Motilak tablets p / o 10mg, No. 30

• A complex of dyspeptic symptoms often associated with delayed gastric emptying (a feeling of fullness in the epigastrium, a feeling of bloating, pain in the upper abdomen, belching, flatulence, heartburn with or without reflux of stomach contents into the oral cavity), including those caused by damage to the digestive system:

• peptic ulcer or 12 duodenal ulcer;

• gastroesophageal reflux disease;

• diseases of the biliary tract;

• pancreatitis.

• Vomiting and nausea of ??various origins, incl. against the background of functional and organic diseases; infections; caused by radiation therapy; violation of diet and drug therapy (taking morphine apomorphine levodopa and bromocriptine).

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 bedtime.

Children aged 5 to 12 years : 25 mg per 10 kg of body weight 2-3 times a day before meals and, if necessary, before bedtime.

If necessary, the indicated dosage can be doubled.

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

2. In case of nausea and vomiting, adults and children over 12 years of age are prescribed 20 mg (2 tablets) 3-4 times a day before meals and before bedtime. The maximum daily dose is 80 mg.

Children aged 5 to 12 years are prescribed 10 mg 3-4 times a day before meals and before bedtime.

Patients with severe renal impairment (serum creatinine> 6 mg / 100 ml, i.e.> 06 mmol / l): the frequency of administration should be reduced to 1-2 times a day and it may also be necessary to reduce the dose.

One tablet contains:

Active ingredient: domperidone - 10 mg,

Excipients: potato starch 36.3 mg, lactose monohydrate (milk sugar) 57.0 mg, microcrystalline cellulose 6.0 mg, colloidal silicon dioxide (aerosil) 1.2 mg, povidone (polyvinylpyrrolidone) 4.7 mg, magnesium stearate 1.2 mg, sodium carboxymethyl starch (primogel) 3.6 mg.

Sheath: hypromelose (methyloxypropyl cellulose) 1.45 mg, povidone (polyvinylpyrrolidone) 0.91 mg, polysorbate (tween-80) 0.91 mg, titanium dioxide 0.31 mg, talc 0.42 mg.

• 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 and children weighing up to 20 kg).

Carefully:

Renal and / or hepatic impairment lactation pregnancy.

Trade name of the drug

MotilakЃ

International non-proprietary name

Domperidone

Dosage form

film-coated tablets

Composition

One tablet contains:

Active ingredient: domperidone - 10 mg,

Excipients: potato starch 36.3 mg, lactose monohydrate (milk sugar) 57.0 mg, microcrystalline cellulose 6.0 mg, colloidal silicon dioxide (aerosil) 1.2 mg, povidone (polyvinylpyrrolidone) 4.7 mg, magnesium stearate 1.2 mg, sodium carboxymethyl starch (primogel) 3.6 mg.

Sheath: hypromelose (methyloxypropyl cellulose) 1.45 mg, povidone (polyvinylpyrrolidone) 0.91 mg, polysorbate (tween-80) 0.91 mg, titanium dioxide 0.31 mg, talc 0.42 mg.

Description

Film-coated tablets, white or almost white, round, biconvex. At the break, the tablets are white or white with a yellowish tinge.

Pharmacotherapeutic group

antiemetic agent - dopamine receptor blocker central

ATX code

A03FA03

Pharmacodynamics:

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

The antiemetic effect of domperidone is possibly 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 is rapidly absorbed. Possesses low bioavailability (about 15%). Reduced acidity of gastric contents reduces the absorption of domperidone. The maximum plasma concentration is reached after 1 hour.

Distribution

Domperidone is widely distributed in various tissues in the brain tissues, its concentration is low. Plasma protein binding is 91-93%. Poorly penetrates the blood-brain barrier.

Metabolism

Undergoes intensive metabolism in the intestinal wall and liver.

Withdrawal

It is excreted through the intestines (66%) and by the kidneys (33%) in unchanged form, respectively, 10% and 1% of the dose. The half-life is 7-9 hours with severe renal failure, it is lengthened. In patients with severe renal failure (serum creatinine> 6 mg / 100 ml, i.e.> 06 mmol / L), the half-life of domperidone increased from 74 to 208 hours.

Indications:

• A complex of dyspeptic symptoms often associated with delayed gastric emptying (a feeling of fullness in the epigastrium, a feeling of bloating, pain in the upper abdomen, belching, flatulence, heartburn with or without reflux of stomach contents into the oral cavity), including those caused by damage to the digestive system:

• peptic ulcer or 12 duodenal ulcer;

• gastroesophageal reflux disease;

• diseases of the biliary tract;

• pancreatitis.

• Vomiting and nausea of ??various origins, incl. against the background of functional and organic diseases; infections; caused by radiation therapy; violation of diet and drug therapy (taking 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 and children weighing up to 20 kg).

Carefully:

Renal and / or hepatic impairment lactation pregnancy.

Pregnancy and lactation:

It has been established that domperidone does not have a teratogenic effect, however, like most drugs, MotilacЃ should be prescribed during the first trimester of pregnancy only if its use is justified by the expected therapeutic benefit.

In women, the concentration of domperidone in breast milk is 4 times lower than the corresponding concentration in plasma. It is not known if this level has an adverse effect on newborns. Therefore, if the mother is taking MotilacЃ, breastfeeding is not recommended unless the expected benefit justifies the potential risk.

Method of administration and dosage:

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 bedtime.

Children aged 5 to 12 years : 25 mg per 10 kg of body weight 2-3 times a day before meals and, if necessary, before bedtime.

If necessary, the indicated dosage can be doubled.

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

2. In case of nausea and vomiting, adults and children over 12 years of age are prescribed 20 mg (2 tablets) 3-4 times a day before meals and before bedtime. The maximum daily dose is 80 mg.

Children aged 5 to 12 years are prescribed 10 mg 3-4 times a day before meals and before bedtime.

Patients with severe renal impairment (serum creatinine> 6 mg / 100 ml, i.e.> 06 mmol / l): the frequency of administration should be reduced to 1-2 times a 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 persons with increased permeability of the blood-brain barrier). These phenomena are completely reversible and disappear spontaneously after stopping treatment.

Allergic reactions : skin rash, urticaria.

From the endocrine system: hyperprolactinemia (galactorrhea gynecomastia).

Overdose:

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

Treatment: The use of activated charcoal and close observation is recommended. Anticholinergics drugs used to treat Parkinson's disease or antihistamines may be effective for extrapyramidal reactions.

Interaction:

Anticholinergic and antacid drugs neutralize the effect of domperidone.

Cimetidine sodium bicarbonate reduces the bioavailability of domperidone.

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

Domperidone is compatible with taking antipsychotic drugs (neuroleptics) with dopaminergic receptor agonists (bromocriptine levodopa).

Special instructions:

With the combined use of MotilacЃ with antacid or antisecretory drugs, the latter are recommended to be taken 2 hours before or 2 hours after taking MotilacЃ.

Impact on the ability to drive vehicles. Wed and fur .:

MotilakЃ does not affect psychomotor reactions and the ability to drive.

Release form / dosage:

Film-coated tablets 10 mg.

Packaging:

10 tablets in a blister strip packaging. There are 30 tablets in a polymer jar. Bank 1 3 blister packs together with instructions for use in a cardboard box.

2 kg or 25 kg in a polymer container equipped with a lid (for export delivery). Polymer containers in corrugated cardboard boxes.

Storage conditions:

At a temperature not higher than 30 ? C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date.

Vacation conditions

Without recipe