Instructions for medical use
Metoclopramide
Tradename
Metoclopramide
International nonproprietary name
Metoclopramide
Dosage form
Solution for injection 0.5% 2 ml
Compound
2 ml of solution contain
active substance - metoclopramide hydrochloride 10 mg,
Excipients: sodium pyrosulfite, sodium chloride, water for injection.
Description
Transparent solution, odorless.
Pharmacotherapeutic group
Drugs for treatment functional disorders Gastrointestinal tract.
Gastrointestinal motility stimulants. Metoclopramide.
ATX code A03FA01
Pharmacological properties
Pharmacokinetics
Suction
The action of metoclopramide hydrochloride begins within 1-3 minutes after intravenous administration, and then intramuscular injection after 10-15 minutes.
The pharmacological effect lasts for 1-2 hours after administration.
Distribution
Metoclopramide hydrochloride is slightly bound to plasma proteins (13 - 30%), mainly to albumin.
The volume of distribution is 3.5 l/kg, which indicates a wide distribution of the drug in tissues.
Metoclopramide hydrochloride crosses the placental barrier and is excreted in breast milk. Drug concentration in breast milk 2 hours after administration is higher than in plasma.
Metoclopramide hydrochloride penetrates the blood-brain barrier.
Metabolism
Metoclopramide hydrochloride is biotransformed only to a small extent. Binds to sulfuric and glucuronic acid.
Elimination
Half-life (T 1/2) of metoclopramide hydrochloride in adults with normal function kidney function is from 5 to 6 hours and increases in patients with impaired renal function.
About 85% of an oral dose of the drug is excreted in the urine, mostly unchanged or bound to sulfuric and glucuronic acid, within 72 hours. The remaining amount is excreted in feces.
Renal dysfunction
Clearance of metoclopramide is reduced by 70% in patients with severe violation renal function, while the plasma half-life increases (approximately 10 hours with creatinine clearance 10-50 ml/min and 15 hours with creatinine clearance<10 мл/мин).
Liver dysfunction
In patients with cirrhosis, metoclopramide accumulation was observed, associated with a 50% decrease in plasma clearance.
Pharmacodynamics
Metoclopramide is a dopamine receptor antagonist. It also exhibits an antagonistic effect on 5-HT 3 receptors and a weak stimulating effect on the ganglia. Blocks presynaptic dopamine receptors and promotes the release of acetylcholine from cholinergic motor neurons in the intestinal wall. Due to this, metoclopramide increases the release of acetylcholine from neurons, which induces spasm by stimulating muscarinic M2 receptors in the smooth muscle cells of the digestive tract. By increasing physiological conductance in cholinergic neurons, metoclopramide inhibits dopamine-induced relaxation of gastric smooth muscle, thereby enhancing cholinergic responses of gastrointestinal smooth muscle. The drug also stimulates the motility of the upper gastrointestinal tract (including increasing the static tone of the lower esophageal sphincter). In addition, gastroduodenal coordination between pyloric function and proximal duodenal motility is improved. Almost no effect on the motility of the colon and gall bladder. Does not affect the secretion of gastric juice, bile and pancreatic enzymes.
Metoclopramide penetrates the blood-brain barrier, producing effects on the central nervous system (CNS) that are typical of a dopamine receptor blocker. Has a sedative and antiemetic effect, eliminates nausea.
Indications for use
Use in adults:
Prevention of postoperative nausea and vomiting
Symptomatic treatment of nausea and vomiting, including nausea and vomiting in acute migraine
Prevention of nausea and vomiting induced by radiation therapy
Prevention of delayed chemotherapy-induced nausea and vomiting
Use in children:
Prevention of delayed chemotherapy-induced nausea and vomiting as a second-line treatment option
Treatment of postoperative nausea and vomiting as a second-line treatment option
Directions for use and doses
Metoclopramide is administered intramuscularly (IM) or intravenously (IV).
IV injections should be administered as a bolus slowly (at least 3 minutes).
Dosage regimen for adults:
To eliminate postoperative nausea and vomiting, the recommended single dose is 10 mg. For the symptomatic treatment of nausea and vomiting, including nausea and vomiting in acute migraine, as well as for the prevention of nausea and vomiting induced by radiation therapy and the prevention of delayed nausea and vomiting induced by chemotherapy: The recommended single dose is 10 mg up to three times daily.
Dosage regimen for children and adolescents (1-18 years):
|
Age |
Body mass |
Dose |
Frequency of administration |
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Up to 3 times a day |
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|
Up to 3 times a day |
|||
|
Up to 3 times a day |
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|
Up to 3 times a day |
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More than 60 kg |
Up to 3 times a day |
When prescribing the drug, a minimum six-hour interval between drug administration must be observed.
The maximum recommended treatment duration is 48 hours for the treatment of postoperative nausea and vomiting. The maximum recommended treatment duration is 5 days for the management of delayed chemotherapy-induced nausea and vomiting. In some cases, the duration of treatment is determined by the doctor, assessing the potential benefits and risks for the child. For children aged 1-14 years, metoclopramide is prescribed only in case of a confirmed diagnosis.
Elderly
Dose reduction should be considered in elderly patients based on renal and liver function and general condition.
Kidney failure
In patients with end-stage renal failure (creatinine clearance ≤ 15 ml/min), the daily dose should be reduced by 75%.
In patients with moderate to severe renal failure (creatinine clearance 15-60 ml/min), the daily dose should be reduced by 50%.
Liver failure
In patients with severe liver failure, the daily dose should be reduced by 50%
Side effects
Often (≥ 1/100,< 1/10)
Asthenia
Extrapyramidal disorders (especially in children and young people and/or when the recommended dose is exceeded, even after one dose of the drug), parkinsonism, akathisia
Depression
Hypotension, especially with intravenous administration
Not often (≥ 1/1000,< 1/100)
Bradycardia (especially with intravenous administration)
Amenorrhea, hyperprolactinemia
Hypersensitivity
Dystonia, dyskinesia, depression of consciousness
Hallucinations
Rarely (≥ 1/10,000,< 1/1000)
Insomnia, headaches, dizziness, visual disturbances, confusion
Swelling of the tongue or larynx
Galactorrhea
Seizures, especially in patients with epilepsy
Very rarely (< 1/10 000)
Neutropenia, leukopenia, agranulocytosis without a definite connection with the use of Metoclopramide
Bronchospasm, especially in patients with a history of asthma
Rash, hives
Unknown
Methemoglobinemia
Cardiac arrest occurring shortly after injection, atrioventricular block, QT prolongation
Gynecomastia, impotence
Porphyria
Inflammation and local phlebitis at the injection site
Anaphylactic reactions (including anaphylactic shock), especially with intravenous administration
Tardive dyskinesia, which may be permanent, during or after long-term treatment, especially in elderly patients, neuroleptic malignant syndrome
Shock, fainting after injections, acute arterial hypertension in patients with pheochromocytoma
Urinary incontinence, frequent urination
* Endocrine disorders during long-term treatment associated with hyperprolactinemia (amenorrhea, galactorrhea, gynecomastia).
