Pharmacotherapeutic group: Peristalsis stimulants (propulsants). ATX code A03F A01.
active substance: metoclopramide;
1 tablet contains metoclopramide hydrochloride 10 mg excipients: potato starch, lactose, microcrystalline cellulose, povidone, calcium stearate.
In adults, the drug is indicated for the prevention of nausea and vomiting caused by radiation, delayed nausea and vomiting caused by chemotherapy, as well as for the symptomatic treatment of nausea and vomiting, including those associated with acute migraines (in combination with oral analgesics to improve their absorption). In children, drug should only be used as a second-line drug to prevent delayed chemotherapy-induced nausea and vomiting.
Hypersensitivity to metoclopramide or to any other component of the drug, gastrointestinal bleeding; mechanical intestinal obstruction; gastrointestinal perforation; confirmed or suspected pheochromocytoma due to the risk of severe attacks of arterial hypertension; tardive dyskinesia caused by neuroleptics or metoclopramide, history of epilepsy (increased frequency and intensity of seizures); Parkinson’s disease, concomitant use with levodopa or dopaminergic agonists; established methemoglobinemia with the use of the drug or with a NADH-cytochrome-b5-reductase deficiency in the history of tumor prolactin; increased convulsive readiness (extrapyramidal movement disorders).
Method of administration and dosage:
Take orally before meals, without chewing, drinking plenty of fluids. In order to minimize the risks of adverse reactions from the nervous system and other adverse reactions, the drug is prescribed only for short-term treatment (up to 5 days).
Adults. The usual therapeutic dose of the drug is 10 mg up to 3 times a day. The maximum daily dose is 30 mg or 0.5 mg / kg of body weight. The maximum duration of use is 5 days.
Children. The recommended dose of the drug for the prevention of delayed nausea and vomiting caused by chemotherapy is 0.1-0.15 mg / kg body weight up to 3 times a day. The maximum daily dose is 0.5 mg / kg of body weight. The maximum duration of use is 5 days.
Elderly patients. Consideration should be given to dose reduction in elderly patients due to age-related decline in renal and hepatic function.
Impaired renal function. In patients with end-stage renal disease (creatinine clearance ≤ 15 ml / min), the dose of the drug should be reduced by 75%. Patients with moderate and severe renal insufficiency (creatinine clearance 15-60 ml / min), the dose of the drug should be reduced by 50%.
Liver dysfunction. In patients with severe hepatic impairment, a half dose of the drug should be used.
The drug should not be used to treat chronic conditions such as gastroparesis, dyspepsia and gastroesophageal reflux disease, or as an adjunct to surgical or radiological procedures.
Neurological disorders. Extrapyramidal disturbances may occur, especially in children and / or with high doses. These reactions are usually observed at the beginning of treatment and may occur after a single use. If extrapyramidal symptoms develop, metoclopramide should be discontinued immediately. In general, these effects completely disappear after discontinuation of treatment, but may require symptomatic treatment (benzodiazepines for children and / or anticholinergic antiparkinsonian drugs for adults).
Between each administration of the drug, even in the case of vomiting with the elimination of the dose of the drug along with the vomit, in order to avoid overdose, an interval of at least 6 hours must be observed. Long-term treatment with drug can lead to tardive dyskinesia, which is potentially irreversible, especially in the elderly. Treatment should not be continued for more than 3 months due to the risk of tardive dyskinesia.
Treatment should be discontinued if clinical signs of tardive dyskinesia appear. With the use of the drug in combination with antipsychotics, as well as with drug alone, the development of neuroleptic malignant syndrome has been reported. In the event of symptoms of neuroleptic malignant syndrome, the use of the drug should be stopped immediately and appropriate treatment initiated.
With regard to patients with concomitant neurological diseases and patients receiving treatment with other drugs acting on the central nervous system, you need to be especially careful. The use of the drug may also increase the symptoms of Parkinson’s disease.
Keep out of the reach of children in its original packaging at a temperature not exceeding 25 ° C.
Produced in Ukraine