Motonium^® (Tablets, Suspension) Instructions for Use

ATC Code

A03FA03 (Domperidone)

Active Substance

Domperidone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Centrally acting antiemetic drug blocking dopamine receptors

Pharmacotherapeutic Group

Antiemetic agent – central dopamine receptor blocker

Pharmacological Action

Antiemetic agent. It has an antiemetic effect, soothes hiccups and in some cases eliminates nausea.

The action is due to the blockade of central dopamine receptors.

Due to this, the inhibitory effect of dopamine on the motor function of the gastrointestinal tract is eliminated and the evacuation and motor activity of the stomach increases.

Pharmacokinetics

Absorption after oral administration on an empty stomach is rapid (administration after meals, reduced gastric acidity slow down and reduce absorption).

C_max is reached in 1 h.

Bioavailability is 15% (first-pass effect through the liver).

Plasma protein binding is 90%.

It penetrates into various tissues, poorly passes through the blood-brain barrier.

It is metabolized in the liver and in the intestinal wall (by hydroxylation and N-dealkylation).

It is excreted through the intestine 66%, by the kidneys – 33%, including unchanged – 10% and 1%, respectively.

T_1/2 is 7-9 h, in severe chronic renal failure – it is prolonged.

Indications

Nausea, vomiting, hiccups of various origins (in toxemia, radiation therapy, dietary disorders, intake of certain drugs /morphine/, endoscopic and radiopaque studies, in the postoperative period).

Postoperative hypotension and atony of the stomach and intestines, biliary dyskinesia, flatulence, reflux esophagitis, cholecystitis, cholangitis, various types of dyspepsia.

Nausea and vomiting caused by the intake of dopamine mimetics.

ICD codes

Dosage Regimen

Administer orally.

Determine the dose individually based on the patient’s age, body weight, and clinical presentation.

For adults and adolescents aged 12 years and older with a body weight of 35 kg or more, the usual dose is 10 mg (one tablet or 10 ml of suspension) taken three to four times daily.

Take the dose 15-30 minutes before meals and, if necessary, before bedtime.

Do not exceed the maximum daily dose of 30 mg.

The duration of treatment should not exceed one week for nausea and vomiting; reassess the patient if symptoms persist.

For children aged 5 to 11 years with a body weight of 20 kg or more, use only the oral suspension.

The pediatric dose is 0.25 mg per kg of body weight, administered three to four times daily.

For a child weighing 20 kg, this equates to 5 ml of suspension per dose.

Do not exceed a single dose of 10 mg or a total daily dose of 30 mg for this age group.

For children aged 1 to 4 years, use only the oral suspension under strict medical supervision.

The dose is 0.25 mg per kg of body weight, given three to four times daily.

Calculate the exact volume using the suspension’s concentration.

This medication is contraindicated in children under 1 year of age and in children under 5 years or weighing less than 20 kg for the tablet formulation.

In patients with moderate to severe renal impairment (serum creatinine >6 mg/100 ml), reduce the dosing frequency to once or twice daily.

Monitor these patients closely.

Exercise caution and consider dose reduction in patients with hepatic impairment.

Adverse Reactions

From the central nervous system rarely – increased excitability and/or extrapyramidal disorders, headache.

From the digestive system spasms of the smooth muscles of the gastrointestinal tract, dry mouth, thirst.

Allergic reactions itching, rash, urticaria.

Other increased plasma prolactin level, galactorrhea, gynecomastia.

Contraindications

Gastrointestinal bleeding, mechanical intestinal obstruction, perforation of the stomach or intestine, prolactinoma, pregnancy, lactation period (breastfeeding), hypersensitivity to domperidone; children under 12 years of age and body weight less than 35 kg (for tablets).

Use in Pregnancy and Lactation

Domperidone is contraindicated for use during pregnancy and lactation.

Use in Hepatic Impairment

It should be used with caution in case of liver function disorders.

Use in Renal Impairment

It should be used with caution in case of renal function disorders. In renal failure, the frequency of administration should be reduced.

Pediatric Use

Contraindicated in children under 1 year of age (under 5 years and children with body weight less than 20 kg – for tablets).

Special Precautions

It should be used with caution in case of liver and kidney function disorders.

Drugs containing Domperidone should be taken in children in dosage forms intended for the appropriate age.

Drug Interactions

With simultaneous use with antacids, antisecretory drugs (including cimetidine, sodium bicarbonate) the bioavailability of domperidone decreases.

With simultaneous use with anticholinergic drugs, the action of domperidone is suppressed.

Since Domperidone is metabolized mainly with the participation of the CYP3A4 isoenzyme, it is believed that with simultaneous use of domperidone and inhibitors of this isoenzyme (including antifungal drugs of the azole group, antibiotics of the macrolide group, HIV protease inhibitors, nefazodone), an increase in the level of domperidone in blood plasma is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.