TRAZODONE HYDROCHLORIDE tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

MedVantx, Inc.

INN（国际名称）:

Trazodone Hydrochloride

组成:

Trazodone Hydrochloride 50 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of trazodone hydrochloride tablets has been established in trials with the immediate release formulation of trazodone [see Clinical Studies (14)] . None. 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 – 50 times the proposed maximum human dose. There was also an increase in congenital anomalies in one of three rabbit studies at approximately 15 – 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 milk. Caution should be exercis

產品總結:

Trazodone hydrochloride tablets, USP are available as follows: Trazodone hydrochloride tablets 50 mg are scored, white, film coated, round, debossed MP 118 Bottles of 30 NDC 53489-510-07 Bottles of 100 NDC 53489-510-01 Trazodone hydrochloride tablets 100 mg are scored, white, film coated, round, debossed MP 114 Bottles of 30 NDC 53489-511-07 Bottles of 100 NDC 53489-511-01 Trazodone hydrochloride tablets 150 mg are scored in the divided dose design, white, round, debossed on one side and MP 168 on the reverse side. Bottles of 30 NDC 53489-517-07 Bottles of 100 NDC 53489-517-01 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

授权状态:

Abbreviated New Drug Application

资料单张

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET, FILM COATED
MedVantx, Inc.
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MEDICATION GUIDE
Trazodone hydrochloride 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 healthcar

产品特点

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET, FILM COATED
MEDVANTX, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAZODONE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TRAZODONE.
TRAZODONE HYDROCHLORIDE TABLETS, 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 are indicated for the treatment of
major depressive disorder (1).
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Bisectable tablets of 50 mg, 100 mg or 150 mg (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5% and twice that of
placebo) are: somnolence/sedation, dizziness,
constipation, vision blurred (6).
Efficacy was established in trials of trazodone immediate release
formulation in patients with major depressive
disorder (14).
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 along the score lines, and
should not be chewed or crushed (2).
When discontinued, gradual dose reduction is recommended (2).
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
tre