Itopra^® (Tablets) Instructions for Use

Marketing Authorization Holder

FP Obolenskoe, JSC (Russia)

Manufactured By

Ildong Pharmaceutical, Co., Ltd. (Republic of Korea)

Labeled By

Siberian Center of Pharmacology and Biotechnology, JSC (Russia)

Or

FP OBOLENSKOE, JSC (Russia)

Contact Information

ALIUM JSC (Russia)

ATC Code

A03FA (Gastrointestinal motility stimulants)

Active Substance

Itopride (Rec.INN registered by WHO)

Dosage Form

Itopra®

Film-coated tablets, 50 mg: 10, 20, 30, 40, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; on one side of the tablet, the marking “ID 50” is applied by embossing; the core on the cross-section is white or almost white.

Excipients : lactose monohydrate – 40 mg, corn starch – 10 mg, hypromellose – 4 mg, sodium carboxymethylcellulose – 15 mg, magnesium stearate – 3 mg.

10 pcs. – blister packs (aluminum/PVC) (1) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (2) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (3) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (4) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (5) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (10) – cardboard packs.

Clinical-Pharmacological Group

A drug that increases the tone and motility of the gastrointestinal tract. Acetylcholine release stimulant

Pharmacotherapeutic Group

GI motility stimulator – acetylcholine release stimulator

Pharmacological Action

A drug that stimulates gastrointestinal motility. Itopride enhances gastrointestinal motility due to antagonism of dopamine D₂ receptors and inhibition of acetylcholinesterase.

Itopride activates the release of acetylcholine and suppresses its degradation. Itopride has an antiemetic effect due to interaction with D₂ receptors located in the trigger zone. It causes dose-dependent suppression of vomiting induced by apomorphine.

Itopride activates the propulsive motility of the stomach due to antagonism with D₂ receptors and dose-dependent inhibition of acetylcholinesterase activity.

Itopride has a specific effect on the upper gastrointestinal tract, accelerates gastric transit, and improves its emptying.

It does not affect serum gastrin concentrations.

Indications

Symptomatic treatment of functional non-ulcer dyspepsia (chronic gastritis) including

• Abdominal bloating (flatulence);
• Pain or discomfort in the epigastric region (gastralgia);
• Anorexia;
• Heartburn;
• Nausea, vomiting;
• Feeling of rapid satiety.

ICD codes

Dosage Regimen

Administer orally, before meals.

The standard adult dosage is 50 mg (one tablet) three times daily.

The maximum recommended total daily dose is 150 mg.

Adjust the dosage for elderly patients and for patients with impaired renal or hepatic function; initiate therapy at a lower dose.

Do not exceed the prescribed daily dose.

Swallow the tablet whole with a glass of water; do not chew or crush.

The duration of treatment is determined by the prescribing physician based on symptom response.

Discontinue use if symptoms of gastrointestinal bleeding, obstruction, or perforation occur.

Monitor for potential adverse effects, including reversible increases in serum prolactin, liver transaminases, and allergic reactions.

Use with caution in patients with known lactose intolerance due to the excipient content.

Adverse Reactions

From the hematopoietic system: leukopenia, thrombocytopenia.

Allergic reactions: skin hyperemia, skin itching, rash, anaphylactic shock.

From the endocrine system: gynecomastia, increased prolactin level.

From the digestive system: increased salivation, nausea, diarrhea, constipation, abdominal pain, jaundice.

From the nervous system: headache, dizziness, tremor.

Laboratory parameters: increased activity of AST, ALT, GGT, ALP, bilirubin level.

Contraindications

• Hypersensitivity to itopride or any excipient of the drug;
• Gastrointestinal bleeding;
• Mechanical obstruction and perforation of the gastrointestinal tract;
• Children under 16 years of age;
• Pregnancy;
• Lactation (breastfeeding).

With caution: due to the presence of lactose in the drug, Itopride should be used with caution in congenital lactase deficiency, lactose intolerance, glucose-galactose malabsorption and in geriatrics in elderly patients with impaired liver and kidney function.

Use in Pregnancy and Lactation

The drug Itopra^® is contraindicated during pregnancy and lactation (breastfeeding).

Special Precautions

The drug Itopra^® should be used with caution in patients for whom the occurrence of cholinergic adverse reactions (associated with the enhancement of acetylcholine action under the influence of the drug) may worsen the course of the underlying disease.

No signs of withdrawal syndrome have been described upon discontinuation of the drug Itopra^®.

No special precautions are required for the destruction of unused medicinal product.

Effect on the ability to drive vehicles and machinery

The action of the drug components does not lead to impaired psychomotor reactions. However, due to possible side effects (dizziness, tremor), a decrease in concentration and an effect on the ability to drive a car and operate machinery cannot be ruled out.

Overdose

Cases of overdose in humans have not been described.

Treatment: in case of possible overdose, gastric lavage and symptomatic therapy are indicated.

Drug Interactions

Metabolic interaction is unlikely because itopride hydrochloride is metabolized by flavin monooxygenase, not CYP450.

No changes in protein binding were observed with simultaneous use of warfarin, diazepam, sodium diclofenac, ticlopidine hydrochloride, nifedipine and nicardipine hydrochloride.

Itopride hydrochloride enhances gastric motility, so the drug may affect the absorption of other drugs administered orally. Particular caution should be exercised when using drugs with a low therapeutic index, as well as sustained-release forms or enteric-coated drugs.

The prokinetic effect of itopride hydrochloride is not altered by the influence of antiulcer drugs (cimetidine, ranitidine, teprenone, cetraxate).

Anticholinergic drugs weaken the effect of the drug.

Storage Conditions

The drug should be stored out of the reach of children, in a dry, light-protected place at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.