Label: TRAZODONE HYDROCHLORIDE tablet
- NDC Code(s): 68382-805-01, 68382-805-05, 68382-805-06, 68382-805-10, view more
- Packager: Zydus Pharmaceuticals USA Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 8, 2022
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE ...
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Table of ContentsTable of Contents
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BOXED WARNING
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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)].
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1 INDICATIONS AND USAGETrazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
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2 DOSAGE AND ADMINISTRATION2.1 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 ...
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3 DOSAGE FORMS AND STRENGTHSTrazodone hydrochloride tablets, USP are available in the following strengths: Trazodone hydrochloride tablets USP, 50 mg are white to off-white, round-shape, biconvex beveled tablets, bisect ...
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4 CONTRAINDICATIONSTrazodone hydrochloride tablets are contraindicated in: Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or ...
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5 WARNINGS AND PRECAUTIONS5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients - In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that ...
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6 ADVERSE REACTIONSThe following serious adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behavior in Children, Adolescents and Young Adults [see Boxed Warning and Warnings ...
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7 DRUG INTERACTIONSMAOIs - MAOIs should not be used within 14 days of trazodone [see Warnings and Precautions (5.8)]. Central Nervous System (CNS) Depressants - Trazodone may enhance the response to alcohol ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers ...
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9 DRUG ABUSE AND DEPENDENCE9.1 Controlled Substance - Trazodone hydrochloride tablets are not a controlled substance. 9.2 Abuse - Although trazodone hydrochloride has not been systematically studied in preclinical or ...
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10 OVERDOSAGEDeath from overdose has occurred in patients ingesting trazodone and other CNS depressant drugs concurrently (alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or ...
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11 DESCRIPTIONTrazodone hydrochloride is a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride, USP is a triazolopyridine derivative designated as ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - The mechanism of trazodone's antidepressant action is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - No drug- or dose-related occurrence of carcinogenesis was evident in rats receiving trazodone in daily oral doses up ...
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14 CLINICAL STUDIESThe efficacy and safety of trazodone hydrochloride were established from inpatient and outpatient trials of the trazodone immediate release formulation in the treatment of major depressive ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGTrazodone 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 ...
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17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors - Advise patients and caregivers to look for the emergence of suicidality ...
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SPL UNCLASSIFIED SECTIONManufactured by: Zydus Lifesciences Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 - Rev.: 06/22
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SPL MEDGUIDEMEDICATION GUIDE - Trazodone Hydrochloride (traz' oh done hye'' droe klor' ide) Tablets USP, for oral use - What is the most important information I should know about trazodone ...
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PACKAGE LABEL.PRINCIPAL DISPLAY PANELNDC 68382-805-01 - Trazodone Hydrochloride Tablets USP, 50 mg - 100 Tablets - Rx only - Zydus - NDC 68382-806-01 - Trazodone Hydrochloride Tablets USP, 100 mg - 100 Tablets - Rx only - Zydus - NDC ...
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INGREDIENTS AND APPEARANCEProduct Information