Composition
Per tablet: Metoclopramide hydrochloride monohydrate-0.0105 g (in terms of anhydrous) – 0.0100 gh Auxiliary substances: lactose monohydrate (milk sugar) – 0.0660 g potato starch-0.0200 g calcium stearate-0.0010 gpovidone-K 30-0.0020 g silicon dioxide colloidal (aerosil) – 0.0005 g
Pharmacological action
Pharmacodynamics Antiemetic agent, is a specific blocker of dopamine (D2) and serotonin receptors. It has an antiemetic effect, eliminates nausea and hiccups. Reduces the motor activity of the esophagus, increases the tone of the lower esophageal sphincter, accelerates the emptying of the stomach, and also accelerates the movement of food through the small intestine, without causing diarrhea. Normalizes bile secretion, reduces spasm of the sphincter of Oddi, eliminates dyskinesia of the gallbladder. It stimulates the secretion of prolactin. Pharmacokinetics Rapidly absorbed from the gastrointestinal tract. Bioavailability – 60-80%. The time to reach the maximum concentration in blood plasma is 1-2 hours. The half-life is from 3 to 5 hours, with impaired renal function-up to 14 hours. Excretion of the drug occurs mainly by the kidneys within 24 hours in unchanged form and in the form of conjugates. Passes through the placental and blood-brain barriers, penetrates into the mother’s milk.
Indications
- Vomiting, nausea, hiccups different Genesis (in some cases it may be effective for nausea caused by radiation therapy or receiving cytotoxic drugs);
- the atonia and hypotonia of the stomach and intestines (in particular, postoperative);
- biliary dyskinesia;
- reflux esophagitis, flatulence, exacerbation of gastric ulcer and 12 duodenal ulcer (in the complex therapy);
- when conducting x-ray contrast studies of the gastrointestinal tract (to enhance the motility).
Use during pregnancy and lactation
The use of the drug in the first trimester of pregnancy is contraindicated. In the second and third trimesters, the drug is used only in cases of extreme necessity, if the potential benefit to the mother exceeds the possible risk to the fetus. If it is necessary to use the drug during lactation, stop breastfeeding for the entire period of treatment.
Contraindications
Hypersensitivity, bleeding from the gastrointestinal tract, gastric pyloric stenosis, mechanical intestinal obstruction, perforation of the stomach or intestinal wall, pheochromocytoma, extrapyramidal disorders, epilepsy, prolactin-dependent tumors, pregnancy, lactation, children under 18 years of age. With caution Bronchial asthma, arterial hypertension, Parkinson’s disease, renal and/or hepatic insufficiency, the elderly.
Side effects
Cardiovascular system: atrioventricular block;
Central nervous system: extrapyramidal disorders – lockjaw, a spasm of facial muscles, spastic torticollis, bulbar type of speech, rhythmic protrusion of tongue, extraocular spasm of the muscles (including oculogyric crisis), muscle opisthotonus, hypertonicity; Parkinson’s disease (muscle rigidity, hyperkinesis – manifestation diaminocarbenes action, the risk of development of children increases with the dose of 0.5 mg/kg / day), diskinezi (in chronic renal failure and in elderly patients), depression, headache, drowsiness, anxiety, fatigue, confusion, noise in the ears;
Endocrine system: rarely (with prolonged therapy in high doses) – galactorrhea, gynecomastia, menstrual disorders;
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 symptoms described above appear, they worsen or develop other side effects, you should consult a doctor.
Interaction
When Metoclopramide is used concomitantly with certain medications, the following effects may occur: Ethanol: increased action on the central nervous system; Cholinesterase inhibitors: weakening the effect of metoclopramide; Hypnotics: increased sedation; H2-histamine receptor blockers: increased effectiveness of therapy; Diazepam, tetracycline, ampicillin, paracetamol, acetylsalicylic acid, levodopa, ethanol: increased absorption; Digoxin, cimetidine: delayed absorption; Antipsychotics: increased risk of extrapyramidal symptoms.
Before concomitant use of Metoclopramide with other medications, it is necessary to consult a doctor.
How to take, course of use and dosage
Inside. Adults – 10 mg 3-4 times a day for 30 minutes before meals, the tablet is swallowed whole and washed down with a small amount of water. The maximum single dose is 20 mg, the daily dose is 60 mg.
Overdose
Symptoms: drowsiness, confusion, irritability, restlessness, convulsions, extrapyramidal movement disorders, impaired cardiovascular function with bradycardia, and low or high blood pressure. In mild cases of poisoning, symptoms disappear within 24 hours after discontinuation of the drug. Depending on the severity of the symptoms, it is recommended to monitor the patient’s vital functions. No fatal cases of overdose poisoning have been identified. Treatment: symptomatic. Extrapyramidal disorders are eliminated by slow use of biperidene at a dose of 2.5-5 mg for adults (biperidene is administered only in a hospital setting, under the supervision of doctors). Diazepam can be used to calm the patient. If large doses of metoclopramide enter the body, gastric lavage is performed, activated carbon and sodium sulfate are used.
Special instructions
During the treatment period, it is not recommended to use ethanol. If necessary, treatment is carried out with central holinoblokatorami and other antiparkinsonian drugs. Elderly patients taking the drug may develop tardive dyskinesia. The risk of developing tardive dyskinesia depends on the duration of the course of pharmacotherapy and the total dose of the drug. Irreversible changes develop, as a rule, when the drug is prescribed for more than 12 weeks. It is not recommended to prescribe the drug for more than 12 weeks, except in cases where the benefits of long-term use of the drug outweigh the potential risks of developing an adverse reaction. When the drug is prescribed in a short course and in low doses, it is also possible to develop tardive dyskinesia, but these changes usually disappear after some time after discontinuation of the drug. Ability to influence the speed of reactions when driving vehicles or working with other mechanisms During treatment, care should be taken when driving vehicles and engaging in other activities that require increased concentration of attention and speed of psychomotor reactions.
Active ingredient
Metoclopramide
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Description
For adults
Indications
Flatulence, Gastric and Duodenal ulcers, Gastroduodenitis, Gastritis, Reflux esophagitis, Biliary Dyskinesia
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