Spasmaton, 20 pcs., tablets
- intolerance or hypersensitivity to dyes (for example, tartrazine) or preservatives (for example, benzoate).
Before using Spasmaton, it is necessary to conduct a thorough interview with the patient. If a risk of developing an anaphylactoid reaction is identified, the use of Spasmaton is possible only after assessing the risk/benefit ratio.
In the case of using Spasmaton in such patients, strict medical monitoring of their condition is necessary and the availability of means to provide them with emergency assistance in the event of the development of anaphylactic/anaphylactoid reactions is required.
Predisposed patients may experience anaphylactic shock, so patients with asthma or atopy should prescribe Spasmaton with caution.
Life-threatening skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been described with the use of metamizole sodium. If symptoms of these diseases appear (such as a progressive skin rash, often with blisters or lesions of the mucous membrane), treatment with Spasmaton should be stopped immediately and should not be restarted.
During therapy with metamizole-containing drugs, agranulocytosis may develop. It lasts at least a week, does not depend on the dose, can be severe, life-threatening and even lead to the death of the patient. In this regard, if symptoms possibly associated with neutropenia appear (fever, chills, sore throat, difficulty swallowing, stomatitis, erosive and ulcerative lesions of the oral cavity, vaginitis or proctitis, a decrease in the number of neutrophils in peripheral blood - less than 1500 mm3), it is necessary to stop treatment with Spasmaton and consult a doctor.
If the patient receives antibiotic therapy, then the typical manifestations of agranulocytosis may be minimally expressed. The erythrocyte sedimentation rate is significantly increased, while lymph node enlargement is mild or absent. Typical symptoms of thrombocytopenia are an increased tendency to bleeding and the appearance of petichiae on the skin and mucous membranes.
In case of pancytopenia, treatment should be stopped immediately; complete blood count parameters should be monitored until they return to normal.
All patients should be aware that if symptoms of pathological changes in the blood appear (for example, general malaise, infections, persistent fever, hematoma formation, bleeding, pale skin) while using Spasmaton, they should immediately consult a doctor.
Administration of a metamizole-containing drug may cause individual hypotensive reactions. These reactions may be dose dependent and occur more often after parenteral administration.
To avoid the development of severe hypotensive reactions, you should adhere to the following recommendations:
— intravenous administration of Spasmaton should be carried out slowly, in the “lying” position;
- blood pressure, heart rate and breathing should be monitored;
- patients with existing hypotension, decreased circulating blood volume, dehydration, hemodynamic instability or with the initial stage of circulatory failure require normalization of hemodynamics;
- Caution should be used when treating patients with high body temperature.
Spasmaton Neo tablets p/o No. 10x2
Name
Spasmaton Neo No. 20
Description
Film-coated tablets, white, round, with a biconvex surface.
Main active ingredient
Ibuprofen+pitofenone+fenpiverinium bromide
Release form
film-coated tablets
special instructions
It is necessary to monitor serum creatinine 48–72 hours after the start of administration in patients with chronic heart failure of functional class III-IV according to the New York classification and chronic renal failure with a glomerular filtration rate of less than 60 ml/min. With long-term use (more than a week), monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary. In patients with arterial hypertension and diabetes mellitus, monitoring of renal function is mandatory even in the first week of use. In patients for whom the production of prostaglandins has a compensatory role in maintaining renal blood flow (states of dehydration, impaired renal and liver function, heart failure, severe atherosclerosis, taking diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), old age), the risk of developing complications from kidney To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a blood test to determine hemoglobin and hematocrit, and a stool test for occult blood. If it is necessary to determine 17-ketosteroids, drugs should be discontinued 48 hours before the study. During the treatment period you should refrain from drinking alcohol.
