"Renalgan ®" injection solution is used for the symptomatic treatment of pain syndrome in spasms of the smooth muscles of internal organs:
gastric and intestinal colic; renal colic in urolithiasis; spastic dyskinesia of the biliary tract; dysmenorrhea.
Composition
1 ml of solution contains (active ingredients):
metamizole sodium - 500 mg; fenpiverinium bromide - 0.02 mg; pitophenone hydrochloride - 2 mg.
The excipient is water for injection.
Contraindication
hypersensitivity to the components of the drug, to pyrazolone derivatives (butadione, tribuzone) or to other nonsteroidal anti-inflammatory drugs (NSAIDs); severe hepatic or renal failure, acute hepatic porphyria, suspected surgical pathology, prostate adenoma of the II and III degree, congenital deficiency of glucose-6-phosphate dehydrogenase with a tendency to urinary retention, tachyarrhythmia, angle-closure glaucoma, gastrointestinal obstruction (including mechanical obstruction) and megacolon, atony of the gallbladder or bladder, diseases of the hematopoietic system (agranulocytosis, leukopenia, anemia of any etiology, including aplastic anemia, infectious neutropenia, hemolytic anemia), collaptoid state, decompensated heart failure, bronchial asthma, impaired bone marrow function (for example, after treatment with cytostatics), hypotonic states and hemodynamic instability.
Method of application
"Renalgan ®", solution for injection, should be used intramuscularly only. Use only for short-term treatment.
The injection solution should be used under strict medical supervision due to the risk of anaphylactic shock in patients with hypersensitivity to metamizole or pyrazolone derivatives.
Adults and children over 15 years old
Adults and children over 15 years of age (with a body weight of more than 53 kg) should be administered intramuscularly from 2 to 5 ml of solution for injection. If necessary, repeat the dose after 6-8 hours. The maximum daily dose should not exceed 10 ml of solution for injection (equivalent to 5 g of metamizole sodium). Duration of treatment - 2-3 days. After achieving a therapeutic effect, you can switch to treatment with oral analgesics and antispasmodics. In the absence of a therapeutic effect, treatment with the drug should be discontinued.
Patients over 65 years of age
Usually, no dose reduction is required. For patients with age-related liver and kidney dysfunction, the dose should be reduced, as the half-life of metamizole metabolites may increase.
Patients with renal impairment
Metamizole is excreted in the urine as metabolites. For patients with mild to moderate renal impairment, ½ the adult dose is recommended.
Patients with liver dysfunction
In these patients, the half-life of the active metabolites of metamizole is slowed down. High doses should be avoided in patients with impaired liver function. With short-term use, there is no need to reduce the dose.
There is insufficient experience with longer-term use in patients with impaired renal or hepatic function.
Application features
Pregnant women
Do not use the drug during pregnancy or breastfeeding.
Children
The drug should not be used in children under 15 years of age.
Drivers
Due to the possibility of adverse reactions from the nervous system (dizziness, accommodation disorders), you should refrain from driving or working with other mechanisms that affect the speed of reaction.
Overdose
Symptoms
In case of overdose, symptoms of metamizole intoxication in combination with anticholinergic effects predominate. Most often, toxic-allergic syndrome, hematotoxicity, cerebral manifestations are observed, including hypothermia, a pronounced decrease in blood pressure, palpitations, shortness of breath, tinnitus, stomach pain, weakness, oliguria, anuria, symptoms of hematopoietic function impairment, gastrointestinal disorders, in severe cases - symptoms of brain damage. Vomiting, dry mouth, nausea, epigastric pain, decreased sweating, accommodation disorders, drowsiness, delirium, confusion, impaired liver and kidney function, convulsions, possible development of agranulocytosis, hemorrhagic syndrome, paralysis of the respiratory muscles.
Treatment
If an overdose is suspected, the drug should be immediately discontinued and measures should be taken to remove it from the body as quickly as possible (forced diuresis, infusion of water-salt solutions, if necessary - hemodialysis, peritoneal dialysis). Therapy is symptomatic. There is no specific antidote.
Side effects
On the part of the immune system: anaphylactic shock, anaphylactic or anaphylactoid reactions. Such reactions may occur during the administration of the drug or immediately after discontinuation of the administration, but may also occur several hours later. They usually develop within the first hour after injection. Milder reactions manifest themselves in the form of typical reactions from the skin and mucous membranes (such as itching, burning, redness, urticaria, edema - local or general), dyspnea and, rarely, gastrointestinal complaints. Mild reactions may progress to more severe forms with generalized urticaria, severe angioedema (including laryngeal), severe bronchospasm, cardiac arrhythmias, decreased blood pressure (sometimes with a previous increase in blood pressure).
For this reason, if any skin hypersensitivity reaction, symptoms of renal dysfunction or hematotoxic reactions occur, the drug should be discontinued immediately.
Asthma attack (in patients with analgesic asthma), circulatory shock. Shock may be accompanied by cold sweat, dizziness, drowsiness, changes in consciousness, pale skin, due to compression in the heart area, shallow breathing or tachypnea, tachycardia, cold extremities, a sharp drop in blood pressure. At the first signs of shock, treatment should be canceled and appropriate emergency measures should be taken.
Skin and subcutaneous tissue disorders: fixed drug eruption, maculopapular and other types of rashes, Lyell's syndrome or Stevens-Johnson syndrome, angioedema.
If any skin reaction occurs, the use of metamizole should be discontinued immediately.
On the part of the gastrointestinal tract: nausea, vomiting, abdominal pain and discomfort, burning sensation in the epigastric region, dry mouth, constipation, exacerbation of gastritis and gastric ulcer, in rare cases - vomiting with blood and intestinal bleeding, ulceration.
Hepatobiliary disorders: hepatitis.
From the side of the central nervous system: headache, dizziness.
On the part of the organs of vision: visual disturbances, accommodation disorders.
Cardiovascular system: hypotension, tachycardia, cardiac arrhythmias, palpitations, cyanosis, hyperemia. Hypotensive reactions may rarely occur during or after administration. They may or may not be accompanied by other symptoms of anaphylactoid or anaphylactic reactions. Rarely, such reactions may result from a sharp decrease in blood pressure. Rapid intravenous administration increases the risk of hypotensive reactions.
Critical decrease in blood pressure without other signs of hypersensitivity is dose-dependent and may manifest as hyperpyrexia.
From the blood and lymphatic system: anemia (hemolytic anemia, aplastic anemia), granulocytopenia, leukopenia, thrombocytopenia, agranulocytosis (may manifest itself as the following symptoms: increased body temperature for no apparent reason, chills, sore throat, stomatitis, development of vaginitis or proctitis).
The risk of agranulocytosis cannot be predicted. Agranulocytosis may also occur in patients who have used metamizole in the past without experiencing similar adverse reactions.
Respiratory system: bronchospasm.
On the part of the urinary system: impaired renal function, oliguria, anuria, proteinuria, red urine color, interstitial nephritis, urinary retention, difficulty urinating, development of acute renal failure, polyuria.
Other: decreased sweating.
Local reactions: pain at the injection site, possible infiltrates at the injection site, asthenia.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 2 years.
