablets: 50 mg, 100 mg, 150 mg and 300 mg ( 3).
Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within
14 days of stopping MAOIs (
4).
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 t