Pain caused by contractions of the smooth muscles of the digestive and genitourinary system: severe stomach cramps, intestinal colic, painful spasms of the urinary tract and bladder, renal colic, bile colic in the course of cholelithiasis, painful menstruation.
Composition:
1 ml of solution contains: 500 mg of sodium metamizol, 0.02 mg of fenpiverine bromide, 2 mg of pitophenone hydrochloride.
Action:
A combined preparation with diastolic and analgesic effects. Metamizol has a strong analgesic and antipyretic effect, and also has a low anti-inflammatory and anti-spasmolytic effect. Fenpiverrin moderately blocks the nerve ganglia and affects the end of the parasympathetic nerves, which reduces the tone and motility of the smooth muscle of the stomach, intestines, biliary and urinary tracts. Pitophenone hydrochloride has a papaverine-like effect with a strong relaxation effect on vascular and extravascular muscles. The preparation after intramuscular administration is absorbed quickly from the place of administration. The bioavailability of metamizole, both after intravenous and intramuscular administration, is about 85%. Metamizole is extensively metabolised. Its main metabolites are 4-methylammofenazone, 4-formylaminophenazone, 5-aminophenazone and 4-acetylaminophenazone. The main metabolites were detected in cerebrospinal fluid and in mother's milk. They bind to plasma proteins in about 60%. They are mainly excreted by the kidneys.
Contraindications:
Hypersensitivity to the preparation ingredients or other pyrazolone derivatives. Severe hepatic and renal failure. acute dashed porphyria. G-6-PD deficiency. Blood composition disorders such as agranulocytosis, leukopenia. Pregnancy and breastfeeding. Children up to 15 years old. Prostate adenoma. Atony of the gallbladder and / or bladder. Asthma triggered or exacerbated by NSAIDs.
Precautions:
The product should be injected with caution due to the risk of hypersensitivity reactions. Special care should be taken in patients with food allergies, hypersensitivity to other drugs (especially analgesics and antipyretics, NSAIDs) or with such atopic diseases as hay fever and bronchial asthma. In patients with a history of blood disorders, the drug should be administered only if clearly necessary, after determining the risk-benefit balance - blood composition should be monitored throughout the whole period of use. Caution should be exercised in patients with renal or hepatic failure (doses should be determined individually). It is possible that the side effects of metamizol on the kidneys or the prolongation of the half-life of its metabolites in people with impaired liver function. Administration should be discontinued if symptoms of hypersensitivity or renal or hematopoietic dysfunction occur. Mechanical obstruction of the gastrointestinal tract, i.e. achalasia, narrowing of the duodenal pylorus may lead to stagnation of gastrointestinal content and intoxication, as a result of the intensified effect of the diastolic formulation. It is not recommended to re-administer the drug. Administration of the preparation to patients with gastro-oesophageal reflux, intestinal atony, paralytic ileus, glaucoma,myasthenia gravis, heart disease (arrhythmia, ischemic heart disease, congestive heart failure) requires special care and an assessment of the risk-benefit ratio due to the possibility of a patient's deterioration. It is recommended to use the preparation in patients over 15 years. After parenteral administration of this drug to children under 15 years, collapse and other side effects have frequently occurred.
Pregnancy and lactation:
Metamizole was teratogenic in animal studies (increased Wilms tumor in offspring). There are no adequate studies in pregnant women. Do not use the preparation during pregnancy. Due to the fact that metabolites of metamizol are excreted into breast milk, the drug should not be administered during breastfeeding.
Side effects:
The most common side effects are hypersensitivity reactions: from light skin symptoms such as pruritus, erythema, rash, urticaria, severe, i.e. Lyell or Stevenson-Johnson syndrome, to severe anaphylactoid reactions and shock (most commonly after parenteral administration of the drug, especially after intravenous administration). The following may occur: retention of blood nitrogen compounds, visual disturbances, dry mouth, urinary retention, oliguria, hematuria, interstitial nephritis, agranulocytosis (there is a suspicion that the risk of agranulocytosis is genetically determined, the risk of agranulocytosis after metamizol varies depending on from latitude). Prolonged administration of the drug at high doses to patients with gastritis or peptic ulcer disease may result in worsening of the disease.
Dosage:
Intramuscularly. The single dose is 2 to 5 ml, depending on the severity of the symptoms. If necessary, the dose can be repeated after 6-8 h. Adult should not be administered more than 3 times a day, adolescents over 15 years - no more than 10 ml per day (which corresponds to 5 g metamizol). In the absence of therapeutic effect, the drug should be discontinued. After intravenous administration, hypersensitivity reactions and agranulocytosis were the most common, therefore intravenous administration is not recommended.