The following reactions, sometimes associated, occur more often when using the drug in large doses:
Extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonian syndrome, akathisia, even after a single dose of the drug, especially in children and young adults
Drowsiness, depression of consciousness, confusion, hallucinations.
Contraindications
Hypersensitivity to any component of the drug
Bleeding from the gastrointestinal tract
Pyloric stenosis
Mechanical intestinal obstruction
Perforation of the stomach or intestines
Confirmed or suspected pheochromocytoma due to risk of severe episodes of hypertension
Epilepsy (increased frequency and intensity of seizures)
Parkinson's disease
Concomitant use of anticholinergic drugs, levodopa and dopaminergic agonists.
History of tardive dyskinesia induced by antipsychotics or metoclopramide
A history of methemoglobinemia when combined with metoclopramide or NADH-cytochrome b5 reductase deficiency.
Prolactinoma or prolactin-dependent tumor
Children's age up to 1 year
III trimester of pregnancy and lactation period
Drug interactions
The combination is contraindicated
Levodopa or dopaminergic agonists and Metoclopramide are antagonists.
Combination to avoid
Alcohol enhances the sedative effect of Metoclopramide.
Combination to be taken into account
Metoclopramide increases the absorption of diazepam, tetracycline, ampicillin, paracetamol, acetylsalicylic acid, levodopa, ethanol; slows down the absorption of digoxin and cimetidine.
Anticholinergic drugs and morphine derivatives
Anticholinergic drugs and morphine derivatives may have mutual antagonism with metoclopramide in their effect on gastrointestinal motility.
Depressants that inhibit the activity of the central nervous system (morphine derivatives, tranquilizers, sedative H1 histamine receptor blockers, sedative antidepressants, barbiturates, clonidine and the like)
Metoclopramide potentiates the sedative effect of sedatives affecting the central nervous system.
Neuroleptics
When metoclopramide is used simultaneously with antipsychotics, the risk of developing extrapyramidal disorders increases.
Serotonergic drugs
Using metoclopramide with serotonergic drugs such as SSRIs may increase the risk of developing serotonin syndrome.
Digoxin
Metoclopramide may reduce the bioavailability of digoxin. Careful monitoring of plasma digoxin concentrations is required.
Cyclosporine
Metoclopramide increases the bioavailability of cyclosporine (Cmax by 46% and effect by 22%). Careful monitoring of cyclosporine plasma concentrations is required.
Mivacurium and suxamethonium
Metoclopramide injections may prolong the duration of neuromuscular blockade (by inhibiting plasma cholinesterase).
Strong inhibitorsCYP2 D6
Metoclopramide exposure is increased when coadministered with strong CYP2D6 inhibitors such as fluoxetine and paroxetine.
MAO inhibitors
In patients with hypertension treated with MAO inhibitors (monoamine oxidase inhibitors), metoclopramide potentiates the effect of MAO inhibitors.
special instructions
Neurological disorders
Extrapyramidal disorders may occur, especially in children and young people, and/or when using high doses of metoclopramide. These reactions usually occur at the beginning of treatment and may appear after a single dose. Metoclopramide should be discontinued immediately if symptoms of extrapyramidal disorders occur. These symptoms are usually completely reversible after cessation of treatment, but symptomatic treatment (benzodiazepines in children and/or antiparkinsonian anticholinergic drugs in adults) may be required.
Long-term treatment with metoclopramide may lead to tardive dyskinesia, which is potentially irreversible, especially in the elderly. Treatment should not exceed three months due to the risk of tardive dyskinesia. Treatment should be discontinued if clinical signs of tardive dyskinesia appear.
Neuroleptic malignant syndrome may occur when taking metoclopramide in combination with antipsychotics, as well as when taking metoclopramide alone. The drug should be stopped immediately if symptoms of neuroleptic malignant syndrome occur and appropriate treatment should be initiated.
When prescribing the drug, special attention should be paid to patients with concomitant neurological diseases and patients receiving other centrally acting drugs.
Cardiovascular diseases
Use intravenously with caution in elderly patients, patients with cardiac conduction abnormalities (including QT prolongation), patients with uncorrected electrolyte imbalances, those with bradycardia, and those taking other drugs that prolong the QT interval.
IV metoclopramide should be administered slowly (over at least 3 minutes) to reduce the risk of side effects (eg, hypotension, akathisia).
Metoclopramide is used with caution in patients with bronchial asthma, arterial hypertension, impaired liver and/or kidney function.
Patients with impaired renal and liver function
When using the drug in patients with impaired renal function and in patients with severe liver dysfunction, a dose reduction is recommended.
Hypokalemia
In patients with impaired renal function, hypokalemia may occur during treatment with metoclopramide because the drug increases plasma aldosterone concentrations and decreases sodium excretion.
Depression
In patients with a history of depression, especially moderate or severe depression, accompanied by suicidal tendencies, a relapse of the disease may occur during treatment with metoclopramide. Before starting treatment, it is necessary to weigh the ratio of the potential benefits of treatment to the possible risks.
Endocrine system disorders
Metoclopramide causes a transient increase in aldosterone levels in
plasma. This can lead to fluid retention in the body, especially in patients with cirrhosis or congestive heart failure.
Application in pediatrics
For children aged 1-14 years, metoclopramide is prescribed only in case of a confirmed diagnosis.
Application in geriatrics
When used in elderly patients, it must be borne in mind that with long-term use of the drug in high or medium doses, the most common side effect is extrapyramidal disorders, especially parkinsonism and tardive dyskinesia.
Pregnancy and lactation
Numerous data obtained on the use of metoclopramide in pregnant women (more than 1000 described cases) indicate the absence of fetotoxicity and the ability to cause malformations in the fetus. But embryotoxic data do not indicate complete safety of the drug. Therefore, metoclopramide can be used during pregnancy (I-II trimesters of pregnancy) only if the potential benefit to the mother outweighs the potential risk to the fetus. It is not used in the third trimester of pregnancy, since the possibility of developing extrapyramidal symptoms in the newborn cannot be excluded. Metoclopramide is excreted in breast milk and is not recommended for use during breastfeeding.
Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms
When taking the drug, you should avoid potentially hazardous activities that require increased attention, rapid mental and motor reactions (driving vehicles, etc.).
Overdose
Symptoms: drowsiness, confusion, hallucinations, irritability, convulsions, extrapyramidal movement disorders, dysfunction of the cardiovascular system with bradycardia and arterial hypo- or hypertension.
Treatment: drug withdrawal, symptomatic therapy. If symptoms of extrapyramidal disorders occur, symptomatic treatment is carried out (benzodiazepines in children and/or antiparkinsonian anticholinergic drugs in adults).
Release form and packaging
2 ml in ampoules made of colorless transparent glass.
5 ampoules are placed in a plastic container. 1 container, along with instructions for medical use in the state and Russian languages, is placed in a cardboard box.
Storage conditions
Store in a dry place, protected from light, at a temperature not exceeding 25°C. The drug should be stored out of the reach of children!
Shelf life
Do not use the drug after the expiration date indicated on the package.
Conditions for dispensing from pharmacies
On prescription
Manufacturer
Pharmaceutical plant "Polpharma" JSC
st. Pelplinska 19, 83-200 Starogard Gdanski, Poland
Registration Certificate Holder
"Khimpharm" JSC, Republic of Kazakhstan
Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan
JSC "Khimpharm", Shymkent, Republic of Kazakhstan,
st. Rashidova, 81
Phone number 7252 (561342)
Fax number 7252 (561342)
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Read these instructions carefully before you start taking/using this medicine.
Save the instructions, you may need them again.
If you have any questions, consult your doctor
This medicine is for you personally and should not be given to others because it may harm them even if they have the same symptoms as you.
Registration number:
Tradename:
Metoclopramide
INN:
metoclopramide
Dosage form:
solution for intravenous and intramuscular administration.
Compound:
1 ampoule (2 ml) contains metoclopramide hydrochloride monohydrate as the active substance (in terms of metoclopramide hydrochloride) – 10 mg.
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 – up to 2.0 ml .
Description:
transparent colorless liquid.
Pharmacotherapeutic group:
antiemetic – central dopamine receptor antagonist.
ATX code:
pharmachologic effect
Pharmacodynamics
Antiemetic. A specific blocker of dopamine (D 2) and serotonin (5-NT3) receptors, inhibits chemoreceptors of the trigger zone of the brain stem, weakens the sensitivity of the visceral nerves that transmit impulses from the pylorus of the stomach and duodenum to the vomiting center. Through the hypothalamus and parasympathetic nervous system (innervation of the gastrointestinal tract) it has a regulating and coordinating effect on the tone and motor activity of the upper gastrointestinal tract (including the tone of the lower esophageal sphincter). Increases the tone of the stomach and intestines, accelerates gastric emptying, reduces hyperacid stasis, prevents duodenopyloric and gastroesophageal reflux, stimulates intestinal motility. Normalizes the secretion of bile, reduces spasm of the sphincter of Oddi. Without changing its tone, it eliminates dyskinesia of the gallbladder of the hypomotor type. Does not affect the tone of the blood vessels of the brain, blood pressure, respiratory function, as well as the kidneys and liver, hematopoiesis, secretion of the stomach and pancreas. Stimulates the secretion of prolactin. Increases tissue sensitivity to acetylcholine (the effect does not depend on vagal innervation, but is eliminated by m-anticholinergic blockers). By stimulating the secretion of aldosterone, it enhances the retention of sodium ions and the excretion of potassium ions.
The onset of action on the gastrointestinal tract is observed 1-3 minutes after intravenous administration, 10-15 minutes after intramuscular administration and is manifested by accelerated evacuation of gastric contents (from approximately 0.5-6 hours depending on the route of administration) and an antiemetic effect ( lasts 12 hours).
Pharmacokinetics
Communication with plasma proteins is about 30%. Metabolized in the liver. The half-life is 4-6 hours, in case of impaired renal function - up to 14 hours. The drug is excreted mainly through the kidneys within 24-72 hours in unchanged form and in the form of conjugates. Passes through the placental and blood-brain barriers and penetrates into breast milk.
Indications for use
- vomiting, nausea, hiccups of various origins (in some cases it can be effective for vomiting caused by radiation therapy or taking cytostatics);
- atony and hypotension of the stomach and intestines (in particular, postoperative);
- hypomotor type biliary dyskinesia;
- reflux esophagitis;
- flatulence;
- functional pyloric stenosis;
- as part of complex therapy for exacerbations of gastric and duodenal ulcers;
- used to enhance peristalsis during radiopaque studies of the gastrointestinal tract;
- as a means of facilitating duodenal intubation (to speed up gastric emptying and move food through the small intestine).
Contraindications
- hypersensitivity to metoclopramide or any of the components of the drug;
- bleeding from the gastrointestinal tract;
- pyloric stenosis;
- mechanical intestinal obstruction;
- perforation of the wall of the stomach or intestines;
- 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 (first trimester), lactation period (see section “Use during pregnancy and breastfeeding”);
- early childhood (children under 2 years of age - the use of metoclopramide in the form of any dosage forms is contraindicated, children under 6 years of age - parenteral administration is contraindicated).
Not prescribed after gastrointestinal surgery (such as pyloroplasty or intestinal anastomosis) because vigorous muscle contractions interfere with healing.
If you are hypersensitive to metoclopramide or other components of the drug, before taking
Carefully
Bronchial asthma, arterial hypertension, Parkinson's disease, renal and/or liver failure, old age (over 65 years), childhood (increased risk of developing dyskinetic syndrome).
If you have one of the listed diseases, before taking the drug Be sure to consult your doctor.
Use during pregnancy and breastfeeding
Metoclopramide is contraindicated for use in the first trimester of pregnancy.
Use in the second and third trimesters of pregnancy is possible only for health reasons.
If it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be decided.
Directions for use and doses
Intravenously or intramuscularly.
Adults at a dose of 10-20 mg 1-3 times a day (maximum daily dose – 60 mg).
Children over 6 years old: 5 mg 1-3 times a day.
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 body weight 30 minutes before the use of cytostatics or radiation; if necessary, the administration is repeated after 2-3 hours.
Before an X-ray examination, adults are administered intravenously 10-20 mg 5-15 minutes before the start of the examination.
