Reglaned injection solution ampoules 2ml N10
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Active ingredients
Metoclopramide
Composition
Solution for intravenous and intramuscular administration, composition (1 ml): active substance: metoclopramide hydrochloride monohydrate - 5.27 mg; (equivalent to 5 mg of metoclopramide hydrochloride); excipients: sodium sulfite - 0.125 mg; disodium edetate - 0.4 mg; sodium chloride - 8 mg; water for injection 991.705 mg
Pharmacological effect
CERUKAL - an antiemetic, is a specific blocker of dopamine (D2) and serotonin receptors. The mechanism of action 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 irritation threshold of the vomiting center. Has antiemetic effect, eliminates nausea and hiccups. It reduces the motor activity of the esophagus, increases the tone of the lower esophageal sphincter, accelerates gastric emptying, and also accelerates the movement of food through the small intestine, without causing diarrhea. Normalizes the secretion of bile, reduces spasm of the sphincter of Oddi, does not change its status, eliminates dyskinesia of the gall bladder. Stimulates the secretion of prolactin.
Pharmacokinetics
Vd is 2.2 - 3.4 l / kg; Metabolized in the liver. The half-life is from 3 to 5 hours, with chronic renal failure - 14 hours. It is excreted by the kidneys during the first 24 hours in unchanged form and in the form of metabolites (about 80% of the dose taken once). Easily penetrates the blood-brain barrier and is excreted in breast milk.
Indications
The drug is used to treat conditions associated with impaired motor activity of the digestive tract, including irritable bowel syndrome, heartburn, functional pyloric stenosis .; Vomiting and nausea of various origins, including those resulting from abnormal liver and kidney function, traumatic brain injury and migraine, as well as nausea and vomiting caused by medications .; Paresis of the stomach that developed due to diabetes .; When conducting a diagnosis of the digestive tract, including X-ray diagnosis of the stomach and small intestine.
Contraindications
pheochromocytoma; intestinal obstruction; ; bleeding from the digestive tract; ; perforation of the digestive tract; ; prolactin-dependent tumor; ;epilepsy; extrapyramidal movement disorders; ; I trimester of pregnancy; lactation (breastfeeding); ; children's age up to 2 years; hypersensitivity to metoclopramide; ; hypersensitivity to sodium sulfite,especially in patients with bronchial asthma and other allergic diseases (for the injection form of Cerucal) .; With caution: the drug should be prescribed for arterial hypertension, bronchial asthma, abnormal liver function, hypersensitivity to procaine and procainamide, children aged 2 to 14 years.
Use during pregnancy and lactation
During the period of treatment, it is necessary to refrain from driving vehicles and practicing potentially hazardous activities that require increased concentration and psychomotor speed of reaction .; In the process of treatment, patients are prohibited from drinking alcohol .; In adolescents and in patients with severely impaired renal function, the possible development of side effects is monitored and, if they occur, the drug is canceled .; Not effective in vomiting of vestibular genesis.
Dosage and administration
Intramuscularly or slowly intravenously .; Adults and teenagers over 14 years old: 1 ampoule (10 mg of metoclopramide) 3-4 times a day .; Children from 3 to 14 years of age: therapeutic dose is 0.1 mg metoclopramide / kg body weight, the maximum daily dose is 0.5 mg metoclopramide / kg body weight.
Side effects
Incompatible with infusion solutions having an alkaline environment .; Reducing the effect of anticholinesterase drugs .; Enhances the absorption of antibiotics (tetracycline, ampicillin), paracetamol, levodopa, lithium and alcohol .; Reduces digoxin and cimetidine absorption; Strengthens the effect of alcohol and drugs that depress the central nervous system .; Neuroleptic drugs should not be given at the same time as metoclopramide in order to avoid a possible increase in extrapyramidal disorders .; May affect the action of tricyclic antidepressants, monoamine oxidase inhibitors (MAO) and symptomatic agents .; Reduces the effectiveness of therapy H2-histamine blockers .; Increased risk of hepatotoxicity when combined with hepatotoxic drugs .; Reduces the effectiveness of pergolid, levodopa .; Increases the bioavailability of cyclosporine, which may require monitoring its concentration .; Increases bromocriptine concentration .; With the simultaneous appointment of cerucal with thiamine (Vitamin B1), the latter quickly disintegrates.
Overdose
On the part of the nervous system: sometimes there may be a feeling of tiredness, headaches, dizziness, fear, anxiety, depression, drowsiness, tinnitus; in some cases, mainly in children, dyskinetic syndrome may develop (involuntary tichoid twitching of the muscles of the face, neck or shoulders). Extrapyramidal disorders may occur: spasm of the facial muscles, trismism, rhythmic protrusion of the tongue, bulbar type of speech, spasm of extraocular muscles (including ocular curvature), spastic torticollis, opisthotonus, muscle hypertonus. Parkinsonism (tremor, muscle twitching, limited mobility, the risk of development in children and adolescents increases when a dose of 0.5 mg / kg / day is exceeded) and late dyskinesias (in elderly patients with chronic renal failure). In rare cases, the development of severe neuroleptic syndrome is possible .; With prolonged treatment with cerucalum, elderly patients may develop parkinsonism symptoms (tremor, muscle twitching, limited mobility) and late dyskinesias .; From the hemopoietic system: agranulocytosis .; Since the cardiovascular system: supraventricular tachycardia, hypotension, hypertension .; On the part of the gastrointestinal tract: constipation, diarrhea, dry mouth .; On the part of the endocrine system: with prolonged use of the drug, gynecomastia (breast enlargement in men), galactorrhea (spontaneous outflow of milk from the mammary glands) or menstrual disorders may occur; with the development of these phenomena, metoclopramide is canceled.
Interaction with other drugs
Precautionary measures
special instructions
Symptoms: drowsiness, confusion, irritability, anxiety, convulsions, extrapyramidal movement disorders, disorders of the cardiovascular system with bradycardia and arterial hypo- or hypertension. In mild forms of poisoning, the symptoms disappear 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 overdose have not yet been identified .; Treatment: symptomatic.Extrapyramidal disorders eliminate the slow introduction of biperidine (doses for adults - 2.5 - 5 mg; you should adhere to the manufacturer's recommendation). Diazepam may be used.