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:

Aphena Pharma Solutions - 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)]. 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

Tóm tắt sản phẩm:

Trazodone hydrochloride tablets, USP 50 mg are available for oral administration as white, round, biconvex, tablets. Engraved “APO” bisect “T50” on one side, other side plain. Bottles of 100 (NDC 60505-2653-1) Bottles of 500 (NDC 60505-2653-5) Unit Dose Blister Packages of 100 (10 x 10 unit dose) (NDC 60505-2653-0) Trazodone hydrochloride tablets, USP 100 mg are available for oral administration as white, round, biconvex, tablets. Engraved “APO” bisect “T100” on one side, other side plain. Bottles of 100 (NDC 60505-2654-1) Bottles of 500 (NDC 60505-2654-5) Unit Dose Blister Packages of 100 (10 x 10 unit dose) (NDC 60505-2654-0) Trazodone hydrochloride tablets, USP 150 mg are available for oral administration as white, oval, flat faced beveled-edge tablets with a full bisect and 2 partial trisects. Engraved “APO” bisect “T150” on one side, and “50 50 50” on the other side. Bottles of 100 (NDC 60505-2655-1) Bottles of 500 (NDC 60505-2655-5) 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). -For 75 mg, break the score down the middle of the tablet (one-half of a tablet). -For 100 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 150 mg, use the entire tablet. Trazodone hydrochloride tablets, USP 300 mg are available for oral administration as white, oval, flat faced beveled-edge tablets with a full bisect and 2 partial trisects. Engraved “APO” bisect “T300” on one side, and “100 100 100” on the other side with the middle “100” perpendicular to the others. Bottles of 100 (NDC 60505-2659-1) Bottles of 500 (NDC 60505-2659-5) Directions for using the correct score when breaking the tablet, please refer to the following: -For 100 mg, break the score on either the left or right side of the tablet (one-third of a tablet).  -For 150 mg, break the score down the middle of the tablet (one-half of a tablet). -For 200 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 300 mg, use the entire tablet. Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 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
Aphena Pharma Solutions - Tennessee, LLC
----------
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 aggressiv

Đặc tính sản phẩm

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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, USP 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 TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS (8.4)
INDICATIONS AND USAGE
Trazodone hydrochloride tablets are 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 of 50mg, 100mg ,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 patients with risk factors for pr