Cerucal pills 10 mg №50

Active ingredient

Cerucal pills white, round, flat, with a risk on one side, with a smooth surface and one-piece beveled edges.
1 pill contains Metoclopramide hydrochloride monohydrate 10.54 mg
(which corresponds to 10 mg of metoclopramide hydrochloride);
Excipients: potato starch, lactose monohydrate, gelatin, Magnesium stearate, precipitated silica;
in the package 50 pcs.

injection transparent colorless.
1 vial (2 ml) contains metoclopramide hydrochloride 10 mg;
Excipients: sodium sulfite, disodium EDTA, sodium chloride, water for injection;
in ampoules of 2 ml; in packaging of blister 5 ampoules; in box 2 packs.

Reglan - antiemetic drug. A specific dopamine receptor blocker, weakens the sensitivity of the visceral nerves, which transmit impulses from the pyloric region of the stomach and duodenum to the emetic center. Through the hypothalamus and the parasympathetic nervous system has a regulating and coordinating effect on the tone and motor activity of the upper part of the gastrointestinal tract (including the tone of the lower digestive sphincter alone).
Increases muscle tone of the stomach and intestines, accelerates gastric emptying, reduces hyperacid stasis, prevents pyloric and esophageal reflux. Stimulates intestinal motility.

Indications and usage

- vomiting and nausea of ​​various origins;
- Atonia and hypotonia of the stomach and intestines (including postoperative);
- biliary dyskinesia;
- reflux esophagitis;
- functional pyloric stenosis;
- to enhance peristalsis when conducting radiopaque studies of the gastrointestinal tract;
- paresis of the stomach with diabetes;
- as a means of facilitating duodenal intubation (to accelerate gastric emptying and the movement of food through the small intestine).

Contraindications

- pheochromocytoma;
- intestinal obstruction;
- bleeding from the gastrointestinal tract;
- perforation of the digestive tract;
- prolactin-dependent tumor;
- epilepsy;
- extrapyramidal movement disorders;
- I trimester of pregnancy;
- lactation (breastfeeding);
- children's age up to 2 years;
- hypersensitivity to metoclopramide;
- hypersensitivity to sodium sulfite, especially in patients with bronchial asthma and other allergic diseases (for the injection form of Cerukal).
Carefully It should appoint a drug for hypertension, bronchial asthma, abnormal liver function, hypersensitivity to procaine and procainamide, children aged 2 to 14 years.

Dosage and administration

Set individually depending on the clinical symptoms and the patient's age.
Adults and teenagers aged 14 and over administered orally at 10 mg 3-4 times / day.
If necessary, Cerucal can be administered intramuscularly or intravenously in a dose of 10 mg. The frequency of administration is 3-4 times / day.
The average duration of treatment is 4-6 weeks; in some cases - up to 6 months.
For children aged 2-14 years the maximum single dose for oral administration and for parenteral use is 0.1 mg / kg body weight; the maximum daily dose is 0.5 mg / kg.
Inside the drug should be taken 30 minutes before a meal.
Patients with impaired renal function correction of dosing regimen required.
With creatinine clearance of 60-11 ml / min, the dose is 15 mg / day, divided into 2 doses (10 mg and 5 mg).
When Clearance <= 10 ml / min dose - 10 mg 1 time / day.

Adverse reactions

From the side of the central nervous system: sometimes there may be a feeling of tiredness, headaches, dizziness, a feeling of fear, anxiety, depression, drowsiness, tinnitus; in some cases (mainly in children), dyskinetic syndrome may develop (involuntary tichoid twitching of the muscles of the face, neck or shoulders); extrapyramidal disorders may occur - spasm of the facial muscles, trismism, rhythmic protrusion of the tongue, bulbar type of speech, spasm of extraocular muscles (including ocular curvature), spasmodic torticollis, opisthotonus, muscle hypertonus, parkinsonism symptoms (the risk of development in children and adolescents with an excess dose of 0.5 mg / kg / day) and tardive dyskinesia (in elderly patients with chronic renal failure); in isolated cases, the development of severe neuroleptic syndrome is possible.
With prolonged treatment with Cerucul in elderly patients, symptoms of parkinsonism and late dyskinesia may develop.
Hemic and lymphatic: agranulocytosis.
Cardiovascular: supraventricular tachycardia, hypotension or hypertension.
Gastrointestinal: constipation, diarrhea, dry mouth.
On the part of the endocrine system: rarely - with long-term use of the drug, gynecomastia, galactorrhea, or menstrual disorders may occur (with the development of these phenomena, metoclopramide is canceled).

Pregnancy and breastfeeding

Reglan is contraindicated for use in the first trimester of pregnancy.
The use of Cerukal in the II and III trimesters of pregnancy is possible only under strict indications.
If necessary, the use of Cerukal during lactation should decide on the termination of breastfeeding.

Special notes

Care should be taken when appointing Cerucal to children, adolescents and patients with impaired renal function. This cohort of patients has an increased risk of side effects. In the event of side effects of the drug should be immediately canceled.
Reglan is not effective in vomiting vestibular origin.
With the use of metoclopramide, data may be distorted by laboratory parameters of liver function and determine the concentration of aldosterone and prolactin in plasma.
In the process of treatment patients are prohibited from drinking alcohol.
Influence on ability to drive motor transport and control mechanisms
Patients taking Zerakal should refrain from potentially dangerous activities that require increased attention and speed of psychomotor reactions (driving cars, working with moving mechanisms).

Overdosage

Symptoms: drowsiness, confusion, irritability, anxiety, convulsions, extrapyramidal motor disorders, cardiovascular dysfunction with bradycardia and arterial hypo- or hypertension.
In milder forms of poisoning, symptoms disappear 24 hours after discontinuation of the drug. Depending on the severity of the symptoms, it is recommended to establish monitoring of the vital functions of the patient. Deaths of poisoning during overdose have not been identified.
Treatment: conduct symptomatic therapy. Extrapyramidal disorders eliminate slow on / in the introduction of biperidine (doses for adults - 2.5-5 mg). Diazepam may be used.

Drug Interactions

With the simultaneous use of Reglan reduces the effect of anticholinesterase drugs.
With the simultaneous use of Cerucal and neuroleptics may increase extrapyramidal symptoms.
With simultaneous use of Cerucul with cimetidine and Digoxin, it is possible to decrease the absorption of the latter.
With the simultaneous use of Cerucul with some antibiotics (tetracycline, ampicillin), lithium preparations, Paracetamol, levodopa, lithium, ethanol, the absorption of the latter is enhanced.
Reglan enhances the action of ethanol and drugs that depress the central nervous system.
With the simultaneous use of Cerucul and tricyclic antidepressants, MAO inhibitors and sympathomimetic drugs, their effects may change.
Reglan reduces the effects of H blockers₂- histamine receptors.
Reglan increases the risk of hepatotoxicity when combined with hepatotoxic drugs.
Reglan reduces the effectiveness of pergolid, levodopa.
Reglan increases the bioavailability of cyclosporine, which may require monitoring its plasma concentration.
Reglan increases the concentration of Bromocriptine .
Pharmaceutical Interaction
When mixing solutions of Cerucal and vitamin B₁ the destruction of the vitamin occurs.

List B. The drug should be stored in a dark place, out of the reach of children at a temperature not exceeding 30 ° C.