Pharmacological properties
Pharmacodynamics
Combined analgesic, anti-inflammatory and antispasmodic agent. The drug contains the non-steroidal anti-inflammatory drug ibuprofen, the myotropic antispasmodic - pitofenone and the M-anticholinergic drug - fenpiverinium bromide. The combination of drug components (drug) leads to mutual potentiation of their pharmacological action. Ibuprofen is a derivative of phenylpropionic acid. It has analgesic, anti-inflammatory and antipyretic effects. The main mechanism of action is inhibition of the synthesis of prostaglandins - modulators of pain sensitivity, thermoregulation and inflammation in the central nervous system (CNS) and peripheral tissues. In women with primary dysmenorrhea, it reduces the increased level of prostaglandins in the myometrium and thereby reduces intrauterine pressure and the frequency of uterine contractions. Pitophenone hydrochloride has a direct myotropic antispasmodic effect on the smooth muscles of internal organs and causes its relaxation (papaverine-like effect). Phenpiverinium bromide has an M-anticholinergic effect and has an additional relaxing effect on smooth muscles.
Pharmacokinetics
Absorption and distribution When taken orally, the components of the drug Spazmaton Neo® are well absorbed in the gastrointestinal tract (GIT). Cmax in blood plasma is achieved in approximately 1–2 hours. The main drug component ibuprofen is 99% bound to blood plasma proteins and accumulates in the synovial fluid. Metabolism and excretion Ibuprofen is metabolized in the liver and is excreted 90% in the urine in the form of metabolites and conjugates. A small portion of ibuprofen is excreted in bile. T? from blood plasma is 2 hours. The pharmacokinetics of pitofenone hydrochloride and fenpiverinium bromide have not been sufficiently studied.
Indications for use
- pain syndrome (mild or moderate) with spasms of smooth muscles of internal organs: renal and biliary colic, biliary dyskinesia, intestinal colic;
- dysmenorrhea;
- headache, incl. migraine character;
- for short-term symptomatic treatment of joint pain, neuralgia, sciatica, myalgia.
Directions for use and doses
Orally, 1 hour before or 3 hours after meals. To avoid irritating effects on the stomach, you can take the drug immediately after meals or wash it down with milk. In the absence of special instructions from a doctor, Spazmaton Neo® is recommended to be taken for spastic pain, 1 tablet up to 3 times a day. The maximum daily dose is 3 tablets. Do not exceed the indicated dose! The course of treatment with Spasmaton Neo®, without consulting a doctor, should not exceed 5 days. Longer use is possible under the supervision of a physician with monitoring of peripheral blood parameters and the functional state of the liver.
Use during pregnancy and lactation
The drug is contraindicated during pregnancy and lactation (breastfeeding).
Interaction with other drugs
When taken as recommended, the risk of developing significant drug interactions is low. Inducers of microsomal oxidation enzymes in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of developing severe intoxications. Microsomal oxidation inhibitors reduce the risk of hepatotoxicity. The risk of developing undesirable interactions and impaired renal function increases when administered simultaneously with drugs that block the renin-angiotensin-aldosterone system. The drug reduces the hypotensive activity of vasodilators and the natriuretic effect of furosemide and hydrochlorothiazide. Reduces the effectiveness of uricosuric drugs. Strengthens the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (which increases the risk of bleeding). Increases the side effects of mineralocorticosteroids, glucocorticosteroids (increases the risk of gastrointestinal bleeding), estrogens, ethanol. Enhances the hypoglycemic effect of sulfonylurea derivatives. Antacids and cholestyramine reduce the absorption of ibuprofen. The drug increases the concentration of digoxin, lithium, and methotrexate in the blood. Enhances the effect of m-anticholinergic blockers, histamine H1 receptor blockers, butyrophenones, phenothiazines, amantadine and quinidine. Concomitant administration of other NSAIDs increases the incidence of side effects. Caffeine enhances the analgesic effect. When administered simultaneously, it reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after starting to take Spazmaton Neo®). Cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin increase the incidence of hypoprothrombinemia when administered simultaneously. Myelotoxic drugs increase the manifestations of hematotoxicity of drugs. Cyclosporine and gold preparations enhance the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxic effects. Drugs that block tubular secretion reduce excretion and increase plasma concentrations of ibuprofen.
