TRAZODONE HYDROCHLORIDE tablet

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 USP are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of trazodone hydrochloride tablets USP has been established in trials with the immediate release formulation of trazodone [see Clinical Studies (14)]. None. 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 two studies using the rat when given at dose levels approximately 30 to 50 times the proposed maximum human dose. There was also an increase in congenital anomalies in one of three rabbit studies at approximately 15 to 50 times the maximum human dose. There are no adequate and well-controlled studies in pregnant women. Trazodone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 8.3 Nursing Mothers Trazodone and/or its metabolites have been found in the milk of lactating rats, suggesting that th

Product summary:

Trazodone hydrochloride tablets USP are available as follows: 50 mg: White, round, compressed tablet, debossed “PLIVA 433” on one side and scored on the other side. Available in bottles of 100, 500 and 1000. 100 mg: White, round, compressed tablets, debossed “PLIVA 434” on one side and scored on the other side. Available in bottles of 100, 500 and 1000 Tablets and Unit Dose Blisters of 100 (10 x 10) Tablets. 150 mg: White, trapezoid, flat-face, beveled edge tablet, scored and debossed as “PLIVA” and “441” on one side and tri-scored and debossed as “50” in each section on the other side. Available in bottles of 100 and 500 Tablets. 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° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
DIRECT RX
----------
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 about antidepres

Summary of Product characteristics

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
DIRECT_RX
----------
TRAZODONE HYDROCHLORIDE
BOXED WARNING SECTION
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
ANTIDEPRESSANTS INCREASED THE RISK COMPARED TO PLACEBO OF SUICIDAL
THINKING AND BEHAVIOR
(SUICIDALITY) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM
STUDIES OF MAJOR
DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS. ANYONE
CONSIDERING THE USE OF
TRAZODONE HYDROCHLORIDE TABLETS OR ANY OTHER ANTIDEPRESSANT IN A
CHILD, ADOLESCENT, OR
YOUNG ADULT MUST BALANCE THIS RISK WITH THE CLINICAL NEED. SHORT-TERM
STUDIES DID NOT SHOW
AN INCREASE IN THE RISK OF SUICIDALITY WITH ANTIDEPRESSANTS COMPARED
TO PLACEBO IN ADULTS
BEYOND AGE 24; THERE WAS A REDUCTION IN RISK WITH ANTIDEPRESSANTS
COMPARED TO PLACEBO IN
ADULTS AGED 65 AND OLDER. DEPRESSION AND CERTAIN OTHER PSYCHIATRIC
DISORDERS ARE
THEMSELVES ASSOCIATED WITH INCREASES IN THE RISK OF SUICIDE. PATIENTS
OF ALL AGES WHO ARE
STARTED ON ANTIDEPRESSANT THERAPY SHOULD BE MONITORED APPROPRIATELY
AND OBSERVED CLOSELY
FOR CLINICAL WORSENING, SUICIDALITY, OR UNUSUAL CHANGES IN BEHAVIOR.
FAMILIES AND CAREGIVERS
SHOULD BE ADVISED OF THE NEED FOR CLOSE OBSERVATION AND COMMUNICATION
WITH THE PRESCRIBER.
TRAZODONE HYDROCHLORIDE TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS [SEE
WARNINGS AND PRECAUTIONS (5.1) AND PATIENT COUNSELING INFORMATION
(17.1)].
INDICATIONS & USAGE SECTION
Trazodone hydrochloride tablets USP are indicated for the treatment of
major depressive disorder
(MDD) in adults. The efficacy of trazodone hydrochloride tablets USP
has been established in trials
with the immediate release formulation of trazodone [see Clinical
Studies (14)].
DOSAGE & ADMINISTRATION SECTION
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.
Trazodone hydrochloride tablets should
be taken short