Patients with clinically significant liver and/or renal failure are prescribed a dose that is half the usual dose, the subsequent dose depends on the patient’s individual response to metoclopramide.
Side effect
From the nervous system: extrapyramidal disorders - spasm of the facial muscles, trismus, rhythmic protrusion of the tongue, bulbar type of speech, spasm of extraocular muscles (including oculogyric crisis), spastic torticollis, opisthotonus, muscle hypertonicity; parkinsonism (hyperkinesis, muscle rigidity - a manifestation of a dopamine-blocking effect, the risk of development in children and adolescents increases when the dose exceeds 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.
From the hematopoietic system: neutropenia, leukopenia, sulfhemoglobinemia in adults.
From the cardiovascular system: atrioventricular block.
From the side of metabolism: porphyria.
Allergic reactions: urticaria, bronchospasm, angioedema.
From the endocrine system: rarely (with long-term use in high doses) - gynecomastia, galactorrhea, menstrual irregularities.
Others: 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 indicated in the instructions, immediately consult a doctor.
If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, Tell your doctor about this.
Overdose
Symptoms: hypersomnia, disorientation and extrapyramidal disorders.
As a rule, symptoms disappear after stopping the drug for 24 hours. If necessary, treatment is carried out with m-anticholinergics and antiparkinsonian drugs.
Interaction with other drugs
It enhances the effect of ethanol on the central nervous system, the sedative effect of hypnotics, and increases the effectiveness of therapy with H2-histamine receptor blockers.
Increases the absorption of diazepam, tetracycline, ampicillin, paracetamol, acetylsalicylic acid, levodopa, ethanol; slows down the absorption of digoxin and cimetidine.
When used simultaneously with antipsychotics, the risk of developing extrapyramidal symptoms increases.
The effect of metoclopramide may be reduced by cholinesterase inhibitors.
If you are taking other drugs, you should consult your doctor.
special instructions
Not effective for vomiting of vestibular origin.
Due to the sodium sulfite content, metoclopramide injection solution should not be prescribed to patients with bronchial asthma or hypersensitivity to sulfites (see section “Contraindications”).
During the use of metoclopramide, distortion of data on laboratory parameters of liver function and determination of the concentration of aldosterone and prolactin in plasma is possible.
Most side effects occur within 36 hours of starting treatment and disappear within 24 hours after discontinuation. Treatment should be short-term if possible.
During treatment with the drug, alcohol consumption is not recommended.
Features of the effect of the drug on the ability to drive a vehicle or when operating potentially dangerous mechanisms
Release form
Solution for intravenous and intramuscular administration 5 mg/ml.
2 ml in ampoules of colorless neutral glass type I with a colored break ring or with a colored dot and notch. The ampoules are additionally coated with one, two or three colored rings and/or a two-dimensional bar code, and/or an alphanumeric coding, or without additional color rings, a two-dimensional bar code, or an alphanumeric coding. 5 ampoules per blister pack. 1 or 2 blister packs along with instructions for use in a cardboard pack.
Storage conditions
In a place protected from light at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Best before date
5 years. Do not use after the expiration date stated on the packaging.
Vacation conditions
On prescription.
Manufacturer:
CJSC PharmFirma Sotex
141345, Russia, Moscow region, Sergiev Posad municipal district, rural settlement Bereznyakovskoye, pos. Belikovo, no. 10, no. 11, no. 12
or
LLC "Ellara"
601122, Russia, Vladimir region, Petushinsky district, Pokrov, st. Franz Stolwerka, 20, building 2
Registration Certificate Holder:
CJSC PharmFirma Sotex.
Consumer complaints should be sent to the manufacturer's address.
Metoclopramide: instructions for use and reviews
Latin name: Metoclopramide
ATX code: A03FA01
Active substance: metoclopramide
Manufacturer: Federal State Unitary Enterprise "Moscow Endocrine Plant", LLC "Ellara", OJSC "Novosibkhimpharm", CJSC "PharmFirma SOTEX", LLC "Promomed Rus", CJSC "Update PFK" (Russia), PROMED EXPORTS (India), Borisov Medicinal Products Plant ( Belarus), JSC "Pharmaceutical Plant POLFARMA" (Poland)
Updating the description and photo: 18.09.2019
Metoclopramide is a drug with antiemetic action.
Release form and composition
Metoclopramide is available in the following dosage forms:
- Tablets: flat-cylindrical, round, chamfered, almost white or white, marbling is allowed (50 pcs. in blister packs, 1 pack in a cardboard box; 10 pcs. in blister packs or blisters, 1-5, 10 packages or blisters in a cardboard pack; 14 pcs. in blister packs, 4 packs in a cardboard pack; 50 pcs. in polymer or dark glass jars, 1 jar in a cardboard pack);
- Solution for intravenous and intramuscular administration (in ampoules of 2 ml, 5 or 10 ampoules in a cardboard box, or 5 or 10 ampoules in plastic or cell contour packages (pallets), 1 or 2 packs in a cardboard box).
1 tablet of Metoclopramide contains:
- Active substance: metoclopramide hydrochloride – 10 mg (in the form of metoclopramide hydrochloride monohydrate in terms of dry matter);
- Auxiliary components: lactose monohydrate – 60 mg, “Extra” potato starch – 28.47 mg, povidone – 0.53 mg, calcium stearate – 1 mg.
1 ml of Metoclopramide injection solution contains the active substance: metoclopramide hydrochloride – 5 mg.
Pharmacological properties
Pharmacodynamics
Metoclopramide is a specific blocker of dopamine (D 2) and serotonin (5-HT 3) receptors. It suppresses the activity of chemoreceptors localized in the trigger zone of the brain stem and reduces the sensitivity of the visceral nerves responsible for transmitting impulses from the duodenum and pylorus to the vomiting center.
Metoclopramide acts on the hypothalamus and parasympathetic nervous system, which leads to innervation of the gastrointestinal tract and allows you to regulate and coordinate motor activity and tone of the upper gastrointestinal tract (including the tone of the lower esophageal sphincter). Strengthens the tone of the stomach and intestines, activates intestinal motility, accelerates gastric emptying, prevents esophageal and pyloric reflux, and reduces the severity of hyperacid stasis. The drug normalizes bile secretion and eliminates spasm of the sphincter of Oddi, as well as dyskinesia of the gallbladder, without affecting the tone of the latter.
