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

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 pyloric and duodenum 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 pyloric and esophageal 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. 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 holinoblokatorami). Stimulating the secretion of aldosterone, enhances the retention of Na + and the excretion of K +.

The onset of action on the gastrointestinal tract is noted 1-3 minutes after IV introduction, 10-15 minutes after intravenous administration, and is manifested by the acceleration of evacuation of the stomach contents and antiemetic effect (lasts 12 hours).

Pharmacokinetics:Connection with plasma proteins - 13-30%. It is metabolized in the liver. The half-life period is from 2.5 to 6 hours, with kidney failure - up to 14 hours. Removal of the drug occurs mainly through the kidneys for 24-72 hours in an 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 can be effective in vomiting caused by radiation therapy or the use of cytotoxic drugs). 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). It is used to enhance peristalsis during radiocontrast studies of the gastrointestinal tract.

Contraindications:Hypersensitivity, bleeding from the gastrointestinal tract, pyloric stenosis, mechanical intestinal obstruction, perforation of the stomach or intestine, pheochromocytoma, epilepsy, extrapyramidal disorders, prolactin-dependent tumors, pregnancy, lactation.

Carefully:Renal and / or hepatic insufficiency, bronchial asthma, arterial hypertension, Parkinson's disease, early childhood (increased risk of dyskinetic syndrome).

Dosing and Administration:

Enter iv in or in / m 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 children under 6 years of age, the daily dose is 0.5-1 mg / kg body weight, the frequency of administration is 1-3 times.

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, repeat the introduction 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 renal insufficiency initially receive 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 hypertonus; Parkinsonism (hyperkinesis, muscle rigidity is a manifestation of dopamine-blocking effect, the risk of development in children and adolescents increases when the dose is exceeded 0.5 mg / kg / day), dyskinesia (in the elderly, with chronic renal failure), drowsiness, fatigue, anxiety, confusion, headache, tinnitus.

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

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

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

Overdose:There may be hypersomnia, disorientation and extrapyramidal disorders. As a rule, the symptomatology disappears after stopping the drug within 24 hours. If necessary, treatment with 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 H₂-gastamin blockers.

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 action of metoclopramide may weaken the anticholinesterase drugs.

Special instructions:

It is not effective for vomiting of vestibular genesis.

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 as short as possible.

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

Effect on the ability to drive transp. cf. and fur:When taking the drug should be avoided potentially dangerous activities that require increased concentration of attention, rapid mental and motor reaction (driving vehicles, etc.).

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

Packaging:2 ml per ampoule of dark glass. For 5 or 10 ampoules in a plastic pallet, which is placed in a cardboard box along with instructions for use.

Storage conditions:In the dark place at a temperature of no higher than 25 ° C. Do not freeze. Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N012729 / 02

Date of registration:22.10.2007 / 24.11.2008

Expiration Date:Unlimited

The owner of the registration certificate:Promed Exports Pvt. Ltd.Promed Exports Pvt. Ltd. India

Manufacturer: & nbsp

PROMED EXPORTS, Pvt. Ltd. India

Information update date: & nbsp09.05.2018

Illustrated instructions

Instructions

Metoclopramide-Promed (Metoclopramide-Promed)