Trittico Trazodone Hydrochloride Sustained-release Tablets

1. Indications and Usage
Major Depressive Disorder (MDD): Treatment of adult patients with major depressive disorder, with or without anxiety.
2. Dosage and Administration
Route of Administration: Oral administration ONLY.
Recommended Dosage: Starting dose is typically 150 mg/day in divided doses. The dose may be gradually increased to a maximum of 400 mg/day depending on patient response and tolerability.
Critical Administration Instructions:
Timing: Should be taken after a meal or light snack to minimize gastrointestinal distress.
Swallowing: Tablets must be swallowed whole; do not crush, chew, or break.
Discontinuation: Do not stop abruptly. Taper the dose gradually to avoid withdrawal symptoms.
3. Mechanism of Action
Serotonin Modulation: Trazodone is a serotonin antagonist and reuptake inhibitor (SARI).
Receptor Binding: It inhibits the reuptake of serotonin (5-HT) and antagonizes 5-HT2A receptors.
Sedative Effect: Its strong antagonism at alpha-1 adrenergic and histamine H1 receptors contributes to its sedative properties, making it useful for improving sleep continuity in depressed patients.
4. Safety and Warnings
Suicidal Ideation: Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (≤24 years) during short-term use.
Priapism: A medical emergency requiring immediate intervention. Patients must be advised to discontinue the drug and seek immediate medical attention if an erection persists for more than 4 hours.
Serotonin Syndrome: Risk increases when used with other serotonergic drugs (e.g., SSRIs, triptans).
Cardiovascular Effects: May cause orthostatic hypotension, syncope, and arrhythmias (e.g., QT prolongation), especially in elderly patients.
Discontinuation Syndrome: Abrupt cessation can lead to nausea, headache, and malaise.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Somnolence, dry mouth, headache, dizziness, and blurred vision.
Serious Adverse Reactions: Priapism, severe skin reactions (e.g., Stevens-Johnson syndrome), and serotonin syndrome.
Clinical Research Highlights: Clinical trials demonstrated efficacy in reducing depressive symptoms and improving sleep quality compared to placebo.
6. Drug Interactions
CYP3A4 Inhibitors: Strong inhibitors (e.g., ketoconazole, ritonavir) can significantly increase trazodone exposure and the risk of adverse effects (e.g., cardiac arrhythmias).
Serotonergic Drugs: Concomitant use with SSRIs, SNRIs, or triptans increases the risk of serotonin syndrome.
Anticoagulants: May increase the risk of bleeding when used with warfarin or other anticoagulants.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Trazodone Hydrochloride.
Appearance: Film-coated tablets (typically 100 mg or 150 mg).
Packaging: Blister packaging.
Storage: Store at controlled room temperature; protect from moisture and light.