Metoclopramide is not characterized by ganglioblocking, m-anticholinergic, antiserotonin and antihistamine effects. Also, the substance does not change respiratory function, the functioning of the liver and kidneys, and does not affect the tone of the blood vessels of the brain, hematopoiesis, blood pressure, secretion of the stomach and pancreas.
Metoclopramide stimulates the synthesis of prolactin and increases the sensitivity of tissues to acetylcholine (the effect is not determined by vagal innervation, but is eliminated with the help of anticholinergic drugs). It also activates the production of aldosterone, while slowing down the excretion of sodium and potassium ions from the body.
Pharmacokinetics
Metoclopramide begins to act on the gastrointestinal tract approximately 10–15 minutes after intramuscular administration and 1–3 minutes after intravenous administration, which is reflected in accelerated evacuation of gastric contents and an antiemetic effect. The substance is metabolized in the liver and excreted primarily in the urine within 24–72 hours (approximately 85% of the dose), 30% of metoclopramide ingested is excreted unchanged. It easily crosses the blood-brain and placental barriers and is also detected in breast milk.
When taken orally, metoclopramide is rapidly absorbed from the gastrointestinal tract, with its bioavailability being 80 ± 15%. The degree of binding to plasma proteins (in particular albumin) varies from 13 to 22%. Maximum metoclopramide blood concentrations are directly proportional to the dose taken and are usually achieved within 1–2 hours. The half-life of the drug in tablet form is 2.5-6 hours (with reduced renal function - up to 14 hours).
In patients with severe renal dysfunction, the clearance of metoclopramide is reduced by 70%. There is also an increase in its half-life from blood plasma (approximately 15 hours with QC less than 10 ml/min and 10 hours with QC 10‒50 ml/min). In patients with liver cirrhosis, accumulation of metoclopramide is possible, which is explained by a decrease in plasma clearance by 50%.
Indications for use
- Nausea, vomiting, hiccups of various etiologies (in some cases, Metoclopramide can be effective in the treatment of vomiting caused by taking cytostatics or radiation therapy);
- Functional pyloric stenosis;
- Flatulence;
- Hypotension and atony of the stomach and intestines, including postoperative;
- Reflux esophagitis;
- Biliary dyskinesia of hypomotor type;
- Peptic ulcer of the stomach and duodenum (with exacerbation, simultaneously with other medications).
The drug is also prescribed for X-ray contrast studies of the gastrointestinal tract (to enhance peristalsis) and as a means of facilitating duodenal intubation (to speed up gastric emptying and move food through the small intestine).
Contraindications
Absolute:
- Glaucoma;
- Pyloric stenosis;
- Bleeding from the gastrointestinal tract;
- Perforation of the walls of the stomach or intestines;
- Prolactin-dependent tumors;
- Parkinson's disease;
- Mechanical intestinal obstruction;
- Pheochromocytoma;
- Extrapyramidal disorders;
- Epilepsy;
- Vomiting associated with treatment or overdose of antipsychotics, as well as in patients with breast cancer;
- Bronchial asthma due to hypersensitivity to sulfites (injection solution);
- Lactase deficiency, glucose-galactose deficiency, lactose intolerance (tablets);
- I trimester of pregnancy and lactation period;
- Age up to 2 years (any dosage forms of metoclopramide); up to 6 years (injection solution); up to 14 years (tablets);
- Hypersensitivity to the components of the drug.
According to the instructions, Metoclopramide in any dosage form should not be used after operations on the gastrointestinal tract (intestinal anastomosis, pyloroplasty), since vigorous muscle contractions interfere with healing.
Relative (Metoclopramide should be used with caution in the presence of the following diseases/conditions):
- Bronchial asthma;
- Arterial hypertension;
- Liver and/or renal failure;
- Children and elderly (from 65 years old) age;
- II-III trimesters of pregnancy.
Instructions for use of Metoclopramide: method and dosage
Injection solution
Metoclopramide is administered intravenously or intramuscularly.
The drug is prescribed depending on age:
- Adults: 1-3 times a day, 10-20 mg (maximum – 60 mg per day);
- Children from 6 years old: 1-3 times a day, 5 mg.
30 minutes before taking cytostatics or radiation therapy for the treatment and prevention of nausea and vomiting, Metoclopramide is administered intravenously at a dose of 2 mg/kg body weight. If necessary, the solution can be re-introduced after 2-3 hours.
5-15 minutes before the X-ray examination, 10-20 mg of Metoclopramide is administered intravenously.
In case of clinically significant liver and/or renal failure, the dose must be reduced by 2 times, the subsequent dose is determined by the patient’s individual response to therapy.
Pills
Metoclopramide tablets are taken orally, 30 minutes before meals, with a small amount of water.
A single dose for adults is 10 mg, the maximum daily dose is 30 mg or 0.5 mg per 1 kg of body weight.
Metoclopramide for children over 14 years of age is prescribed 0.1-0.15 mg per 1 kg of body weight, maximum per day - 0.5 mg per 1 kg of body weight.
The maximum duration of therapy is 5 days.
In case of renal failure, dose adjustment is necessary:
- Terminal stage (with creatinine clearance less than 15 ml per minute): 25% of the daily dose;
- Moderate and severe stage (with creatinine clearance 15-60 ml per minute): 50% of the daily dose.
In severe liver failure, the dose should be reduced by 50%.
Side effects
- Cardiovascular system: atrioventricular block;
- Central nervous system: extrapyramidal disorders - trismus, spasm of the facial muscles, spasmodic torticollis, bulbar type of speech, rhythmic protrusion of the tongue, spasm of the extraocular muscles (including oculogyric crisis), muscular opisthotonus, hypertonicity; parkinsonism (muscle rigidity, hyperkinesis - a manifestation of dopamine-blocking action, the risk of development in children increases when the dose exceeds 0.5 mg/kg per day), dyskinesia (in chronic renal failure and in elderly patients), depression, headache, drowsiness, anxiety, fatigue, confusion, tinnitus;
- Endocrine system: rarely (with prolonged therapy in high doses) - galactorrhea, gynecomastia, menstrual irregularities;
- Digestive system: diarrhea, constipation; rarely – dry mouth;
- Hematopoietic system: leukopenia, neutropenia, sulfhemoglobinemia in adults;
- Metabolism: porphyria;
- Allergic reactions: angioedema, bronchospasm, urticaria;
- Other: at the beginning of treatment - agranulocytosis; rarely (when using high doses) - hyperemia of the nasal mucosa.
If the above symptoms appear, worsen, or develop other side effects, you should consult a doctor.
