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 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 ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    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 USAGE
    Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
  • 2 DOSAGE AND ADMINISTRATION
    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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Trazodone 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 ...
  • 4 CONTRAINDICATIONS
    Trazodone hydrochloride tablets are contraindicated in:   Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 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 ...
  • 6 ADVERSE REACTIONS
    The 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 ...
  • 7 DRUG INTERACTIONS
    MAOIs - 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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    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 ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Trazodone hydrochloride tablets are not a controlled substance. 9.2 Abuse - Although trazodone hydrochloride has not been systematically studied in preclinical or ...
  • 10 OVERDOSAGE
    Death from overdose has occurred in patients ingesting trazodone and other CNS depressant drugs concurrently (alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or ...
  • 11 DESCRIPTION
    Trazodone hydrochloride is a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist.  Trazodone hydrochloride, USP is a triazolopyridine derivative designated as ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 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 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 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 ...
  • 14 CLINICAL STUDIES
    The 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 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    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 ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise 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 ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 - Rev.: 06/22
  • SPL MEDGUIDE
    MEDICATION 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 ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 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 ...
  • INGREDIENTS AND APPEARANCE
    Product Information