Cerucal solution 10mg 2ml ampoules, 10pcs

Composition

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1 ml of the solution contains:

Active ingredient:

metoclopramide hydrochloride monohydrate 5.27 mg (equivalent to 5 mg of metoclopramide hydrochloride);

Auxiliary substances:

sodium sulfite-0.125 mg;

disodium edetate-0.4 mg;

sodium chloride-8 mg;

water for injection-991.705 mg

Pharmacological action

CERUCAL is an antiemetic agent, it is a specific blocker of dopamine (D2) and serotonin receptors. The mechanism of action is based on both central and peripheral effects of metoclopramide. The antiemetic effect is associated with the blockade of dopamine receptors in the brain, which causes an increase in the threshold of irritation of the emetic center.

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, does not change its status, eliminates dyskinesia of the gallbladder. It stimulates the secretion of prolactin.

The pharmacokinetics

of Vd is 2.2 – 3.4 l/kg.

It is metabolized in the liver. The half-life is from 3 to 5 hours, with chronic renal failure-14 hours. It is excreted by the kidneys during the first 24 hours in unchanged form and in the form of metabolites (about 80% and a single dose). It easily penetrates the blood-brain barrier and is excreted in breast milk.

Indications

• -vomiting and nausea of various origins;- atony and hypotension of the stomach and intestines (in particular, postoperative);- biliary dyskinesia, reflux esophagitis, functional pyloric stenosis; – to enhance peristalsis during X-ray contrast studies of the gastrointestinal tract;- paresis of the stomach in diabetes mellitus;— as a means to facilitate duodenal probing (to accelerate the emptying of the stomach and the movement of food through the small intestine).

Use during pregnancy and lactation

Cerucal is contraindicated for use in the first trimester of pregnancy.

The use of Cerucal in the second and third trimesters of pregnancy is possible only under strict indications.

If it is necessary to use Cerucal during lactation, the question of stopping breastfeeding should be decided.

Contraindications

-hypersensitivity to metoclopramide;- pheochromocytoma (possible hypertensive crisis, due to the release of catecholamines);— intestinal obstruction, intestinal perforation and gastrointestinal bleeding— – prolactin-dependent tumor— – epilepsy and extrapyramidal motor disorders, first trimester of pregnancy and lactation, age up to 2 years. With caution: with arterial hypertension, liver function disorders, hypersensitivity to procaine and procainamide, children aged 2 to 14 years during the 2nd and 3rd trimester of pregnancy, the drug Cerucal is prescribed only for vital indications. In patients with reduced renal function, the drug is prescribed in reduced doses. Due to the content of sodium sulfite, Cerucal should not be prescribed to patients with bronchial asthma with hypersensitivity to sulfite.

Side effects

Nervous system disorders:  sometimes there may be a feeling of fatigue, headaches, dizziness, fear, anxiety, depression, drowsiness, tinnitus; in some cases, mainly in children, dyskinetic syndrome (involuntary tic-like twitching of the muscles of the face, neck or shoulders) may develop. Extrapyramidal disorders may occur: 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 hypertonus. Parkinsonism (tremor, muscle twitching, limited mobility, the risk of development in children and adolescents increases with exceeding the dose of 0.5 mg / kg / day) and tardive dyskinesia (in elderly patients with chronic renal failure). In isolated cases, severe neuroleptic syndrome may develop.

With long-term treatment with cerucal, elderly patients may develop symptoms of Parkinsonism (tremor, muscle twitching, limited mobility) and tardive dyskinesia.

From the hematopoietic system:  agranulocytosis.

From the cardiovascular system:  supraventricular tachycardia, hypotension, hypertension.

From the gastrointestinal tract:  constipation, diarrhea, dry mouth.

From the endocrine system:  with prolonged use of the drug, gynecomastia (enlargement of the mammary glands in men), galactorrhea (spontaneous leakage of milk from the mammary glands) or menstrual disorders may occur; with the development of these phenomena, metoclopramide is canceled.

Interaction

Incompatible with infusion solutions that have an alkaline environment.

Reducing the effect of anticholinesterase agents.

Increases the absorption of antibiotics (tetracycline, ampicillin), paracetamol, levodopa, lithium and alcohol.

Reduces the absorption of digoxin and cimetidine.

Increases the effect of alcohol and drugs that depress the central nervous system.

Neuroleptic drugs should not be administered simultaneously with metoclopramide in order to avoid a possible increase in extrapyramidal disorders.

May affect the effects of tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), and symptomatic agents.

Reduces the effectiveness of therapy with H2-histamine blockers.

Increased risk of hepatotoxicity in combination with hepatotoxic agents.

Reduces the effectiveness of pergolide, levodopa.

Increases the bioavailability of cyclosporine, which may require monitoring of its concentration.

Increases the concentration of bromocriptine.

With simultaneous use of cerucal with thiamine (Vitamin B 1), the latter quickly breaks down.

How to take, course of use and dosage

Intramuscularly or slowly intravenously.

Adults and teenagers over 14 years of age:  1 ampoule (10 mg of metoclopramide) 3-4 times a day.

Children from 3 to 14 years old:  the therapeutic dose is 0.1 mg of metoclopramide/kg body weight, the maximum daily dose is 0.5 mg of metoclopramide/kg body weight.

Overdose

Symptoms:  somnolence, confusion, irritability, restlessness, convulsions, extrapyramidal movement disorders, disorders of the cardiovascular system with bradycardia and arterial hypo – or hypertension. 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. Fatal cases of poisoning from overdose have not yet been identified.

Treatment:  symptomatic. Extrapyramidal disorders are eliminated by slow use of biperidene (adult doses-2.5-5 mg; follow the manufacturer’s recommendation). Diazepam may be used.

Special instructions

During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

During treatment, patients are prohibited from drinking alcohol.

In adolescents and in patients with severe renal impairment, the possible development of side effects is monitored, and if they occur, the drug is discontinued.

It is not effective for vomiting of vestibular origin.

Form of production

Solution for injection

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

5 years

Active ingredient

Metoclopramide

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion