Spasmalgon 5ml 10 ampoules

Form

khsnari

Pack

10

Qualitative and quantitative composition: Each 5 ml ampoule of solution for injection contains active substances: metamizole sodium monohydrate 2500 mg, pitofenone hydrochloride 10 mg, fenpiverinium bromide 0.1 mg. Dosage form: Solution for injection, a clear, practically particle-free, yellowish-green or yellowish-brown liquid. Therapeutic indications: For short-term symptomatic treatment of acute, moderately severe to severe pain associated with spasms of the smooth muscles of internal organs: gastrointestinal colic; renal colic in nephrolithiasis; spastic dyskinesia of the biliary tract; dysmenorrhea. Dosage and administration: Solution for injection is for intramuscular use only. For short-term treatment only. The solution for injection should be administered under strict medical supervision and with readiness to provide emergency care in patients with hypersensitivity to metamizole or pyrazolone derivatives due to the risk of anaphylactic shock. Adults and children over 15 years of age: For adults and children over 15 years of age (>53 kg), the solution for injection is administered at a dose of 2 or 5 ml intramuscularly. If necessary, the dose can be repeated after 6-8 hours. The maximum daily dose should not exceed 6 ml of the solution for injection (equivalent to 3 g of metamizole sodium). Duration of treatment: 2-3 days. After achieving the therapeutic effect, treatment can be switched to oral analgesics and antispasmodics. If there is no therapeutic effect, treatment with the preparations is discontinued. It is not recommended to administer Spasmalgon solution for injection to children under 15 years of age. Special populations: Elderly, debilitated patients, and patients with reduced creatinine clearance: In elderly, debilitated patients, and patients with reduced creatinine clearance, the dose should be reduced, as the elimination of metamizole metabolites may be prolonged. Hepatic and renal insufficiency: Since the elimination rate is reduced in patients with impaired kidney or liver function, repeated high doses should be avoided. Dose reduction is not necessary for short-term use only. To date, there is insufficient experience with the long-term use of metamizole in patients with severe hepatic and renal insufficiency. Contraindications: Hypersensitivity to the active substances; hypersensitivity to pyrazolone derivatives (including patients with a history of agranulocytosis after previous use of such drugs) or other non-steroidal anti-inflammatory drugs; severe hepatic and renal insufficiency; acute hepatic porphyria; glucose-6-phosphate dehydrogenase deficiency; gastrointestinal obstruction and megacolon; bone marrow dysfunction (e.g., after cytostatic therapy) or diseases of the hematopoietic system (agranulocytosis, leukopenia, aplastic anemia); stage II and III benign prostatic hyperplasia; atony of the bladder and bile ducts; hypotonic states and hemodynamic instability; pregnancy and lactation; children under 15 years of age. Interactions with other medicinal products and other forms of interaction: Combination of Spasmalgon with other medicinal products requires increased attention due to the metamizole content, which is an inducer of liver enzymes. Fertility, pregnancy and lactation: Pregnancy: Controlled clinical studies in pregnant women have not been conducted, and there are no observational data on its use in this group. There are only limited data on the use of metamizole in pregnant women. Based on published observational data on pregnant women exposed to metamizole (n=568) in the first trimester, no evidence of teratogenic or embryotoxic effects has been identified. In isolated cases, single doses of metamizole during the first and second trimesters may be acceptable when other treatment options are not available. However, in general, the use of metamizole during the first and second trimesters is not recommended. Use in the third trimester is associated with fetotoxicity (renal failure and constriction of the arterial duct), therefore, the use of metamizole is contraindicated in the third trimester of pregnancy. In case of accidental use of metamizole during the third trimester, the amniotic fluid and arterial duct should be monitored using ultrasound and echocardiography. Lactation: Metamizole metabolites are excreted in breast milk in significant amounts, and a risk to the breastfed infant cannot be excluded; therefore, repeated use of metamizole during lactation should be avoided. In case of single use of metamizole, breastfeeding mothers are recommended to collect and discard milk for 48 hours after taking the dose. Ability to drive and use machines: The active substance fenpiverinium, which is part of the Spasmalgon preparation, has a cholinolytic effect and can cause dizziness and accommodation disorders. Metamizole can negatively affect attention and impair reactions in unexpected situations. Side effects: The side effects described below are classified by system organ class and frequency as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), unknown frequency (cannot be estimated from available data). Cases of severe skin adverse reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with metamizole treatment. The side effects listed below are mainly caused by metamizole, which is part of the medicinal product. Blood and lymphatic system disorders: Rare: leukopenia. Very rare: agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia. The risk of agranulocytosis cannot be predicted. Agranulocytosis can also occur in patients who have previously used metamizole without such side effects. Immune system disorders: Uncommon: fixed drug eruption. Rare: maculopapular rash, anaphylactic or anaphylactoid reactions, especially after parenteral administration. Such reactions can occur during or immediately after discontinuation of the drug, but reactions can also occur several hours later. They most often occur within the first hour after injection. Milder reactions manifest as typical skin and mucous membrane reactions (e.g., itching, burning, redness, rash, urticaria, swelling - local or generalized), dyspnea, and in rare cases, gastrointestinal complaints. These milder reactions can progress to more severe forms with generalized urticaria, severe angioedema (including laryngeal), severe bronchospasm, cardiac arrhythmias, and decreased blood pressure (sometimes preceded by increased blood pressure). For this reason, if skin reactions develop, metamizole use should be discontinued immediately. Very rare: asthmatic attack (in patients with analgesic asthma); Stevens-Johnson or Lyell's syndrome; circulatory shock. Nervous system disorders: dizziness, headache. Eye disorders: visual disturbances, accommodation disorders. Cardiac disorders: Uncommon: palpitations, tachycardia, rhythm disturbances, cyanosis. Vascular disorders. Skin and subcutaneous tissue disorders: Unknown frequency: drug reaction with eosinophilia and systemic symptoms (DRESS). Uncommon: hypotension. Gastrointestinal disorders: Unknown frequency: dry mouth, nausea, vomiting, abdominal pain and discomfort, constipation, exacerbation of gastritis and gastric ulcer disease, in rare cases ulceration and bleeding. Hepatobiliary system disorders: Unknown frequency: drug-induced liver injury, including acute hepatitis, jaundice, elevated liver enzymes (see section 4.4). Kidney and urinary tract disorders: Rare: proteinuria, oliguria, anuria, polyuria, interstitial nephritis, red discoloration of urine. Unknown frequency: urinary retention. General disorders and administration site conditions: Pain at the injection site and local reactions may occur with parenteral administration. Overdose: Symptoms: Symptoms of metamizole intoxication predominate, combined with cholinolytic manifestations. Most common are toxic-allergic syndrome, hematotoxicity, gastrointestinal disorders, cerebral manifestations. Therapy: Discontinue the use of the preparation and take measures for its rapid elimination from the body (forced diuresis, infusion of water-salt solutions, hemodialysis if necessary). Symptomatic agents are used. There is no specific antidote. Pharmacological properties: Pharmacotherapeutic group: Antispasmodics, in combination with analgesics, ATC code: А 03DA 02. Spasmalgon is a combined medicinal product with pronounced antispasmodic and analgesic action. Metamizole has a pronounced analgesic and antipyretic effect combined with weak anti-inflammatory and antispasmodic effects. Its effects are the result of inhibition of prostaglandin synthesis and synthesis of endogenous algogens, increased excitability threshold in the thalamus, effect on the hypothalamus and formation of endogenous pyrogens. Fenpiverinium has a moderately pronounced ganglion-blocking and cholinolytic effect. It inhibits the tone and motility of the smooth muscles of the stomach, intestines, biliary tract, and urinary tract. Pitofenone hydrochloride exhibits a papaverine-like effect with a pronounced antispasmodic effect on smooth muscles. Pharmacokinetic properties: Absorption: Rapidly absorbed after intramuscular administration. Metamizole has a systemic bioavailability of approximately 85%. Distribution: Metamizole is bound to plasma proteins by 50-60%. It crosses the blood-brain and placental barriers. The volume of distribution is approximately 0.7 L/kg. Metabolism: Undergoes intensive biotransformation in the liver. Its main metabolite, 4-methyl-amino-antipyrine (MAA), is metabolized in the liver to form other metabolites, including 4-amino-antipyrine (AA), which is pharmacologically active. Maximum plasma concentration (for all metabolites) is reached approximately 30-90 minutes after administration. Elimination: Excreted by the kidneys in the form of metabolites, with only 3% of the excreted amount of metamizole being unchanged. The half-life is approximately 10 hours. Patients with impaired liver function: The half-life of the active metabolite MAA is approximately 3 times longer in patients with impaired liver function. Lower doses of metamizole are recommended for these patients. Patients with impaired renal function: In patients with impaired renal function, the elimination of some metabolites is reduced. Lower doses of metamizole are recommended for these patients. Incompatibilities: No undesirable chemical and pharmaceutical incompatibilities are known. Shelf life: 4 years Special storage conditions: Store in the original packaging, in a dry place protected from light, at a temperature not exceeding 25°C. Do not freeze! Dispensing category: Pharmaceutical product group III, available without a prescription.