Metoclopramide Darnytsia tablets 10 mg 50 pcs.

Active ingredient: metoclopramide (one tablet contains metoclopramide hydrochloride 10 mg).

Excipients: potato starch, lactose monohydrate, microcrystalline cellulose, povidone, calcium stearate.

• hypersensitivity to metoclopramide or 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;
• history of tardive dyskinesia caused by neuroleptics or metoclopramide;
• Parkinson’s disease;
• simultaneous use with levodopa or dopaminergic agonists;
• methemoglobinemia has been established with the use of metoclopramide or with a history of NADH-cytochrome-b5-reductase deficiency;
• prolactin-dependent tumors;
• increased seizure readiness (extrapyramidal movement disorders).

Take orally before meals, without chewing, with sufficient liquid.

In order to minimize the risks of nervous system and other adverse reactions, metoclopramide should only be prescribed for short-term treatment (up to 5 days).

Adults

The usual therapeutic dose of metoclopramide is 10 mg up to 3 times a day. The maximum daily dose is 30 mg or 0.5 mg/kg body weight. The maximum duration of metoclopramide use is 5 days.

Children.

The recommended dose of metoclopramide for the prevention of delayed nausea and vomiting induced 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 body weight.

Dosage regimen (body weight):

• 10-14 kg – 1 mg up to 3 times a day;
• 15-19 kg – 2 mg up to 3 times a day;
• 20-29 kg – 2.5 mg up to 3 times a day;
• 30-60 kg – 5 mg up to 3 times a day;
• > 60 kg – 10 mg up to 3 times a day.

The maximum duration of metoclopramide use is 5 days.

Metoclopramide is contraindicated in children under one year of age due to the increased risk of extrapyramidal disorders. For children weighing <30 kg, metoclopramide should be used in dosage forms that allow for the required dosage.

Pregnant women

A large amount of data from pregnant women (more than 1000 outcomes of drug use) indicate the absence of any toxicity leading to malformation or fetotoxicity. Metoclopramide can be used during pregnancy if clinically necessary. Due to its pharmacological properties (as with other neuroleptics), the occurrence of extrapyramidal syndrome in the newborn cannot be excluded when metoclopramide is used in late pregnancy. The use of metoclopramide in late pregnancy should be avoided. The newborn should be observed when metoclopramide is used.

Metoclopramide is excreted in breast milk in small amounts. Therefore, the use of metoclopramide during breastfeeding is not recommended. Discontinuation of metoclopramide use in breastfeeding women should be considered.

Drivers

Metoclopramide may cause drowsiness, dizziness, dyskinesia and dystonia, which may affect vision and the ability to drive or operate other automated systems.

Symptoms

Drowsiness, depressed level of consciousness, confusion, irritability, restlessness and its increase, convulsions, extrapyramidal disorders, cardiovascular dysfunction with bradycardia and increased or decreased blood pressure, hallucinations, respiratory and cardiac arrest. Isolated cases of methemoglobinemia have been reported.

Treatment

In case of extrapyramidal symptoms associated with overdose, only symptomatic treatment is carried out (benzodiazepines – for children and / or anticholinergic antiparkinsonian drugs – for adults). In case of use of large doses of metoclopramide, it is necessary to remove it from the gastrointestinal tract by gastric lavage or taking activated charcoal and sodium sulfate.

According to the clinical condition, symptomatic treatment and constant monitoring of the functions of the cardiovascular and respiratory systems should be carried out.

Gastrointestinal: nausea, dry mouth, dyspepsia, constipation, diarrhea.

From the nervous system: dyskinetic syndrome, mainly in children (involuntary spasmodic movements, particularly in the head, neck and shoulders, tonic blepharospasm, spasm of the facial and masticatory muscles, speech deviation, spasm of the pharyngeal muscles and tongue muscles, incorrect posture of the head and neck, overstrain of the spine, spasmodic flexion of the arms, spasmodic extension of the legs), headache, dizziness, increased fatigue, drowsiness, extrapyramidal disorders (which can occur even after taking a single dose, mainly in children and adolescents and / or when the recommended dose is exceeded), parkinsonism (tremor, muscle rigidity, akinesia), akathisia, dystonia, dyskinesia, depressed level of consciousness, tardive dyskinesia (which may be permanent during or after long-term treatment, especially in elderly patients), neuroleptic malignant syndrome (characteristic symptoms: fever, rigidity muscle weakness, loss of consciousness, fluctuations in blood pressure, seizures (mainly in patients with epilepsy).

On the part of the psyche: asthenia, depression, hallucinations, confusion, anxiety, restlessness, confusion, tinnitus.

Cardiovascular system: bradycardia, atrioventricular block, sinus node block, QT prolongation, torsades de pointes, hypotension, shock, syncope, acute hypertension in patients with pheochromocytoma.

Blood and lymphatic system disorders: methemoglobinemia, which may be associated with NADH-cytochrome b5-reductase deficiency, especially in infants, sulfhemoglobinemia, mainly associated with concomitant use of high doses of sulfur-releasing drugs.

Immune system disorders: hypersensitivity reactions, including urticaria, angioedema, anaphylactic reactions (including anaphylactic shock).

Skin and subcutaneous tissue disorders: rash, urticaria, hyperemia and itching of the skin.

From the reproductive system and mammary gland function: amenorrhea, hyperprolactinemia, galactorrhea, gynecomastia, menstrual disorders. In such cases, the use of the drug should be discontinued.

Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.

Shelf life – 4 years.