TRAZODONE HYDROCHLORIDE 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:

Denton Pharma, Inc. dba Northwind Pharmaceuticals

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)]. 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

Tóm tắt sản phẩm:

Trazodone hydrochloride tablets, USP 100 mg having functional scoring are available for oral administration as white to off white, round, biconvex, uncoated tablets Engraved “IT” bisect “100” on one side and plain on the other side. Bottles of 30 (NDC 70934-620-30) Bottles of 90 (NDC 70934-620-90) -For 100 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°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 HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
Denton Pharma, Inc. dba Northwind Pharmaceuticals
----------
MEDICATION GUIDE
Trazodone Hydrochloride Tablets
(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

Đặc tính sản phẩm

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
----------
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._
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 TABLET IS NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS ( 8.4)
INDICATIONS AND USAGE
Trazodone hydrochloride 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
Bisectable tablets having functional scoring of 50 mg, 100 mg, 150 mg
and 300 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 pati