TRAZODONE HYDROCHLORIDE tablet

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:

AvKARE

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. 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 mi

產品總結:

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 90 tablets (42291-833-90) and 1,000 tablets (42291-833-10). 100 mg: White, round, compressed tablets, debossed “PLIVA 434” on one side and scored on the other side. Available in bottles of 90 tablets (42291-834-90) and 1,000 tablets (42291-834-10). 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 90 tablets (42291-835-90) and 500 tablets (42291-835-50). 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. 300 mg: White, oval, flat-faced, beveled-edge tablet with one side scored with a full bisect and having two partial trisects. Debossed with stylized barr/733 on one side and 100 100 100 on the other side with the middle 100 perpendicular to the others. Available in bottles of 100 tablets (42291-836-01). Directions for using the correct score when breaking the tablet, please refer to the following: -For 100 mg, break the score on either the left or right side of the tablet (one-third of a tablet). -For 150 mg, break the score down the middle of the tablet (one-half of a tablet). -For 200 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 300 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). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

授权状态:

Abbreviated New Drug Application

资料单张

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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 away if you have any of

产品特点

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
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HIGHLIGHTS OF PRESCRIBING INFORMATION
TRAZODONE HYDROCHLORIDE TABLETS USP
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAZODONE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
TRAZODONE HYDROCHLORIDE TABLETS.
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, 150 mg, and 300 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
monitor for mania/