Instructions Analgin tablets 0.5 g blister No. 10
Composition
active ingredient: metamizole sodium salt;
1 tablet contains metamizole sodium salt 500 mg (0.5 g);
excipients: potato starch, calcium stearate.
Dosage form
Pills.
Main physicochemical properties: white or white with a yellowish tinge of color tablets with a flat surface, a score and a bevel.
Pharmacotherapeutic group
Analgesics and antipyretics. Metamizole sodium. ATX code N02B B02.
Pharmacological properties
Pharmacodynamics
Analgin (metamizole sodium salt) has analgesic, antipyretic and anti-inflammatory effects. The analgesic effect is due to inhibition of cyclooxygenase and blocking the synthesis of prostaglandins from arachidonic acid, which are involved in the formation of a response to pain stimuli (bradykinins, prostaglandins); slowing the conduction of extra- and proprioceptive pain impulses in the central nervous system, increasing the threshold of excitability of thalamic centers of pain sensitivity and weakening the response of brain structures responsible for the sensation of pain. The antipyretic effect is due to a decrease in the formation and release of substances from neutrophil granulocytes that affect heat production. The anti-inflammatory effect is associated with inhibition of prostaglandin synthesis.
Pharmacokinetics
Metamizole sodium salt is well absorbed in the gastrointestinal tract. Therapeutic plasma concentration is achieved approximately half an hour after taking the drug. The maximum plasma concentration of metamizole sodium salt after oral administration at a dose of 6 mg/kg of body weight is achieved after 1–1.5 hours. It binds to plasma proteins in a small amount and is intensively metabolized in the liver: a significant part of the substance is hydrolyzed to form 4-methylaminoantipyrine, which is demethylated to form pharmacologically active 4-aminoantipyrine, 50–60% of which binds to plasma proteins, the acetylated derivative of which is excreted in the urine. The drug also penetrates the placenta and into breast milk.
Indication
Pain syndrome of various origins: headache, toothache, neuralgia, radiculitis, myalgia, pain during menstruation. As an auxiliary agent for reducing pain after surgical and diagnostic interventions. Hyperthermic syndrome in infectious and inflammatory diseases.
Contraindication
Known or suspected hypersensitivity to metamizole sodium salt and to other components of the drug, pyrazolone derivatives (butadione, tribuzone, antipyrine); suspected acute surgical pathology; anemia of any etiology, cytostatic or infectious neutropenia; changes in the composition of peripheral blood: agranulocytosis, leukopenia; severe liver and/or kidney dysfunction; glucose-6-phosphate dehydrogenase deficiency; bronchial asthma; hereditary hemolytic anemia.
Interaction with other medicinal products and other types of interactions
Radiocontrast agents, colloidal blood substitutes, penicillin - should not be used during treatment with metamizole sodium salt.
Chlorpromazine or other phenothiazine derivatives - possible development of severe hypothermia.
Indirect anticoagulants, phenytoin, glucocorticosteroids, indomethacin, ibuprofen - metamizole sodium salt increases the activity of these drugs by displacing them from protein binding.
Glutethimide reduces the effectiveness of metamizole sodium salt.
Other nonsteroidal anti-inflammatory drugs - their analgesic and antipyretic effects are enhanced and the likelihood of additive undesirable side effects increases.
Thiamazole, drugs that suppress bone marrow activity, including gold preparations - the likelihood of hematotoxicity, including the development of leukopenia, increases.
Methotrexate - metamizole sodium salt in high doses can lead to an increase in the concentration of methotrexate in the blood plasma and an increase in its toxic effects (primarily on the digestive tract and the hematopoietic system).
Diuretics (furosemide) – possible reduction in diuretic effect.
Simultaneous use of metamizole sodium salt with other non-narcotic analgesics can lead to mutual enhancement of toxic effects. Sedatives and tranquilizers (sibazon, trioxazine, valocardin, codeine, anaprilin, H2-receptor blockers) enhance the analgesic effect of metamizole sodium salt. Tricyclic antidepressants (amizol, doxepin), oral contraceptives, allopurinol disrupt the metabolism of metamizole sodium salt in the liver and increase its toxicity. Barbiturates (phenobarbital, belaspon), phenylbutazone and other inducers of liver microsomal enzymes weaken the effect of metamizole sodium salt. Caution is required when using the drug simultaneously with sulfonamide, sugar-lowering drugs (hypoglycemic effect is enhanced) and diuretics (furosemide). Sarcolysin and mercazolil increase the likelihood of leukopenia. Metamizole sodium enhances the sedative effect of alcohol and reduces the plasma concentration of cyclosporine.
