Cerucal tablets 10 mg 50 pcs. (metoclopramide)

packaging 50 pcs

Pharmacological action

CERUCAL - an antiemetic, is a specific blocker of dopamine (D2) and serotonin receptors. The mechanism of action is based both on the central and peripheral effects of metoclopramide. The antiemetic effect is associated with blockade of the dopamine receptors of the brain, which causes an increase in the threshold of irritation of the vomiting 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. It normalizes the secretion of bile, reduces the spasm of the sphincter of Oddi, does not change its status, eliminates dyskinesia of the gallbladder. Stimulates the secretion of prolactin.

Pharmacokinetics

After oral administration, it is rapidly absorbed, the time to reach Cmax is 30-120 minutes. Bioavailability is 60-80%.

Metabolized in the liver. The elimination half-life is from 3 to 5 hours, with impaired renal function, it can increase to 14 hours. It is excreted by the kidneys during the first 24 hours unchanged and in the form of metabolites (about 80% of the dose taken). 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 (including postoperative)

biliary dyskinesia

reflux esophagitis

functional stenosis of the pyloric

to enhance peristalsis during X-ray studies of the gastrointestinal tract

gastric paresis in patients with diabetes

as a means of gastrointestinal tract conduction gut).

Contraindications

pheochromocytoma

ileus

bleeding from the gastrointestinal tract

perforation gastrointestinal

prolaktinzavisimaya tumor

epilepsy

extrapyramidal movement disorders

I trimester

lactation (breastfeeding)

children up to 2 years

hypersensitivity to

metoclopramide hypersensitivity to sodium sulfite, especially in patients with bronchial asthma and other allergic diseases (for injection of Cerucal).

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

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 according to strict indications.

If you need to use Cerucal during lactation, you should decide whether to stop breastfeeding.

Composition

1 tablet contains:

Active ingredient: metoclopramide hydrochloride monohydrate 10.54 mg (equivalent to 10 mg metoclopramide hydrochloride)

Excipients: potato starch - 36.75 mg lactose monohydrate - 76.65 mg gelatin dioxide - 2.6 mg of magnesium stearate - 1.3 mg.

Side effects of the

From the nervous system: sometimes you may experience fatigue, headaches, dizziness, fear, anxiety, depression, drowsiness, tinnitus, in some cases, mainly in children, dyskinetic syndrome (involuntary tick-like twitching of the muscles of the face, neck or shoulders) may develop. Extrapyramidal disorders are possible: spasm of the facial muscles, trismus, rhythmic protrusion of the tongue, bulbar type of speech, spasm of extraocular muscles (including oculogyric crisis), spastic torticollis, opistotonus, muscle hypertonicity. With prolonged treatment in some elderly patients, as well as in children and adolescents (when exceeding a dose of 0.5 mg / kg / day), the development of parkinsonism (tremor, muscle twitching, limited mobility) is possible. In elderly patients with chronic renal failure, tardive dyskinesia may also develop.

In isolated cases, the development of a malignant antipsychotic syndrome is possible (characteristic signs: fever, muscle contracture, altered consciousness and increased blood pressure).

From the hematopoietic system: agranulocytosis.

From the cardiovascular system: supraventricular tachycardia, decreased or increased blood pressure.

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

From the endocrine system: with prolonged use of the drug in rare cases, gynecomastia (enlargement of the mammary glands in men), galactorrhea (spontaneous outflow of milk from the mammary glands), or menstrual irregularities with the development of these phenomena can be canceled.

From the nervous system: sometimes there may be a feeling of fatigue, headaches, dizziness, a sense of fear, anxiety, depression, drowsiness, tinnitus, in some cases, mainly in children, dyskinetic syndrome (involuntary tick-like twitching of the muscles of the face, neck or shoulders) may develop. Extrapyramidal disorders are possible: spasm of the facial muscles, trismus, rhythmic protrusion of the tongue, bulbar type of speech, spasm of extraocular muscles (including oculogyric crisis), spastic torticollis, opistotonus, muscle hypertonicity. With prolonged treatment in some elderly patients, as well as in children and adolescents (when exceeding a dose of 0.5 mg / kg / day), the development of parkinsonism (tremor, muscle twitching, limited mobility) is possible. In elderly patients with chronic renal failure, the development of tardive dyskinesia is also possible.

In isolated cases, the development of a malignant antipsychotic syndrome is possible (characteristic signs: fever, muscle contracture, change in consciousness and increase in blood pressure).

From the hematopoietic system: agranulocytosis.

From the cardiovascular system: supraventricular tachycardia, decreased or increased blood pressure.

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

From the endocrine system: with lengthWhen using the drug in rare cases, gynecomastia (enlargement of the mammary glands in men), galactorrhea (spontaneous outflow of milk from the mammary glands) or menstrual irregularities during the development of these phenomena can be canceled.

Drug Interaction

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

Increased extrapyramidal symptoms may occur when Cerucal and neuroleptics are used simultaneously.

With the simultaneous use of Cerucal with cimetidine and digoxin, the absorption of the latter may be decreased.

With the simultaneous use of Cerucal with some antibiotics (tetracycline, ampicillin), lithium, paracetamol, levodopa, lithium, and ethanol absorb the latter.

Cerucal enhances the action of ethanol and CNS depressants.

When Cerucal and tricyclic antidepressants, MAO inhibitors and sympathomimetic agents are used simultaneously, their effects may change.

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 plasma concentrations of cyclosporine.

Cerucal increases the concentration of bromocriptine.

Overdose

Symptoms: drowsiness, confusion, irritability, restlessness, convulsions, extrapyramidal motor disorders, cardiovascular system disorders with bradycardia or arterial hypersensitivity.

With mild forms of poisoning, symptoms disappear 24 hours after drug withdrawal. Depending on the severity of the symptoms, it is recommended to monitor the vital functions of the patient. Fatal cases of overdose poisoning have not been identified.

Treatment: carry out symptomatic therapy. Extrapyramidal disorders are eliminated by slow in / in administration of biperiden (adult doses are 2.5-5 mg). The use of diazepam is possible.

Storage conditions

At a temperature not exceeding 30 ° C.

Expiration

5 Chron

dosage form

dosage form

tablets

Teva Pharmaceutical Enterprise Co., Ltd., Israel



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