Trazodone Hydrochloride (Page 4 of 7)
6.2 Postmarketing Experience
The following adverse reactions have been identified during post-approval use of trazodone hydrochloride tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure:
Blood and lymphatic system disorders: hemolytic anemia, leukocytosis
Cardiac disorders: cardiospasm, congestive heart failure, conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, ventricular ectopic activity, including ventricular tachycardia and QT prolongation. Prolonged QT interval, torsade de pointes, and ventricular tachycardia have been reported at doses of 100 mg per day or less [see Warnings and Precautions (5.3)].
Endocrine disorders: inappropriate ADH syndrome
Eye disorders: diplopia
Gastrointestinal disorders: increased salivation, nausea/vomiting
General disorders and administration site conditions: chills, edema, unexplained death, weakness
Hepatobiliary disorders: cholestasis, jaundice, hyperbilirubinemia, liver enzyme alterations
Investigations: increased amylase
Metabolism and nutrition disorders: methemoglobinemia
Nervous system disorders: aphasia, ataxia, cerebrovascular accident, extrapyramidal symptoms, grand mal seizures, paresthesia, tardive dyskinesia, vertigo
Psychiatric disorders: abnormal dreams, agitation, anxiety, hallucinations, insomnia, paranoid reaction, psychosis, stupor
Renal and urinary disorders: urinary incontinence, urinary retention
Reproductive system and breast disorders: breast enlargement or engorgement, clitorism, lactation, priapism [see Warnings and Precautions (5.6)]
Respiratory, thoracic and mediastinal disorders: apnea
Skin and subcutaneous tissue disorders: alopecia, hirsutism, leukonychia, pruritus, psoriasis, rash, urticaria
Vascular disorders: vasodilation
7 DRUG INTERACTIONS
7.1 Drugs Having Clinically Important Interactions with Trazodone Hydrochloride Tablets
Table 3: Clinically Important Drug Interactions with Trazodone Hydrochloride Tablets | |
Monoamine Oxidase Inhibitors (MAOIs) | |
Clinical Impact: | The concomitant use of MAOIs and serotonergic drugs including trazodone hydrochloride tablets increases the risk of serotonin syndrome. |
Intervention: | Trazodone hydrochloride tablets are contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Contraindications (4), Dosage and Administration (2.3, 2.4), and Warnings and Precautions (5.2)]. |
Examples: | isocarboxazid, moclobemide, phenelzine, selegiline, tranylcypromine |
Other Serotonergic Drugs | |
Clinical Impact: | The concomitant use of serotonergic drugs including trazodone hydrochloride tablets and other serotonergic drugs increases the risk of serotonin syndrome. |
Intervention: | Monitor patients for signs and symptoms of serotonin syndrome, particularly during trazodone hydrochloride tablets initiation. If serotonin syndrome occurs, consider discontinuation of trazodone hydrochloride tablets and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2)]. |
Examples: | triptans, antidepressants (tricyclic and serotonin uptake inhibitors), fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort |
Antiplatelet Agents and Anticoagulants | |
Clinical Impact: | Serotonin release by platelets plays an important role in hemostasis. The concurrent use of an antiplatelet agent or anticoagulant with trazodone hydrochloride tablets may potentiate the risk of bleeding. |
Intervention: | Inform patients of the increased risk of bleeding with the concomitant use of trazodone hydrochloride tablets and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio (INR) when initiating or discontinuing trazodone hydrochloride tablets [see Warnings and Precautions (5.5)]. |
Examples: | warfarin, rivaroxaban, dabigatran, clopidogrel |
Strong CYP3A4 Inhibitors | |
Clinical Impact: | The concomitant use of trazodone hydrochloride tablets and strong CYP3A4 inhibitors increased the exposure of trazodone compared to the use of trazodone hydrochloride tablets alone. |
Intervention: | If trazodone hydrochloride tablets is used with a potent CYP3A4 inhibitor, the risk of adverse reactions, including cardiac arrhythmias, may be increased and a lower dose of trazodone hydrochloride tablets should be considered [see Dosage and Administration (2.5), Warnings and Precautions (5.3)]. |
Examples: | itraconazole, ketoconazole, clarithromycin, indinavir |
Strong CYP3A4 Inducers | |
Clinical Impact: | The concomitant use of trazodone hydrochloride tablets and strong CYP3A4 inducers decreased the exposure of trazodone compared to the use of trazodone hydrochloride tablets alone. |
Intervention: | Patients should be closely monitored to see if there is a need for an increased dose of trazodone hydrochloride tablets when taking CYP3A4 inducers [see Dosage and Administration (2.5)]. |
Examples: | rifampin, carbamazepine, phenytoin, St. John’s wort |
Digoxin and Phenytoin | |
Clinical Impact: | Digoxin and phenytoin are narrow therapeutic index drugs. Concomitant use of trazodone hydrochloride tablets can increase digoxin or phenytoin concentrations. |
Intervention: | Measure serum digoxin or phenytoin concentrations before initiating concomitant use of trazodone hydrochloride tablets. Continue monitoring and reduce digoxin or phenytoin dose as necessary. |
Examples: | digoxin, phenytoin |
Central Nervous System (CNS) Depressants | |
Clinical Impact: | Trazodone hydrochloride tablets may enhance the response CNS depressants. |
Intervention: | Patients should be counseled that trazodone hydrochloride tablets may enhance the response to alcohol, barbiturates, and other CNS depressants. |
Examples: | alcohol, barbiturates |
QT Interval Prolongation | |
Clinical Impact: | Concomitant use of drugs that prolong the QT interval may add to the QT effects of trazodone hydrochloride tablets and increase the risk of cardiac arrhythmia. |
Intervention: | Avoid the use of trazodone hydrochloride tablets in combination with other drugs known to prolong QTc [see Warnings and Precautions (5.3)]. |
Examples: | Class 1A antiarrhythmics: quinidine, procainamide, disopyramide; Class 3 antiarrhythmics: amiodarone, sotalol; Antipsychotics: ziprasidone, chlorpromazine, thioridazine; Antibiotics: gatifloxacin |
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/trazodone-hydrochloride-65/page/4/