Mig 400 coated pills 400mg N20
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Active ingredients
Ibuprofen
Release form
Pills
Composition
1 tablet, film-coated, contains: Core: Active ingredient: ibuprofen - 400.0 mg. ; Excipients: corn starch - 215.00 mg, sodium carboxymethyl starch (type A) - 26.00 mg, anhydrous colloidal silicon dioxide - 13.00 mg, magnesium stearate - 5.60 mg; Shell: hypromellose (viscosity 6 mPa · s) - 2.940 mg, povidone (K value = 30) - 0.518 mg, macrogol 4000 - 0.560 mg, titanium dioxide (E 171) - 1.918 mg.
Pharmacological effect
Nonsteroidal anti-inflammatory drug (NSAIDs). Ibuprofen is a derivative of propionic acid and has analgesic, antipyretic and anti-inflammatory effects due to non-selective blockade of COX-1 and COX-2, as well as an inhibitory effect on the synthesis of prostaglandins .; less more The analgesic effect is most pronounced for inflammatory pain. Analgesic activity of the drug does not belong to the narcotic type .; less more Like other NSAIDs, ibuprofen has antiaggregant activity.
Pharmacokinetics
Absorption: after oral administration, ibuprofen is partially absorbed in the stomach, then completely - in the small intestine. The maximum concentration (Cmax) of ibuprofen in the blood plasma after taking the drug orally is reached within 1-2 hours. The therapeutic concentration in the blood plasma (10 μg / ml) is reached approximately 10 minutes after the ingestion .; Distribution: binding to plasma proteins is about 99% .; Metabolism: metabolized in the liver mainly by hydroxylation and carboxylation of the isobutyl group. Metabolites are pharmacologically inactive .; Withdrawal: has a two-phase kinetics of elimination. The half-life (T1 / 2) is 1.8-3.5 hours. Excreted by the kidneys (90%) and to a lesser extent by the intestines. In the range of doses of 200-400 mg, the pharmacokinetics of ibuprofen is linear, at higher doses - non-linear.
Indications
The drug is intended for symptomatic treatment as: less pain; more painkillers for pain syndrome of weak and moderate intensity, including: for headaches, migraines, toothache, pain in muscles and joints, painful menstruation; fewer more febrifuge in case of acute respiratory diseases.
Contraindications
hypersensitivity to ibuprofen and / or any of the components that make up the drug; less is a complete or incomplete combination of bronchial asthma, recurrent pollinosis or paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in history); less erosive and ulcerative changes in the mucous membrane of the stomach and / or duodenum, active gastrointestinal bleeding, including a history (two or more confirmed episodes of peptic ulcer or ulcerative bleeding); cerebrovascular bleeding or other bleeding; less intracranial hemorrhage; less longer period after coronary artery bypass surgery; less hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis; less disease of blood of unknown etiology (leukopenia and anemia); less inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the acute phase; less severe liver failure; less severe renal failure severe (creatinine clearance less than 30 ml / min); less progressive kidney disease; less severe heart failure; less w more pregnancy (III trimester); less child age up to 6 years (body weight less than 20 kg).
Use during pregnancy and lactation
The use of the drug in the first and second trimesters of pregnancy should be avoided; if necessary, the use of the drug MIG 400 is recommended to consult a doctor .; In the third trimester of pregnancy, the use of the drug MIG 400 is contraindicated due to the increased risk of complications for the mother and fetus .; There is evidence that ibuprofen penetrates into breast milk in small quantities without any adverse effects on the health of the infant, so with a short-term use of the need to stop breastfeeding usually does not occur. If necessary, long-term use of the drug MIG 400 during lactation, breastfeeding for the period of taking the drug should be discontinued. There is evidence that the COX / prostaglandin synthesis, can affect the reproductive ability of women due to the effect on ovuyatsiyu. This influence is reversible and disappears after drug withdrawal .;
Dosage and administration
The drug is taken orally.Dosing regimen set individually depending on the evidence .; Adults and children over 12 years old, the drug is prescribed, usually in the initial dose - 200 mg 3-4 times / day. To achieve a rapid therapeutic effect, the dose can be increased to 400 mg 3 times / day. Upon reaching the therapeutic effect, the daily dose is reduced to 600-800 mg. The drug should not be taken more than 7 days or in higher doses. If necessary, use longer or in higher doses, consult a doctor; In patients with impaired renal function, liver or heart, the dose should be reduced .;
Side effects
