TRAZODONE HYDROCHLORIDE tablet 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:

DIRECT RX

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)]. 8.1 Pregnancy 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/m2in adolescents. There is also an increase in congenital anomalies in the rabbit at approximately 6 to 17 times the MRHD on mg/m2 basis in adolescents. There are no adequate and well-controlled studies in pregnant women. Trazodone hydrochloride should be used during pregnancy only if the potenti

Product summary:

Trazodone Hydrochloride Tablets USP, 150 mg are white to off-white, oval-shape, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on other side. The full bisected side of tablet is debossed with '8' on one side of bisect and '07' on other bisect segments 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). [Trazodone Hydrochloride Tablets USP] -For 150 mg, break the score down the middle of the tablet (one-half of a tablet). [Trazodone Hydrochloride Tablets USP] -For 200 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). [Trazodone Hydrochloride Tablets USP] -For 300 mg, use the entire tablet. [Trazodone Hydrochloride Tablets USP] Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET, FILM COATED
DIRECT RX
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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 or mood
What else do I need to know abo

Summary of Product characteristics

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET, FILM COATED
DIRECT RX
----------
TRAZODONE HYDROCHLORIDE
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behaviors
in pediatric and young adult
patients in short-term studies. Closely monitor all
antidepressant-treated patients for clinical
worsening, and for emergence of suicidal thoughts and behaviors [see
Warnings and Precautions
(5.1)]. Trazodone is not approved for use in pediatric patients [see
Use in Specific Populations
(8.4)].
Trazodone hydrochloride tablets are indicated for the treatment of
major depressive disorder (MDD) in
adults.
2.1 Dose Selection
An initial dose of 150 mg/day in divided doses is suggested. The
dosage should be initiated at a low-
dose and increased gradually, noting the clinical response and any
evidence of intolerance. Occurrence
of drowsiness may require the administration of a major portion of the
daily dose at bedtime or a
reduction of dosage.
The dose may be increased by 50 mg/day every 3 to 4 days. The maximum
dose for outpatients usually
should not exceed 400 mg/day in divided doses. Inpatients (i.e., more
severely depressed patients) may
be given up to but not in excess of 600 mg/day in divided doses.
Once an adequate response has been achieved, dosage may be gradually
reduced, with subsequent
adjustment depending on therapeutic response.
2.2 Improtant Administration Instructions
Trazodone hydrochloride tablets can be swallowed whole or administered
as a half tablet by breaking
the tablet along the score line.
Trazodone hydrochloride tablets should be taken shortly after a meal
or light snack.
2.3 Screen for Bipolar Disorder Prior to Starting Trazodone
Prior to initiating treatment with trazodone hydrochloride tablets or
another antidepressant, screen
patients for a personal or family history of bipolar disorder, mania,
or hypomania [see Warnings and
Precautions (5.7)].