![]() However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression. It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months. Thoughts or Behaviors per 1000 Patients Treated Table 1: Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patientsĭrug-Placebo Difference in Number of Patients of Suicidal Glaucoma 5.11 Hyponatremia 6 ADVERSE REACTIONS 6.1 Clinical TrialsĮxperience 7 DRUG INTERACTIONS 7.1 Drugs HavingĬlinically Important Interactions with Trazodone Hydrochloride Tablets 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 8.7 Hepatic Impairment 9 DRUG ABUSE AND DEPENDENCE 9.1 Controlled Substance 9.2 Abuse 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed. Of Treatment with Trazodone Hydrochloride Tablets 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Suicidal ThoughtsĪnd Behaviors in Pediatric and Young Adult Patients 5.2 SerotoninĬognitive and Motor Impairment 5.10 Angle-Closure Recommendations for Concomitant Use with Strong CYP3A4 Inhibitors or Inducers 2.6 Discontinuation ( 5.10).įULL PRESCRIBING INFORMATION: CONTENTS * WARNING: SUICIDAL THOUGHTS AND BEHAVIORS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Dose Selection 2.2 ImportantĪdministration Instructions 2.3 Screen forīipolar Disorder Prior to Starting Trazodone Hydrochloride Tablets 2.4 Switching to orįrom Monoamine Oxidase Inhibitor Antidepressant 2.5 Dosage Angle-Closure Glaucoma: Avoid use of antidepressants, including trazodone hydrochloride tablets, in patients with untreated anatomically narrow angles.Advise patients to use caution when operating machinery ( 5.9). Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills.Activation of Mania or Hypomania: Screen for bipolar disorder and monitor for mania or hypomania ( 5.7). ![]() Immediate medical attention should be sought if signs and symptoms of prolonged penile erections or priapism are observed ( 5.6). Priapism: Cases of painful and prolonged penile erections and priapism have been reported.Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk ( 5.5).Orthostatic Hypotension and Syncope: Warn patients of risk and symptoms of hypotension ( 5.4).Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval ( 5.3) Cardiac Arrhythmias: Increases the QT interval.If it occurs, discontinue trazodone hydrochloride tablets and initiate supportive treatment ( 5.2). Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone.
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