TRAZODONE HYDROCHLORIDE- trazodone hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

St. Mary's Medical Park Pharmacy

INN (International Name):

TRAZODONE HYDROCHLORIDE

Composition:

TRAZODONE HYDROCHLORIDE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)]. 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 in

Product summary:

Trazodone hydrochloride tablets USP, 100 mg are white, film-coated, round, convex, scored tablets, debossed “61” bisect “61” on one side and debossed “V” on the reverse side. They are available as follows: NDC 60760-434-60 BOTTLES OF 60 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP/NF.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

St. Mary's Medical Park Pharmacy
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MEDICATION GUIDE
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 or violent
•
Acting on dangerous impulses
•
An extreme increase in activity and talking (mania)
•
Other unusual changes in behavior

Summary of Product characteristics

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET, FILM COATED
ST. MARY'S MEDICAL PARK PHARMACY
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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, 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 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
Scored tablets: 50 mg, 100 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