Yitian Itopride Hydrochloride Capsules

1. Indications and Usage
Gastrointestinal Disorders: Treatment of chronic gastritis and functional dyspepsia characterized by abdominal fullness, pain, bloating, and discomfort.
2. Dosage and Administration
Adults: The usual dosage is 1 capsule (50 mg) taken 3 times daily, 30 minutes before meals.
Administration: Capsules should be swallowed with water.
Duration: If symptoms do not improve after 1 to 2 weeks of treatment, the medication should be discontinued.
3. Mechanism of Action
Dopamine Antagonism: Itopride hydrochloride acts as a competitive antagonist at dopamine D2 receptors in the gastrointestinal tract.
Acetylcholine Release: It also inhibits acetylcholinesterase, which increases the concentration of acetylcholine in the enteric nervous system.
Prokinetic Effects: These dual actions enhance gastrointestinal motility, accelerate gastric emptying, and improve digestive symptoms.
4. Safety and Warnings
Contraindications: Contraindicated in patients with gastrointestinal hemorrhage, mechanical obstruction, or perforation.
Special Populations: Use with caution in patients with hepatic or renal impairment. Safety in pregnant or breastfeeding women has not been fully established.
Monitoring: Patients should be monitored for signs of adverse reactions, particularly in the elderly.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Diarrhea, abdominal pain, dry mouth, dizziness, and headache may occur occasionally.
Other Effects: Elevations in liver function tests, leukopenia, and hyperprolactinemia-related symptoms (e.g., galactorrhea, gynecomastia) have been reported.
6. Drug Interactions
Anticholinergics: Concomitant use with anticholinergic drugs may reduce the prokinetic effects of itopride.
CYP Enzymes: Itopride is metabolized by CYP enzymes; inhibitors or inducers of these enzymes may alter its plasma concentrations.
7. Pharmaceutical Information
Active Ingredient: Itopride Hydrochloride.
Strength: Each capsule typically contains 50 mg of itopride hydrochloride.
Appearance: Capsules are usually white or off-white.
Storage: Store in a well-closed, dry place at temperatures not exceeding 30°C.