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

Excipients: disodium edetate 0.20 mg, sodium sulfite 0.25 mg, sodium chloride 18.00 mg, sodium acetate trihydrate 1.08 mg, acetic acid 0.00132 ml, water for injection 2.0 ml .

Description:Transparent colorless liquid.

Pharmacotherapeutic group:Antiemetics - dopamine receptor antagonist central

ATX: & nbsp

A.03.F.A Motility stimulators GIT

A.03.F.A.01 Metoclopramide

Pharmacodynamics:

Antiemetic means. A specific blocker of dopamine (D₂) and serotonin (5-HT3) receptors, inhibits the chemoreceptors of the trigger zone of the brainstem, weakens the sensitivity of the visceral nerves that transmit impulses from the pylorus to the vomiting center. Through the hypothalamus and the parasympathetic nervous system (innervation of the gastrointestinal tract) has a regulating and coordinating effect on the tone and motor activity of the upper gastrointestinal tract (including the tone of the lower sphincter of the esophagus). Increases the tone of the stomach and intestines, accelerates the emptying of the stomach, reduces the hyperacid stasis, prevents duodenopiloric and gastroesophageal reflux, stimulates intestinal peristalsis. Normalizes the separation of bile, reduces the spasm of the sphincter of Oddi. Without changing its tone, it eliminates dyskinesia of the gallbladder according to the hypomotor type. Does not affect the tone of the blood vessels of the brain, blood pressure, respiratory function, as well as kidney and liver, on hematopoiesis, gastric and pancreatic secretion. Stimulates the secretion of prolactin.Increases the sensitivity of tissues to acetylcholine (the action does not depend on vagal innervation, but is eliminated by m-holinoblokatorami). Stimulating the secretion of aldosterone, enhances the retention of sodium ions and the excretion of potassium ions.

The onset of action on the gastrointestinal tract is noted 1-3 minutes after intravenous administration, 10-15 minutes after intramuscular injection and is manifested by accelerating the evacuation of the stomach contents (approximately from 0.5-6 hours depending on the route of administration) and antiemetic effect ( lasts 12 hours).

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. Removal of the drug 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 different genesis (in some cases it can be effective in vomiting caused by radiation therapy or cytotoxic therapy);

- atony and hypotension of the stomach and intestines (in particular, postoperative);

- dyskinesia of the biliary tract along the hypomotor type;

- reflux esophagitis;

- Flatulence;

- Functional stenosis of the pylorus; .

- in the complex therapy of exacerbations of peptic ulcer of the stomach and duodenum;

- is used to enhance peristalsis during radiocontrast studies of the gastrointestinal tract;

- as a means to facilitate duodenal sounding (to accelerate the emptying of the stomach and promote food through the small intestine).

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;

- Parkinson's disease;

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");

- early childhood (children under 2 years - metoclopramide in the form of any dosage forms is contraindicated, children under 6 years of age are not indicated parenteral administration).

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

If you are hypersensitive to metoclopramide or other components of the drug, be sure to consult a doctor before you take it.

Carefully:

Bronchial asthma, arterial hypertension, Parkinson's disease, renal and / or hepatic insufficiency, elderly age (over 65 years), children's age (increased risk of dyskinetic syndrome).

If you have any of these diseases, consult a doctor before taking the drug.

Pregnancy and lactation:

Metoclopramide is contraindicated in the first trimester of pregnancy. Application in the II and III trimesters of pregnancy is possible only for life indications.

If you need to use the drug during lactation, you should decide whether to stop breastfeeding.

Dosing and Administration:

Intravenous or intramuscular.

Adults in a dose of 10-20 mg 1-3 times a day (maximum daily dose - 60 mg). Children older than 6 years of 5 mg 1-3 times a day.

For the prevention and treatment of nausea and vomiting due to the use of cytostatics or radiation therapy, the drug is administered intravenously at a dose of 2 mg / kg body weight 30 minutes before the use of cytostatics or radiation; if necessary, the administration is repeated after 2-3 hours.

