Pains of various origins of high severity. Fever when other treatments are ineffective. Metamizole in the form of an injection solution should only be used if oral administration is not indicated.
Composition:
1 ampoule 2 ml contains 1 g, 1 ampoule 5 ml contains 2.5 g of sodium metamizol.
Action:
A pyrazolone derivative with analgesic, antipyretic and spasmolytic activity. Metamizole and its active metabolite, metamizol, 4-methyl-amino-antipyrine (MAA), probably act through the central and peripheral nervous system. After intramuscular administration, the bioavailability of 4-MAA is 87%. It binds 58% to plasma proteins. T0,5 in the elimination phase for metamizol it is about 14 minutes. It is excreted in urine (96%) and faeces (6%). It passes through the placenta barrier and into breast milk. In elderly patients, the AUC increases 2-3-fold. In patients with liver cirrhosis T0,5 MAA in the elimination phase increases about 3 times. In patients with impaired renal function, the elimination rate of some metabolites decreases.
Contraindications:
Hypersensitivity to metamizole, other pyrazolone derivatives or NSAIDs, in particular manifested by asthma, angioneurotic edema, urticaria, rhinitis. Changes in the morphological picture of the blood (eg agranulocytosis, leukopenia, anemia). acute renal or hepatic failure, acute hepatic porphyria. Congenital deficiency of glucose-6-phosphate dehydrogenase (G-6-PD). Do not use together with other pyrazolone derivatives (aminofenazone, phenylbutazone, oxyfenbutazone). Pregnancy and breastfeeding. Children under 1 year
Precautions:
Caution use in patients with systolic blood pressure <100 mm Hg, heart failure, renal or hepatic failure, gastric and duodenal ulcer disease, bronchial asthma (especially if polyposis of the nose and sinus concomitantly). Use of the drug in high doses or prolonged increases the risk of agranulocytosis - should not be used for more than 7 days. If you need long-term use of the drug, you should monitor the blood picture (risk of bone marrow damage). If symptoms of agranulocytosis or anaphylactic reaction occur, the medicine should be discontinued immediately.
Pregnancy and lactation:
Metamizol is not allowed during pregnancy. Metamizole was teratogenic in animal studies and metamizol metabolites decreased from blood during pregnancy and lactation. The preparation is contraindicated in pregnancy and breast-feeding. The use of metamizol during pregnancy increases the risk of developing Wilms tumor in children.
Side effects:
Uncommon: drug eruption, hypotensive reactions. Rare: cutaneous maculopapular lesions, leukopenia. Very rare: asthma attack, Stevens-Johnson syndrome or toxic epidermal necrolysis, shock, agranulocytosis, thrombocytopenia, sudden deterioration of renal function (in some cases proteinuria, oliguria, anuria and acute renal failure may occur), interstitial nephritis, phlebitis . Anaphylactoid and anaphylactic reactions may occur, especially after intravenous administration, reactions at the injection site (including pain, reactions in the form of skin lesions and mucous membranes, shortness of breath and less frequent stomach and intestinal disorders, lighter reactions may pass into more severe forms of generalized urticaria, severe angioedema, severe bronchospasm, arrhythmias, hypotension), nausea, vomiting, abdominal pain, stomach irritation, diarrhea, dry mouth, liver damage, headache and dizziness, hemolytic anemia, aplastic anemia , bone marrow damage (sometimes ending in death). After using very high doses of metamizol, a red urine may appear. In patients with GP-6-D deficiency, metamizol causes haemolysis of the blood cells.
Dosage:
Intravenously or intramuscularly. Adults and children> 15 years (about the month> 53 kg): a single dose is 0.5-1 g; if necessary, a single dose of 2.5 g can be given, however, due to the possibility of reducing blood pressure, care should be taken. If necessary, the dose should be administered every 6-8 h. The maximum daily dose is 5 g. Children (only in severe, life-threatening fever, when other antipyretics are ineffective or contraindicated): children at birth. 9-15 kg 0.2-0.5 ml; mc. 16-23 kg 0.3-0.8 ml; mc. 24-30 kg 0.4-1.0 ml; mc. 31-45 kg 0.5-1.0 ml; mc. 46-53 kg 0.8-1.8 ml. If necessary, the dose should be administered every 6-8 hours. In elderly patients with cirrhosis or impaired renal function, high doses should be avoided. It is recommended to dilute the drug at a concentration of 1:10 in a solution of 5% Glucose, 0.9% NaCl or Ringer's solution before intravenous administration. Intravenous injection is very slow (500 mg / 1 min). The preparation should not be used for more than 7 days.
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