Application features
Before starting treatment with the drug, you should consult a doctor.
Since metamizole sodium salt has anti-inflammatory and analgesic properties, it can mask signs of infection, symptoms of non-infectious diseases and complications with pain syndrome, which can make their diagnosis difficult.
When using the drug, you should refrain from drinking alcoholic beverages.
The drug should be used with caution in patients:
elderly age - may lead to an increase in the frequency of adverse reactions, especially from the digestive tract; with existing allergic diseases (including hay fever) or with a history of such diseases - the risk of allergic reactions increases; with inflammatory bowel diseases, including nonspecific ulcerative colitis and Crohn's disease; with impaired renal function, with a history of kidney diseases (pyelonephritis, glomerulonephritis); with severe arterial hypotension, cardiovascular failure; with chronic alcoholism; with simultaneous use of cytostatic drugs (only under the supervision of a doctor).
Patients should be warned before starting treatment that if chills, fever, sore throat, difficulty swallowing, bleeding gums, pale skin, asthenia, vaginitis or proctitis develop without any apparent cause, the drug should be discontinued immediately. The drug should also be discontinued at the first rash on the skin and mucous membranes. If these symptoms appear, you should immediately consult a doctor.
Use for the relief of acute abdominal pain is excluded (until the cause is determined).
Patients with atopic bronchial asthma and hay fever are at increased risk of developing hypersensitivity reactions.
Regular long-term use of the drug is not recommended due to the myelotoxicity of metamizole sodium salt; in case of prolonged use (more than 7 days), it is necessary to monitor the peripheral blood picture (leukocyte formula), kidney and liver function.
It should be used in children under the constant supervision of a doctor.
During treatment, urine may turn red (due to metabolite excretion), which is of no clinical significance.
The drug should not be used for longer than the prescribed period without consulting a doctor.
If the signs of the disease do not disappear or, on the contrary, the state of health worsens, or undesirable phenomena appear, it is necessary to suspend the use of the drug and consult a doctor regarding further use.
When using the drug, it is necessary to monitor the composition of peripheral blood (leukocyte formula).
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy or breastfeeding.
Method of administration and doses
Adults and adolescents over 14 years of age are prescribed ½–1 tablet 1–2 times a day. Tablets should be taken after meals, with a small amount of water. The maximum single dose is 1 g (2 tablets), the maximum daily dose is 1 g (2 tablets). The duration of taking the drug is no more than 3 days.
If the symptoms of the disease do not disappear within 3 days, you should consult a doctor regarding further use of the drug.
Children
The drug should be used in children over 14 years of age.
Overdose
Symptoms: hypothermia, pronounced decrease in blood pressure, tachycardia, dysphagia, palpitations, shortness of breath, tinnitus, nausea, vomiting, gastralgia/gastritis, stomach pain, oliguria, anuria, weakness, drowsiness, delirium, impaired consciousness, convulsive syndrome; possible development of acute agranulocytosis, hemorrhagic syndrome, acute renal and hepatic failure, paralysis of the respiratory muscles.
Treatment: cancel the drug, induce vomiting, perform gastric lavage, prescribe saline laxatives, activated charcoal. Perform forced diuresis, alkalization of the blood, symptomatic therapy aimed at maintaining vital functions. In case of convulsive syndrome, administer diazepam and fast-acting barbiturates intravenously. In severe cases, hemodialysis, hemoperfusion, peritoneal dialysis may be required.
At the first symptoms of overdose, you should seek medical help immediately.
Adverse reactions
From the urinary system: transient oliguria, anuria, proteinuria, interstitial nephritis, red urine.
From the hematopoietic system: granulocytopenia, anemia, agranulocytosis, leukopenia, thrombocytopenia.
Allergic reactions: possible manifestations of hypersensitivity reactions, including skin and mucous membrane rashes, hyperemia, conjunctivitis, itching, urticaria, angioedema, bronchospastic syndrome, anaphylactic shock, Stevens-Johnson syndrome, Lyell's syndrome. Others: decreased blood pressure, weakness, numbness, tremor, loss of consciousness, hepatitis.
Expiration date
5 years.
Do not use after the expiry date stated on the packaging.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in blisters.
Vacation category
Without a prescription.
Producer
PJSC "Chempharmaceutical Plant "Chervona Zirka".
Location of the manufacturer and its business address
61010, Ukraine, Kharkiv, 1 Hordienkivska St.
