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

Excipients: fructose (Advantoza FS 95), sugar (sucrose), glucose, polyplasdone IKS EL-10 (crospovidone), sodium carboxymethyl starch (primogel), magnesium stearate, peppermint oil.

Description:

Tablets are white or almost white, round, biconvex, with a characteristic odor.

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.

Domperidone poorly penetrates the blood-brain barrier, so domperidone is rarely accompanied by extrapyramidal side effects, especially in adults, but domperidone stimulates the release of prolactin from the pituitary gland. Its antiemetic effect may be 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:

Absorption after ingestion, fasting - fast (intake after meals, decreased acidity of gastric juice slow down and reduce absorption). The maximum concentration in blood plasma (TC_max) - 1 hour Bioavailability - 15% (effect of "first passage" through the liver). The connection with plasma proteins is 90%. It penetrates into various tissues, it does not pass well through the blood-brain barrier (GEB). Metabolized in the liver and in the intestinal wall (by hydroxylation and Ndealkylation). Output through the intestine 66%, kidneys - 33%, incl. in unchanged form - 10 and 1% respectively. The half-life (T_1/2) - 7-9 hours, with severe chronic renal failure (CRF) - lengthened.

Indications:

A complex of dyspeptic symptoms, often associated with delayed emptying of the stomach, gastroesophageal reflux, esophagitis:

- a feeling of overflow in the epigastrium, a sensation of bloating, a pain in the upper abdomen;

- eructation, flatulence;

- heartburn with or without casting of gastric contents into the oral cavity.

Nausea and vomiting of a functional, organic, infectious origin caused by radiotherapy, drug therapy or diet disorders, and against dopamine agonists when used in Parkinson's disease (such as L-dopa and bromocriptine)

Contraindications:

Hypersensitivity, bleeding from the gastrointestinal tract, mechanical intestinal obstruction, perforation of the stomach or intestines, prolactinoma, children's age (up to 5 years and children weighing up to 20 kg).

Carefully:

Renal / hepatic failure, lactation, pregnancy.

Pregnancy and lactation:

The use of the drug in the first trimester of pregnancy is possible only in cases where the expected benefit of therapy for the mother exceeds the potential risk to the fetus. To date, there is no evidence of an increased risk of human developmental malformations.

In women, the concentration of domperidone in breast milk is 4 times lower than the corresponding concentration in the plasma. It is not known whether domperidone in this concentration a negative effect on the newborn. Therefore, during the lactation period (breastfeeding) the use of Motilac® is not recommended, except when the expected benefit of therapy for the mother exceeds the potential risk for the infant.

Dosing and Administration:

Tablets: should dissolve 15-20 minutes before meals. Adults and children over 5 years with chronic dyspeptic phenomena - 10 mg 3-4 times a day and, if necessary, additionally before bedtime. At the expressed nausea and vomiting - on 20 mg 3-4 times a day and before a dream.

For patients with renal insufficiency, dose adjustment is necessary, the frequency of administration should not exceed 1-2 times during the day.

Side effects:

From the digestive system: transient intestinal spasms.

From the nervous system: extrapyramidal disorders (in children and in persons with increased permeability of the BBB).

Allergic reactions: skin rash, hives.

Other: hyperprolactinemia (galactorrhea, gynecomastia).

Overdose:

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

Treatment: reception of activated carbon, with extrapyramidal disorders - anticholinergic drugs, antiparkinsonian or antihistamine drugs with anticholinergic properties.

Interaction:

Cimetidine, sodium hydrogen carbonate reduce the bioavailability of domperidone.

Anticholinergic and antacid drugs (LS) neutralize the action of domperidone.

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

Compatible with the use of antipsychotic drugs (neuroleptics), dopaminergic receptor agonists (bromocriptine, L-dopa).

Simultaneous administration with paracetamol and digoxin had no effect on the concentration of these drugs in the blood.

Form release / dosage:Tablets for resorption of 10 mg.

Packaging:

10 tablets per contour cell pack.

For 30 tablets in a jar of lightproof glass.

Each jar or 1 or 3 contour mesh packages together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LS-002036

Date of registration:27.12.2011 / 13.01.2016

Expiration Date:Unlimited

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: & nbsp01.06.2018

Illustrated instructions

Instructions

Motilac® (Motilak®)