Motonium® tablets 10 mg

Instructions for use Motonium® tablets 10 mg

Trade name of the drug: Motonium^®

International nonproprietary name: Domperidone

Dosage form: film-coated tablets

Composition per one film-coated tablet:

Active substance: Domperidone - 10.0 mg

Excipients:

• Lactose monohydrate - 48.44 mg,
• Microcrystalline cellulose - 10.0 mg,
• Povidone (low molecular weight polyvinylpyrrolidone) - 10.0 mg,
• Glycerol (glycerin) - 0.56 mg,
• Magnesium stearate - 1.0 mg,
• Corn starch - up to a core tablet weight of 100.0 mg

Description:

Round, biconvex, film-coated tablets, white in color; the core is white on cross-section.

Pharmacotherapeutic group:

Antiemetic agent, dopamine receptor blocker (central).

ATC code: A03FA03

Pharmacological action

Pharmacodynamics

Blocks peripheral and central (in the trigger zone of the brain) dopamine receptors, eliminates the inhibitory effect of dopamine on the motor function of the gastrointestinal tract, and enhances gastric evacuation and motor activity. It has an antiemetic effect, relieves hiccups, and eliminates nausea. Increases the concentration of prolactin in the blood serum.

Pharmacokinetics

Absorption after oral administration on an empty stomach is rapid (administration after meals, reduced gastric acidity slow down and reduce absorption). Time to reach maximum concentration (T_max) - 1 hour. Bioavailability - 15% (due to first-pass metabolism in the liver). Plasma protein binding - 90%. Penetrates into various tissues, poorly crosses the blood-brain barrier. Metabolized in the liver and intestinal wall (via hydroxylation and N-dealkylation). Excreted via the intestines - 66%, by the kidneys - 33%, including unchanged - 10% and 1%, respectively. Half-life - 7-9 hours; in severe chronic renal failure, it is prolonged.

Indications for use

• Vomiting and nausea of various origins (including due to functional and organic diseases, infections, toxemia, radiation therapy, dietary errors, drug-induced - intake of morphine, apomorphine, levodopa, and bromocriptine; during endoscopic and radiological contrast studies of the gastrointestinal tract), hiccups, gastrointestinal atony (including postoperative); the need to accelerate peristalsis during radiological contrast studies of the gastrointestinal tract.
• Dyspeptic disorders associated with delayed gastric emptying, gastroesophageal reflux, and esophagitis: feeling of fullness in the epigastrium, sensation of abdominal bloating, flatulence, gastralgia, belching, heartburn with or without regurgitation of gastric contents into the oral cavity.

Contraindications

Hypersensitivity, gastrointestinal bleeding, mechanical intestinal obstruction, perforation of the stomach or intestine, prolactinoma, children under 5 years of age and children with body weight under 20 kg.

With caution

Renal and/or hepatic insufficiency, lactation period, pregnancy.

Use during pregnancy and lactation

Use of the drug during pregnancy or breastfeeding is permissible only if the expected benefit to the mother outweighs the potential risk to the fetus and child.

Dosage and administration

Orally, 30 minutes before meals.

Adults and children over 5 years with chronic dyspeptic symptoms: 10 mg 3-4 times daily and, if necessary, additionally before bedtime. For severe nausea and vomiting: 20 mg 3-4 times daily and before bedtime.

For severe nausea and vomiting in children: 5 mg/10 kg body weight 3-4 times daily and before bedtime. If necessary, the dose can be doubled. For patients with renal insufficiency, dose adjustment is necessary; the frequency of administration should not exceed 1-2 times per day.

Adverse reactions

Gastrointestinal disorders: transient intestinal spasms.

Nervous system disorders: extrapyramidal disorders (in children and in individuals with increased permeability of the blood-brain barrier).

Allergic reactions: skin rash, urticaria.

Other: hyperprolactinemia (galactorrhea, gynecomastia).

Overdose

Symptoms: drowsiness, disorientation, extrapyramidal disorders (especially in children).

Treatment: administration of activated charcoal; for extrapyramidal disorders - anticholinergic drugs, antiparkinsonian or antihistamine drugs with anticholinergic properties.

Drug interactions

Cimetidine, sodium bicarbonate reduce the bioavailability of domperidone. Anticholinergic drugs neutralize the effect of domperidone.

The following increase the plasma concentration of domperidone: azole antifungal agents, macrolide antibiotics, HIV protease inhibitors, nefazodone (an antidepressant). Compatible with the use of antipsychotic drugs (neuroleptics), dopaminergic receptor agonists (bromocriptine, levodopa).

Concurrent administration with paracetamol and digoxin did not affect the blood concentrations of these drugs.

Information on possible influence on the ability to drive vehicles and operate machinery

No specific data available.

Dosage form

Film-coated tablets 10 mg. 10 tablets in a blister strip. 30 tablets in a polymer jar.

1, 2, 3, 4, or 5 blister packs or 1 jar, together with the instructions for use, are placed in a cardboard carton.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of reach of children.

Shelf life

2 years. Do not use after the expiration date printed on the packaging.

Prescription status:

By prescription.

Manufacturer/Organization accepting claims:

JSC "AVVA RUS", Russia, 610044, Kirov, Luganskaya st., 53A.