Spasmalgon

Solution for injections "Renalgan^®"Used for the symptomatic treatment of pain with spasms of smooth muscles of internal organs:

• gastric and intestinal colic;
• renal colic with kidney stone disease;
• spastic biliary dyskinesia;
• dysmenorrhea.

Structure

1 ml of solution contains (active substances):

• metamizole sodium - 500 mg;
• fenpiverinia bromide - 0.02 mg;
• pitophenone hydrochloride - 2 mg.

Excipient - water for injection.

Contraindications

• hypersensitivity to the components of the drug, to pyrazolone derivatives (butadion, tribuzon) or to other non-steroidal anti-inflammatory drugs (NSAIDs);
• severe hepatic or renal failure, acute hepatic porphyria, suspected surgical pathology, grade II and III prostate adenoma, with a tendency to urinary retention, congenital deficiency of glucose-6-phosphate dehydrogenase, tachyarrhythmia, angle-closure form of glaucoma, obstruction of the gastrointestinal tract ( including mechanical obstruction) and megacolon, atony of the gall or bladder, diseases of the hematopoietic system (agranulocytosis, leukopenia, anemia of any etiology, including aplastic an mia, infectious neutropenia, hemolytic anemia), kollaptoidnye state, decompensated heart failure, asthma, disorders of bone marrow function (e.g., after the treatment with cytostatics), hypotonic condition and hemodynamic instability.

Mode of application

"Renalgan^®", Injection, use only intramuscularly. Use only for short-term treatment.

The injection should be used under the strict supervision of a physician 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 (weighing more than 53 kg) intramuscularly inject from 2 to 5 ml of a 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). The duration of treatment is 2-3 days. After achieving a therapeutic effect, you can switch to treatment with oral painkillers and antispasmodics. In the absence of a therapeutic effect, treatment with the drug should be discontinued.

Patients older than 65 years

Usually you do not need to reduce the dose. For patients with impaired liver and kidney function associated with age, it is necessary to reduce the dose, since it is possible to increase the half-life of metamizole metabolites.

Patients with impaired renal function

Metamizole is excreted in the urine as metabolites. For patients with mild to moderate impaired renal function, ½ dose for adults is recommended.

Patients with impaired liver function

In these patients, the half-life of the active metabolites of metamizole slows 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 not enough experience with longer use in patients with impaired renal or hepatic function.

Application features

Pregnant women

Do not use the drug during pregnancy or lactation.

Children

The drug should not be used for children under 15 years of age.

Drivers

Due to the possibility of adverse reactions from the nervous system (dizziness, disturbance of accommodation), one should refrain from driving vehicles or working with other mechanisms that affect the reaction rate.

Overdose

Symptoms

In case of an overdose, symptoms of intoxication with metamizole predominate in combination with anticholinergic effects.Most often, toxic-allergic syndrome, hematotoxicity, cerebral manifestations, including hypothermia, a marked decrease in blood pressure, palpitations, shortness of breath, tinnitus, gastralgia, weakness, oliguria, anuria, symptoms of damage to the blood, gastrointestinal disorders, are observed. in severe cases - symptoms of brain damage. Vomiting, a feeling of dry mouth, nausea, pain in the epigastric region, decreased sweating, impaired accommodation, drowsiness, delusions, confusion, impaired liver, kidney function, convulsions, agranulocytosis, hemorrhagic syndrome, and respiratory muscle paralysis are possible.

Treatment

If you suspect an overdose, you should immediately stop using the drug and take measures to remove it from the body as soon as possible (forced diuresis, infusion of water-salt solutions, if necessary - hemodialysis, peritoneal dialysis). Therapy is symptomatic. There is no specific antidote.

Side effects

The adverse reactions listed below are mainly caused by metamizole sodium, which is part of the drug.

From the immune system: anaphylactic shock, anaphylactic or anaphylactoid reactions. Such reactions may occur during administration of the drug or immediately after the termination of administration, but may appear after a few hours. Usually they develop within the first hour after the injection. Lighter reactions manifest themselves in the form of typical reactions from the skin and mucous membrane (such as itching, burning, redness, urticaria, edema - local or general), dyspnea and, rarely, gastrointestinal complaints. Mild reactions can go into more severe forms with generalized urticaria, severe angioedema (including laryngeal), severe bronchospasm, impaired heart rate, decreased blood pressure (sometimes with a preliminary increase in blood pressure).

For this reason, if any skin hypersensitivity reaction, symptoms of impaired renal function or hematotoxic reactions occur, the use of the drug should be stopped immediately.

An asthmatic attack (in patients with analgesic asthma), circulatory shock. Shock can be accompanied by cold sweat, dizziness, drowsiness, changes in consciousness, pallor of the skin, squeezing in the heart, shallow breathing or tachypnea, tachycardia, cooling of the extremities, a strong drop in blood pressure. At the first sign of shock, treatment should be discontinued and appropriate emergency measures taken.

On the part of the skin and subcutaneous tissue: fixed drug exanthema, maculopapular and other types of rashes, Lyell syndrome or Stevens-Johnson syndrome, angioedema.

If any skin reaction occurs, the use of metamizole should be discontinued immediately.

From 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 impurities of blood and intestinal bleeding, ulceration.

On the part of the liver and biliary tract: hepatitis.

From the central nervous system: headache, dizziness.

On the part of the organs of vision: visual impairment, impaired accommodation.

From the cardiovascular system: arterial hypotension, tachycardia, cardiac arrhythmias, palpitation, cyanosis, hyperemia. Antihypertensive reactions rarely occur during or after use. They may or may not be accompanied by other symptoms of anaphylactoid or anaphylactic reactions. Rarely, such reactions can be the result of a sharp decrease in blood pressure.Fast intravenous administration increases the risk of antihypertensive reactions.

A critical decrease in blood pressure without other signs of hypersensitivity is dose-dependent and may manifest as hyperpyrexia.

On the part of the blood system and lymphatic system: anemia (hemolytic anemia, aplastic anemia), granulocytopenia, leukopenia, thrombocytopenia, agranulocytosis (may manifest the following symptoms: fever without visible cause, chills, sore throat, stomatitis, development of vaginitis or proctitis) .

The risk of agranulocytosis cannot be foreseen. Agranulocytosis can also occur in patients who have used metamizole in the past without the occurrence of such adverse reactions.

From the respiratory system: bronchospasm.

From the urinary system: impaired renal function, oliguria, anuria, proteinuria, red staining of urine, interstitial nephritis, urinary retention, difficulty urinating, the development of acute renal failure, polyuria.

Other: decreased sweating.

Local reactions: pain at the injection site, infiltrates at the injection site, asthenia are possible.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 ° C, out of the reach of children.

Shelf life is 2 years.