The preparation contains a pyrazolone derivative - metamizol sodium, which occasionally can cause life-threatening shock and agranulocytosis (see section "Side effect").
In the treatment of patients receiving cytotoxic drugs and children under 5 years of treatment with metamizole sodium should only be carried out under the supervision of a doctor.
Patients who have anaphylactoid reactions in response to metamizole sodium use are also at risk of developing them in response to other non-narcotic analgesics / NSAIDs.
Patients who have anaphylactic or other immuno-mediated reactions (eg agranulocytosis) in response to metamizole sodium use are also at risk of developing them in response to the use of other pyrazolones and pyrazolidines.
Anaphylactic / anaphylactoid reactions
An increased risk of hypersensitivity reactions metamizol sodium stipulates the following states:
- analgesic bronchial asthma or intolerance to analgesics;
bronchial asthma, especially with concomitant polyposis rhinosinusitis;
- chronic urticaria;
- alcohol intolerance (hypersensitivity to alcohol), against which even with the intake of a small amount of some alcoholic drinks, patients experience sneezing, lacrimation, and severe reddening of the face. Alcohol intolerance may indicate a previously unidentified syndrome of aspirin asthma;
- intolerance or hypersensitivity to dyes (eg, tartrazine) or to preservatives (eg benzoate).
Before using metamizole sodium it is necessary to conduct a thorough questioning of the patient in order to reveal anamnestic information.
In the case of sodium metamizole, these patients need strict medical supervision of their condition and need to have the means to provide them with emergency care in case of anaphylactic / anaphylactoid reactions.
In predisposed patients, anaphylactic shock can occur, so patients with asthma or atopy metamizol sodium should be administered with caution.
Severe skin reactions
With the use of metamizole sodium, life-threatening skin reactions, such as Stevens-Johnson syndrome (SSD) and toxic epidermal necrolysis (TEN), have been described.When symptoms of SS or TENS (such as a progressive skin rash often with blisters or mucosal lesions) appear, treatment with metamizole should be stopped immediately, and should not be re-started.
Patients should be aware of the symptoms of these diseases. They should carefully monitor skin reactions, especially during the first weeks of treatment.
Agranulocytosis / pancytopenia
With prolonged use, it is necessary to monitor the picture of peripheral blood. Against the background of taking metamizole sodium, the development of agranulocytosis is possible. It occurs very rarely, lasts at least a week, does not depend on the dose, can be severe, threaten life and even lead to the death of the patient.
In this regard, if symptoms of fever, chills, sore throat, difficulty swallowing, stomatitis, erosive-ulcerative lesions of the oral cavity, vaginitis or proctitis are detected, a decrease in the number of neutrophils in the peripheral blood is less than 1500 / mm3 it is necessary to stop taking the drug and consult a doctor.
In case of development of pancytopenia, treatment should be stopped immediately, it is necessary to monitor the indicators of the developed blood test up to their normalization.
All patients should be aware that when symptoms of abnormal blood changes (eg, general malaise, infections, persistent fever, formation of hematomas, bleeding, pallor) appear against the background of metamizole sodium intake, seek medical help immediately.
Isolated hypotensive reactions
Metamizole sodium can cause hypotensive reactions (see also the "Side effect" section). These reactions can be dose-dependent. The risk of such reactions is also increased with: previous arterial hypotension, decreased circulating blood volume or dehydration, unstable hemodynamics or acute circulatory disturbance (eg, in patients with myocardial infarction or trauma), in patients with fever.
In this regard, these patients should be carried out detailed diagnostics and establish close monitoring. In order to reduce the risk of hypotensive reactions, preventive measures (stabilization of hemodynamics) may be required.
In patients in whom a reduction in blood pressure should be avoided at all costs (eg, in severe coronary heart disease or significant stenosis of the cerebral arteries), metamizol sodium It can only be used with careful monitoring of hemodynamic parameters.
Abdominal pain
It is inadmissible to use the drug to relieve acute pain in the abdomen (until finding out their cause).
Dysfunction of the liver and kidneys
In patients with impaired liver or kidney function, it is recommended to avoid the use of metamizole sodium in high doses.
Excipients
Since the drug contains sodium, this should be taken into account for people on a diet low in sodium.
If there is no effect within 3 days, stop taking the drug and consult a doctor.