Motilac - instructions for use, dose, side effects, contraindications

One tablet contains: domperidone 10 mg, potato starch 36.3 mg,lactose monohydrate (milk sugar) 57.0 mg, microcrystalline cellulose 6.0 mg, silicon dioxide colloid (aerosil) 1.2 mg, povidone (polyvinylpyrrolidone) 4.7 mg, magnesium stearate 1.2 mg, carboxymethyl starch sodium (primogel) 3.6 mg.

Sheath: gipromeloza (methyloxypropylcellulose) 1.45 mg, povidone (polyvinylpyrrolidone) 0.91 mg, polysorbate (tween 80) 0.91 mg, titanium dioxide 0.31 mg, talc 0.42 mg.

Description:The tablets covered with a film cover, white or almost white color, round, biconcave. On the break the tablets are white or white with a yellowish tint of color.

Pharmacotherapeutic group:antiemetics - dopamine receptor blocker central

ATX: & nbsp

A.03.F.A.03 Domperidone

Pharmacodynamics:

Increases the duration of peristaltic contractions of the antral part of the stomach and duodenum, accelerates the emptying of the stomach in case of slowing of this process, increases the tone of the lower esophageal sphincter, eliminates the development of nausea and vomiting.

The antiemetic effect of domperidone may be due to a combination of peripheral (gastrokinetic) action and antagonism to dopamine receptors in the chemoreceptor trigger zone.The use of domperidone is rarely accompanied by extrapyramidal side effects, especially in adults. Domperidone stimulates the release of prolactin from the pituitary gland. Domperidone has no effect on gastric secretion.

Pharmacokinetics:

Suction

After taking the drug inside domperidone quickly absorbed. It has low bioavailability (about 15%). The decreased acidity of the gastric contents reduces the absorption of domperidone. The maximum concentration in the plasma is achieved after 1 hour.

Distribution

Domperidone is widely distributed in various tissues, in the brain tissues its concentration is low. Binding to plasma proteins is 91-93%. Poorly penetrates the blood-brain barrier.

Metabolism

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

Excretion

It is excreted through the intestine (66%) and kidneys (33%), in unchanged form, respectively, 10% and 1% of the dose value. The half-life is 7-9 hours, with prolonged renal failure, it lengthens. In patients with severe renal insufficiency (serum creatinine> 6 mg / 100 ml, i.e.> 0.6 mmol / L) increased the half-life of domperidone from 7.4 to 20.8 hours.

Indications:

- Complex of dyspeptic symptoms, often associated with delayed gastric emptying (a feeling of fullness in the epigastrium, sense of abdominal distention, pain in the upper abdomen, belching, flatulence, heartburn with reflux or without casting of gastric contents into the mouth), including those caused by the defeat of the digestive system:

- Stomach ulcer or duodenal ulcer;

- gastroesophageal reflux disease;

- diseases of the biliary tract;

- pancreatitis.

- Vomiting and nausea of various origins, incl. on the background of functional and organic diseases; infections; caused by radiotherapy; diet disorder and drug therapy (receiving morphine, apomorphine, levodopa and bromocriptine).

Contraindications:Hypersensitivity to the drug, gastrointestinal bleeding, mechanical intestinal obstruction, perforation of the stomach or intestines, prolactin-secreting pituitary tumor (prolactinoma), children's age (up to 5 years of age and children weighing up to 20 kg).

Carefully:

Renal and / or hepatic insufficiency, lactation, pregnancy.

Pregnancy and lactation:

Determined that domperidone does not have a teratogenic effect, however, like most drugs, Motilac® should be given during the first trimester of pregnancy only if its use is justified by the expected therapeutic benefit.

In women, concentrations of domperidone in breast milk are 4 times lower than the corresponding concentrations in plasma. It is not known whether this level has a negative effect on newborns. Therefore, if the mother takes Motilac®, breast-feeding is not recommended, except when the expected benefit justifies the potential risk.

Dosing and Administration:

Inside.

1. Chronic dyspepsia

Adults and children over 12 years of age: 10 mg (1 tablet) 3 times a day, 15-30 minutes before meals and, if necessary, before bed.

Children aged 5 to 12 years: 2.5 mg per 10 kg body weight 2-3 times a day before meals and, if necessary, before bed.

If necessary, the indicated dosage can be doubled.

The duration of the course depends on the type and severity of the disease and on average is 3-4 weeks, if necessary - can be increased to 3 months.If necessary, the course of therapy can be repeated.

2. With nausea and vomiting adults and children over 12 years prescribe 20 mg (2 tablets) 3-4 times a day, before meals and at bedtime. The maximum daily dose is 80 mg.

Children aged 5 to 12 years prescribe 10 mg 3-4 times daily before meals and at bedtime.

Patients with severe renal insufficiency (serum creatinine> 6 mg / 100 ml, i.e.> 0.6 mmol / l): the frequency of administration should be reduced to 1-2 times per day, and it may also be necessary to reduce the dose.

Side effects:

From the gastrointestinal tract: transient intestinal spasms.

From the nervous system: Extrapyramidal phenomena (in children and people with increased blood-brain barrier permeability). These phenomena are completely reversible and spontaneously disappear after discontinuation of treatment.

Allergic reactions: skin rash, hives.

From the endocrine system: hyperprolactinemia (galactorrhea, gynecomastia).

Overdose:

Symptoms: drowsiness, disorientation, extrapyramidal reactions, especially in children.

Treatment: It is recommended to use activated carbon and careful observation. Anticholinergics, drugs,used to treat parkinsonism, or antihistamines may be effective in the occurrence of extrapyramidal reactions.

Interaction:

Anticholinergic and antacid drugs neutralize the action of domperidone.

Cimetidine, sodium hydrogen carbonate reduce the bioavailability of domperidone.

Increase the concentration of domperidone in the plasma: antifungal drugs azole, antibiotics from the group of macrolides, inhibitors of HIV protease, nefazodone (antidepressant).

Domperidone is compatible with the use of antipsychotic drugs (neuroleptics), dopaminergic receptor agonists (bromocriptine, levodopa).

Special instructions:

When combined use of Motilac® with antacid or antisecretory drugs, the latter is recommended to be taken 2 hours before or 2 hours after taking Motilac®.

Effect on the ability to drive transp. cf. and fur:

Motilac® does not affect psychomotor reactions and the ability to drive.

Form release / dosage:

Tablets, film-coated, 10 mg.

Packaging:

For 10 tablets in a planar cell package. 30 tablets in a polymer can.To the bank, 1, 3 contour mesh packages together with instructions for use in a pack of cardboard.

2 kg or 2.5 kg per container polymer, equipped with a lid (for export delivery). Polymer containers in corrugated cardboard boxes.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:P N001852 / 01

Date of registration:06.10.2008 / 16.09.2015

The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia

Manufacturer: & nbsp

VEROPHARM SA Russia

Representation: & nbspVEROPHARM, AO VEROPHARM, AO Russia

Information update date: & nbsp19.01.2016

Illustrated instructions

Instructions

Motilac® (Motilak®)