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Active ingredients
Ibuprofen + Pitofenon + Fenpiverinium bromide
Release form
Pills
Composition
Each tablet, film coated contains: Active substances: ibuprofen 400 mg, pitofenone hydrochloride 5 mg, fenpiverinium bromide 0.1 mg.; Excipients: microcrystalline cellulose 55 mg, corn starch 76 mg, glycerol 2.9 mg, colloidal silicon dioxide 5 mg, talc 12 mg, magnesium stearate 4 mg; shell: hypromellose 6 cps 5,686 mg, macrogol 6000 1.124 mg, talc 1.957 mg, titanium dioxide 1.059 mg, polysorbate 80 0.058 mg, sorbic acid 0.058 mg, dimethicone 0.058 mg.
Pharmacological effect
The combined drug has analgesic, anti-inflammatory and antispasmodic action. Suppresses prostaglandin synthesis (Pg). The preparation contains nonsteroidal anti-inflammatory agent ibuprofen, myotropic antispasmodic pitofenone hydrochloride and m-antinox blocking agent of the central and peripheral action of fenpiverinium bromide .; Ibuprofen is a derivative of phenylpropionic acid. It has analgesic, anti-inflammatory and antipyretic effects. The main mechanism of action is the inhibition of the biosynthesis of prostaglandins - modulators of pain sensitivity, thermoregulation and inflammation in the central nervous system and peripheral tissues. In women with primary dysmenorrhea, an increased level of prostaglandins in the myometrium decreases, thereby reducing intrauterine pressure and the frequency of uterine contractions .; Pitofenone hydrochloride, like papaverine, has a direct myotropic effect on the smooth muscles of the internal organs and causes its relaxation.; Fenpiverinium bromide has an additional relaxing effect on the smooth muscles .; The combination of the three components of the drug leads to mutual enhancement of their pharmacological action.
Pharmacokinetics
The components of the drug Novigan well absorbed in the gastrointestinal tract. The peak concentration in the blood plasma is reached approximately 1-2 hours after taking the drug. The main component of the drug ibuprofen is 99% bound to plasma proteins, it can accumulate in the synovial fluid, is metabolized in the liver and is excreted by 90% in the urine as metabolites and conjugates. A small part of the drug is excreted in the bile. The half-life of plasma is 2 hours.
Indications
- Mild or moderate pain syndrome in spasms of smooth muscles of internal organs: renal and biliary colic, biliary dyskinesia, intestinal colic .; - Gynecological diseases: dysmenorrhea .; - Headache, including migraine nature .; - Short-term symptomatic treatment of pain in the joints, neuralgia, sciatica, myalgia.
Contraindications
Hypersensitivity to any of the ingredients that make up the drug; erosive and ulcerative changes of the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding; inflammatory bowel disease in the acute phase, including ulcerative colitis; history of an attack of bronchial obstruction, rhinitis, urticaria, after taking acetylsalicylic acid or another nonsteroidal anti-inflammatory drug - NSAIDs (complete or incomplete intolerance syndrome acetylsalicylic acid - rhinosinusitis, urticaria, nasal polyps, bronchial asthma) liver failure or active liver disease; renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease; confirmed hyperkalemia; hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis; the period after coronary artery bypass surgery; acute intermittent porphyria; granulocytopenia; blood disorders; glucose-6-phosphate dehydrogenase deficiency; tachyarrhythmia; angle-closure glaucoma; diseases of the optic nerve; prostatic hyperplasia; intestinal obstruction; pregnancy and breastfeeding, age up to 16 years.
Use during pregnancy and lactation
Contraindicated
Dosage and administration
Inside, 1 hour before or 3 hours after meals. In order to avoid irritating the stomach, you can take the drug immediately after eating or drink milk .; In the absence of specific doctor's instructions, it is recommended to take Novigan for spastic pains, 1 tablet up to 3 times a day. The maximum daily dose is 3 pills. Do not exceed the specified dose !; The course of treatment with Novigan, without consulting a doctor, should not exceed 5 days.Longer use is possible under the supervision of a physician with monitoring of peripheral blood and the functional state of the liver.
