Composition, a form of release, and packaging
Solution – 1 ml.:
active ingredient: metamizole sodium – 500 mg;
excipient: water for injection – up to 1 ml.
5 ml dark glass ampoules (type I) with a breakpoint.
5 ampoules in an uncoated plastic blister pack (pallet).
1 pallet together with instructions for use in a cardboard box.
Description of the dosage form
Clear, colorless or slightly colored liquid.
Pharmacotherapeutic group
Analgesic non-narcotic agent.
Pharmacodynamics
Analgesic non-narcotic agent, pyrazolone group, has analgesic, antipyretic and antispasmodic effects. Its mechanism of action has not been definitively established. Available data suggest that metamizole and its main metabolite (4N-methylaminoantipyrine [4-MAA]) have a central and peripheral mechanism of action. At doses higher than therapeutic doses, an anti-inflammatory effect can be achieved, possibly due to the suppression of prostaglandin synthesis.
Indications for use
Severe acute or chronic pain syndrome in injuries and in the postoperative period, with colic, oncological diseases, and other conditions in which other therapeutic methods of treatment are contraindicated.
Fever resistant to other treatments.
Dosage and administration
Intravenously, intramuscularly deep into the muscle.
Parenteral administration of the drug is indicated only if it is impossible to take it orally. Before administration, it is recommended to warm the drug to body temperature.
Adults and adolescents over 15 years of age: 1.0-2.0 ml (500-1000 mg) of metamizole solution (intramuscularly or intravenously) is recommended as a single dose. The maximum single dose is 1000 mg (2 ml). The maximum daily dose is 4 ml (2000 mg), divided into 2-3 injections per day.
For children aged 3-11 months (body weight over 5 kg to 9 kg), the drug is administered only intramuscularly at a dose of 50-100 mg per 10 kg of body weight (0.1-0.2 ml of a 500 mg/ml solution). A single dose can be divided into 2-3 injections.
Recommended doses of the drug:
- Children 3-11 months (more than 5 kg to 8 kg. Only intramuscular injection!!!) – 0.1-0.2 ml (corresponding to 50-100 mg metamizol);
- Children 1-3 years old (about 9-15 kg) – 0.2-0.5 ml (which corresponds to 100-250 mg of metamizole);
- Children 4-6 years old (about 16-23 kg) – 0.3-0.8 ml (corresponding to 150-400 mg metamizole);
- Children 7-9 years old (about 24-30 kg) – 0.4-1.0 ml (corresponding to 200-500 mg metamizole);
- Children 10-12 years old (about 31-45 kg) – 0.5-1.0 ml (corresponding to 250-500 mg metamizole);
- Children 13-14 years old (about 46-53 kg) – 0.8-1.8 ml (which corresponds to 400-900 mg of metamizole);
- Adults and adolescents over 15 years of age (weighing over 53 kg) – 1.0-2.0 ml (corresponding to 500-1000 mg of metamizole).
Intravenous administration should be carried out very slowly (the rate of administration is not more than 1 ml/min) with the patient lying down, under the control of blood pressure. At the first signs of the development of anaphylactic/anaphylactoid reactions, it is necessary to stop the administration of the drug.
Since hypotensive reactions are dose-dependent, parenteral administration of a dose of 1000 mg of metamizole should be carried out with extreme caution.
If the drug is administered too quickly, a critical drop in blood pressure and shock may occur.
Special patient groups
Elderly patients need to use smaller doses due to a possible decrease in the excretion of metamizole metabolites from the body.
Patients in serious condition and in violation of creatinine clearance should use smaller doses due to a possible decrease in the excretion of metamizole metabolites from the body.
In patients with impaired liver and kidney function, the rate of elimination of the drug is slow, so repeated use of the drug should be avoided. There is no experience of long-term use. With short-term therapy, dose adjustment is not required.
Duration of therapy
When used as an analgesic, the duration of therapy is 1-5 days. When used as an antipyretic – 1-3 days.
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