Analgin-Zdorovye, solution for infection 50% on 2 ml No. 10
Producer: LLC Pharmaceutical Company Zdorovye Ukraine
Code of automatic telephone exchange: N02B B02
Release form: Liquid dosage forms. Solution for injections.
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: transparent colourless or yellowish liquid; structure: 1 ml contains metamizole sodium in terms of 100% substance of 500 mg; excipients: sodium metabisulphite, dinatrium эдетат (Trilonum of B), 1M hydroxide sodium solution, water for injections
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. After introduction metamizol is hydrolyzed to an active metabolite (at intravenous administration not changed metamizol is found in plasma in insignificant quantities). Communication of an active metabolite with 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), feverish syndrome (infectious and inflammatory diseases, stings of insects, posttransfusion complications).
Route of administration and doses:
Appoint intramusculary and intravenously struyno. The way of introduction and a dose depends on disease severity and is defined individually. Intravenously appoint at severe pains. The analgesic effect at intravenous administration is higher, than at intramuscular. Doses more than 2 ml (1 g) should be entered intravenously.
The entered solution has to have body temperature. For prevention of a sharp lowering of arterial pressure intravenous administration has to be carried out slowly (with a speed no more than 1 ml/min.), in situation "lying", at control of arterial pressure, heart rate and dykhaniye. The procedure demands existence of conditions for performing antishock therapy. At intravenous administration it is necessary to use a long needle.
The adult appoint 0,5–2 ml (0,25–1 g) 2–3 times a day. The maximum single dose at both ways of introduction – 2 ml (1 g), daily – 4 ml (2 g).
To teenagers 12 years are more senior appoint in a dose 0,1 - 0,2 ml (0,05–0,1 g) to 10 kg of body weight, but no more than 0,5 ml (0,5 g) 2–3 times a day.
Features of use:
At parenteral administration medical control (high frequency of allergic reactions, including with a lethal outcome) and existence of conditions for performing antishock therapy is necessary.
At patients with atopic bronchial asthma and pollinoses the risk of development of reactions of hypersensitivity is increased.
Use for removal of acute abdominal pains of unspecified genesis is excluded (before clarification of the reason).
At appointment as the patient with acute cardiovascular pathology careful control of a hemodynamics is necessary. With care apply to patients with the level of arterial pressure below 100 mm of mercury., at a myocardial infarction, a multiple injury, 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 metamizole sodium 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.
Hypodermic introduction drug is not used because of possible irritation of fabrics.
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. The majority of states at which use of an injection form of drug is shown excludes a possibility of control of vehicles and mechanisms. In other cases during treatment it is necessary to abstain from control of motor transport and performance of potentially dangerous types
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: a lowering of arterial pressure, infiltrates in an injection site (at intramuscular introduction).
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.
Pharmaceutical incompatibility. Because of high probability of pharmaceutical incompatibility it is impossible to mix drug with other medicines in one syringe.
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 of glyukozo-6-fosfatde-hydrogenase, an abdominal pain 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: 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 high-speed barbiturates.
Storage conditions:
To store in the place protected from light at a temperature from 8 °C to 25 °C. To store in the place, unavailable to children.
Period of validity – 3 years.
Issue conditions:
According to the recipe
Packaging:
Solution for injections of 50% on 1 ml or 2 ml in ampoules No. 10 in a pack.