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:

St. Mary's Medical Park Pharmacy

INN (nume internaţional):

TRAZODONE HYDROCHLORIDE

Compoziție:

TRAZODONE HYDROCHLORIDE 100 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults. Trazodone hydrochloride tablets are contraindicated in: -   Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7.1)]. Teratogenic Effects Pregnancy Category C Trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 6 to 9 times the maximum recommended human dose (MRHD) of 400 mg/day on mg/m 2 in adolescents. There is also an increase in congenital anomalies in the rabbit at approximately 6 to 17 times the MRHD  on mg/m 2 basis in adolescents. 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. Animal Data No teratogenic effects were observed when trazodone was given to pregnant rats and rabbits during the period of organogenesis at oral doses up to 450 mg/kg/day. This dose is 9 and 17 times, in rats and rabbits, respectively, the maximum recommended human dose (MRHD) of 400 mg/day on mg/m 2 basis in adolescents. Increased fetal resorption and other adverse effects on the fetus in rats at 6 to 9 times the MRHD and increase in congenital anomalies in rabbits at 6 to 17 times the MRHD on mg/m 2 basis in adolescents were observed. 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 exercised when trazodone is administered to a nursing woman. Safety and effectiveness in the pediatric population have not been established.  Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [ see Boxed Warning, Warnings and Precautions ( 5.1) ]. Reported clinical literature and experience with trazodone has not identified differences in responses between elderly and younger patients. However, as experience in the elderly with trazodone hydrochloride is limited, it should be used with caution in geriatric patients. Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients who may be at greater risk for this adverse reaction [ see Warnings and Precautions (5.11) ]. Trazodone has not been studied in patients with renal impairment. Trazodone should be used with caution in this population. Trazodone has not been studied in patients with hepatic impairment. Trazodone should be used with caution in this population. Trazodone hydrochloride tablets are not a controlled substance. Although trazodone hydrochloride has not been systematically studied in preclinical or clinical studies for its potential for abuse, no indication of drug-seeking behavior was seen in the clinical studies with trazodone hydrochloride.

Rezumat produs:

Trazodone Hydrochloride Tablets USP, 100 mg are white to off-white, round-shape, biconvex beveled tablets, bisect on one side and plain on other side. The bisected side of tablet is debossed with '8' on upper side of bisect and '06' on lower side of bisect and are supplied as follows: NDCs 60760-806-60 BOTTLES OF 60 60760-806-30 BOTTLES OF 30 - INACTIVE Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
ST. MARY'S MEDICAL PARK PHARMACY
----------
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: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ANTIDEPRESANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIORS
IN PEDIATRIC
AND YOUNG ADULT PATIENTS (5.1)
CLOSELY MONITOR FOR CLINICAL WORSENING AND EMERGENCE OFSUICIDAL
THOUGHTS AND
BEHAVIORS (5.1)
TRAZODONE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (8.4)
INDICATIONS AND USAGE
Trazodone is a selective serotonin reuptake inhibitor indicated for
the treatment of major depressive
disorder (MDD) (1). (1)
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 (2.1).
Trazodone hydrochloride tablets should be taken shortly after a meal
or light snack (2.2).
Tablets should be swallowed whole or broken in half along the score
line (2.2).
When discontinued, gradual dose reduction is recommended (2.6).
DOSAGE FORMS AND STRENGTHS
Scored tablets of 50mg, 100mg, 150 mg and 300 mg ( 3).
CONTRAINDICATIONS
None ( 4).
Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within
14 days of stopping MAOIs
(4).
WARNINGS AND PRECAUTIONS
SEROTONIN SYNDROME: Increased risk when co-administered with other
serotonergic agents (e.g.,
SSRI, SNRI, triptans), but also when taken alone. If it occurs,
discontinue trazodone and initiate supportive
treatment (5.2). (5)
CARDIAC ARRHYTHMIAS: Increases the QT interval. Avoid use with drugs
that also increase the QT
interval and in patients with risk factors for prolonged QT interval
(5.3)
ORTHOSTATIC HYPOTENSION AND SYNCOPE: Warn patients of risk and
symptoms