TRAZODONE HYDROCHLORIDE tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Trazodone Hydrochloride (UNII: 6E8ZO8LRNM) (Trazodone - UNII:YBK48BXK30)

Disponible depuis:

Oxford Pharmaceuticals, LLC

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 hydrochloride tablets use in pregnant women have not identifie

Descriptif du produit:

Trazodone hydrochloride tablets USP, 50 mg are white, film-coated, round, convex, scored tablets, debossed "8 | 84" on one side and debossed “O” on the other side. They are available as follows: Bottles of 100:   NDC 69584-884-10 Bottles of 500:   NDC 69584-884-50 Bottles of 1000: NDC 69584-884-90   Trazodone hydrochloride tablets USP, 100 mg are white, film-coated, round, convex, scored tablets, debossed "8 | 85" on one side and debossed “O” on the other side. They are available as follows: Bottles of 100:   NDC 69584-885-10 Bottles of 500:   NDC 69584-885-50 Bottles of 1000: NDC 69584-885-90   Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].   Dispense in a tight, light-resistant container as defined in the USP.   Dispense with Medication Guide available at: https:/www.oxford-rx.com/med-guides

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET, FILM COATED
Oxford Pharmaceuticals, LLC
----------
MEDICATION GUIDE
Trazodone Hydrochloride
(traz’ oh done hye” droe klor’ ide)
Tablets, for oral use
Dispense with Medication Guide available at:
https://www.oxford-rx.com/med-guides
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
�

Résumé des caractéristiques du produit

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET, FILM COATED
OXFORD PHARMACEUTICALS, 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, 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 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).
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
Scored tablets: 50 mg, 100 mg (3).
CONTRAINDICATIONS
Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within
14 days of stopping MAOIs (4).
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)
Orthostatic Hypotension and Syncope: Warn patients of risk and
symptoms of hypotension (5.4).
Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal
anti-inflammatory d