Side effects
In recommended doses, the drug Novigan does not cause side effects .; On the part of the gastrointestinal tract: NSAID gastropathy (abdominal pains, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation, ulceration of the mucous membrane of the gastrointestinal tract, which, in some cases, are complicated by perforation and bleeding; irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the mucous membrane of the gums, aphthous stomatitis, pancreatitis .; From the side of the hepatobiliary system: hepatitis .; From the respiratory system: shortness of breath, bronchospasm .; From the senses: on hearing loss: hearing loss, ringing or tinnitus, visual impairment: toxic damage to the optic nerve, blurred visual perception, scotoma, dryness and irritation of the eyes, conjunctiva and eyelid edema (allergic origin), accommodation paresis .; On the part of the central and peripheral nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psycho-motor agitation, drowsiness, depression, confusion, gallucinations, aseptic meningitis (often in patients with autoimmune disorders). a-disease) .; Since the cardiovascular system: heart failure, tachycardia, increased blood pressure .; On the part of the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), oliguria, anuria, polyuria, proteinuria, cystitis, urine staining in red .; Allergic reactions: skin rash (typically erythematous or nettle-ca), pruritus, angioedema, anaphylactoid reactions, anaphylactic shock, bronchoconstriction or dyspnea, fever, exudative erythema multiforme (including, Stevens-Johnson syndrome), toxic epidermal necrolysis ( Lyell's syndrome), eosinophilia, allergic rhinitis .; On the part of the blood-forming organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia .; Other: increased or decreased sweating .; From the 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), activity of liver transaminases (may increase) .; If taking the drug has caused a change in your normal condition, stop taking it and consult a doctor immediately.
Overdose
Do not exceed the specified dose. If you exceed the dose, consult a doctor or the nearest medical facility immediately. Take the product package with you .; Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, low blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory depression .; Treatment: gastric lavage (only within an hour after ingestion), activated carbon, alkaline drinking, forced diuresis, symptomatic therapy (correction of the acid-base state, blood pressure). There is no specific antidote.
Interaction with other drugs
In therapeutic doses, the drug NoviganO does not enter into significant interactions with widely used drugs .; Inductors 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 .; Inhibitors of microsomal oxidation reduce the risk of hepatotoxic action .; Reduces the hypotensive activity of vasodilators and the natriuretic effect of furosemide and hydrochlorothiazide .; Reduces the effectiveness of uricosuric drugs. It enhances the effect of indirect anticoagulants, antiplatelet agents, fibrinolitikov (which increases the risk of bleeding) .; Strengthens the side effects of mineral corticosteroids, glucocorticosteroids (increases the risk of gastrointestinal bleeding), estrogen, ethanol; enhances the hypoglycemic effect of sulfonylurea derivatives .; Antacids and colestyramine reduce the absorption of ibuprofen .; Increases blood concentration of digoxin, lithium preparations and methotrexate .; Enhances the action of M-anticholinergics, H1-histamine blockers, butyrophenones, phenothiazines,amantadine and quinidine .; The simultaneous appointment of other NSAIDs increases the frequency of side effects .; Caffeine enhances analgesic (analgesic) effect .; With simultaneous appointment reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients who receive small doses of acetylsalicylic acid as an antiplatelet agent, after starting the drug NoviganO); Cefamandol, cefoperazone, cefotetan, valproic acid, plykamycin increase the incidence of hypoprothrombinemia with simultaneous appointment .; Myelotoxic drugs increase the hematotoxicity of the drug .; Cyclosporine and gold preparations enhance the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by an increase in nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects .; Drugs that block tubular secretion, reduce excretion and increase the plasma concentration of ibuprofen.
special instructions
With long-term use, it is necessary to control the picture of peripheral blood and the functional state of the liver and kidneys .; To reduce the risk of adverse events from the gastrointestinal tract, a minimum effective dose should be used. When symptoms of gastropathy appear, close monitoring is shown, including esophagogastroduodenoscopy, a blood test with hemoglobin and hematocrit, and fecal occult blood analysis .; If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the period of treatment should refrain from taking alcohol.