TRAZODONE HYDROCHLORIDE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Direct Rx

INN (nume internaţional):

TRAZODONE HYDROCHLORIDE

Compoziție:

TRAZODONE HYDROCHLORIDE 150 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Trazodone Hydrochloride Tablets USP are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of Trazodone Hydrochloride Tablets USP has been established in trials with the immediate release formulation of trazodone [see Clinical Studies ( 14)]. 8.1 Pregnancy 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. 8.3 Nursing Mothers Trazodone and/or its metabolites have been found in the milk of lactating r

Rezumat produs:

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 100 tablets (50111-433-01), 500 tablets (NDC 50111-433-02) and 1000 tablets (50111-433-03). 100 mg: White, round, compressed tablet, debossed “PLIVA 434” on one side and scored on the other side. Available in bottles of 100 tablets (50111-434-01), 500 tablets (NDC 50111-434-02) and 1000 tablets (NDC 50111-434-03). 150 mg: White, trapezoid, flat-faced, beveled edge tablet, scored and debossed as “PLIVA” bisect “441” on one side and tri-scored and debossed as “50” in each section on the other side. Available in bottles of 100 tablets (NDC 50111-441-01) and 500 tablets (50111-441-02). 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). [Image 1] - For 75 mg, break the score down the middle of the tablet (one-half of a tablet). [Image 2] - For 100 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). [Image 3] - For 150 mg, use the entire tablet. [Image 4] 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.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
DIRECT RX
----------
TRAZODONE HYDROCHLORIDE
HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATIONTHESE HIGHLIGHTS DO NOT INCLUDE
ALL THE
INFORMATION NEEDED TO USE TRAZODONE HYDROCHLORIDE TABLETS USP SAFELY
AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR TRAZODONE HYDROCHLORIDE TABLETS USP.
TRAZODONE HYDROCHLORIDE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1981WARNING: SUICIDALITY AND ANTIDEPRESSANT
DRUGSSEE
FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.RECENT MAJOR
CHANGES
Warnings and Precautions ( 5.12) 06/2014
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 and 150 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/hypomania ( 5.3).
• QT Prolongation: Increases the QT interval. Avoid use with drugs
that also increase the QT interval
and in patients with risk factors for prolonged