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Active ingredients
Metamizole sodium + Pitofenon + Fenpiverinium bromide
Release form
Pills
Composition
Metamizole sodium - 500 mg; Pitofenone hydrochloride - 5 mg; Fenpiverinium bromide - 0.1 mg; Auxiliary substances, including lactose monohydrate
Pharmacological effect
Antispasmodic - a combined analgesic with pronounced antispasmodic activity. The composition of the drug Spazmalgon includes three active ingredients - metamizole sodium, pitofenone hydrochloride and fenpiverinium bromide. The mechanism of action of the drug and its pharmacological effects are based on the pharmacological properties of the active components in its composition. Metamizole sodium is a nonsteroidal anti-inflammatory drug derived from pyrazolone. Metamizole has a pronounced analgesic effect, has anti-inflammatory and antipyretic effect. The mechanism of action of metamizole sodium is associated with its ability to inhibit the activity of the enzyme cyclooxygenase, as a result of which the metabolism of arachidonic acid is disturbed and the synthesis of proinflammatory prostaglandins, prostacyclins and thromboxane is reduced. Metamizole sodium belongs to the group of non-selective non-steroidal anti-inflammatory drugs and equally inhibits the activity of both isoforms of the cyclooxygenase enzyme - cyclooxygenase-1 and cyclooxygenase-2. Owing to a decrease in the number of prostaglandins in the inflammatory focus, a decrease in the sensitivity of the chemoreceptors of the endings of afferent neurons of pain sensitivity to bradykinin and histamine is noted. In addition, a decrease in the number of prostaglandins in the focus of inflammation leads to a decrease in the production of endogenous biologically active substances involved in the inflammatory response. Thus, metamizole sodium has an analgesic effect by reducing the activity of the inflammatory process and reducing the effect of inflammatory mediators on painful endings. The antipyretic effect of the drug is associated with a decrease in the number of prostaglandins in the center of thermoregulation in the hypothalamus. Pitofenone hydrochloride is a derivative of piperidine, and has antispasmodic myotropic activity.The drug has papaverine-like effect, causes a decrease in tone and relaxation of smooth muscles. Pitofenone hydrochloride contributes to the elimination of pain caused by spasm of the smooth muscles of the internal organs. Fenpiverinium bromide is a drug of the M-holinoblokatorov group that contains quaternary nitrogen in its structure. The drug relieves spasm of the smooth muscle layer of internal organs, reduces the tone and reduces the motility of the stomach and intestines, relaxes the smooth muscles of the urinary and biliary tract. The pharmacologically active substances that make up the Spasmalgon preparation mutually enhance the therapeutic effect of each other. metamizole sodium, because at the moment reliable data on the pharmacokinetics of pitofenone hydrochloride and fenpiverinium bromide is absent. When administered orally, metamizole sodium is well absorbed in the gastrointestinal tract. In the intestinal walls, the drug is hydrolyzed to form a pharmacologically active substance, the peak concentration of the active substance in the blood plasma is noted 30-120 minutes after oral administration. When parenterally administered, the bioavailability of the drug is about 85%. The active substance is partially bound to plasma proteins. Metabolized in the liver to form pharmacologically active metabolites. Excreted mainly by the kidneys in the form of metabolites, a small part is excreted by the liver. About 3% of the drug is excreted from the body as unchanged metamizol. The amount of the drug that is biotransformed individually for each patient and depends on many factors, including the genetically determined type of acetylation. Patients suffering from cirrhosis of the liver have a change in the clearance indicators of metamizol.
Indications
The drug Spasmalgon in the form of pills is used for the symptomatic treatment of patients suffering from pain syndrome of weak or moderate intensity, including the drug is indicated for such diseases: Urinary tract diseases, which are accompanied by pain and urination disordersincluding inflammatory diseases of the urinary system and urolithiasis. Gastric and intestinal colic, diseases of the digestive tract, which are accompanied by spasm of smooth muscles of the intestine and stomach and pain syndrome. pain syndrome of weak or moderate intensity with primary and secondary dysmenorrhea. If necessary, the drug can be used for mptomaticheskogo treatment of pain in patients suffering from diseases of the musculoskeletal system and neuralgia. However, in this case, the drug is recommended for a short time.
Contraindications
- Increased individual sensitivity to the components of the drug and other drugs of the group of nonsteroidal anti-inflammatory drugs; - increased individual sensitivity to pyrazolone derivatives; - suspicion of surgical pathology; - dysfunction of the hematopoietic system, including agranulocytosis, leukopenia, aplastic anemia; - the drug is contraindicated in patients suffering from severe hepatic and / or renal failure, acute hepatic porphyria, as well as a decrease in urinary tone o and / or gallbladder; - the drug is not prescribed to patients suffering from angle-closure glaucoma, tachyarrhythmia, and deficiency of glucose-6-phosphate dehydrogenase; - spasmalgon is contraindicated in case of obstruction of the gastrointestinal tract, megacolone, collaptoid states. adenoma of the prostate gland, which is accompanied by disorders of urination. It is not recommended to prescribe the drug to women during pregnancy and lactation, as well as to children under the age of 15 years. They are prescribed for patients with hay fever, bronchial asthma and allergic rhinitis, as they have an increased risk of hypersensitivity reactions. bowel tone, glaucoma, paralytic ileus and diseases of the cardiovascular system. The drug should be prescribed with caution to patients whose work associated with the management of potentially dangerous machinery and driving a car.
