Motinorm

General characteristics. Structure:

Active ingredient: 10 mg of a domperidon.

Excipients: to lactose monohydrate, starch corn, methylparaben (Е 218), propylparaben (Е 216), magnesium stearate.

The antiemetic drug strengthening a stomach peristaltics against swelling, nausea and weight, kills pain.

Pharmacological properties:

Pharmacodynamics. Domperidon is the antagonist of receptors of a dopamine, a prokinetic. Antiemetic action is predetermined by a combination of peripheral (gastrokinetichesky) action and antagonism to receptors of a dopamine (D2) in a trigger zone of chemoceptors. Domperidon raises a tone in a lower part of a gullet, improves antroduodenal mobility and accelerates gastric emptying. Practically does not influence gastric secretion.

Pharmacokinetics. Domperidon is quickly absorbed from intestines after oral administration on an empty stomach with achievement of the maximum levels in a blood plasma in 30-60 min. Reduced acidity of a stomach reduces absorption of a domperidon.

Bioavailability makes about 15%. The food considerably reduces bioavailability of a domperidon.

Linkng with blood proteins represents 91-93%.

Drug is metabolized in a liver by a hydroxylation and N-dealkylation. At researches of metabolism of the drug in vitro with use of diagnostic inhibitors it was established that the isoenzyme 3A4 is the main isoenzyme of system of P450 cytochrome which takes part in process of N-dezalklirovaniya of a domperidon whereas isoenzymes of CYP 3a4, CYP 1a2, CYP 2e1 take part in process of an aromatic hydroxylation of a domperidon. Drug gives in to extensive primary metabolism in a wall of intestines and in a liver which causes its low bioavailability.

It is removed by kidneys (31%) and with excrements (66%) of the accepted dose respectively. In steady-state condition only the insignificant percent of drug is removed (10% - with excrements and about 1% - kidneys).

The elimination half-life of a domperidon from a blood plasma after reception of a single dose represents 7-9 hours.

Domperidon practically does not get through a blood-brain barrier.

Indications to use:

The complex of dispepsichesky symptoms which is associated with the slowed-down gastric emptying, a gastroesophagal reflux, an esophagitis: feeling of overflow in epigastriums, feeling of abdominal distention, pain in an upper part of a stomach; eructation, meteorism; heartburn with throwing or without throwing of contents of a stomach in an oral cavity.

The nausea and vomiting of a functional, organic, infectious origin caused by radiotheraphy, medicinal therapy or disturbance of a diet and also against the background of dopamine agonists (for example a levodopa and Bromocriptinum), in case of their use at Parkinson's disease.

Children have a weakening of symptoms of vomiting and nausea.

Route of administration and doses:

Drug is recommended to be accepted to food.

To adults and children age 12 years with the body weight of 35 kg are more senior and more appoint 10-20 mg (1-2 tablets) 3 times to days in 15 - 30 minutes prior to food and in case of need - before going to bed. The maximum daily dose of drug - 80 mg (8 tablets).

Duration of primary treatment - 4 weeks, need of further use of drug is defined by the doctor.

At a renal failure it is necessary to reduce the frequency of administration of drug.

Features of use:

There are restrictions concerning use of a domperidona by pregnant women. Motinorm it is possible to appoint at pregnancy only when the expected advantage for mother exceeds potential risk for a fruit.

Motinorm is excreted in breast milk (generally in the form of metabolites). Concentration of a domperidon in breast milk of the woman who feeds represents from 10 to 50% of the corresponding concentration in a blood plasma and does not exceed 10 ng/ml. For this time it is not established whether it is harmful to the newborn.

In case of need drug uses women who feed груддю for treatment need to stop feeding груддю.

In view of a high metabolic rate of a domperidon in a liver, it is not necessary to appoint drug sick with a liver failure.

Considering that sensitive patients at use of a preaparat can have side reactions (drowsiness, extrapyramidal side effects) therefore this patients for the period of administration of drug should refrain from control of vehicles and performance of other works where concentration of attention is necessary.

At prolonged use of a domperidon by the patient with a renal failure it is necessary to reduce the frequency of reception to 1 - 2 times for days, depending on weight of renal failures. For such patients it is necessary to establish regular medical control.

Side effects:

Hyperexcitability and/or extrapyramidal frustration, headache, sleeplessness, slackness or excitability, dizziness. Spasms of smooth muscles of bodies of a GIT, dryness in a mouth, thirst. Hypostases, heart consciousness, ventricular arrhythmias. Short-term intestinal spasms. Frequent urination. Itch, rash, urticaria. Increase in level of prolactin in plasma, a galactorrhoea, a gynecomastia. From laboratory indicators - increase in the ALT, nuclear Heating Plant level і cholesterol.

Interaction with other medicines:

Anticholinergic drugs can neutralize anti-dispeptic action of Motinorm.

At simultaneous use of Motinorm with Cimetidinum or sodium bicarbonate Motinorm's bioavailability decreases.

It is not necessary to accept antiacid and anti-secretory drugs along with Motinorm as they reduce its bioavailability after reception internally.

At simultaneous use of a domperidon with medicines which substantially suppress CYP3a4 isoenzyme there can be an increase in level of a domperidon in a blood plasma.

At simultaneous use of Motinorm with m cholinolytics and narcotic analgetics influence of a domperidon on a motor evakuatornuyu activity of a stomach and intestines decreases.

In a research of interaction of a domperidon and ketokonazol it is established that at combined use of a domperidon in a dose of 10 mg 4 times for days and a ketokonazol in a dose of 200 mg 2 times for days are observed lengthening of an interval of QT on an ECG on 10 - 20 ms. At monotherapy domperidony both in similar doses, and at reception of a daily dose of 160 mg (that exceeds the most admissible daily dose twice) it was not recorded clinically significant changes of an interval of QT.

Simultaneous use of Motinorm for patients who in parallel receive paracetamol and/or digoxin did not influence the level of these drugs in blood.

Motinorm can be also combined with:

- neuroleptics which action it strengthens;

- dofaminergichny antagonists (bromkriptiny, a levodopa) whose undesirable peripheral actions, such as digestion disturbance, nausea, vomiting, it suppresses without neutralization of their main properties.

Contraindications:

- hypersensitivity to a domperidon or to any of excipients;

- gastrointestinal bleeding, mechanical impassability or perforation of a stomach;

- prolactin - a secretory tumor of a hypophysis (prolaktinom);

- simultaneous use with ketokonazoly, erythromycin or other strong CYP3A4 inhibitors, medicines which prolong QT interval, such as флуконазол, вориконазол, кларитромицин, Amiodaronum, телитромицин;

- abnormal liver function;

- heavy renal failures.

Overdose:

At overdose it is noted: drowsiness, disorientation and extrapyramidal frustration.

The specific antidote does not exist. In case of overdose the gastric lavage, uses of absorbent carbon, fixed supervision of the doctor of the patient and other supporting actions is recommended.

Anticholinergic drugs, drugs for treatment of parkinsonism or antihistaminic drugs with anticholinergic properties can be effective for correction of extrapyramidal frustration.

Storage conditions:

To store in the dry places not available ждя children, at a temperature not above 25 degrees Celsius.

Issue conditions:

Without recipe

Packaging:

On 10 tablets in the blister. On 3 blisters in cardboard packaging.