TRAZODONE HYDROCHLORIDE- 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:

KAISER FOUNDATION HOSPITALS

INN (International Name):

TRAZODONE HYDROCHLORIDE

Composition:

TRAZODONE HYDROCHLORIDE 50 mg

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. 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. Trazodone and/or its metabolites have been found in the milk of lactating rats, suggesting that the drug may be secreted in human m

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 30, 50, 60 and 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, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

KAISER FOUNDATION HOSPITALS
----------
MEDICATION GUIDE
Trazodone Hydrochloride (traz' oh done hye'' droe klor' ide) Tablets
USP
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
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 aw

Summary of Product characteristics

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
KAISER FOUNDATION HOSPITALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAZODONE HYDROCHLORIDE TABLETS USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRAZODONE
HYDROCHLORIDE TABLETS USP.
TRAZODONE HYDROCHLORIDE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1981
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER
PSYCHIATRIC DISORDERS. TRAZODONE IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS ( 5.1).
INDICATIONS AND USAGE
Trazodone Hydrochloride Tablets USP are indicated for the treatment of
major depressive disorder ( 1).
• Efficacy was established in trials of trazodone immediate release
formulation in patients with major depressive disorder (
14).
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
Bisectable tablets of 50 mg, 100 mg and 150 mg ( 3).
CONTRAINDICATIONS
None ( 4).
WARNINGS AND PRECAUTIONS
• Clinical Worsening/Suicide Risk: Monitor for clinical worsening
and suicidal thinking and behavior ( 5.1).
• Serotonin Syndrome or Neuroleptic Malignant Syndrome-Like
Reactions: Have been reported with antidepressants. Discontinue
trazodone hydrochloride tablets and initiate supportive
treatment ( 5.2, 7).
• Activation of Mania/Hypomania: Screen for bipolar disorder and
mon