Instructions Analgin-Darnitsa solution for injection 50% ampoule 2 ml No. 10
Composition
active ingredient: metamizole sodium;
1 ml of solution contains metamizole sodium (analgin) 500 mg;
Excipients: sodium sulfite anhydrous (E 221), sodium formaldehyde sulfoxylate dihydrate, diluted hydrochloric acid, water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: clear colorless or slightly yellowish liquid.
Pharmacotherapeutic group
Analgesics and antipyretics. Metamizole sodium.
ATX code N02B B02.
Pharmacological properties
Pharmacodynamics.
Nonsteroidal anti-inflammatory drug, a pyrazolone derivative. Nonselectively blocks cyclooxygenase, reduces the formation of prostaglandins from arachidonic acid. Prevents the conduction of painful extra- and proprioceptive impulses along the bundles of Hall and Burdach, increases the threshold of excitability of thalamic centers of pain sensitivity, increases heat dissipation. A distinctive feature is the insignificant severity of the anti-inflammatory effect, which causes a weak effect on water-salt metabolism (retention of Na+ and water) and the mucous membrane of the gastrointestinal tract. It has analgesic, antipyretic and some antispasmodic (relative to the smooth muscles of the urinary and biliary tract) effects.
Pharmacokinetics.
When administered intramuscularly, it is quickly and completely absorbed into the blood. In the liver, it undergoes oxidative deamination with the formation of an active metabolite. The binding of the active metabolite to proteins is 50-60%. In children, deamination processes occur somewhat more slowly than in adults. With frequent administration (more than 4 times a day), cumulation of the drug and intoxication are possible in children. It is quickly and evenly distributed in tissues. The maximum concentration is reached 1-1.5 hours after intramuscular administration. The half-life (T1/2) is approximately 7 hours. It is excreted in the urine.
Indication
Pain syndrome of low and medium intensity of various origins and localization (headache, toothache, burns, pain in the postoperative period, dysmenorrhea, arthralgia, neuralgia, radiculitis, myositis); hyperthermic syndrome, febrile conditions (with influenza, acute respiratory and other infections); renal and hepatic colic (in combination with antispasmodics).
Contraindication
Hypersensitivity to the components of the drug. Agranulocytosis, cytostatic or infectious neutropenia. Hepatic and/or renal failure. Hereditary hemolytic anemia associated with glucose-6-phosphate dehydrogenase deficiency. Attacks of bronchial asthma caused by acetylsalicylic acid. Abdominal pain of unknown origin. Anemia, leukopenia. Kidney disease: pyelonephritis, glomerulonephritis, including a history. It is not recommended to administer intravenously to patients with systolic blood pressure below 100 mm Hg. Polytrauma. Shock. Porphyria.
Interaction with other medicinal products and other types of interactions
Due to the high probability of pharmaceutical incompatibility, it cannot be mixed with other drugs in the same syringe.
Ethanol – the effect of ethanol is enhanced.
Chlorpromazine or other phenothiazine derivatives - simultaneous use may lead to the development of severe hypothermia.
Radiocontrast agents, colloidal blood substitutes and penicillin should not be used during treatment with metamizole sodium.
Cyclosporine - simultaneous use reduces the concentration of cyclosporine in the blood.
Oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids, phenytoin, ibuprofen and indomethacin - metamizole sodium increases the activity of these drugs by displacing them from protein binding.
Phenylbutazone, barbiturates and other hepatoinducers, when used simultaneously, reduce the effectiveness of metamizole sodium.
Non-narcotic analgesics, tricyclic antidepressants, hormonal contraceptives and allopurinol - simultaneous use of metamizole sodium with these drugs may lead to increased toxicity.
Other nonsteroidal anti-inflammatory drugs - their analgesic and antipyretic effects are potentiated and the likelihood of additive undesirable side effects increases.
Sedatives and tranquilizers (sibazon, trioxazine, valocordin) enhance the analgesic effect of metamizole sodium.
Sarcolysin, mercazolil (thiamazole), drugs that suppress bone marrow activity, including gold preparations - the likelihood of hematotoxicity increases, including the development of leukopenia.
Codeine, histamine H2 blockers and propranolol enhance the effect of metamizole sodium.
Caution is required when using the drug simultaneously with sulfonamide-type hypoglycemic drugs (increased hypoglycemic effect) and diuretics (furosemide).
Myelotoxic drugs lead to increased hematotoxicity.
Methotrexate - metamizole in high doses can lead to an increase in the concentration of methotrexate in the blood plasma and an increase in its toxic effects (on the digestive system and the hematopoietic system).
Application features
Parenteral administration requires medical supervision (high frequency of allergic reactions, including fatal ones) and the availability of conditions for anti-shock therapy.
Patients with atopic bronchial asthma and hay fever are at increased risk of developing hypersensitivity reactions.
Severe skin reactions
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug-induced eosinophilia with systemic symptoms (DRESS syndrome), which can be life-threatening or fatal, have been reported with metamizole treatment.
