Itopride 50 mg 30 tablets

Description:

Itopride 50 mg is an oral gastroprokinetic medication containing itopride hydrochloride — a benzamide derivative with a dual mechanism of action: dopamine D2 receptor antagonist and acetylcholinesterase inhibitor. It increases acetylcholine activity, improving gastrointestinal motility, accelerating gastric emptying, and enhancing coordination in the upper GI tract. It also has an antiemetic effect by acting on D2 receptors in the chemoreceptor trigger zone.

Pharmacological Action:

Stimulates gastric motility
Increases lower esophageal sphincter tone
Accelerates gastric emptying
Improves gastroduodenal coordination
Provides antiemetic action
Does not affect serum gastrin levels
Clinical studies confirm effectiveness in functional dyspepsia.

Indications for Use:

Treatment of symptoms related to impaired gastric motility and delayed gastric emptying:
Bloating
Early satiety
Feeling of fullness after meals
Pain or discomfort in the upper abdomen
Loss of appetite
Heartburn
Nausea and vomiting
Functional (non-ulcer) dyspepsia
Chronic gastritis.

Dosage and Administration:

Adults:

Recommended daily dose: 150 mg
One tablet (50 mg) three times daily before meals
Dosage may be adjusted depending on age and symptom severity
Treatment duration: up to 8 weeks.

Contraindications:

Hypersensitivity to itopride or any components of the drug
Conditions where increased GI motility is dangerous:
Gastrointestinal bleeding
Mechanical obstruction
GI perforation.

Precautions and Warnings:

May cause cholinergic side effects due to increased acetylcholine activity
Contains lactose; not recommended for patients with:
Hereditary galactose intolerance
Lapp lactase deficiency
Glucose-galactose malabsorption syndrome.

Side Effects:

Common:
GI: Abdominal pain, diarrhea
Nervous system: Dizziness, headache.

Uncommon:
GI: Increased salivation
Skin: Rash
Laboratory tests: Elevated ALT, decreased leukocyte count.

Post-marketing data (frequency unknown):
Blood: Leukopenia, thrombocytopenia
Immune system: Hypersensitivity, anaphylactoid reactions
Endocrine system: Increased prolactin levels
GI: Constipation, nausea, increased salivation
Liver: Jaundice, elevated liver enzymes
Skin: Erythema, itching
Reproductive system: Gynecomastia
Laboratory tests: Elevated AST, ALT, GGT, ALP, bilirubin.

Storage Conditions:

Store at temperatures not exceeding 30°C
Protect from moisture; keep in a dry place.

Packaging:

Cardboard box containing 3 blisters of 10 tablets each and an instruction leaflet.