Universal reference book for medicines
Product name: CERUCHAL ® (CERUCAL)

Active substance: metoclopramide

Type: Antiemetic drug of central action blocking dopamine receptors

Manufacturer: AWD.pharma (Germany) produced by PLIVA HRVATSKA (Croatia)
Composition, form of production and packaging
Tablets are
white, round, flat, with a risk on one side.

1 tab.

metoclopramide hydrochloride monohydrate 10.54 mg,

in t.ch.
metoclopramide hydrochloride 10 mg
Auxiliary substances: potato starch, lactose monohydrate, gelatin, silicon dioxide, magnesium stearate.

50 pcs.
- bottles of dark glass (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

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. Antiemetic action is associated with blockade of dopamine receptors of the brain, which causes an increase in the threshold of irritation of the vomiting center. Has antiemetic effect, eliminates nausea and hiccups. Reduces the motor activity of the esophagus, increases the tone of the lower sphincter of the esophagus, accelerates the emptying of the stomach, and accelerates the movement of food through the small intestine, without causing diarrhea. 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 C max is 30-120 minutes.
Bioavailability is 60-80%.
Metabolised in the liver.
The half-life period is from 3 to 5 hours, with violations of the kidneys can increase to 14 hours. It is excreted by the kidneys during the first 24 hours in the unchanged form and in the form of metabolites (about 80% of the dose taken). Easily penetrates the blood-brain barrier and is excreted in breast milk.
INDICATIONS

- Vomiting, hiccough and nausea of ​​various origins;

- atony and hypotension of the stomach and intestines (in particular, postoperative);

- diabetic gastroparesis.

DOSING MODE

Inside, 30 minutes before eating, squeezed with water.

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

Adolescents older than 14 years: the recommended dose is 0.5 - 1 tablet 2-3 times a day.

The maximum single dose: 2 tablets (20 mg);
the maximum daily dose: 6 tablets (60 mg).
The duration of treatment is about 4-6 weeks.
In some cases, treatment can be continued up to 6 months.
When the renal function is impaired, the dose of the drug is selected accordingly to the degree of severity of renal dysfunction:

Creatinine clearance The dose of metoclopramide

up to 10 ml / min 10 mg once a day

from 11 to 60 ml / min daily dose of 15 mg divided into two doses (10 mg + 5 mg)

In case of serious violations of liver function with ascites, the prescribed dose is half of the usually recommended dose.

SIDE EFFECT

From the side of 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, a dyskinetic syndrome may develop (involuntary tick-like twitching of the muscles of the face, neck or shoulders).
Perhaps the appearance of extrapyramidal disorders: spasm of facial muscles, trismus, rhythmic protrusion of the tongue, bulbar type of speech, spasm of extraocular muscles (including oculogic crisis), spasmodic torticollis, opisthotonus, muscle hypertonia. With long-term treatment in some elderly patients, as well as in children and adolescents (when the dose exceeds 0.5 mg / kg / day), development of parkinsonism (tremor, twitching of muscles, limited mobility) is possible. In elderly patients with chronic renal failure, the development of tardive dyskinesia is also possible.
In isolated cases, malignant neuroleptic syndrome (characteristic signs: fever, muscle contracture, altered consciousness and increased blood pressure) is possible.

From the side of the hematopoiesis system: agranulocytosis.

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

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

On the part of the endocrine system: with prolonged use of the drug in rare cases, there may be gynecomastia (enlargement of the mammary glands in men), galactorrhea (spontaneous discharge of milk from the mammary glands) or menstrual cycle disorders;
When these phenomena develop, metoclopramide is canceled.
From the side of 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, a dyskinetic syndrome may develop (involuntary tick-like twitching of the muscles of the face, neck or shoulders).
Perhaps the appearance of extrapyramidal disorders: spasm of facial muscles, trismus, rhythmic protrusion of the tongue, bulbar type of speech, spasm of extraocular muscles (including oculogic crisis), spasmodic torticollis, opisthotonus, muscle hypertonia. With long-term treatment in some elderly patients, as well as in children and adolescents (when the dose exceeds 0.5 mg / kg / day), development of parkinsonism (tremor, twitching of muscles, limited mobility) is possible. In elderly patients with chronic renal failure, the development of tardive dyskinesia is also possible.
In isolated cases, malignant neuroleptic syndrome (characteristic signs: fever, muscle contracture, altered consciousness and increased blood pressure) is possible.

From the side of the hematopoiesis system: agranulocytosis.

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

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

On the part of the endocrine system: with prolonged use of the drug in rare cases, there may be gynecomastia (enlargement of the mammary glands in men), galactorrhea (spontaneous discharge of milk from the mammary glands) or menstrual cycle disorders;
When these phenomena develop, metoclopramide is canceled.
CONTRAINDICATIONS

- hypersensitivity to the components of the drug;

- pheochromocytoma;

- mechanical intestinal obstruction;

- Stenosis of the pylorus of the stomach;

- Perforation of the wall of the stomach and intestines, gastrointestinal bleeding;

- Prolactin-dependent tumor;

- epilepsy and extrapyramidal movement disorders;

- First trimester of pregnancy;

- Children's age till 14 years.

With caution: pregnancy of the 2nd and 3rd trimester, hypertension, bronchial asthma, impaired liver and / or kidney function, Parkinson's disease, advanced age.

PREGNANCY AND LACTATION

Contraindicated in the first trimester of pregnancy.

Use with caution in the II and III trimesters of pregnancy.

APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with severe renal dysfunction, there is an increased risk of side effects.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution apply this drug for violations of liver function.

APPLICATION FOR CHILDREN

Contraindicated in children under 14 years (in the form of tablets).

Children and adolescents from 2 to 14 years with the goal of correct dosing the drug is prescribed only in the form of injections.

Adolescents have an increased risk of side effects.

APPLICATION IN ELDERLY PATIENTS

Use with caution in old age.

SPECIAL INSTRUCTIONS

Children and adolescents from 2 to 14 years with the goal of correct dosing the drug is prescribed only in the form of injections.

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

During the treatment should refrain from drinking alcohol.

In adolescents and patients with severe impairment of kidney function, there is an increased risk of side effects.

Against the background of the use of metoclopramide, there are possible distortions of these laboratory parameters of liver function and determination of the concentration of aldosterone and prolactin in plasma.

OVERDOSE

Symptoms: drowsiness, confusion, irritability, anxiety, seizures, extrapyramidal movement disorders, cardiovascular system dysfunction with bradycardia, and a decrease or increase in blood pressure.

With mild forms of poisoning, symptoms disappear after 24 hours after drug withdrawal.
Depending on the severity of the symptoms, it is recommended to establish monitoring of the vital functions of the patient. Deaths of poisoning in case of an overdose have not been identified.
Treatment: symptomatic.
Extrapyramidal disorders are eliminated by slow administration of biperidene (doses for adults 2.5-5 mg). Biperiden is administered only in a hospital, under the supervision of doctors. To calm the patient, diazepam can be used. When large amounts of metoclopramide enter the body, rinsing of the stomach is done, activated carbon and sodium sulfate are used.
DRUG INTERACTION

Anticholinergics can weaken the action of metoclopramide.

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

Metoclopramide reduces the absorption of digoxin and cimetidine.

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

Neuroleptic drugs with concomitant administration with metoclopramide may increase the risk of developing extrapyramidal disorders.

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

Metoclopramide decreases the effectiveness of pergolide, levodopa.

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

Metoclopramide increases the concentration of bromocriptine in plasma.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B.

The drug should be stored in a dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Shelf life - 5 years.
Do not use after the expiration date.
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