Analgin-Zdorovye, the tab. on 0,5g No. 10
Producer: LLC Pharmaceutical Company Zdorovye Ukraine
Code of automatic telephone exchange: N02B B02
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
International and chemical names: metamizole sodium; [(1,5-dimethyl-3-oxo-2-phenyl-2,3-digidro - 1N pyrazol-4-silt) - methylamine N-] – Methansulfonas natricum;
main physical and chemical properties: tablets of color, white or white with a yellowish shade, with a flat surface, risky and a facet; structure: 1 tablet contains metamizole sodium 0,5 g; excipients: potato starch, calcium stearate.
Pharmacological properties:
Pharmacodynamics. Anesthetic, febrifugal, spasmolytic (on smooth muscles of urinary and bilious tract) means of group of derivatives of pyrazyl ketone. Antiinflammatory action is expressed poorly.
The mechanism of action is caused by cyclooxygenase inhibition that leads to decrease in synthesis of prostaglandins causing development of pain, temperature increase and increase in fabric permeability in the inflammation center and also disturbance of carrying out painful extra-and proprioretseptivny impulses, increase in an excitation threshold of the thalamic centers of painful sensitivity, increase in a thermolysis.
Pharmacokinetics. Metamizole sodium is well soaked up in a digestive tract. In a wall of intestines it is hydrolyzed with formation of an active metabolite (not changed Methimazolum in blood is absent). Therapeutic concentration of an active metabolite in blood is reached approximately in 0,5 h after reception; the maximum concentration – in 1–1,5 h (after reception of a dose of 6 mg/kg of body weight). Communication of an active metabolite with blood proteins – 50–60%. It is metabolized in a liver, removed by kidneys. Gets through a placental barrier and into breast milk.
Indications to use:
Pain syndrome of various genesis (bilious, intestinal and renal gripes, neuralgia, mialgiya, injuries, burns, head or dentagra, dysmenorrhea, radiculitis, etc.), feverish syndrome (infectious and inflammatory diseases, stings of insects, posttransfusion complications).
Route of administration and doses:
Appoint inside after food, washing down with a small amount of water. To adults and teenagers 14 years are more senior appoint for 0,25 - 0,5 (½ – 1 tablet) 2–3 times a day. The maximum single dose – 1 g (2 tablets), daily – 3 g (6 tablets).
To teenagers aged from 12 up to 14 years appoint in a dose 0,25 g (½ tablets) 2–3 times a day. The maximum single dose – 0,5 g (1 tablet), daily – 2 g (4 tablets).
Duration of administration of drug – no more than 3 days.
Features of use:
Use for removal of acute abdominal pains is excluded (before clarification of the reason).
At patients with atopic bronchial asthma and pollinoses the risk of development of reactions of hypersensitivity is increased.
With care apply to patients with anamnestic instructions on diseases of kidneys (pyelonephritis, a glomerulonephritis), at treatment by cytostatics, at an alcoholism.
Regular long administration of drug because of a metamizol miyelotoksichnost is not recommended; in case of prolonged use (more than 7 days) it is necessary to control a pattern of peripheral blood (a leukocytic formula).
At use of drug development of an agranulocytosis in this connection, at identification of unmotivated rise in temperature, a fever, pharyngalgias, the complicated swallowing, stomatitis, and also an inflammation of external genitals and an anus, immediate drug withdrawal is necessary is possible.
During treatment coloring of urine in red color is possible (as a result of allocation of a metabolite) that has no clinical value.
Use during pregnancy and feeding by a breast. Drug is contraindicated during pregnancy. For the period of treatment it is necessary to stop feeding by a breast since metamizole sodium gets into breast milk.
Influence on an opportunity to manage vehicles and mechanisms. During treatment it is necessary to abstain from control of motor transport and performance of potentially dangerous types of activity connected with need of concentration of attention and the increased speed of psychomotor reactions.
Side effects:
From an urinary system: an oliguria, an anury, a proteinuria, intersticial nephrite, coloring of urine in red color. From system of a hemopoiesis: agranulocytosis, leukopenia, thrombocytopenia. Allergic reactions: urticaria, conjunctivitis, Quincke's edema; seldom – Stephens-Johnson's syndrome, a Lyell's disease, a bronkhospastichesky syndrome, an acute anaphylaxis. Another: lowering of arterial pressure.
Interaction with other medicines:
Toxic effect of drug amplifies at simultaneous use with other non-narcotic analgesics, tricyclic antidepressants (амизол, доксепин), hormonal contraceptives and Allopyrinolum. Sarcolysine and mercazolil (Thiamazolum) increase probability of development of a leukopenia. The effect of drug is strengthened by histamine H2 blockers, propranolol (анаприлин), weaken – barbiturates and other inductors of microsomal enzymes of a liver. Analgeziruyushchy effect of drug is strengthened by sedatives and tranquilizers (Sibazonum, Trioxazinum, valocordin, codeine, etc.). Drug increases activity of peroral hypoglycemic means, indirect coagulants, glucocorticosteroids and indometacin (releases from communication with blood proteins), sedative activity of alcohol, reduces concentration of cyclosporine in plasma. Simultaneous use with derivatives of a fenotiazin (хлопромазин, etc.) can lead to development of the expressed hyperthermia.
It is impossible to use drug along with X-ray contrast substances, colloid blood substitutes and penicillin.
Contraindications:
The increased individual sensitivity to metamizole sodium and other derivatives of pyrazyl ketone, a bronchospasm, hemopoiesis disturbances (an agranulocytosis, a cytostatic or infectious neutropenia), renal failures and/or a liver, the hereditary hemolitic anemia caused by deficit glyukozo-6-fosfatdegid-rogenazy, abdominal pains of unspecified genesis, pregnancy, feeding by a breast, children's age up to 12 years.
Overdose:
Symptoms: a hypothermia, the expressed lowering of arterial pressure, a heart consciousness, an asthma, a sonitus, nausea, vomiting, weakness, drowsiness, nonsense, consciousness disturbances, a convulsive syndrome; development of an acute agranulocytosis, hemorrhagic syndrome, an acute renal and liver failure, paralysis of respiratory muscles is possible. Treatment: cancellation of administration of drug, induction of vomiting, probe gastric lavage, purpose of salt laxatives, absorbent carbon. Carrying out an artificial diuresis, hemodialysis, blood alkalization, the symptomatic therapy directed to maintenance of zhiznennovazhny functions. At development of a convulsive syndrome carry out intravenous administration of diazepam and quickly operating barbiturates.
Storage conditions:
To store in the dry, protected from light place at a temperature from 8 °C to 25 °C. To store in the place, unavailable to children.
Period of validity – 5 years.
Issue conditions:
Without recipe
Packaging:
Tablets on 0,5 g No. 6, No. 10 in a blister strip packaging in a pack; No. 6, No. 10 in a blister strip packaging.