Spasmaton, 20 pcs., tablets
- intolerance or hypersensitivity to dyes (for example, tartrazine) or preservatives (for example, benzoate).
Before using Spasmaton, it is necessary to conduct a thorough interview with the patient. If a risk of developing an anaphylactoid reaction is identified, the use of Spasmaton is possible only after assessing the risk/benefit ratio.
In the case of using Spasmaton in such patients, strict medical monitoring of their condition is necessary and the availability of means to provide them with emergency assistance in the event of the development of anaphylactic/anaphylactoid reactions is required.
Predisposed patients may experience anaphylactic shock, so patients with asthma or atopy should prescribe Spasmaton with caution.
Life-threatening skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been described with the use of metamizole sodium. If symptoms of these diseases appear (such as a progressive skin rash, often with blisters or lesions of the mucous membrane), treatment with Spasmaton should be stopped immediately and should not be restarted.
During therapy with metamizole-containing drugs, agranulocytosis may develop. It lasts at least a week, does not depend on the dose, can be severe, life-threatening and even lead to the death of the patient. In this regard, if symptoms possibly associated with neutropenia appear (fever, chills, sore throat, difficulty swallowing, stomatitis, erosive and ulcerative lesions of the oral cavity, vaginitis or proctitis, a decrease in the number of neutrophils in peripheral blood - less than 1500 mm3), it is necessary to stop treatment with Spasmaton and consult a doctor.
If the patient receives antibiotic therapy, then the typical manifestations of agranulocytosis may be minimally expressed. The erythrocyte sedimentation rate is significantly increased, while lymph node enlargement is mild or absent. Typical symptoms of thrombocytopenia are an increased tendency to bleeding and the appearance of petichiae on the skin and mucous membranes.
In case of pancytopenia, treatment should be stopped immediately; complete blood count parameters should be monitored until they return to normal.
All patients should be aware that if symptoms of pathological changes in the blood appear (for example, general malaise, infections, persistent fever, hematoma formation, bleeding, pale skin) while using Spasmaton, they should immediately consult a doctor.
Administration of a metamizole-containing drug may cause individual hypotensive reactions. These reactions may be dose dependent and occur more often after parenteral administration.
To avoid the development of severe hypotensive reactions, you should adhere to the following recommendations:
— intravenous administration of Spasmaton should be carried out slowly, in the “lying” position;
- blood pressure, heart rate and breathing should be monitored;
- patients with existing hypotension, decreased circulating blood volume, dehydration, hemodynamic instability or with the initial stage of circulatory failure require normalization of hemodynamics;
- Caution should be used when treating patients with high body temperature.
Spasmaton
When treating children under 5 years of age and patients receiving cytotoxic drugs, treatment with the drug should be carried out only under the supervision of a physician.
When choosing a method of drug administration, it should be taken into account that parenteral use is associated with a higher risk of anaphylactic/anaphylactoid reactions. Parenteral administration is recommended in cases where oral administration is not possible or absorption from the gastrointestinal tract is impaired.
An increased risk of developing hypersensitivity reactions to metamizole sodium included in the drug is caused by the following conditions:
- bronchial asthma, especially in combination with polypous rhinosinusitis;
- chronic urticaria;
- alcohol intolerance (increased sensitivity to alcohol), against the background of which, even when taking a small amount of certain alcoholic beverages, patients experience sneezing, lacrimation and severe redness of the face.
Alcohol intolerance may indicate previously unidentified aspirin asthma syndrome;
- intolerance or hypersensitivity to dyes (for example, tartrazine) or preservatives (for example, benzoate).
Before using Spasmaton, it is necessary to conduct a thorough interview with the patient. If a risk of developing an anaphylactoid reaction is identified, the use of Spasmaton is possible only after assessing the risk/benefit ratio.
In the case of using Spasmaton in such patients, strict medical monitoring of their condition is necessary and the availability of means to provide them with emergency assistance in the event of the development of anaphylactic/anaphylactoid reactions is required.
Predisposed patients may experience anaphylactic shock, so patients with asthma or atopy should prescribe Spasmaton with caution.
Life-threatening skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been described with the use of metamizole sodium. If symptoms of these diseases appear (such as a progressive skin rash, often with blisters or lesions of the mucous membrane), treatment with Spasmaton should be stopped immediately and should not be restarted.
