TRAZODONE HYDROCHLORIDE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Trazodone Hydrochloride (UNII: 6E8ZO8LRNM) (trazodone - UNII:YBK48BXK30)

Commercializzato da:

Contract Pharmacy Services-PA

INN (Nome Internazionale):

Trazodone Hydrochloride

Composizione:

Trazodone Hydrochloride 50 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Trazodone hydrochloride tablets are indicated for the treatment of depression. The efficacy of trazodone has been demonstrated in both inpatient and outpatient 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 two 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. Trazodone hydrochloride tablets are contraindicated in patients hypersensitive to tra

Dettagli prodotto:

Trazodone Hydrochloride Tablets USP, 50 mg are white, film-coated, round, convex, scored tablets, debossed “61” bisect “60” on one side and debossed “V” on the reverse side. 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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
Contract Pharmacy Services-PA
----------
MEDICATION GUIDE
Rx only
Antidepressant Medicines, Depression and other Serious Mental
Illnesses, and Suicidal Thoughts or
Actions
Read the Medication Guide that comes with your 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, wor

Scheda tecnica

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
CONTRACT PHARMACY SERVICES-PA
----------
TRAZODONE HYDROCHLORIDE TABLETS, USP
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 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, 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-(3-chlorophenyl)-1-piperazinyl]
propyl]-1,2,4-triazolo[4,3-a]pyridin-3 (2_H_)-one hydrochloride. It
is a white odorless crystalline powder which is freely soluble in
water. It has a structural formula as
follows:
Each tablet for oral administration contains 50 mg or 100 mg of
trazodone hydrochloride.
Trazodone hydrochloride tablets 50 mg and 100 mg contain the inactive
ing