Expiration date: 01/2026

Composition and form of release:

Solution for intravenous and intramuscular administration, 1 ml contains:

active substance:

metoclopramide hydrochloride monohydrate 5, 27mg

(corresponds to 5 mg of metoclopramide hydrochloride)

excipients: sodium sulfite-0, 125 mg disodium edetate-0, 4 mg sodium chloride-8 mg water for injection-991, 705 mg

2 ml in ampoules of transparent glass (type I) with colored rings (upper green and lower blue) on the head of the ampoule and a white ring on the neck of the ampoule in a package of contour cell 5 ampoules in a pack of cardboard 2 packages.

Description of the dosage form:

Solution: transparent colorless solution.

Pharmacological action:

Blocks dopamine (D2) and serotonin receptors, affects chemoreceptors of the trigger zone of the medulla oblongata.

Pharmacokinetics:

Quickly absorbed from the gastrointestinal tract, bioavailability-60-80%, Cmax is reached in 1-2 hours. Passes through the BBB, the placental barrier, into breast milk. It is excreted mainly through the kidneys in unchanged form and in the form of conjugates. T1/2 — 3-5 h

Description of pharmacological action:

It has antiemetic effect, regulates and normalizes the activity of the gastrointestinal tract (decreases motility of the esophagus, increases the tone of the lower esophageal sphincter, accelerates gastric emptying and promote food on thin intestine). It stimulates the secretion of prolactin.

Indications:

Vomiting and nausea of various origins, atonia and hypotonia of the stomach and intestines (including postoperative), biliary dyskinesia, reflux esophagitis, functional stenosis of the pylorus.

To enhance peristalsis during radiopaque studies of the gastrointestinal tract, as well as as a means to facilitate duodenal probing.

Contraindications:

Hypersensitivity, intestinal obstruction, bleeding or perforation of the gastrointestinal tract, pyloric stenosis, pheochromocytoma, prolactin-dependent tumors, epilepsy, extrapyramidal disorders, childhood (up to 2 years-parenterally, up to 6 years — tablets), pregnancy.

Use during pregnancy and lactation:

It is contraindicated in the I trimester of pregnancy in the II and III trimesters — only for vital indications. Breast-feeding should be stopped during treatment.

Side effect:

From the nervous system and sensory organs: fatigue, drowsiness, headache, dizziness, dry mouth, depression, agitation, irritability with prolonged use in elderly patients — parkinsonism, dyskinesia.

From the digestive tract: constipation, diarrhea in some cases (mainly in children) — dyskinetic syndrome.

Other: in rare cases, with prolonged use of high doses — methemoglobinemia, edema, galactorrhea, gynecomastia, menstrual disorders, allergic reactions.

Drug interaction:

• Anticholinesterase agents weaken the effect.
• Increases the absorption of tetracycline, ampicillin, paracetamol, acetylsalicylic acid, levodopa reduces-digoxin, cimetidine.
• Increases the effect of alcohol and drugs that depress the Central nervous system increases the risk of extrapyramidal reactions when taken simultaneously with neuroleptics.