Mig 400 coated pills 400mg N10
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Active ingredients
Ibuprofen
Release form
Pills
Composition
1 tab.: Ibuprofen 400 mg. Auxiliary substances: corn starch - 215 mg, sodium carboxymethyl starch (type A) - 26 mg, colloidal silicon dioxide - 13 mg, magnesium stearate - 5.6 mg. The composition of the shell: hypromellose (viscosity 6 MPa · s ) - 2.946 mg, titanium dioxide (E171) - 1.918 mg, povidone K30 - 0.518 mg, macrogol 4000 - 0.56 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. The analgesic effect is most pronounced with inflammatory pain. Analgesic activity of the drug does not belong to the narcotic type. Like other NSAIDs, ibuprofen has antiplatelet activity.
Pharmacokinetics
AbsorptionAfter ingestion, the drug is well absorbed from the gastrointestinal tract. Cmax of ibuprofen in plasma is approximately 30 μg / ml and is reached approximately 2 hours after taking the drug at a dose of 400 mg. Distribution Binding to plasma proteins is about 99%. It is slowly distributed in the synovial fluid and is eliminated from it more slowly than from plasma. Metabolism Ibuprofen is metabolized in the liver mainly by hydroxylation and carboxylation of the isobutyl group. Metabolites are pharmacologically inactive. ExcretionIt is characterized by a biphasic elimination kinetics. T1 / 2 of plasma is 2-3 hours. Up to 90% of the dose can be detected in the urine as metabolites and their conjugates. Less than 1% is excreted unchanged in the urine and, to a lesser extent, in the bile.
Indications
- headache; - migraine; - toothache; - neuralgia; - pain in muscles and joints; - menstrual pain, fever with colds and flu.
Contraindications
- erosive and ulcerative diseases of the organs: gastrointestinal tract (including gastric ulcer and duodenal ulcer in the acute phase, Crohn's disease, UC); - aspirin triad; - hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis; bleeding of various etiologies; glucose-6-phosphate dehydrogenase deficiency; optic nerve diseases; pregnancy; lactation period; children under 12; hypersensitivity to the components of the drug; hypersensitivity to acetylsalicylic acid or and other NSAIDs in history.
Precautionary measures
Do not exceed the recommended dose. The drug should be used with caution in the following cases: advanced age; heart failure; arterial hypertension; cirrhosis of the liver with portal hypertension; hepatic and / or renal failure, nephrotic syndrome, hyperbilirubinemia; peptic ulcer of the stomach and duodenum (in history), gastritis, enteritis, colitis; blood diseases of unknown etiology (leukopenia and anemia).
Use during pregnancy and lactation
Adequate and strictly controlled studies of the safety of ibuprofen in pregnancy are not available. The drug is contraindicated for use during pregnancy and lactation (breastfeeding). The use of ibuprofen can adversely affect female fertility and is not recommended for women who are planning a pregnancy.
Dosage and administration
The drug is taken orally. The dosage regimen is set individually depending on the indications. Adults and children over 12 years old are prescribed the drug, 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 for more than 7 days or in higher doses. If necessary, use longer or in higher doses, you should consult a doctor. In patients with impaired renal function, liver or heart, the dose should be reduced.
Side effects
On the part of the digestive system: NSAIDs-gastropathy - abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation; rarely, ulceration of the gastrointestinal tract mucosa, which in some cases is 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, hepatitis are possible. On the respiratory system: shortness of breath, bronchospasm. On the part of the sense organs: hearing loss, ringing or tinnitus, toxic damage to the visual nerve, blurred vision or double vision, scotoma dryness and eye irritation, conjunctival edema and eyelids (allergic origin). For the central nervous system and peripheral nervous system: headache, dizziness, insomnia, anxiety, nervousness, and rage, psychomotor agitation, drowsiness, depression, confusion, hallucinations,rarely - aseptic meningitis (more often in patients with autoimmune diseases). From the cardiovascular system: heart failure, tachycardia, increased blood pressure. From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis. Allergic reactions: skin rash (usually erythematous or urtikarnaya), pruritus, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, fever, erythema multiforme exudative (including syndrome Stevens-Johnson), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis. From the hematopoietic system: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukoprophytesis. an increase in bleeding time, a decrease in serum glucose concentration, a decrease in CC, a decrease in hematocrit or hemoglobin, an increase in serum creatinine concentration, and an increase in the activity of hepatic transaminases are possible. prolonged use of the drug in high doses increases the risk of ulceration of the gastrointestinal tract mucous membrane, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (color vision disorders, scotomas, optic nerve damage).
Overdose
Symptoms: abdominal pain, nausea, vomiting, lethargy, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest. Treatment: gastric lavage ( only within one hour after administration), activated carbon, alkaline drinking, forced diuresis, symptomatic therapy (correction of the acid-base state, blood pressure).
Interaction with other drugs
It is possible to decrease the efficacy of furosemide and thiazide diuretics due to sodium retention associated with inhibition of prostaglandin synthesis in the kidneys. Ibuprofen may enhance the effect of oral anticoagulants (simultaneous use is not recommended). With simultaneous administration with acetylsalicylic acid, ibuprofen reduces its antiaggregant effect (it may increase acute coronary insufficiency in patientsreceiving as an antiplatelet agent small doses of acetylsalicylic acid). Ibuprofen can reduce the effectiveness of antihypertensive drugs. In the literature, isolated cases of increased plasma concentrations of digoxin, phenytoin and lithium were described while taking ibuprofen. Ibuprofen, like other NSAIDs, should be used with caution. with acetylsalicylic acid or other NSAIDs and GKS, because this increases the risk of adverse effects of the drug on the gastrointestinal tract. Ibuprofen may increase the concentration of methotrexate in plasma. In combination therapy with zidovudine and ibuprofen, the risk of hemarthrosis and hematoma may be increased in HIV-infected patients with hemophilia. due to impaired prostaglandin synthesis in the kidneys. Ibuprofen enhances the hypoglycemic effect of oral hypoglycemic their means and insulin; dose adjustment may be necessary.
special instructions
If signs of bleeding from the gastrointestinal tract occur, ibuprofen should be canceled. Ibuprofen can mask objective and subjective symptoms, so the drug should be prescribed with caution to patients with infectious diseases. The occurrence of bronchospasm is possible in patients suffering from bronchial asthma or allergic reactions in history or present. be reduced when using the drug in the minimum effective dose. With long-term use of analgesics, there is a risk of developing analgesic nephropathy. Patients who notice visual impairment during ibuprofen therapy should stop treatment and undergo an ophthalmologic examination. Ibuprofen can increase the activity of liver enzymes. During treatment, control of the pattern of peripheral blood and the functional state of the liver and kidneys is necessary. When symptoms of gastropathy appear, close monitoring is shown, including esophagogastroduodenoscopy, a blood test to determine m of hemoglobin, hematocrit, fecal occult krov.Dlya prevention of NSAID-gastropathy ibuprofen should be combined with prostaglandin E medication (misoprostol) .Ifthe need to determine 17-ketosteroids should be discontinued 48 hours before the study. Ethanol administration is not recommended during treatment. Effect on ability to drive motor vehicles and control mechanisms Patients should refrain from all activities requiring increased attention and quickness of psychomotor reactions.