Overdose
The main symptoms of a metoclopramide overdose are extrapyramidal disorders, respiratory and cardiac arrest, drowsiness, hallucinations, clouded consciousness, fainting and semi-fainting states.
If a patient is diagnosed with extrapyramidal symptoms provoked by an overdose or another cause, it is recommended to prescribe symptomatic therapy (anticholinergic antiparkinsonian drugs in adults and/or benzodiazepines in children).
Depending on the clinical condition of the patient, symptomatic treatment and regular monitoring of respiratory and cardiac functions are required.
special instructions
For vomiting of vestibular origin, Metoclopramide is not effective.
When using Metoclopramide, data on laboratory parameters of liver function and determination of the concentration of prolactin and aldosterone in plasma may be distorted.
Side effects in most cases develop within 36 hours after using the drug and disappear without additional treatment within 24 hours after its discontinuation.
Therapy, if possible, should be short-term.
It is not recommended to drink alcohol while using Metoclopramide.
During the treatment period, care should be taken when working with potentially dangerous mechanisms that require increased concentration and rapid psychomotor reactions, as well as when driving vehicles.
Use during pregnancy and lactation
The use of metoclopramide is contraindicated in the third trimester of pregnancy, as this can lead to the development of extrapyramidal disorders in newborns. When prescribing the drug to pregnant women, constant monitoring of newborns is necessary.
Metoclopramide is detected in breast milk, so the lactation period is a contraindication to the prescription of the drug. Before starting treatment, you should stop breastfeeding.
Use in childhood
Use extreme caution when prescribing Metoclopramide to children, especially young children, since in this case the risk of developing dyskinetic syndrome significantly increases.
Drug interactions
When metoclopramide is used simultaneously with certain drugs, the following effects may occur:
- Ethanol: increased effect on the central nervous system;
- Cholinesterase inhibitors: weakening of the effect of metoclopramide;
- Sleeping pills: increased sedative effect;
- H2-histamine receptor blockers: increasing the effectiveness of therapy;
- Diazepam, tetracycline, ampicillin, paracetamol, acetylsalicylic acid, levodopa, ethanol: increased absorption;
- Digoxin, cimetidine: slower absorption;
- Neuroleptics: increased risk of developing extrapyramidal symptoms.
Before using other medications at the same time, you should consult your doctor.
Analogues
Analogs of Metoclopramide are: Metamol, Vero-Metoclopramide, Perinorm, Cerucal, Metoclopramide-Vial, Metoclopramide-Eskom, Reglan.
Terms and conditions of storage
Store in a dry, dark place, out of reach of children, at temperatures up to 25°C.
Best before date:
- Tablets – 2 years;
- Injection solution – 4 years.
Food poisoning, inflammatory diseases of the digestive system, infections - all these pathological processes can cause a phenomenon such as vomiting in a person. And constant vomiting is a dangerous and unpleasant symptom that needs to be eliminated. And here Metoclopramide, an effective new generation antiemetic drug, can come to the rescue.
Description
Vomiting is a reflexive protective reaction of the body, the purpose of which is to remove a potentially dangerous substance from the stomach cavity. Vomiting is often observed with food poisoning and infectious diseases of the gastrointestinal tract. However, vomiting is not always beneficial. When it is repeated constantly, it brings great inconvenience to the patient and can lead to a worsening of his condition. Thus, in some cases, vomiting must be controlled.
How does the gag reflex occur? A special part of the brain is responsible for it - the vomiting center, located in the medulla oblongata. It receives appropriate signals from the digestive organs, and itself gives them commands to vomit out the contents of the stomach. Metoclopramide blocks chemoreceptors located in the medulla oblongata and responsible for receiving signals from the digestive organs. At the same time, metoclopramide blocks a number of dopamine and serotonin receptors on the surface cells of the mucous membrane of the stomach and intestines, weakens the signals of the visceral nerves that transmit signals from the pylorus of the stomach and duodenum to the vomiting center. It has an effect on the hypothalamus and parasympathetic nervous system of the gastrointestinal tract, due to which the muscle tone of its upper sections is normalized.
Metoclopramide is characterized by the following types of action:
- blocking vomiting;
- preventing hiccups;
- increased activity of the small intestine and antrum of the stomach;
- decreased motor activity of the esophagus;
- reduction of hyperacid stasis;
- reducing spasm of the sphincter of Oddi;
- normalization of bile secretion;
- increased tone of the lower esophageal sphincter;
- acceleration of the movement of the food bolus through the stomach and intestines;
- reducing the reflux of food into the esophagus, preventing reflux esophagitis.
Metoclopramide does not affect the secretion of the stomach and pancreas, but in general it has a positive effect on the treatment of stomach and duodenal ulcers and does not contribute to diarrhea. Also, the drug normally does not affect the blood vessels of the brain, blood pressure, respiratory functions, liver, kidneys and hematopoiesis.
At the same time, Metoclopramide increases the synthesis of the pituitary hormone prolactin, increases tissue sensitivity to acetylcholine, retains sodium ions and promotes the removal of potassium ions and fluid retention in the body.
The main active ingredient of Metoclopramide is the compound of the same name. Thus, metoclopramide is the international nonproprietary name of the drug.
Pharmacokinetics
Metoclopramide is quickly absorbed into the blood through the intestinal wall, penetrates the blood-brain and placental barriers, and into breast milk. The biological availability of the drug is quite high and reaches 80%. The maximum concentration of metoclopramide is observed 1-2 hours after administration, the half-life is 3-5 hours.
The speed at which the drug affects the patient depends on how it is introduced into the body. When administered intravenously, the drug begins to act after 1-3 minutes, and when administered intramuscularly, the speed of action of Metoclopramide is 10-15 minutes. The effect, manifested in an increase in the rate of evacuation of stomach contents, lasts up to 6 hours, the antiemetic effect lasts up to 12 hours.
Indications
Metoclopramide is prescribed for various diseases of the gastrointestinal tract and unpleasant symptoms associated with it. Indications for Metoclopramide include:
- vomiting of various origins;
- nausea;
- hiccups;
- hypotension and atony of the stomach, including diabetic and postoperative;
- flatulence;
- peptic ulcer (as part of complex therapy);
- reflux esophagitis;
- hypotonic biliary dyskinesia;
- dyspeptic syndrome with myocardial infarction and heart failure.
