Trittico Trazodone Hydrochloride Sustained-release Tablets

1. Indications and Usage
Major Depressive Disorder (MDD):
Treatment of major depressive disorder (with or without anxiety) in adults.
2. Dosage and Administration
Route of Administration:
For Oral Use ONLY.
Recommended Dosage:
Starting Dose: Typically 150 mg once daily.
Titration: Dose can be increased by 75 mg/day at intervals of every 3 days based on clinical response and tolerability.
Maintenance: Recommended dose range is 150 mg to 300 mg once daily.
Maximum Dose: Typically 400–600 mg/day (depending on severity and formulation).
Critical Administration Instructions:
Take with Food: Should be taken during or after a meal (within 1 hour after a meal). Taking on an empty stomach increases peak plasma levels and may worsen dizziness or orthostatic hypotension.
Swallow Whole: Tablets should generally be swallowed whole to maintain the sustained-release profile.
3. Mechanism of Action
SARI Profile:
Trazodone is a multifunctional drug with a unique pharmacological profile.
Antagonist Activity:
5-HT2A Antagonist: Acts as a potent antagonist at serotonin 5-HT2A receptors (contributing to antidepressant and anxiolytic effects).
Alpha-1 Antagonist: Blocks alpha-1 adrenergic receptors (causing sedation and orthostatic hypotension).
Histamine Antagonist: Blocks H1 receptors (contributing to sedative effects).
Reuptake Inhibition:
Weakly inhibits the reuptake of serotonin (5-HT) via the serotonin transporter (SERT).
4. Safety and Warnings
Suicidal Thoughts and Behaviors (Boxed Warning):
Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults.
Priapism:
A rare but serious condition (prolonged erection) that requires immediate medical attention to prevent permanent impotence.
Orthostatic Hypotension:
Can cause a drop in blood pressure upon standing, leading to syncope (fainting), falls, and injury.
Cardiac Arrhythmias:
May cause QT prolongation and ventricular arrhythmias (e.g., Torsades de Pointes). Contraindicated in patients with acute myocardial infarction.
Serotonin Syndrome:
Risk increases when combined with other serotonergic drugs.
5.Adverse Reactions
Most Common:
Somnolence, sedation, dizziness, dry mouth, headache, fatigue, nausea, and vomiting.
6.Drug Interactions
MAO Inhibitors (Contraindicated):
Contraindicated within 14 days of discontinuing an MAOI due to the risk of serotonin syndrome and hypertensive crisis.
CYP3A4 Inhibitors:
Strong inhibitors (e.g., ketoconazole, ritonavir) can significantly increase trazodone plasma levels; dose reduction is necessary.
QT-Prolonging Drugs:
Concomitant use with other QT-prolonging drugs is not recommended.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Trazodone Hydrochloride.
Available Strength: 75 mg, 150 mg tablets.
Appearance: White to off-white, long-shaped tablets with score lines.
Storage: Store at controlled room temperature (20°C to 25°C).