Patients should be informed about the signs and symptoms of skin reactions and monitored closely.
If signs and symptoms suggestive of these reactions appear, metamizole treatment should be discontinued and under no circumstances restarted (see section "Contraindications").
Use for the relief of acute abdominal pain of unknown origin is excluded (until the cause is determined).
The drug should be used with caution in patients:
elderly age - may lead to an increased frequency of adverse reactions, especially from the digestive system;
with inflammatory bowel diseases, including ulcerative colitis and Crohn's disease.
When prescribing to patients with acute cardiovascular pathology, careful hemodynamic monitoring is necessary. Use with caution in patients with blood pressure below 100 mm Hg. Art., with myocardial infarction, multiple trauma, with anamnestic indications of liver and kidney diseases (pyelonephritis, glomerulonephritis), during treatment with cytostatics, with chronic alcoholism, severe allergic history, blood diseases.
Regular long-term use of the drug is not recommended due to the myelotoxicity of metamizole sodium; it is necessary to monitor the peripheral blood picture (leukocyte formula).
When using the drug, the development of agranulocytosis is possible, therefore, if an unmotivated increase in temperature, chills, sore throat, difficulty swallowing, stomatitis, as well as inflammation of the external genitalia and anus are detected, the drug should be immediately discontinued.
Subcutaneous administration of the drug should not be used due to possible tissue irritation.
During treatment, urine may turn red (due to metabolite excretion), which is of no clinical significance.
Rarely, sodium sulfite anhydrous (E 221) may cause hypersensitivity reactions and bronchospasm.
The use of the drug must be discontinued if rashes appear on the skin and mucous membranes.
This medicine contains less than 1 mmol sodium/dose, i.e. it is essentially sodium-free.
Use during pregnancy or breastfeeding
Contraindicated during pregnancy, especially in the first trimester and the last 6 weeks.
Breastfeeding should be discontinued during treatment, as metamizole sodium passes into breast milk.
Ability to influence reaction speed when driving vehicles or other mechanisms
During the treatment period, driving and engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions are not allowed.
Method of administration and doses
Administer intramuscularly and intravenously by jet. The method of administration and dose depend on the severity of the disease and are determined individually. The analgesic effect with intravenous administration is higher than with intramuscular administration.
The solution to be administered should be at body temperature. To prevent a sharp decrease in blood pressure, intravenous administration should be carried out slowly (at a rate of no more than 1 ml/min), the patient should be in a supine position, blood pressure, heart rate and breathing should be monitored. The procedure requires conditions for anti-shock therapy. For intravenous administration, a long needle should be used.
Adults should be prescribed 0.5-1 ml (250-500 mg) 2-3 times a day. The maximum single dose for both routes of administration is 1 ml (500 mg), daily dose is 2 ml (1 g).
Children under 1 year of age should be administered at a dose of 0.01 ml/kg of body weight. Children under 1 year of age should be administered the drug only intramuscularly.
Duration of use – up to 3 days.
Children aged 1 year and older should be given 0.1 ml per 1 year of life 1-2 times a day. Duration of use – up to 3 days.
Children.
For children under 1 year of age, the drug is administered only intramuscularly. For children, use under the supervision of a physician for serious and vital indications.
Overdose
Treatment: induction of vomiting, gastric lavage, administration of saline laxatives, activated charcoal. Conducting forced diuresis, hemodialysis, alkalization of blood, symptomatic therapy aimed at supporting vital functions. In the event of the development of convulsive syndrome, intravenous administration of diazepam and fast-acting barbiturates is recommended.
Adverse reactions
Liver and biliary tract disorders: hepatitis.
On the part of the kidneys and urinary system: oliguria, anuria, proteinuria, interstitial nephritis, red urine color.
From the cardiovascular system: decreased blood pressure, tachycardia.
From the blood and lymphatic system: agranulocytosis, leukopenia, thrombocytopenia, anemia, granulocytopenia.
On the part of the immune system: hypersensitivity reactions, including rashes on the skin and mucous membranes, skin hyperemia, itching, urticaria, conjunctivitis, angioedema; bronchospastic syndrome, anaphylactoid reactions, anaphylactic shock.
Skin and subcutaneous tissue disorders: rarely - Stevens-Johnson syndrome, Lyell's syndrome; frequency unknown - drug-induced eosinophilia with systemic symptoms (DRESS).
General disorders and administration site conditions: injection site infiltrates (with intramuscular administration), hyperemia, edema, local rashes and itching of the skin at the injection site.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ° C. Do not freeze.
Keep out of reach of children.
Incompatibility.
Due to the high probability of pharmaceutical incompatibility, the drug cannot be mixed with other drugs in the same syringe.
Packaging
2 ml in an ampoule; 5 ampoules in a contour blister pack; 2 contour blister packs in a pack.
Vacation category
According to the recipe.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and its business address.
Ukraine, 02093, Kyiv, Boryspilska St., 13.
