TRAZODONE HYDROCHLORIDE- trazodone hydrochloride tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

American Health Packaging

DCI (Denominação Comum Internacional):

TRAZODONE HYDROCHLORIDE

Composição:

TRAZODONE HYDROCHLORIDE 150 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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)]. Teratogenic Effects Pregnancy Category C 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 approximately 6 to 9 times the maximum recommended human dose (MRHD) of 400 mg/day on mg/m 2 in adolescents. There was also an increase in congenital anomalies in the rabbit at approximately 6 to 17 times the MRHD on mg/m 2 basis in adolescents . There are no adequate and well-controlled studies in pregnant women. Trazodone hydrochloride should be used during pregnancy only if the po

Resumo do produto:

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. Unit dose packages of 100 (10 x 10) NDC 68084-608-01 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. 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]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

American Health Packaging
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MEDICATION GUIDE
8260801/0418
Trazodone hydrochloride tablets, USP, for oral use
(traz' oh done hye'' droe klor' ide)
Read the Medication Guide that comes with trazodone hydrochloride
tablets before you start taking it and
each time you get a refill. There may be new information. This
information does not take the place of
talking to your healthcare provider about your medical condition or
treatment. Talk to your healthcare
provider or pharmacist if there is something you do not understand or
you want to learn about trazodone
hydrochloride tablets.
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

Características técnicas

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
AMERICAN HEALTH PACKAGING
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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, USP 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 HYDROCHLORIDE TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS ( 8.4)
INDICATIONS AND USAGE
Trazodone hydrochloride tablets are 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 ( 2.1).
Trazodone hydrochloride tablets should be taken shortly after a meal
or light snack ( 2.2).
Tablets should be swallowed whole or broken in half along the score
line ( 2.2).
When discontinued, gradual dose reduction is recommended ( 2.6).
DOSAGE FORMS AND STRENGTHS
Bisectable tablets 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 patients
with risk factors for prolonged QT interval ( 5.3).
Orth