During therapy with metamizole-containing drugs, agranulocytosis may develop. It lasts at least a week, does not depend on the dose, can be severe, life-threatening and even lead to the death of the patient. In this regard, if symptoms possibly associated with neutropenia appear (fever, chills, sore throat, difficulty swallowing, stomatitis, erosive and ulcerative lesions of the oral cavity, vaginitis or proctitis, a decrease in the number of neutrophils in peripheral blood - less than 1500/mm3), it is necessary to stop treatment with Spasmaton and consult a doctor.
If the patient receives antibiotic therapy, then the typical manifestations of agranulocytosis may be minimally expressed. The erythrocyte sedimentation rate is significantly increased, while lymph node enlargement is mild or absent.
Typical symptoms of thrombocytopenia are an increased tendency to bleeding and the appearance of petichiae on the skin and mucous membranes.
In case of pancytopenia, treatment should be stopped immediately; complete blood count parameters should be monitored until they return to normal.
All patients should be aware that if symptoms of pathological changes in the blood appear (for example, general malaise, infections, persistent fever, hematoma formation, bleeding, pale skin) while using Spasmaton, they should immediately consult a doctor.
Administration of a metamizole-containing drug may cause individual hypotensive reactions. These reactions may be dose dependent and occur more often after parenteral administration.
To avoid the development of severe hypotensive reactions, you should adhere to the following recommendations:
— intravenous administration of Spasmaton should be carried out slowly, with the patient in the “lying” position;
- blood pressure, heart rate and breathing should be monitored;
- patients with existing hypotension, decreased circulating blood volume, dehydration, hemodynamic instability or with the initial stage of circulatory failure require normalization of hemodynamics;
- Caution should be used when treating patients with high body temperature. In patients who should avoid lowering blood pressure (for example, with severe coronary heart disease or stenosis of blood vessels supplying the brain), Spasmaton therapy should be carried out only with careful hemodynamic monitoring.
During treatment with the drug you should refrain from drinking alcohol.
It is unacceptable to use the drug to relieve acute abdominal pain (until the cause is determined).
In patients with impaired liver or kidney function, it is recommended to avoid the use of Spazmaton in high doses due to a decrease in the rate of elimination of the drug. IV administration of Spasmaton should be carried out very slowly (no more than 1 ml/min), so that at the first signs of anaphylactic/anaphylactoid reactions, the injection can be stopped and the risk of individual hypotensive reactions can be minimized.
For intramuscular administration, it is necessary to use a needle for intramuscular administration.
During the use of the drug, urine may turn red due to the presence of a metabolite in it - rubazonic acid (it has no clinical significance).
Spasmaton solution for intramuscular administration in ampoules 5 ml No. 10
Name
Spasmaton di solution in amp 5 ml in pack No. 10
Main active ingredient
Metamizole sodium + pitofenone + fenpiverinium bromide
Release form
injection
Dosage
5 ml
Indications for use
Pain syndrome (mild or moderate) with spasms of smooth muscles of internal organs: renal colic, spasm of the ureter and bladder; biliary colic, intestinal colic; algodismenorrhea. For short-term treatment: arthralgia, myalgia, neuralgia, sciatica. As an auxiliary drug: pain syndrome after surgical interventions and diagnostic procedures.
Directions for use and doses
The drug is administered intravenously (IV) and intramuscularly (IM). For adults and adolescents over 15 years of age with acute severe colic, 2 ml are administered intravenously slowly (1 ml over 1 minute); if necessary, re-inject after 6 - 8 hours. IM - 2 - 5 ml of solution 2 - 3 times a day. The daily dose should not exceed 10 ml. The duration of treatment is no more than 5 days. Children are prescribed IV and IM depending on age in the following doses: 3 - 5 months (5 - 8 kg): only IM, recommended single dose 0.1 ml, maximum daily dose 0.8 ml (0 .2 ml 4 times/day); 6 - 11 months (8 - 10 kg) - IM only - recommended single dose 0.1 ml, maximum daily dose 1.2 ml (0.3 ml 4 times a day); 1 - 2 years (12 - 14 kg) - recommended single dose 0.2 ml, maximum daily dose 1.6 ml (0.4 ml 4 times a day); 3 - 4 years (14 - 18 kg) - recommended single dose 0.2 ml, maximum daily dose 2.4 ml (0.6 ml 4 times a day); 5 - 7 years (24 - 30 kg) - recommended single dose 0.4 ml, maximum daily dose 3.2 ml (0.8 ml 4 times a day); 8 - 11 years (31 - 45 kg) - recommended single dose 0.5 ml, maximum daily dose 4 ml (1 ml 4 times a day); 12 - 14 years (body weight about 50 kg) - recommended single dose 0.8 ml, maximum daily dose 6.4 ml (1.6 ml 4 times a day); Before administering the solution, the ampoule should be warmed in your hand.