Metoclopramide is effective against most types of vomiting, but not all. You can use the drug for vomiting caused by poisoning, infections, allergies, taking medications (antibiotics, cytostatics, anesthetic drugs, etc.), toxicosis of pregnancy, heart attack and heart failure, liver diseases, traumatic brain injuries. However, for vomiting caused by psychogenic or vestibular causes (for example, motion sickness syndrome), the drug will be ineffective, and for vomiting caused by an overdose of antipsychotics, it is generally contraindicated.
Metoclopramide can also be used to prevent vomiting during chemotherapy or radiation treatments. The drug is often prescribed to prepare the gastrointestinal tract for upcoming diagnostic procedures, for example, X-ray contrast examination of the stomach, or duodenal intubation. The fact is that due to its ability to increase the tone of the stomach muscles, metoclopramide helps to accelerate its emptying.
In addition, Metoclopramide is often used for migraines, alone or in combination with other drugs, while relieving the attacks of nausea and partly headaches that accompany migraines. The drug is also effective for Tourette's syndrome in children.
Release form
Metoclopramide is available in two main forms - tablets and solution for intramuscular/intravenous administration. This solution can also be used intranasally, as recommended by your doctor.
The dosage of the tablets is 10 mg of the active substance. The tablets also contain excipients:
- magnesium stearate,
- colloidal silicon,
- lactose,
- talc,
- starch.
The solution contains 0.5% of the active substance, which means that 5 mg of metoclopramide is dissolved in 1 ml of solution. The solution is available in 2 ml ampoules. Thus, one ampoule is approximately equivalent to one tablet.
Also, the Metoclopramide solution contains, in addition to water, the following substances:
- acetic acid,
- sodium acetate,
- sodium metabisulfite,
- disodium salt of ethylenediaminetetraacetic acid.
Metoclopramide is a prescription drug and is sold in pharmacies only as prescribed by a doctor.
The shelf life of Metoclopramide tablets is 3 years. They should be stored at a temperature no higher than +25 °C, in a dark place inaccessible to children.
Metoclopramide analogs
On the market you can find a number of drugs containing metoclopramide - Metamol, Perinorm, Cerukal, Reglan, Ceruglan. However, a drug with an international nonproprietary name is mainly produced by domestic manufacturers, so it is distinguished by its affordability. You can also find drugs from manufacturers from Belarus and India on sale.
Among the drugs with a similar effect, but with a different main component, we can mention Domrid, Domstal, Motoricum, Dimetcarb, Dimetpramid.
Contraindications
Not all categories of patients can take the drug. There are a fairly large number of cases in which taking Metoclopramide can cause more harm than good. It is for this reason that you should not prescribe this drug yourself, without consulting a doctor.
The main contraindications for Metoclopramide include:
- intolerance to the components of the drug,
- severe forms of liver and kidney failure,
- severe forms of heart failure,
- age up to 2 years,
- severe form of hypertension,
- intestinal obstruction of a mechanical nature,
- bleeding in the gastrointestinal tract,
- perforation of the walls of the stomach or intestines,
- glaucoma or suspicion of it,
- epilepsy (risk of increased likelihood of seizures),
- pheochromocytoma (risk of developing severe hypertensive crises),
- bronchial asthma,
- Parkinson's disease,
- extrapyramidal disorders,
- bronchial asthma (for injections),
- recovery period after certain types of gastric surgery,
- pyloric stenosis.
Metoclopramide should be used with caution in children and the elderly (over 65 years of age), with kidney and liver diseases, and hypertension.
Use of the drug during pregnancy and lactation
Due to the fact that the drug easily penetrates the placental barrier, it is not recommended to take the drug in the 1st and 3rd trimesters of pregnancy and during lactation. Although animal experiments have not revealed potential harm to the fetus, doctors nevertheless believe that it is not worth the risk. In mid-pregnancy, the drug can only be taken under medical supervision. If there is a need to take the drug during lactation, you must stop breastfeeding.
Side effects
In some cases, taking Metoclopramide can cause a number of side effects. These include:
- dizziness
- headache;
- dry mouth;
- constipation and diarrhea;
- allergic reactions (urticaria, dermatitis, Quincke's edema);
- increase or decrease in blood pressure;
- tachycardia or bradycardia;
- fluid retention in the body;
- increased frequency of urination;
- gynecomastia (in men);
- menstrual irregularities, galactorrhea (in women);
- blood composition disorders (leukopenia and neutropenia, agranulocytosis);
- atrioventricular block;
- anxiety, fatigue;
- extrapyramidal disorders (hyperkinesis, torticollis, spasm of the facial muscles, increased muscle tone);
- noise in ears;
- depression;
- hallucinations;
- disorientation;
- drowsiness (in 10% of cases);
- hyperemia of the nasal mucosa;
- parkinsonism, dyskinesia (mainly in elderly patients);
- akathisia (feeling of internal motor restlessness, in every tenth case);
- hyperemia;
- porphyria;
- bronchospasm.
- Extrapyramidal disorders are most likely to occur in children and young people; they may appear even after a single dose. If side effects develop, treatment with Metoclopramide is recommended to be interrupted. Metoclopramide is contraindicated for use by persons driving vehicles performing work requiring concentration due to possible side effects, affecting the patient’s nervous system. In case of overdose, drowsiness, disorientation, and extrapyramidal disorders are possible. In such a case, the drug must be interrupted and such phenomena will disappear within a day. With prolonged use of Metoclopramide, potassium deficiency may develop in the body, which leads to insomnia and irritability.
Instructions for use of Metoclopramide
The standard single dose of Metoclopramide tablets for adults is 10 mg (1 tablet). The tablet is taken 2-3 times a day, half an hour before meals, with a small amount of liquid. The course of treatment depends on the disease and is determined by the doctor. Usually it lasts no more than 5 days, but can reach 4-6 weeks, and in rare cases it can be extended to six months.
Children over 6 years old are usually given 5 mg (half a tablet) 1-3 times a day.
The solution can be administered intravenously or intramuscularly. Typically, 2 ml of solution (10 mg metoclopramide) is administered at a time. The number of injections per day is 2-3.
For children over 6 years old, 1 ml is administered 1-3 times a day.
For children under 6 years of age, daily metoclopramide is calculated based on body weight (0.5-1 mg/kg). The number of injections is 2-3 times a day.
The solution can also be administered intranasally, with the permission of the attending physician. With this method, 2-4 ml of solution is instilled into each nostril 2-3 times a day.
For all administration options, the maximum single dose of Metoclopramide for adults is 20 mg, the daily dose is 60 mg.
Patients with impaired renal function are prescribed a dose that is half the standard dose.
