Motonium, 10 mg 30 pcs.

Motonium is a gastrointestinal normalizer and antiemetic.

Pharmacodynamics

It increases the duration of peristaltic contraction of the antrum of the stomach and duodenum, accelerates gastric emptying in case this process is delayed, increases the tone of the lower esophageal sphincter, eliminates the development of nausea and vomiting.

Stimulates release of prolactin from the pituitary gland. The antiemetic effect is probably due to a combination of peripheral (gastrokinetic) action and antagonism to dopamine receptors in the chemoreceptor trigger zone. Domperidone has no effect on gastric secretion.

Pharmacokinetics

After oral administration, the drug is rapidly absorbed. It has low bioavailability (about 15%). C_max in plasma is reached after 1 hour. Decreased acidity of gastric contents decreases absorption of domperidone. It poorly penetrates through the HEB, so the use of domperidone is rarely accompanied by extrapyramidal side effects, especially in adults.

It is well distributed in various tissues; its concentration is low in brain tissues. Binding to plasma proteins is 91-93%.

It is subjected to intensive metabolism in the intestinal wall and the liver.

Extracted through the intestine (66%) and the kidneys (33%), in unchanged form, 10 and 1% of the dose value, respectively. T_1/2 is 7-9 h, in severe renal insufficiency it is prolonged (see section “Precautions”).

Indications

Complex dyspeptic symptoms associated with delayed gastric emptying, gastroesophageal reflux, esophagitis: Feeling of congestion in the epigastrium, feeling of bloating, pain in the upper abdomen; belching, flatulence; heartburn with or without gastric contents being thrown into the mouth.

Nausea and vomiting of functional, organic, infectious origin caused by radiotherapy, drug therapy or dietary disturbances, as well as with dopamine agonists (such as levodopa and bromocriptine), if used in Parkinson’s disease.

Active ingredient

Composition

Active substance:

Domperidone 10 mg;

Associates:

Lactose;

MCC;

Corn starch;

Low molecular weight povidone;

Glycerin;

Magnesium stearate;

Shell: oxypropyl methylcellulose; polyethylene glycol 6000;

How to take, the dosage

Ingestion, 15-30 minutes before a meal.

In chronic dyspepsia. Adults – 10 mg (1 tablet) 3 times a day, and if necessary – before bedtime. Children over 5 years of age – 2.5 mg/10 kg body weight 3 times a day and, if necessary, before bedtime. If necessary, the above dosage may be doubled.

Acute and subacute conditions (especially nausea and vomiting). Adults – 20 mg (2 tablets) 3-4 times a day and before bedtime. Children over 5 years of age – 5 mg/10 kg of body weight 3-4 times a day and before bedtime.

Interaction

Cimetidine, sodium bicarbonate, other antacids and antisecretory drugs decrease the bioavailability of domperidone.

Anticholinergic agents neutralize the effect of domperidone.

The azole antifungal agents, antibiotics from the group of macrolides, HIV-protease inhibitors, nefazodone increase the plasma concentration of domperidone.

Special Instructions

In patients with severe renal impairment (serum creatinine greater than 6 mg/100 ml, i.e., greater than 0.6 mmol/L), the T1/2 increased from 7.4 to 20.8 h, but plasma concentrations of the drug were lower than in healthy volunteers.

Because a very small percentage of the drug is excreted unchanged by the kidneys, adjustment of the single dose in patients with renal impairment is hardly necessary. However, if repeated administration, the frequency of administration should be reduced to 1-2 times per day, depending on the degree of insufficiency.

It may also be necessary to reduce the dose. Patients should be monitored regularly if therapy is prolonged.

Contraindications

Hypersensitivity, gastrointestinal bleeding, mechanical intestinal obstruction, gastric or intestinal perforation, prolactin-secreting pituitary tumor (prolactinoma), children under 5 years of age.

With caution:hepatic/renal insufficiency.

Side effects

Digestive system disorders:Transient intestinal spasms.

Nervous system disorders:extrapyramidal disorders (in children and persons with increased barrier permeability).

Allergic reactions: skin rash, urticaria.

Others:hyperprolactinemia (galactorrhea, gynecomastia).

Overdose

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

Treatment: administration of activated charcoal, antihistamines; in case of extrapyramidal reactions – anticholinergic anti-Parkinsonian drugs.

Pregnancy use

Perhaps use in the first trimester of pregnancy if the expected effect of therapy exceeds the potential risk to the fetus. Breastfeeding should be discontinued during treatment (it is unknown whether the drug has adverse effects on newborns).

When administered to animals in doses up to 160 mg/kg/day domperidone had no teratogenic effect. To date, there are no data on increased risk of malformations in humans. In women, concentrations of domperidone in breast milk are 4 times lower than the corresponding concentrations in plasma.

Similarities