Use during pregnancy and lactation
The use of the drug in the first trimester and in the last 6 weeks of pregnancy is not recommended. During other periods of pregnancy, prescription is possible only according to strict indications, under the supervision of a doctor. During lactation, breastfeeding should be stopped during treatment with spasmaton.
Precautionary measures
Renal/liver failure, bronchial acid triad, tendency to arterial hypotension, hypersensitivity to other non-steroidal anti-inflammatory drugs, long-term ethanol abuse.
Interaction with other drugs
Due to the high likelihood of developing pharmaceutical incompatibility, spasmaton should not be mixed with any other medications in the same syringe. Enhances the effects of ethanol. X-ray contrast drugs, colloidal blood substitutes and b-lactam antibiotics enhance the nephrotoxic effect of metamizole sodium. When used simultaneously with other analgesics, antipyretics and non-steroidal anti-inflammatory drugs, mutual enhancement of toxic effects is possible. Phenylbutazone, barbiturates and other inducers of microsomal liver enzymes, when administered simultaneously, reduce the effectiveness of metamizole sodium. The effect is enhanced by codeine, H2-histamine receptor blockers and propranolol (slows down the inactivation of metamizole sodium). Increases the risk of developing leukopenia when used together with thiamazole and cytostatic agents. Increases the effect of oral hypoglycemic agents, indirect anticoagulants, glucocorticosteroids and indomethacin due to their displacement from connection with blood proteins. When used simultaneously with phenothiazine derivatives, severe hyperthermia may develop. Tricyclic antidepressants, combined oral contraceptives and allopurinol slow down the metabolism of metamizole and increase its toxicity. If you are taking other medications, you must inform your doctor.
Contraindications
Hypersensitivity (including to pyrazolone derivatives), inhibition of bone marrow hematopoiesis, severe hepatic and/or renal failure, glucose-6-phosphate dehydrogenase deficiency, tachyarrhythmias, severe angina pectoris, decompensated chronic heart failure, angle-closure glaucoma, benign prostatic hyperplasia (with clinical manifestations), intestinal obstruction, megacolon, collapse, pregnancy (especially in the first trimester and the last 6 weeks), lactation. For intravenous administration - infancy (up to 3 months) or body weight less than 5 kg.
Compound
5 ml of solution contains: active ingredients: metamizole sodium - 2500 mg; pitofenone hydrochloride - 10 mg; fenpiverinium bromide - 0.1 mg; excipients: hydrochloric acid, water for injection.
Overdose
Symptoms: nausea, vomiting, gastralgia, decreased blood pressure, tachycardia, shortness of breath, tinnitus, weakness, drowsiness, confusion, convulsions, impaired liver and kidney function. Treatment: gastric lavage, saline laxatives, administration of activated carbon; carrying out forced diuresis, hemodialysis, with the development of convulsive syndrome - intravenous administration of diazepam and fast-acting barbiturates. It is necessary to stop using the drug and consult a doctor.
Side effect
Allergic reactions: urticaria, rarely: malignant exudative erythema, bronchospasm, anaphylactic shock. From the urinary system: impaired renal function, oliguria, anuria, proteinuria, interstitial nephritis, red staining of urine. From the cardiovascular system: decreased blood pressure, tachycardia. From the hematopoietic organs: thrombocytopenia, leukopenia, agranulocytosis (may be manifested by the following symptoms: unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis, as well as the development of vaginitis or proctitis). Local reactions: with intravenous administration, infiltrates are possible at the injection site. If any other reactions not listed in this leaflet occur, you should stop taking the medicine and contact your doctor.
Storage conditions
In a place protected from light, at a temperature not exceeding 25 ° C. Keep out of the reach of children.
