The solution for intramuscular administration of Spazmofarm contains a combination of active substances (metamizole sodium, pitophenone hydrochloride, fenpiverinium bromide), which provide an analgesic and antispasmodic effect. Prescription Available!
Active ingredients: metamizole sodium - 500 mg, pitophenone hydrochloride - 2.0 mg, fenpiverinia bromide -0.02 mg; Excipients: water for injection - up to 1 ml.
Indications / Application Notes
For short-term symptomatic treatment of acute pain severe and moderate syndrome with smooth muscle spasms internal organs: - gastric and intestinal colic; - renal colic with kidney stone disease; - spastic biliary dyskinesia; - algodismenorea
Contraindications - Hypersensitivity to any component of the drug; - Hypersensitivity to pyrazolone derivatives (including patients undergoing agranulocytosis due to the use of these drugs) or other NSAIDs; - Severe renal and hepatic insufficiency; - Acute hepatic porphyria; - Deficiency of glucose-6-phosphate dehydrogenase; - Intestinal obstruction and megacolon; - Violations of bone marrow hematopoiesis (for example, due to treatment with cytostatics) and diseases of the hematopoietic system (agranulocytosis, leukopenia, aplastic anemia); - Hyperplasia of the prostate gland II - III degree; - Atony of the gall and bladder; - Arterial hypotension and hemodynamic instability; - Pregnancy and breastfeeding; - Children's age up to 15 years.
Mode of application
Introduced strictly intramuscularly! The drug is intended for short-term use! Management should be carried out under the strict supervision of a physician, with emergency risk management capabilities anaphylactic shock in patients with hypersensitivity to metamizole sodium or a pyrazolone derivative. Adults and children over 15 years of age (> 53 kg). Adults and children over 15 years of age, the drug is administered intramuscularly in volume 2-5 ml. If necessary, the dose is repeated after 6-8 hours. The maximum daily dose should not exceed 6 ml of the drug (equivalent to 3 g of metamizole sodium). The duration of treatment is 2-3 days. After reaching the therapeutic effect, it is allowed to switch to treatment with oral painkillers and antispasmodics means. In the absence of a therapeutic effect, treatment is discontinued. Patients over the age of 65 Dose reduction is usually not required. In patients with age impaired liver and kidney function, it is necessary to reduce the dose, since it is possible to increase the half-life of metabolites metamizole sodium (see section "Pharmacokinetics"). Patients with impaired renal function Metamizole sodium is excreted in the urine as metabolites. In patients with mild to moderate renal failure recommended apply half the dose for adults. Patients with impaired liver function In such patients, the half-life of active Metamizole sodium metabolites. In patients with impaired function high doses should be avoided by the liver. For short application to reduce the dose is not required. There is insufficient experience with prolonged use in patients with impaired renal or hepatic function.
Adverse reactions are grouped but to systems and organs, as well as frequency of occurrence: Frequency gradation: very often (≥1 / 10), often (≥1 / 100 to <1/10), infrequently (≥1 / 1000 to <1/100), rarely (≥1 / 10000 to <1/1000), very rarely (<1/10000), frequency unknown (frequency cannot be determined based on available data). The adverse reactions listed below are due to mainly metamizole sodium, which is part of the drug the drug. Hematologic and lymphatic disorders Rarely: leukopenia. Very rarely: agranulocytosis, thrombocytopenia, anemia (hemolytic anemia, aplastic anemia). The risk of agranulocytosis cannot be foreseen. Agranulocytosis may occur in patients who have previously taken metamizole sodium without the occurrence of such adverse reactions. Immune disorders; Infrequently: limited exanthema. Rarely: maculopapular rash, anaphylactic or anaphylactoid reactions, especially after parenteral administration. Such reactions may occur during administration of the drug or immediately after cessation of administration, however, In a few hours. They usually develop within the first hour. after the injection. Lighter reactions appear as typical reactions from the skin and mucous membranes (e.g., itching, burning, redness, urticaria, edema: local or general), shortness of breath and less commonly complaints from the gastrointestinal tract. Mild reactions can turn into more severe forms with generalized urticaria, severe angioedema edema (including with laryngospasm), severe bronchospasm, violation heart rate, decreased blood pressure (sometimes with previous increase in blood pressure). In this regard, if any skin reaction occurs, the use of the drug should be discontinued immediately. Very rarely: an attack of bronchial asthma (in patients with “aspirin” asthma), Stevens-Johnson syndrome, Lyell syndrome, circulatory shock. Neurological disorders: dizziness, headache. Violations of the organ of vision: visual disturbances, violation accommodation. Heart Disorders: Infrequently: palpitations, tachycardia, cardiac abnormalities rhythm, cyanosis. Violations of the vessels: Infrequently: arterial hypotension. Gastrointestinal Disorders: Frequency unknown: dry mouth, nausea, vomiting, abdominal pain and discomfort, constipation, exacerbation of gastritis and gastric ulcer, rare cases of ulceration and vomiting with an admixture of blood. Violations of the kidneys and urinary tract: Rarely: proteinuria, oliguria, anuria, polyuria, interstitial jade, staining of urine in red. Frequency unknown: urinary retention. General disorders and disorders at the injection site: with parenteral application - pain at the injection site and local reactions.
