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

active substance: metoclopramide hydrochloride (in terms of anhydrous substance) - 5 mg; Excipients: sodium sulphite (sodium sulfite) 0.125 mg, sodium chloride 9 mg, disodium edetate dihydrate 0.5 mg, water for injection up to 1 ml.

Description:A clear, colorless liquid.

Pharmacotherapeutic group:Antiemetics - dopamine receptor blocker central

ATX: & nbsp

A.03.F.A Motility stimulators GIT

A.03.F.A.01 Metoclopramide

Pharmacodynamics:Metoclopramide is a specific blocker of dopamine (D-2) and serotonin (5-HT-3) receptors of the central nervous system,has a pronounced antiemetic effect (except for vomiting of psychogenic and vestibular origin), regulates tone and motor activity of the upper parts of the digestive tract, mainly the stomach and duodenum, without affecting gastric and pancreatic secretion. Besides, metoclopramide increases the tone of the lower sphincter of the esophagus and reduces gastroesophageal reflux. The prokinetic effect of metoclopramide decreases in the distal direction of the digestive rope. The drug normalizes the secretion of bile, reducing spasm of the sphincter of Oddi, reduces dyskinesia of the gallbladder. Stimulates the secretion of aldosterone. It enhances the retention of sodium ions and the excretion of potassium ions.

Pharmacokinetics:The connection with plasma proteins is about 30%. It is metabolized in the liver. The half-life period is 4-6 hours, with renal dysfunction up to 14 hours. The excretion of metoclopramide occurs mainly through the kidneys for 24-72 hours in unchanged form and in the form of conjugates. Passes through the placental and blood-brain barrier and penetrates into the mother's milk.

Indications:Vomiting, nausea, hiccough of various genesis (in some cases it can be effective in vomiting caused by radiation or chemotherapy), atony and hypotension of the stomach and intestines (in particular, postoperative); biliary dyskinesia; reflux-esophagitis, flatulence, exacerbation of gastric ulcer and duodenal ulcer (as part of complex therapy).

Contraindications:

Hypersensitivity to metoclopramide or any of the components of the drug; bleeding from the gastrointestinal tract; stenosis of the pylorus of the stomach; mechanical intestinal obstruction; Perforation of the wall of the stomach or intestine; pheochromocytoma; epilepsy; glaucoma; extrapyramidal disorders; prolactin-dependent tumors; vomiting during treatment or overdose with antipsychotics and in patients with breast cancer; bronchial asthma in patients with hypersensitivity to sulfites (see section "Special instructions"); pregnancy (I trimester), lactation period (see section "Application during pregnancy and during breast-feeding"); children's age (up to 6 years).

Do not prescribe after operations on the gastrointestinal tract (such as pyloroplasty or anastomosis of the intestine), because vigorous muscle contractions inhibit healing.

Carefully:Bronchial asthma, arterial hypertension, Parkinson's disease, hepatic and / or renal insufficiency, advanced age, children's age (increased risk of dyskinetic syndrome).

Pregnancy and lactation:

The use of the drug is contraindicated in the first trimester of pregnancy.

In the II and III trimesters of pregnancy, the drug is prescribed only for "vital" indications and under the supervision of a doctor.

If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:

The solution is administered intravenously or intramuscularly to adults in a dose of 10-20 mg 3 times a day (maximum daily dose - 60 mg); children over 6 years - 5 mg 1-3 times a day.

Duration of treatment - usually 4-6 weeks, in some cases, treatment can be continued up to 6 months.

Patients with hepatic and / or renal insufficiency initial dose reduced by 2 times, the subsequent dose depends on the individual reaction of the patient.

For the prevention and treatment of nausea and vomiting caused by the use of cytostatics or radiation therapy, the drug is administered intravenously at a dose of 2 mg / kg 30 minutes before the use of cytostatics or radiation; if necessary, repeat the introduction after 2-3 hours.

Side effects:

Constipation or diarrhea, dryness of the oral mucosa, fatigue, drowsiness, headache, dizziness, depression, anxiety, confusion, tinnitus, extrapyramidal disorders - spasm of facial muscles, trismus, spasmodic torticollis, opisthotonus, muscle hypertonia; neutropenia, leukopenia, atrioventricular block, porphyria, urticaria, bronchospasm, angioedema.

With long-term use of the drug in high doses, more often in elderly patients, there may be phenomena of parkinsonism, dyskinesia, galactorrhea, gynecomastia, menstrual irregularities.

Overdose:

Symptoms: hypersomnia, disorientation and extrapyramidal disorders.

Symptomatology disappears after discontinuation of the drug within 24 hours.

Treatment: symptomatic, m-holinoblokatory, antiparkinsonian means.

Interaction:

Metoclopramide enhances the absorption of acetylsalicylic acid, paracetamol, diazepam, ethyl alcohol, levodopa, tetracycline, ampicillin.

Strengthens the action of ethanol.

Reduces the cardiotropic effect of digoxin.

Reduces the absorption of cimetidine, so higher dosages are required.The combination of metoclopramide and cimetidine should be used in cases of reflux esophagitis refractory to cimetidine.

Metoclopramide does not affect the level of anaprilin in the blood serum when it is ingested.

Special instructions:

During the treatment with the drug is not recommended the use of ethanol.

In connection with the content of sodium sulfite in the preparation of metoclopramide should not be prescribed to patients with bronchial asthma with increased sensitivity to sulfites.

Effect on the ability to drive transp. cf. and fur:During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:Solution for intravenous and intramuscular injection 5 mg / ml.

Packaging:

To 2 ml in the ampoules of neutral glass HC-3.

For 5 or 10 ampoules, together with the instructions for use, they are placed in a pack of cardboard with a liner of paper or corrugated ribbon, or with special nests, and paste a label-parcel of paper. It is allowed to put the text of the label-parcel directly on the packet.

5 ampoules are placed in a contour mesh box made of polyvinyl chloride film and aluminum foil foil or without foil.

For 1 or 2 contour squares, together with the instructions for use, are placed in a pack of cardboard and a sticker is applied. It is allowed to put the text of the label-parcel directly on the packet.

In each pack insert knife ampoule or scarifier.

When you pack the ampoules with a break point or a fracture ring, the ampoule knife or scarifier does not insert.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001898

Date of registration:09.11.2012

Expiration Date:09.11.2017

The owner of the registration certificate:Armavir Biofactory, FKPArmavir Biofactory, FKP Russia

Manufacturer: & nbsp

ARMAVIRSK BIOLOGICAL FACTORY, FSUE Russia

Information update date: & nbsp09.05.2018

Illustrated instructions

Instructions

Metoclopramide (Metoclopramide)