Use of Metoclopramide in chemotherapy and diagnostic procedures
To prevent vomiting caused by cytostatics or radiation therapy, Metoclopramide solution is administered intravenously at a dose of 2 mg/kg body weight. The drug is administered half an hour before the procedure; if necessary, another administration of the drug is possible after 2-3 hours.
Before X-ray procedures, Metoclopramide solution is administered 10-15 minutes before the time of the procedure at a dosage of 10-20 mg.
Interaction with other drugs and substances
A number of drugs reduce the effectiveness of Metoclopramide, and a number, on the contrary, enhance its effect. Metoclopramide is generally incompatible with a number of substances, for example, with antipsychotics or fluoxetine, which increase the risk of extrapyramidal disorders. Therefore, if a patient is taking a number of other drugs, he should consult a doctor before using metoclopramide for unwanted interactions. In some cases, one of the drugs will have to be stopped, and in others the dose will have to be adjusted.
In particular, it enhances the effect of sleeping pills, antacids, and accelerates the absorption of tetracycline, ampicillin, diazepam, paracetamol and acetylsalicylic acid. Opioids block the positive effects of the drug on gastric and intestinal motility. It is also worth noting that the drug should not be taken together with alcohol, since in this case the toxic effect of alcohol on nerve cells will increase many times over.
Recipe (international)
Rp.: Tab. Metoclopramidi 0.01 No. 50
D.S. according to Table I 3 times a day
pharmachologic effect
Metoclopramide is a dopamine receptor antagonist. It also exhibits an antagonistic effect on 5-HT3 receptors and a weak stimulating effect on the ganglia. Blocks presynaptic dopamine receptors and promotes the release of acetylcholine from cholinergic motor neurons in the intestinal wall. Due to this, Metoclopramide increases the release of acetylcholine from neurons, which induces spasm by stimulating muscarinic M2 receptors in the smooth muscle cells of the digestive tract. By increasing physiological conductance in cholinergic neurons, metoclopramide inhibits dopamine-induced relaxation of gastric smooth muscle, thereby enhancing cholinergic responses of gastrointestinal smooth muscle. The drug also stimulates the motility of the upper gastrointestinal tract (including increasing the static tone of the lower esophageal sphincter). In addition, gastroduodenal coordination between pyloric function and proximal duodenal motility is improved. Almost no effect on the motility of the colon and gall bladder. Does not affect the secretion of gastric juice, bile and pancreatic enzymes
Metoclopramide penetrates the blood-brain barrier, producing effects on the central nervous system (CNS) that are typical of a dopamine receptor blocker. Has a sedative and antiemetic effect, eliminates nausea.
Mode of application
For adults: Treatment with Metoclopramide should begin after the first symptoms of the disease appear.
In patients with severe gastric dysfunction, metoclopramide in the form of injections can be used from the first days of therapy.
Gastroesophageal reflux
Adults orally, 10 mg (1 tablet) of Metoclopramide 30 minutes before each meal and before bedtime, no more than 4 times a day. The duration of treatment is determined by the doctor depending on the clinical picture, but not more than 12 weeks.
If symptoms associated with reflux appear sporadically or at certain times of the day, Metoclopramide should be taken the day before the expected onset of symptoms in a single dose of up to 20 mg (2 tablets).
In patients (especially elderly) who are very sensitive to treatment with Metoclopramide, it is necessary to reduce the single dose of the drug to 5 mg.
Stomach dysfunction
Orally, 10 mg (1 tablet) of Metoclopramide 30 minutes before each meal and before bedtime, depending on the results of treatment, for 2 to 8 weeks.
Children aged 15 years and older: with a body weight of more than 59 kg, 10 mg (1 tablet) of metoclopramide orally 3 times a day, with a body weight of 30 - 59 kg orally, 5 mg (1/2 tablet) of metoclopramide 3 times a day.
The duration of therapy is determined by the doctor.
In patients with impaired renal function with creatinine clearance less than 40 ml/min., the initial dose of metoclopramide should be half the dose recommended for patients with normal renal function.
In patients with impaired liver function, dose adjustment of metoclopramide is not necessary.
Indications
Gastroesophageal reflux;
- vomiting, nausea of various origins (including those associated with taking cytostatics and radiation therapy);
- atony, hypotension of the gastrointestinal tract (including postoperative).
Contraindications
Hypersensitivity to any of the components of the drug;
- bleeding, obstruction (of any origin) and perforation of the gastrointestinal tract;
- pheochromocytoma (as metoclopramide can cause a hypertensive crisis);
- epilepsy, Parkinson's disease or concomitant use of anticholinergic drugs and drugs that cause extrapyramidal disorders, due to the risk of increased seizures or extrapyramidal disorders;
- diseases of the central nervous system with depression and suicidal thoughts;
- hereditary intolerance to lactose, galactose, lactose deficiency, galactose deficiency, glucose-galactose malabsorption syndrome;
- glaucoma;
- pyloric stenosis;
- prolactin-dependent tumors;
- I trimester of pregnancy and lactation period.
Side effects
Often (? 1/100, - Not very often (? 1/1000, Rarely (? 1/10,000, - insomnia, headaches, dizziness, depression with suicidal thoughts, visual impairment;
- swelling of the tongue or larynx;
- nausea, flatulence, diarrhea;
- urinary incontinence or frequent urination;
- myalgia, facial muscle spasms, tremor, trismus, torticollis (observed in approximately 0.2% of patients receiving Metoclopramide at a dose of 30 to 40 mg per day);
- toxic effect of metoclopramide on the liver.
Very rarely (- slowness of motor functions (bradykinesia), tremor, mask-like face, stiffness and tardive dyskinesia, involuntary movements of the tongue, face, lips or jaw, sometimes involuntary movements of the torso and limbs;
- restlessness (akathisia), which goes away on its own or after reducing the dose of the medicinal product;
- lactorrhea, amenorrhea, gynecomastia, impotence;
- porphyria;
- hypotension, hypertension;
- methemoglobinemia in newborns, especially after an overdose of a drug product.
isolated cases:
- bronchospasm, especially in patients with a history of asthma;
- rash, urticaria;
- neutropenia, leukopenia, agranulocytosis without a definite connection with the use of Metoclopramide.
Release form
Tab. 10 mg: 50 pcs.
Tablets 1 tab.
metoclopramide hydrochloride 10 mg
Excipients: lactose, potato starch, polyvinylpyrrolidone, magnesium stearate.
50 pcs. - blisters (1) - cardboard packs.
ATTENTION!
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