Use during pregnancy and lactation
At the moment there are no reliable data on the safety of the drug during pregnancy. If you need to use the drug during lactation, it is recommended to temporarily stop breastfeeding. Restoration of breastfeeding is possible not earlier than 48 hours after taking the last dose of the drug.
Dosage and administration
The drug Spazmalgon in the form of pills is taken orally, the tablet is swallowed whole, without grinding and chewing, drinking plenty of water. If necessary, the tablet can be divided. The duration of the course of treatment and the dose of the drug are determined by the attending physician individually for each patient, depending on the nature of the disease and the patient’s individual characteristics. For the treatment of spastic pain, adults and adolescents over 15 years of age usually prescribe 1-2 pills 2-3 times a day . It is not recommended to take more than 6 pills of the drug per day. For the treatment of pains of a spastic nature, children between the ages of 13 and 15 usually prescribe 1 tablet of the drug 2-3 times a day. It is not recommended to take more than 3 pills of the drug per day. For the treatment of pains of a spastic nature, children at the age of 9 to 12 years old usually take 1/2 tablet of the drug 2-3 times a day. It is not recommended to take more than 2 pills of the drug per day. The drug is not recommended to be taken for more than 3 days in a row if the treating physician has not prescribed it differently. The Spasmalgon preparation in the form of injection solution is used only for intramuscular administration. The duration of the course of treatment and the dose of the drug are determined by the attending physician individually for each patient, depending on the nature of the disease and the patient’s individual characteristics. Adults and adolescents over the age of 15 years are usually prescribed 2-5 ml of the drug 2-3 times a day. It is recommended to observe the interval between injections of the drug for at least 6 hours. It is not recommended to inject more than 10 ml of the drug per day. The drug is not recommended to be taken for more than 3 days in a row if the attending physician has not prescribed otherwise. If there is no necessary therapeutic effect, the use of the drug is stopped.If there is a positive trend, therapy is continued with the preparation Spasmalgon in the form of pills.
Side effects
When using the drug Spasmalgon in patients, the following side effects were observed: From the gastrointestinal tract: nausea, vomiting, dry mouth, epigastric pain, exacerbation of chronic diseases of the gastrointestinal tract, including peptic ulcers and gastritis. cardiovascular and hematopoietic systems: increased blood pressure, arrhythmia, increased heart rate, leukopenia, agranulocytosis, thrombocytopenia, anemia, granulocytopenia. From the central side nervous system: headache, dizziness, irritability, visual disturbances. On the urinary system: difficulty urinating, oliguria, polyuria, anuria, proteinuria, urine staining in bright red. In isolated cases, mainly in patients taking the drug for a long time, development of renal dysfunction and interstitial nephritis is noted. Allergic reactions: skin rash, itching, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell's syndrome. In isolated cases, the development of anaphylactoid reactions, including angioedema and anaphylactic shock, was noted. Patients with a tendency to bronchospasm and patients suffering from bronchial asthma may develop bronchospasm during therapy with Spasmalgon. In case of side effects with the use of the drug Smazmalgon, it is recommended to contact your doctor, as some Side Effects require discontinuation of the drug (including Side effects such as impaired renal function, hematopoietic disorders and hypersensitivity reactions).
Overdose
With the use of excessive doses of the drug in patients, symptoms of metamizole intoxication are observed in combination with anticholinergic effects. The most common in patients is the development of toxic-allergic syndrome. With further increase of the dose in patients, there is a development of disorders of the gastrointestinal tract and the central nervous system. There is no specific antidote.In case of drug overdose in the form of pills, gastric lavage and enterosorbent administration are indicated. In case of overdose of the drug, regardless of the form of release, it is indicated to carry out measures for the rapid elimination of the drug from the body, including forced diuresis, administration of water-salt solutions and hemodialysis. If necessary, carry out symptomatic therapy.
Interaction with other drugs
Metamizol, which is part of the Spasmalgon preparation, is an enzyme inducer, therefore the simultaneous use of the Spasmalgon preparation with other drugs should be carried out under the strict supervision of the attending physician. during the period of drug therapy Spazmalgon. With simultaneous use of the drug reduces the effectiveness of coumarin anticoagulants. At the same time When using the drug with phenothiazine derivatives, including chlorpromazine, there is a risk of developing severe hypothermia. Spasmalgon reduces the plasma concentrations of cyclosporine when used simultaneously. with myelotoxic effect. Barbititurates, phenylbutazone and other enzyme inducers with simultaneous application of The therapeutic effect of Metamizole. With simultaneous use of the drug with tricyclic antidepressants, allopurinol and artificial contraceptives, there is an increase in the toxic effect of Metamizole. Non-steroidal anti-inflammatory drugs with simultaneous use with the Spasmalgon drug increase the risk of side effects. sedative drugs. When combined with An increase in anticholinergic action is noted when using a drug containing quinine. Spasmalgon preparation in the form of injection solution should not be mixed with other injection solutions in one syringe. The combination of Spasmalgon with furosemide, glibenclamide and hyoscinbutyl bromide is allowed.
special instructions
With prolonged (more than a week) use of the drug, it is necessary to control the pattern of peripheral blood (white blood cell count) and the functional state of the liver. If you suspect agranulocytosis or in the presence of thrombocytopenia, you should stop taking the drug. Alcohol should not be taken during drug treatment. Use of the drug in nursing mothers requires breastfeeding to stop. Impact on the ability to drive and control mechanisms. hazardous activities that require a quick physical and mental response.