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:

Watson Laboratories, Inc.

INN (International Name):

Trazodone Hydrochloride

Pharmaceutical form:

TABLET

Composition:

50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Trazodone hydrochloride is indicated for the treatment of depression. The efficacy of trazodone has been demonstrated in both inpatient and out-patient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association’s Diagnostic and Statistical Manual, III.a Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts. This product is contraindicated in patients hypersensitive to trazodone.

Product summary:

Trazodone Hydrochloride Tablets USP, 50 mg are scored, round, white, film-coated tablets imprinted DAN DAN and 5600 supplied in bottles of 100 and 1000. Trazodone Hydrochloride Tablets USP, 100 mg are scored, round, white, film-coated tablets imprinted DAN DAN and 5599 supplied in bottles of 100 and 1000. Dispense in a tight, light-resistant container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]

Patient Information leaflet

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
Watson Laboratories, Inc.
----------
MEDICATION GUIDE
ANTIDEPRESSANT MEDICINES, DEPRESSION AND OTHER SERIOUS MENTAL
ILLNESSES,
AND SUICIDAL THOUGHTS OR ACTIONS
Read the Medication Guide that comes with you or your family
member’s antidepressant medicine. This
Medication Guide is only about the risk of suicidal thoughts and
actions with antidepressant medicines.
Talk to your, or your family member’s, healthcare provider about:
•
all risks and benefits of treatment with antidepressant medicines
•
all treatment choices for depression or other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression and
other serious mental illnesses, and suicidal thoughts or actions?
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 particularly high 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
in myself or a family
member?
•
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 the healthcare provider right away to report new or sudden
changes in mood, behavior,
thoughts, or feelings.
•
Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare provider
between visits as needed, especially if you have concerns about
symptoms.
Call a healthcare provider right away if you or your family member has
any of the following symptoms,
especially if they are new, worse, or wo

Summary of Product characteristics

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
WATSON LABORATORIES, INC.
----------
TRAZODONE
HYDROCHLORIDE TABLETS USP
REVISED: AUGUST 2007
RX ONLY
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 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 IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE
WARNINGS: CLINICAL
WORSENING AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND
PRECAUTIONS:
PEDIATRIC USE)
DESCRIPTION
Trazodone hydrochloride is an antidepressant chemically unrelated to
tricyclic, tetracyclic, or other
known antidepressant agents. Trazodone hydrochloride is a
triazolopyridine derivative designated as 2-
[3-[4-(_m_-Chlorophenyl)-1-piperazinyl]propyl]_s_-triazolo[4,3-_a_]-pyridin-3(2_H
_)-one monohydrochloride.
It is a white orderless crystalline powder which is freely soluble in
water. The structural formula is
represented below:
C H CLN O•HCL
M.W. 4 08.32
Trazodone hydrochloride is supplied for oral administration in 50 mg
or 100 mg tablets.
Trazodone Hydrochloride Tablets USP