TRAZODONE HYDROCHLORIDE- trazodone hydrochloride tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30)

Prieinama:

Unit Dose Services

INN (Tarptautinis Pavadinimas):

TRAZODONE HYDROCHLORIDE

Sudėtis:

TRAZODONE HYDROCHLORIDE 100 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 milk. Caut

Produkto santrauka:

Product: 50436-4688 NDC: 50436-4688-1 30 TABLET in a BOTTLE NDC: 50436-4688-2 60 TABLET in a BOTTLE

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

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, for oral
useInitial U.S. Approval: 1981

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TRAZODONE HYDROCHLORIDE-
trazodone hydrochloride tablet  Unit
Dose Services
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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 tr

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Prekės savybės

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
UNIT DOSE SERVICES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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, 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).
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Bisectable tablets of 50 mg, 100 mg and 150 mg (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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 in half along the score
line, 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 treatment (5.2, 7).
Activation of Mania/Hypomania: Screen for bipolar disorder and monitor
for mania/