TRAZODONE HCL tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Advanced Rx Pharmacy of Tennessee, LLC

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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)]. 8.1 Pregnancy 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

Tóm tắt sản phẩm:

Trazodone Hydrochloride Tablets USP, 50 mg are white to off-white, round-shape, biconvex beveled tablets, bisect on one side and plain on other side. The bisected side of tablet is debossed with '8' on upper side of bisect and '05' on lower side of bisect and are supplied as follows: Bottles of 30 Tablets NDC: 80425-0176-01 Bottles of 60 Tablets NDC: 80425-0176-02 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°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

TRAZODONE HCL- TRAZODONE HCL TABLET
Advanced Rx Pharmacy of Tennessee, LLC
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MEDICATION GUIDE
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
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 irritability
Acting aggressive, being angry or violent
Acting on dangerous impulses
An extreme incre

Đặc tính sản phẩm

TRAZODONE HCL- TRAZODONE HCL TABLET
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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TRAZODONE HCL 50MG TABLETS
BOXED WARNING
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behaviors
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)]. Trazodone is not
approved for
use in pediatric patients [see Use in Specific Populations (8.4)].
1. INDICATIONS AND USAGE
Trazodone hydrochloride tablets are indicated for the treatment of
major depressive
disorder (MDD) in adults.
2. DOSAGE AND ADMINISTRATION
2.1 Dose Selection
An initial dose of 150 mg/day in divided doses is suggested. The
dosage should be
initiated at a low-dose and increased gradually, noting the clinical
response and any
evidence of intolerance. Occurrence of drowsiness may require the
administration of a
major portion of the daily dose at bedtime or a reduction of dosage.
The dose may be increased by 50 mg/day every 3 to 4 days. The maximum
dose for
outpatients usually should not exceed 400 mg/day in divided doses.
Inpatients (i.e.,
more severely depressed patients) may be given up to but not in excess
of 600 mg/day
in divided doses.
Once an adequate response has been achieved, dosage may be gradually
reduced, with
subsequent adjustment depending on therapeutic response.
2.2 Improtant Administration Instructions
Trazodone hydrochloride tablets can be swallowed whole or administered
as a half tablet
by breaking the tablet along the score line.
Trazodone hydrochloride tablets should be taken shortly after a meal
or light snack.
2.3 Screen for Bipolar Disorder Prior to Starting Trazodone
Prior to initiating treatment with trazodone hydrochloride tablets or
another
antidepressant, screen patients for a personal or family history of
bipolar disorder,
mania, or hypomania [see Warnings and Precautions (5.7)].
2.4 Switchning to or from Mon