Metoclopramide 10mg tablets 56 Renewal

Country: Russia;

Trade name of the drug: Metoclopramide;

Dosage form: tablets;

Composition for one tablet

Metoclopramide hydrochloride monohydrate - 0.0105 g

(in terms of anhydrous) ... - 0.0100 g

Excipients:

lactose monohydrate (milk sugar) - 0.0660 g

potato starch .......... - 0.0200 g

calcium stearate ...................... - 0.0010 g

povidone-K30 ............................. - 0.0020 g

colloidal silicon dioxide (aerosil) - 0.0005 g

Description

Tablets from white to white with a yellowish or creamy shade,

flat-cylindrical, chamfered, with or without "R" marking on one side.

Pharmacotherapeutic group: antiemetic - dopamine receptors

central blocker.

ATX code: А03FA01

Pharmacological properties

Pharmacodynamics

Antiemetic, is a specific blocker of dopamine (D2) and

serotonin receptors. Has antiemetic effect, eliminates nausea and hiccups.

Reduces the motor activity of the esophagus, increases the tone of the lower esophageal sphincter,

speeds up the emptying of the stomach, and also speeds up the movement of food through the small intestine, not

causing diarrhea. Normalizes the secretion of bile, reduces the spasm of the sphincter of Oddi,

eliminates gallbladder dyskinesia. Stimulates the secretion of prolactin.

Pharmacokinetics

It is rapidly absorbed from the gastrointestinal tract. Bioavailability is 60-80%. Time

reaching the maximum concentration in blood plasma is 1-2 hours. Time

elimination half-life is from 3 to 5 hours, in case of impaired renal function - up to 14 hours.

the drug occurs mainly by the kidneys within 24 hours unchanged and in the form

conjugates. Passes through the placental and blood-brain barriers, enters

mother's milk.

Indications for use

• Vomiting, nausea, hiccups of various origins (in some cases it can be effective

with vomiting caused by radiation therapy or taking cytostatics);

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

• biliary dyskinesia;

• reflux esophagitis, flatulence, exacerbation of gastric ulcer and 12 duodenal ulcer

(as part of complex therapy);

• when carrying out X-ray contrast studies of the gastrointestinal tract (for

strengthening of peristalsis).

Contraindications

Hypersensitivity, gastrointestinal bleeding, pyloric stenosis

stomach, mechanical intestinal obstruction, perforation of the wall of the stomach or intestines,

pheochromocytoma, extrapyramidal disorders, epilepsy, prolactin-dependent tumors,

pregnancy, lactation, children under 18 years of age.

Carefully

Bronchial asthma, arterial hypertension, Parkinson's disease, renal and / or

liver failure, advanced age.

Application during pregnancy and during breastfeeding

The use of the drug in the first trimester of pregnancy is contraindicated. In II and III trimesters

the drug is used only in cases of emergency, if the potential benefit

to the mother outweighs the potential risk to the fetus.

If necessary, use of the drug during lactation should stop breastfeeding.

feeding for the entire period of treatment.

Method of administration and dosage

Inside. Adults - 10 mg 3-4 times a day 30 minutes before meals, the tablet is swallowed

whole and washed down with a little water. The maximum single dose is

20 mg, daily - 60 mg.

Side effect

From the nervous system: sometimes there may be a feeling of fatigue, headache,

dizziness, fear, anxiety, depression, drowsiness, tinnitus; v

in some cases, dyskinetic syndrome (involuntary

teak-like twitching of the muscles of the face, neck or shoulders). Possible appearance

extrapyramidal disorders: spasm of the facial muscles, trismus, rhythmic protrusion

tongue, bulbar type of speech, spasm of extraocular muscles (including oculogyric crisis),

spastic torticollis, opisthotonus, muscle hypertonicity. With long-term treatment in

some elderly patients may develop parkinsonism (tremor,

muscle twitching, limited mobility). In elderly patients with

chronic renal failure may also develop tardive dyskinesia. V

in isolated cases, the development of neuroleptic malignant 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 (breast enlargement in men), galactorrhea may occur

(spontaneous flow of milk from the mammary glands), menstrual irregularities;

with the development of these phenomena, metoclopramide is canceled.

Overdose

Symptoms: Drowsiness, confusion, irritability, restlessness,

seizures, extrapyramidal movement disorders, dysfunction of the cardiovascular system with bradycardia, and a decrease or increase in blood pressure.

In mild forms of poisoning, the symptoms disappear 24 hours after the drug is discontinued. Depending on the severity of the symptoms, it is recommended to establish monitoring of vital

important functions of the patient. Overdose deaths are not

identified.

Treatment: symptomatic. Extrapyramidal disorders resolve slowly

the introduction of biperiden in a dose for adults 2.5-5 mg (biperiden is administered only under conditions

hospital, under the supervision of doctors). Diazepam can be used to calm the patient. At

ingestion of large doses of metoclopramide, gastric lavage is performed,

activated carbon and sodium sulfate.

Interaction with other medicinal products

The action of metoclopramide can be weakened by anticholinesterase drugs.

Metoclopramide enhances the absorption of antibiotics (tetracycline, ampicillin), paracetamol,

acetylsalicylic acid, levodopa, lithium preparations, ethanol; reduces absorption

digoxin and cimetidine; increases the concentration of bromocriptine in plasma. Enhances

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

cyclosporine, which may require monitoring of its concentration. Not recommended

prescribe concurrently with antipsychotic drugs

(antipsychotics), as the risk of extrapyramidal reactions increases.

Use of metoclopramide in combination with serotonin reuptake inhibitors

can lead to increased development of extrapyramidal symptoms, including serotonin

syndrome.

special instructions

It is not recommended to consume ethanol during the treatment period.

If necessary, treatment with central anticholinergics and other

antiparkinsonian drugs.

Elderly patients taking the drug may develop tardive dyskinesia. Risk

the development of tardive dyskinesia depends on the duration of the course of pharmacotherapy and the total dose

drug. Irreversible changes develop, as a rule, when the drug is prescribed

more than 12 weeks. It is not recommended to prescribe the drug for more than 12 weeks, with the exception of

cases where the benefits of long-term use of the drug outweigh the potential risks

the development of an adverse reaction. When prescribing the drug in a short course and in low doses, also

development of tardive dyskinesia is possible, however, these changes usually disappear later

some time after discontinuation of the drug.

The ability to influence the reaction rate when driving or working with

other mechanisms

During the period of treatment, care must be taken when driving

means and engaging in other activities requiring increased concentration

attention and speed of psychomotor reactions.

Release form

10 mg tablets