TRAZODONE HYDROCHLORIDE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Direct_Rx

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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)]. 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/ Risk Summary Published prospective cohort studies, case series, and case reports over several decades with trazodone hydrochloride tablets use in pregnant women have no

Dettagli prodotto:

Trazodone Hydrochloride Tablets USP, 50 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 '05' on lower side of bisect and are supplied as follows: in bottle of 30 tablets in bottle of 90 tablets in bottle of 100 tablets in bottle of 500 tablets in bottle of 1000 tablets in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets 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: in bottle of 30 tablets in bottle of 90 tablets in bottle of 100 tablets in bottle of 500 tablets in bottle of 1000 tablets in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Trazodone Hydrochloride Tablets USP, 150 mg are white to off-white, oval-shape, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on other side. The full bisected side of tablet is debossed with '8' on one side of bisect and '07' on other bisect segments and are supplied as follows: in bottle of 30 tablets in bottle of 90 tablets in bottle of 100 tablets in bottle of 500 tablets in bottle of 1000 tablets in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets 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). [Trazodone Hydrochloride Tablets USP] -For 75 mg, break the score down the middle of the tablet (one-half of a tablet). [Trazodone Hydrochloride Tablets USP] -For 100 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). [Trazodone Hydrochloride Tablets USP] -For 150 mg, use the entire tablet. [Trazodone Hydrochloride Tablets USP] Trazodone Hydrochloride Tablets USP, 300 mg are white to off-white, oval-shape, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on other side. The full bisected side of tablet is debossed with '8' on one side of bisect and '08' on other bisect segment and are supplied as follows: in bottle of 30 tablets in bottle of 90 tablets in bottle of 100 tablets in bottle of 500 tablets in bottle of 1000 tablets in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets 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). [Trazodone Hydrochloride Tablets USP] -For 150 mg, break the score down the middle of the tablet (one-half of a tablet). [Trazodone Hydrochloride Tablets USP] -For 200 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). [Trazodone Hydrochloride Tablets USP] -For 300 mg, use the entire tablet. [Trazodone Hydrochloride Tablets USP] 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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

TRAZODONE HYDROCHLORIDE- TRAZODONE HYDROCHLORIDE TABLET
DIRECT_RX
----------
TRAZODONE HYDROCHLORIDE
WARNING: SUICIDAL THOUGHTS and BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behaviors
in pediatric
and young adult patients in short-term studies. Closely monitor all
antidepressant-
treated patients for clinical worsening, and for emergence of suicidal
thoughts and
behaviors [see Warnings and Precautions (5.1)]. Trazodone is not
approved for
use in pediatric patients [see Use in Specific Populations (8.4)].
Trazodone hydrochloride tablets are indicated for the treatment of
major depressive
disorder (MDD) in adults.
2.1 Dose Selection
An initial dose of 150 mg/day in divided doses is suggested. The
dosage should be
initiated at a low-dose and increased gradually, noting the clinical
response and any
evidence of intolerance. Occurrence of drowsiness may require the
administration of a
major portion of the daily dose at bedtime or a reduction of dosage.
The dose may be increased by 50 mg/day every 3 to 4 days. The maximum
dose for
outpatients usually should not exceed 400 mg/day in divided doses.
Inpatients (i.e.,
more severely depressed patients) may be given up to but not in excess
of 600 mg/day
in divided doses.
Once an adequate response has been achieved, dosage may be gradually
reduced, with
subsequent adjustment depending on therapeutic response.
2.2 Improtant Administration Instructions
Trazodone hydrochloride tablets can be swallowed whole or administered
as a half tablet
by breaking the tablet along the score line.
Trazodone hydrochloride tablets should be taken shortly after a meal
or light snack.
2.3 Screen for Bipolar Disorder Prior to Starting Trazodone
Prior to initiating treatment with trazodone hydrochloride tablets or
another
antidepressant, screen patients for a personal or family history of
bipolar disorder,
mania, or hypomania [see Warnings and Precautions (5.7)].
2.4 Switchning to or from Monoamine Oxidase Inhibitor Antidepressant
At least 14 days must elapse between dis