Before the X-ray study, adults are administered intravenously 10-20 mg for 5-15 minutes before the study.

Patients with clinically expressed hepatic and / or renal insufficiency are prescribed a dose twice as low as usual, the subsequent dose depends on the patient's individual response to metoclopramide.

Side effects:

From the nervous system: extrapyramidal disorders - spasm of facial musculature, trismus, rhythmic protrusion of the tongue, bulbar type of speech, spasm of extraocular muscles (including oculogic crisis), spastic torticollis, opisthotonus,muscular hypertonia; Parkinsonism (hyperkinesis, muscle rigidity - a manifestation of dopaminoblocking action, the risk of development in children and adolescents increases with exceeding the dose of 0.5 mg / kg / day); dyskinesia (in the elderly, with chronic renal failure); drowsiness, fatigue, anxiety, confusion, headache, tinnitus, depression.

From the digestive system: constipation or diarrhea, rarely dry mouth.

On the part of the hematopoiesis system: neutropenia, leukopenia, sulfgemoglobinemia in adults.

From the cardiovascular system: atrioventricular blockade.

From the side of metabolism: porphyria.

Allergic reactions: urticaria, bronchospasm, angioedema.

From the endocrine system: rarely (with prolonged admission in high doses) - gynecomastia, galactorrhea, menstrual cycle.

Other: at the beginning of treatment, agranulocytosis is possible, rarely (when used in high doses) - hyperemia of the nasal mucosa.

If you develop any of the side effects listed in the instructions, contact your doctor as soon as possible.

If any of the side effects listed in the manual are aggravated,or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Symptoms: hypersomnia, disorientation and extrapyramidal disorders.

As a rule, the symptomatology disappears after the drug is discontinued within 24 hours. If necessary, treatment with m-holinoblokatorami and antiparkinsonian means.

Interaction:

Strengthens the action of ethanol on the central nervous system, the sedative effect of hypnotics, increases the effectiveness of therapy with blockers H₂-gistaminovyh receptors.

Increases the absorption of diazepam, tetracycline, ampicillin, paracetamol, acetylsalicylic acid, levodopa, ethanol; slows the absorption of digoxin and cimetidine.

With simultaneous use with neuroleptics, the risk of developing extrapyramidal symptoms increases.

The effects of metoclopramide may weaken cholinesterase inhibitors.

If you are taking other medications, you should consult your doctor.

Special instructions:

It is not effective for vomiting of vestibular genesis.

In connection with the sodium sulfite content, the injectable solution of metoclopramide should not be administered to patients with bronchial asthma,with increased sensitivity to sulfites (see section "Contraindications").

Against the background of the use of metoclopramide, there are possible distortions of these laboratory parameters of liver function and determination of the concentration of aldosterone and prolactin in plasma.

Most side effects occur within 36 hours of the start of treatment and take place within 24 hours after cancellation. Treatment should be, if possible, short-term.

During the treatment with the drug, alcohol is not recommended.

Effect on the ability to drive transp. cf. and fur:It is recommended to use caution when driving a vehicle or when working with potentially dangerous mechanisms that require increased concentration of attention and speed of psychomotor reactions.

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

Packaging:2 ml per ampoule of colorless neutral glass type I with a color fracture ring or with a colored dot and a notch. One, two or three color rings and / or a two-dimensional bar code, and / or alphanumeric coding or without additional color rings, a two-dimensional barcode, alphanumeric coding are applied to ampoules.5 ampoules per contour cell pack. For 1 or 2 contour packs with instructions for use in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:5 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-000393

Date of registration:04.05.2010 / 13.01.2016

Expiration Date:Unlimited

The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia

Manufacturer: & nbsp

FarmSirma Soteks, ZAO Russia

Information update date: & nbsp09.05.2018

Illustrated instructions

Instructions

Metoclopramide (Metoclopramide)