OLEPTRO (trazodone hydrochloride) extended-release tablets Initial U.S. Approval: 1981
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
See full prescribing information for complete boxed warning.
Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. Oleptro is not approved for use in pediatric patients (5.1).
----------------------------INDICATIONS AND USAGE---------------------------
Oleptro is indicated for the treatment of major depressive disorder (1).
• Efficacy was established in one 8-week trial of Oleptro as well as in trials of trazodone immediate release formulation in patients with major depressive disorder (14).
------------------------DOSAGE AND ADMINISTRATION----------------------
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Starting dose: 150 mg once daily. May be increased by 75 mg per day every three days. Maximum dose: 375 mg per day (2).
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Dosing at the same time every day in the late evening, preferably at bedtime, on an empty stomach (2).
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Tablets should be swallowed whole or broken in half along the score line, and should not be chewed or crushed (2).
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When discontinued, gradual dose reduction is recommended (2).
-----------------------DOSAGE FORMS AND STRENGTHS--------------------
Bisectable tablets of 150 mg or 300 mg (3).
--------------------------------CONTRAINDICATIONS-----------------------------
None (4).
-------------------------WARNINGS AND PRECAUTIONS----------------------
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Clinical Worsening/Suicide Risk: Monitor for clinical worsening and suicidal thinking and behavior (5.1).
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Serotonin Syndrome or Neuroleptic Malignant Syndrome-like Reactions: Have been reported with antidepressants. Discontinue Oleptro and initiate supportive treatment (5.2).
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Activation of Mania/Hypomania: Screen for bipolar disorder and monitor for mania/hypomania (5.3).
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QT Prolongation: Increases the QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval (5.4).
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Use in Patients with Heart Disease: Use with caution in patients with cardiac disease (5.5).
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Orthostatic Hypotension and Syncope: Have occurred. Warn patients of risk and symptoms of hypotension (5.6).
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Abnormal Bleeding: May increase the risk of bleeding. Use with NSAIDs, aspirin, or other drugs that affect coagulation may compound this risk (5.7).
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Interaction with MAOIs: Do not use concomitantly or within 14 days of monoamine oxidase inhibitors (5.8).
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Priapism: Has occurred. Warn male patients of this risk and how/when to seek medical attention (5.9).
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Hyponatremia: Can occur in association with SIADH (5.10).
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Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Advise patients to use caution when operating machinery (5.11).
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Discontinuation Symptoms: May occur with abrupt discontinuation and include anxiety and sleep disturbance. Upon discontinuation, taper Oleptro and monitor for symptoms (5.12).
---------------------------------ADVERSE REACTIONS---------------------------- Most common adverse reactions (incidence ≥5% and twice that of placebo) are: somnolence/sedation, dizziness, constipation, vision blurred (6).
To report SUSPECTED ADVERSE REACTIONS, contact Labopharm at 1-877-345-6177 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
---------------------------------DRUG INTERACTIONS----------------------------
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Monoamine Oxidase Inhibitors: Should not be used concomitantly with Oleptro (5.8, 7).
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CNS Depressants: Trazodone may enhance effects of alcohol, barbiturates, or other CNS depressants (7).
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CYP3A4 Inhibitors: May necessitate lower dose of Oleptro (7).
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CYP3A4 Inducers (e.g., carbamazepine): May necessitate higher dose of Oleptro (7).
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Digoxin or Phenytoin: Monitor for increased serum levels (7).
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Warfarin: Monitor for increased or decreased prothrombin time (7).
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Serotonergic Medications: Serotonin syndrome has been reported (5.2, 7).
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NSAIDs, Aspirin or other Anticoagulants: Potential for increased risk of bleeding (5.7, 7).
-------------------------USE IN SPECIFIC POPULATIONS----------------------
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Pregnancy: Based on animal data, may cause fetal harm (8.1).
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Nursing Mothers: Use with caution (8.3).
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Pediatric Patients: Oleptro is not approved in pediatric patients (8.4).
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Renal or Hepatic Impairment: Use with caution (8.6, 8.7).
