Cerucal pills 10mg, 50pcs

Composition

1 tablet contains:

Active ingredient:

metoclopramide hydrochloride monohydrate 10.54 mg (equivalent to 10 mg of metoclopramide hydrochloride);

Auxiliary substances:

potato starch-36.75 mg;

lactose monohydrate-76.65 mg;

gelatin-2.16 mg;

silicon dioxide-2.6 mg;

magnesium stearate-1.3 mg

Pharmacological action

The mechanism of action of CERUCAL 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.

Indications

• biliary dyskinesia;
• reflux esophagitis;
• nausea and vomiting of various origins;
• the atonia and hypotonia of the stomach and intestines (including postoperative);
• functional stenosis of the pylorus;
• to enhance the motility when conducting x-ray contrast studies of the gastrointestinal tract;
• paresis of the stomach in diabetes;
• as a means of facilitating duodenal intubation (to speed up stomach emptying and 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;
• hypersensitivity to sodium sulfite, especially in patients with bronchial asthma and other allergic diseases (for the injectable form of Cerucal).
• pheochromocytoma;
• intestinal obstruction;
• gastrointestinal bleeding;
• gastrointestinal perforation;
• prolactin-dependent tumor;
• epilepsy;
• extrapyramidal movement disorders;
• I trimester of pregnancy;
• lactation (breastfeeding);
• children under 2 years of age;

With caution: the drug should be prescribed for arterial hypertension, bronchial asthma, liver function disorders, hypersensitivity to procaine and procainamide, children aged 2 to 14 years.

Side effects

In isolated cases, neuroleptic malignant syndrome may develop (characteristic signs: fever, muscle contracture, changes in consciousness and increased blood pressure).

From the hematopoietic system:  agranulocytosis.

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. With prolonged treatment, some elderly patients, as well as children and adolescents (if the dose is exceeded 0.5 mg/kg/day) may develop Parkinsonism (tremor, muscle twitching, limited mobility). Elderly patients with chronic renal failure may also develop tardive dyskinesia.

From the cardiovascular system:  supraventricular tachycardia, a decrease or increase in blood pressure.

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

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

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. With prolonged treatment, some elderly patients, as well as children and adolescents (if the dose is exceeded 0.5 mg/kg/day) may develop Parkinsonism (tremor, muscle twitching, limited mobility). Elderly patients with chronic renal failure may also develop tardive dyskinesia.

In isolated cases, neuroleptic malignant syndrome may develop (characteristic signs: fever, muscle contracture, changes in consciousness and increased blood pressure).

From the hematopoietic system:  agranulocytosis.

From the cardiovascular system:  supraventricular tachycardia, a decrease or increase in blood pressure.

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

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

Interaction

When used concomitantly, Cerucal reduces the effect of anticholinesterase drugs.

With the simultaneous use of Cerucal and neuroleptics, extrapyramidal symptoms may increase.

Simultaneous use of Cerucal with cimetidine and digoxin may reduce the absorption of the latter.

When Cerucal is used simultaneously with some antibiotics (tetracycline, ampicillin), lithium preparations, paracetamol, levodopa, lithium, and ethanol, the absorption of the latter increases.

Cerucal enhances the effect of ethanol and drugs that depress the central nervous system.

Concomitant use of Cerucal and tricyclic antidepressants, MAO inhibitors, and sympathomimetic agents may alter their effects.

Cerucal reduces the effects of H2-histamine receptor blockers.

Cerucal increases the risk of hepatotoxicity when combined with hepatotoxic agents.

Cerucal reduces the effectiveness of pergolide, levodopa.

Cerucal increases the bioavailability of cyclosporine, which may require monitoring of its concentration in blood plasma.

Cerucal increases the concentration of bromocriptine.

How to take, course of use and dosage

Inside,30 minutes before meals, with water.

Adults:  The recommended dose is 1 tablet (10 mg of metoclopramide) 3-4 times a day.

Teenagers over 14 years of age:  the recommended dose is 0.5-1 tablet 2-3 times a day.

Maximum single dose: 2 tablets (20 mg); maximum daily dose: 6 tablets (60 mg).

The duration of treatment is about 4-6 weeks. In some cases, treatment can be continued for up to 6 months.

Overdose

Symptoms: drowsiness, 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. No fatal cases of overdose poisoning have been identified.

Treatment: perform symptomatic therapy. Extrapyramidal disorders are eliminated by slow intravenous use of biperiden (adult doses-2.5-5 mg). Diazepam may be used.

Special instructions

During treatment, patients are prohibited from drinking alcohol.

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.

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

Tablets

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

Tablets

Purpose

Children as prescribed by a doctor, Children over 2 years of age, Adults as prescribed by a doctor

Indications

Gastric and duodenal ulcers, Flatulence, Biliary Dyskinesia, Reflux Esophagitis, Gastroduodenitis