When treated with SPAZMOFARM, there is a risk of developing anaphylactic reactions. At the first sign of hypersensitivity drug administration should be discontinued and urgent therapeutic measures (epinephrine, glucocorticosteroids, antihistamines). The risk of anaphylactoid reactions when used metamizole sodium is significantly increased in patients with: - Analgesic asthma syndrome or idiosyncrasy to analgesics in the form of urticaria according to the angioneurotic type; - bronchial asthma, especially accompanied by rhinosinusitis and polyposis of the nasal mucosa; - chronic urticaria; - idiosyncrasy to dyes (e.g. tartrazine) and, respectively preservatives (e.g. benzoate); - intolerance to alcohol. Such patients respond to the use of a minimum amount of alcoholic beverages such symptoms like sneezing, lacrimation, and severe visual impairment. Alcohol intolerance may not be a sign of diagnosed syndrome of "aspirin" asthma. SPAZMOFARM contains metamizole sodium, in the treatment of which there is a small but life-threatening risk of shock and agranulocytosis. The development of agranulocytosis is not dose-dependent and cannot be to predict. It may appear after the first dose or after repeated use. Typical signs of agranulocytosis is a fever, sore throat, soreness when swallowing, inflammation mucous membranes of the mouth, nose, pharynx, anorectal and genital area. With a sudden deterioration in general condition and the appearance of signs of agranulocytosis, the use of the drug should be immediately discontinue without waiting for laboratory confirmation. In the treatment with SPAZMOFARM with patients with hematologic diseases, or having a history of them, it is necessary to control hematological status during treatment. The drug should be used with caution in patients with obstructive diseases of the gastrointestinal tract (achalasia cardia, pyloroduodenal stenosis). Repeated use of the drug SPAZMOFARM in these cases may cause a delay in evacuation gastrointestinal contents and intoxication. Application SPAZMOFARM in patients with gastroesophageal reflux disease, intestinal atony, paralytic intestinal obstruction, glaucoma, myasthenia gravis, heart disease (arrhythmias, coronary heart disease, chronic heart insufficiency) requires special care and medical supervision. Metamizole sodium, which is part of the drug SPAZMOFARM, may cause hypotensive reactions (see section "Side effects"). These reactions are dose-dependent and more commonly observed with parenteral application. The risk of such reactions increases in the following cases: In patients with a history of arterial hypotension, a decrease fluid volume and electrolyte content or dehydration, unstable hemodynamics or circulatory failure (for example, in patients with myocardial infarction or polytrauma); In patients with an increase in body temperature. In such patients, a thorough assessment of the need use of the drug and establish strict control over them. May therapeutic measures required (e.g. stabilization blood circulation) in order to reduce the risk of arterial hypotension. SPAZMOFARM should be used only with careful hemodynamic control in patients who are not shown mandatory forced decrease in blood pressure, for example, with severe coronary heart disease or cerebrovascular stenosis. SPAZMOFARM should be used only after a thorough assessment risk-benefit relationships by taking appropriate measures precautions in patients with impaired renal or hepatic function (see the section "Mode of application and doses"). Impact on the ability to drive vehicles, mechanisms Fenpiverinia bromide has an m-anticholinergic effect and may cause dizziness and disturbance of accommodation. Metamizole sodium may adversely affect attention span and leads to a decrease in the speed of reaction. Patients driving vehicles or working with mechanisms should be warned of possible adverse reactions on the drug. Activities requiring increased attention should be stop until adverse reactions disappear.
Release form Solution for intramuscular injection 500 mg / ml + 2 mg / ml + 0.02 mg / ml. 2 ml of the drug in an ampoule of dark glass type I; 10 ampoules per blister; 1 blister together with instructions for use are placed in cardboard pack.
At a temperature of no higher than 25 °С.Keep out of the reach of children.