Contraindications
- erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding;
- inflammatory bowel diseases in the acute phase, incl. ulcerative colitis;
- anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria, after taking acetylsalicylic acid or another non-steroidal anti-inflammatory drug (NSAID) (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);
- liver failure or active liver disease;
- renal failure creatinine clearance ((creatinine clearance) less than 30 ml/min), progressive kidney disease;
- confirmed hyperkalemia;
- hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis;
- period after coronary artery bypass surgery;
- acute intermittent porphyria;
- granulocytopenia;
- hematopoietic disorders;
- deficiency of glucose-6-phosphate dehydrogenase;
- tachyarrhythmias;
- angle-closure glaucoma;
- optic nerve diseases;
- prostatic hyperplasia;
- intestinal obstruction;
- pregnancy and lactation (breastfeeding);
- age up to 16 years;
- hypersensitivity to any component of the drug.
Carefully
- elderly age;
- congestive heart failure;
- cerebrovascular diseases;
- arterial hypertension;
- cardiac ischemia;
- dyslipidemia/hyperlipidemia;
- diabetes;
- peripheral arterial disease;
- nephrotic syndrome;
- CC 30–60 ml/min or less;
- hyperbilirubinemia;
- peptic ulcer of the stomach and duodenum (history);
- presence of Helicobacter pylori infection;
- gastritis, enteritis, colitis;
- long-term use of NSAIDs;
- blood diseases of unknown etiology (leukopenia, anemia);
- smoking;
- frequent drinking of alcohol (alcoholism);
- severe somatic diseases;
- concomitant therapy with the following drugs: anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (GCS) (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline).
Compound
One tablet contains: active ingredients – ibuprofen – 400 mg, pitofenone hydrochloride – 5 mg, fenpiverinium bromide – 0.1 mg; excipients – microcrystalline cellulose, starch 1500 (partially pregelatinized corn starch), croscarmellose sodium, glycerin, colloidal anhydrous silicon dioxide, talc, magnesium stearate, Opadry II (including polyvinyl alcohol, partially hydrolyzed, talc, macrogol 3350, titanium dioxide E 171).
Overdose
Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased blood pressure (BP), bradycardia, tachycardia, atrial fibrillation, respiratory arrest. Treatment: gastric lavage (only within an hour after administration), activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy (correction of acid-base status, blood pressure). There is no specific antidote.
Side effect
From the digestive system: NSAID gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation, ulceration of the gastrointestinal mucosa, which, in some cases, are complicated by perforation and bleeding; irritation or dryness of the oral mucosa , pain in the mouth, ulceration of the gum mucosa, aphthous stomatitis), pancreatitis, hepatitis. From the respiratory system: shortness of breath, bronchospasm. From the central nervous system and peripheral nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, aseptic meningitis (more often in patients with autoimmune diseases). On the part of the hearing organs: hearing loss, hearing loss, ringing in the ears. From the organs of vision: visual impairment (toxic damage to the optic nerve, blurred visual perception, scotoma, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic origin), accommodation paresis). From the cardiovascular system: heart failure, tachycardia, increased blood pressure. From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), oliguria, anuria, polyuria, proteinuria, cystitis, red staining of urine. Allergic reactions: skin rash (usually erythematous or urticaria), skin itching, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (syndrome) Lyell), eosinophilia, allergic rhinitis. From the hematopoietic organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia. Other: increased or decreased sweating. From laboratory parameters: bleeding time may increase, serum glucose concentration may decrease, creatinine clearance may decrease, hematocrit or hemoglobin may decrease, serum creatinine concentration may increase, hepatic transaminase activity may increase.
Storage conditions
In a place protected from light and moisture, at a temperature not exceeding 25? C. Keep out of the reach of children.
