Product Overview
Structure
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 of
silicon colloidal dioxide (Aerosil) - 0.0005 g
pharmachologic effect
Antiemetic is a specific blocker of dopamine (D2) and serotonin receptors. 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 spasm of the sphincter of Oddi, eliminates dyskinesia of the gallbladder. Stimulates the secretion of prolactin.
Pharmacokinetics
Quickly absorbed from the gastrointestinal tract. Bioavailability is 60-80%. The time to reach maximum plasma concentration is 1-2 hours. The half-life is from 3 to 5 hours, with impaired renal function - up to 14 hours. The drug is excreted mainly by the kidneys within 24 hours unchanged and in the form of conjugates. Passes through the placental and blood-brain barriers, penetrates into breast milk.
Indications
- Vomiting, nausea, hiccups of various origins (in some cases, it can be effective for 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 duodenal ulcer (as part of complex therapy);
- during X-ray contrast studies of the gastrointestinal tract (to enhance peristalsis).
Pregnancy and lactation
If necessary, use the drug during lactation should stop breastfeeding for the entire period of treatment.
Contraindications
Precautions:
Bronchial asthma, arterial hypertension, Parkinson's disease, renal and / or liver failure, advanced age.
Side effects
Cardiovascular system: atrioventricular block;
Central nervous system: extrapyramidal disorders - trismus, spasm of facial muscles, spastic torticollis, bulbar type of speech, rhythmic protrusion of the tongue, spasm of extraocular muscles (including oculogyric crisis), muscle opistotonus, hypertonicity; parkinsonism (muscle rigidity, hyperkinesis - a manifestation of dopamine blocking action, the risk of development in children increases when the dose is higher than 0.5 mg / kg per day), dyskinesias (in chronic renal failure and in elderly patients), depression, headache, drowsiness, anxiety, fatigue, confusion, tinnitus;
Endocrine system: rarely (with prolonged therapy in high doses) - galactorrhea, gynecomastia, menstrual irregularities;
Digestive system: diarrhea, constipation; rarely - dry mouth;
Hematopoietic system: leukopenia, neutropenia, sulfhemoglobinemia in adults;
Metabolism: porphyria;
Allergic reactions: angioedema, bronchospasm, urticaria;
Other: at the beginning of treatment - agranulocytosis; rarely (when using high doses) - hyperemia of the nasal mucosa.
In case of the appearance of the above symptoms, their aggravation or the development of other side effects, you must consult a doctor.
Interaction
With the simultaneous use of metoclopramide with certain drugs, the following effects may occur: Ethanol: increased action on the central nervous system; Cholinesterase inhibitors: weakening the action of metoclopramide; Hypnotics: increased sedation; H2-histamine receptor blockers: increasing the effectiveness of therapy; Diazepam, tetracycline, ampicillin, paracetamol, acetylsalicylic acid, levodopa, ethanol: increased absorption; Digoxin, cimetidine: delayed absorption; Antipsychotics: increased risk of extrapyramidal symptoms.
Before using metoclopramide with other medicines at the same time, you should consult your doctor.
How to take, course of administration and dosage
Overdose
Treatment: symptomatic. Extrapyramidal disorders are eliminated by the slow administration of biperiden in a dose for adults of 2.5-5 mg (biperiden is administered only in a hospital, under the supervision of doctors). Diazepam can be used to calm the patient. When large doses of metoclopramide are ingested, gastric lavage is done, activated carbon and sodium sulfate are used.
Special instructions
If necessary, treatment is carried out with central anticholinergics and other anti-Parkinsonian drugs.
In elderly patients taking the drug, the development of tardive dyskinesia is possible. The risk of developing tardive dyskinesia depends on the duration of the course of pharmacotherapy and the total dose of the drug. Irreversible changes develop, as a rule, with the appointment of the drug for more than 12 weeks.
It is not recommended to prescribe the drug for more than 12 weeks, unless the benefit of prolonged use of the drug exceeds the potential risks of developing an adverse reaction. When prescribing the drug in a short course and at low doses, the development of tardive dyskinesia is also possible, however, these changes usually disappear some time after the drug is discontinued.
Ability to influence the reaction rate when driving vehicles or working with other mechanisms
During treatment, care must be taken when driving vehicles and engaging in other activities that require increased concentration and speed of psychomotor reactions.