The frequency is classified by category in accordance with the classification of the World Health Organization, depending on the occurrence of the case: very often (more than 1/10), often (less than 1/10-more than 1/100), infrequently (less than 1/100-more than 1/1000), rarely (less than 1 / 1000-more than 1 / 10,000), very rarely (less than 1 / 10,000), including individual messages. The list of adverse reactions includes all adverse reactions that occurred during the use of ibuprofen, including, with its long-term with its long-term use and use in high doses .; Disorders of the gastrointestinal tract: Often: NSAIDs - gastropathy (heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation), minor gastrointestinal bleeding.; Infrequently: gastric / duodenal ulcer (peptic ulcers), in some cases with bleeding and perforation, ulceration of the oral mucosa (ulcerative stomatitis), exacerbation of ulcerative colitis or Crohn's disease, gastritis; Very rare: inflammation of the esophagus (esophagitis) and pancreas (pancreatitis), the formation of cicatricial constrictions in the thin and thick st intestine (intestinal stricture) .; Disorders of the liver and biliary ducts: Very rarely: abnormal liver function and liver damage (with long-term therapy), liver failure, acute liver inflammation (hepatitis) .; Disorders of the cardiovascular system: Very rare: disturbance of heartbeat, heart failure, myocardial infarction, increased blood pressure .; Violations of the blood and lymphatic system: Very rare: anemia, leukopenia, thrombocytopenia, pancytopenia,agranulocytosis .; The first signs of the development of the above conditions may be fever, sore throat, erosion of the oral mucosa, "flu-like" symptoms, fatigue, nosebleeds, skin hemorrhages. In case of such symptoms, you should immediately stop using the drug and consult a doctor and refrain from self-medication with painkillers or antipyretics .; Nervous system disorders: Often: headache, dizziness, insomnia, agitation, irritability, fatigue .; Violations of the organ of vision: Infrequently: visual impairment; Disturbances to the organ of hearing and labyrinth disorders: Rarely: tinnitus .; Renal and urinary tract disorders: Very rare: edema (mainly in patients with hypertension or impaired renal function), nephrotic syndrome, interstitial nephritis, acute renal failure, renal tissue damage (necrosis of the renal papillae) and an increase in uric acid concentration in blood plasma .; Disturbances of the skin and subcutaneous tissues: Very rare: skin rash, pruritus, bullous reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis. In very rare cases, severe skin infections and soft tissues are possible during chickenpox .; Immune system disorders: Infrequently: hypersensitivity reactions with skin rash and pruritus, bouts of bronchial asthma (in some cases accompanied by a pronounced decrease in blood pressure); Very seldom: severe general hypersensitivity reactions (angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm) .; Mental Disorders: Very rarely: psychotic reactions, depression .; Other: Very rare: exacerbation of inflammatory processes of infectious origin associated with the use of NSAIDs. Symptoms of aseptic meningitis (severe headaches, nausea, vomiting, fever, stiff neck, or loss of consciousness). Increased risk is characteristic of patients suffering from autoimmune diseases (systemic lupus erythematosus, mixed collagenosis) .; If any undesirable reactions occur, stop using the drug and consult a doctor;
Overdose
Symptoms: headache, dizziness, lethargy and loss of consciousness (myoclonic convulsions in children), abdominal pain, nausea, vomiting, low blood pressure, shortness of breath, cyanosis. Gastrointestinal bleeding and abnormal liver and kidney function are possible .; Treatment: gastric lavage (effective only for one hour after taking the drug), absorption agents, alkaline drinking, forced diuresis, symptomatic therapy (correction of the acid-base state, blood pressure). There is no specific antidote .;
Interaction with other drugs
Simultaneous use with other NSAIDs, including acetylsalicylic acid and selective COX-2 inhibitors, may increase the risk of gastrointestinal ulcers and bleeding. In this regard, the simultaneous use of the drug ibuprofen with other NSAIDs is not recommended .; Increases plasma concentration of digoxin, phenytoin and lithium preparations, which can lead to increased toxicity. As a rule, monitoring plasma concentrations of lithium, digoxin and phenytoin is not required .; Ibuprofen may weaken the action of diuretics and other antihypertensive drugs (angiotensin-converting enzyme inhibitors, beta-blockers and angiotensin II receptor antagonists). In some cases, in patients with impaired renal function (for example, in dehydrated patients or in patients with impaired renal function), simultaneous use of angiotensin-converting enzyme inhibitors, beta-blockers, angiotensin II receptor antagonists and COX inhibitors can lead to a further decrease in renal function, up to development of acute renal failure, which is usually reversible. Patients should receive a sufficient amount of fluid, and renal function should be carefully controlled. olirovat after the start of the simultaneous application .; Combined use with potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium preparations is not recommended due to the risk of hyperkalemia .; Glucocorticoids, platelet aggregation inhibitors and selective serotonin reuptake inhibitors when used concurrently with ibuprofen increase the risk of developing gastrointestinal ulcers or bleeding .; Experimental data showthat the simultaneous use of ibuprofen can inhibit the action of small doses of acetylsalicylic acid on platelet aggregation .; The use of ibuprofen within 24 hours before or after taking methotrexate can lead to an increase in the concentration of methotrexate and an increase in its