Motonium pills 10mg, 30pcs

Composition

Active ingredient:

domperidone 10 mg;

Auxiliary substances:

lactose;

MCC;

corn starch;

low molecular weight povidone,

glycerin;

magnesium stearate;

Shell:  oxypropylmethylcellulose; polyethylene glycol 6000;

Pharmacological action

Motonium – – normalizing the functions of the digestive tract, antiemetic.

Pharmacodynamics

Increases the duration of peristaltic contractions of the antrum and duodenum, accelerates gastric emptying if this process slows down, increases the tone of the lower esophageal sphincter, eliminates the development of nausea and vomiting.

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

Pharmacokinetics

After taking the drug inside, it is rapidly absorbed. It has low bioavailability (about 15%). _Cmax in plasma is reached after 1 h. Reduced acidity of gastric contents reduces the absorption of domperidone. Poorly penetrates the BBB, so the use of domperidone is rarely accompanied by extrapyramidal side effects, especially in adults.

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

It undergoes intensive metabolism in the intestinal wall and liver.

It is excreted through the intestines (66%) and kidneys (33%), unchanged, – 10 and 1% of the dose, respectively. T_1/2 is 7-9 hours, with severe renal insufficiency, it is prolonged (see the section “Precautions”).

Indications

A complex of dyspeptic symptoms associated with delayed gastric emptying, gastro-esophageal reflux, esophagitis: a feeling of fullness in the epigastrium, a feeling of bloating, pain in the upper abdomen; belching, flatulence; heartburn with or without throwing stomach contents into the oral cavity.

Nausea and vomiting of functional, organic, infectious origin, caused by radiotherapy, drug therapy or diet disorders, as well as against the background of dopamine agonists (for example, levodopa and bromocriptine), in the case of their use in Parkinson’s disease.

Use during pregnancy and lactation

It can be used in the first trimester of pregnancy, if the expected effect of therapy exceeds the potential risk to the fetus. Breast-feeding should be discontinued for the duration of treatment (it is not known whether the drug has a negative effect on newborns).

When administered to animals in doses up to 160 mg/kg/day, domperidone did not have a teratogenic effect. To date, there is no evidence of an increased risk of malformations in humans. In women, domperidone concentrations in breast milk are 4 times lower than the corresponding plasma concentrations.

Contraindications

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

With caution:  hepatic / renal insufficiency.

Side effects

From the digestive system:  transient intestinal spasms.

Nervous system disorders:  extrapyramidal disorders (in children and people with increased BBB permeability).

Allergic reactions:  skin rash, urticaria.

Other services:  hyperprolactinemia (galactorrhea, gynecomastia).

Interaction

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

Anticholinergic agents neutralize the effect of domperidone.

Azole antifungal agents, macrolide antibiotics, HIV protease inhibitors, and nefazodone increase the concentration of domperidone in plasma.

How to take, course of use and dosage

Inside,15-30 minutes before meals.

For chronic dyspepsia. Adults — 10 mg (1 tablet) 3 times a day, and if necessary — before bedtime. Children older than 5 years — 2.5 mg/10 kg of body weight 3 times a day and, if necessary, before bedtime. If necessary, the indicated dosage can be doubled.

Acute and subacute conditions (primarily nausea and vomiting). Adults — 20 mg (2 tablets) 3-4 times a day and before bedtime. Children older than 5 years — 5 mg/10 kg of body weight 3-4 times a day and before bedtime.

Overdose

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

Treatment:  use of activated charcoal, antihistamines; in case of extrapyramidal reactions-anticholinergic antiparkinsonian agents.

Special instructions

In patients with severe renal insufficiency (serum creatinine-more than 6 mg / 100 ml, i. e. more than 0.6 mmol / l) T_1/2 increased from 7.4 to 20.8 hours, but the drug concentrations in plasma were lower than in healthy volunteers.

Due to the fact that a very small percentage of the drug is excreted unchanged by the kidneys, it is hardly necessary to adjust the single dose in patients with renal insufficiency. However, with repeated use, the frequency of use should be reduced to 1-2 times a day, depending on the degree of insufficiency.

It may also be necessary to reduce the dose. With long-term therapy, patients should be regularly monitored.

Composition

Tablet Form of production

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Domperidone

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as prescribed by a doctor, for pregnant women as prescribed by a doctor

Indications

Flatulence, Reflux esophagitis, Gastrointestinal motility disorders