toxic effect .; Cyclosporine increases the nephrotoxicity of ibuprofen .; Ibuprofen, like other NSAIDs, enhances the effects of indirect anticoagulants (for example, warfarin) .; There are clinical data on the interaction of NSAIDs and some hypoglycemic agents for oral administration (for example, derivatives of sulfonylurea). Due to the lack of data on the interaction of ibuprofen and sulfonylurea derivatives, with their simultaneous use, more careful control of plasma glucose concentration is recommended .; With simultaneous use with tacrolimus increases the risk of nephrotoxicity .; There is an increased risk of hemarthrosis and hematomas in HIV-positive patients who are simultaneously taking zidovudine and ibuprofen .; Probenecid, or sulfinpirazon, may increase the half-life of ibuprofen .; With simultaneous use of mifepristone, ibuprofen should be started no earlier than 8-12 days after taking mifepristone, since NSAIDs can reduce the effectiveness of mifepristone .; Patients taking both ibuprofen and quinolone antibiotics increase the risk of seizures; With simultaneous use with myelotoxic drugs, ibuprofen, like other NSAIDs, can increase their hematotoxic effect .;
special instructions
Not recommended simultaneous use of the drug MIG 400 with other NSAIDs, including selective blockade COX-2 .; To reduce the risk of adverse events from the gastrointestinal tract, a minimum effective dose of the drug should be used with the shortest possible course .; Caution should be exercised with the simultaneous use of ibuprofen with drugs that increase the risk of complications from the gastrointestinal tract (including bleeding), such as glucocorticosteroids, anticoagulants or antiplatelet agents (warfarin, acetylsalicylic acid) (see section Interaction with other drugs) .; To prevent the development of NSAID-gastropathy, the simultaneous use of ibuprofen with proton pump blockers and prostaglandin E drugs (for example,misoprostol) .; If symptoms of gastropathy appear, it is necessary to discontinue use of the drug and immediately seek medical help. Careful monitoring has been shown, including esophagogastroduodenoscopy, a blood test that measures hemoglobin, hematocrit, and fecal occult blood analysis .; In the case of long-term use of ibuprofen, monitoring of peripheral blood parameters and the functional state of the liver and kidneys is necessary .; Before using in patients with arterial hypertension and / or heart failure, care should be taken to consult a physician, since in this category of patients the use of NSAIDs can lead to fluid retention, edema, and high blood pressure .; The results of clinical studies and epidemiological data indicate that the use of ibuprofen, especially in high doses (2400 mg per day) and prolonged use, can lead to an increased risk of developing arterial thrombosis (the development of stroke or myocardial infarction). In general, according to epidemiological studies, the use of ibuprofen in low doses (less than 1200 mg per day) is not associated with an increased risk of myocardial infarction .; Prolonged use of any painkillers to relieve headaches can lead to its aggravation. In such a situation (or if there is a suspicion of its development), it is necessary to stop the use of painkillers and seek medical help. Frequent, habitual use of painkillers (especially their combinations) can lead to kidney damage with a risk of developing renal failure (analgesic nephropathy) .; In very rare cases, severe skin infections and soft tissue infections are possible with chickenpox. The use of the drug MIG 400 should be avoided for chickenpox .; There is evidence of rare cases of severe skin reactions (such as exfoliative dermatitis, Stephen-Johnson syndrome, toxic epidermal necrolysis), including fatal cases, when using NSAIDs. At the first manifestations of skin rash, mucous membranes or other signs of an allergic reaction, the use of MIG 400 should be immediately stopped .; In patientssuffering from allergic diseases and / or chronic obstructive pulmonary diseases, there is an increased risk of allergic reactions when using ibuprofen .; Allergic reactions can manifest as attacks of bronchial asthma, angioedema, or urticaria. In very rare cases, severe hypersensitivity reactions have been observed (for example, anaphylactic shock). In cases of the first signs of a hypersensitivity reaction, use of the drug MIG 400 should be stopped and consult a doctor. If it is necessary to determine the concentration of 17-ketosteroids in the blood plasma, the use of the drug should be canceled 48 hours before the start of the study. ; In the period of use of the drug MIG 400 alcohol is not recommended .; Ibuprofen can adversely affect reproductive function and ovulation in women, so women planning pregnancy are not recommended to take ibuprofen. Women who have problems with pregnancy or are being tested for infertility should stop taking ibuprofen .; When using the drug in children with signs of dehydration, there is a risk of kidney damage. The effect of the drug on the ability to drive vehicles and other mechanisms; During the period of treatment with ibuprofen, the rate of mental and motor reactions may decrease, therefore care must be taken when driving vehicles and practicing potentially hazardous activities that require high concentration of attention and speed of psychomotor reactions .;