Mig tablets 400mg, No. 20

• Headache;

• migraine;

• toothache;

• neuralgia;

• muscle and joint pain;

• menstrual pain, fever with colds and flu.

The drug is taken orally. The dosage regimen is set individually depending on the indications.

For adults and children over 12 years of age, the drug is prescribed, as a rule, in an initial dose of 200 mg 3-4 times / day. To achieve a quick 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 at higher doses. If it is necessary to use it for a longer time or in higher doses, a doctor's consultation is required.

In patients with impaired renal, liver or heart function, the dose of the drug should be reduced.

Film-coated tablets

1 tab.

ibuprofen 400 mg

Excipients: corn starch, sodium carboxymethyl starch (type A), colloidal silicon dioxide, magnesium stearate.

• Erosive and ulcerative diseases of organs: gastrointestinal tract (including peptic ulcer of the stomach and duodenum in the acute phase, Crohn's disease, NUC);

• 'aspirin triad';

• hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis;

• bleeding of various etiologies;

• deficiency of glucose-6-phosphate dehydrogenase;

• diseases of the optic nerve;

• pregnancy;

• lactation period;

• children under 12 years of age;

• hypersensitivity to drug components;

• a history of hypersensitivity to acetylsalicylic acid or other NSAIDs.

The drug should be used with caution in the following cases: old age; heart failure; arterial hypertension; cirrhosis of the liver with portal hypertension; hepatic and / or renal failure, nephrotic syndrome, hyperbilirubinemia; gastric ulcer and duodenal ulcer (history), gastritis, enteritis, colitis; blood diseases of unknown etiology (leukopenia and anemia).

pharmachologic effect

Non-steroidal anti-inflammatory drug (NSAID). Ibuprofen is a propionic acid derivative and has analgesic, antipyretic and anti-inflammatory effects due to the indiscriminate blockade of COX-1 and COX-2, as well as inhibiting the synthesis of prostaglandins.

The analgesic effect is most pronounced for inflammatory pain. The analgesic activity of the drug is not narcotic.

Like other NSAIDs, ibuprofen has antiplatelet activity.

Pharmacokinetics

Suction

After oral administration, the drug is well absorbed from the gastrointestinal tract. Cmax of ibuprofen in plasma is approximately 30 ?g / ml and is reached approximately 2 hours after taking the drug at a dose of 400 mg.

Distribution

Plasma protein binding is about 99%. It is slowly distributed in the synovial fluid and is excreted from it more slowly than from plasma.

Metabolism

Ibuprofen is metabolized in the liver mainly by hydroxylation and carboxylation of the isobutyl group. The metabolites are pharmacologically inactive.

Withdrawal

It is characterized by two-phase elimination kinetics. T1 / 2 from plasma is 2-3 hours. Up to 90% of the dose can be detected in urine in the form of metabolites and their conjugates. Less than 1% is excreted unchanged in the urine and, to a lesser extent, in the bile.

Side effect

From the digestive system: NSAIDs-gastropathy - abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation; rarely - ulceration of the gastrointestinal mucosa, which in some cases is complicated by perforation and bleeding; possible irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis, hepatitis.

From the respiratory system: shortness of breath, bronchospasm.

From the senses: hearing loss, ringing or tinnitus, toxic damage to the optic nerve, blurred vision or double vision, scotoma dryness and irritation of the eyes, edema of the conjunctiva and eyelids (allergic genesis).

From the side of the central nervous system and peripheral nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, rarely - aseptic meningitis (more often in patients with autoimmune diseases).

From the side of 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 urticarial), pruritus, Quincke's edema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, fever, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal syndrome (epidermal toxicity) Lyell), eosinophilia, allergic rhinitis.

From the hematopoietic system: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.

On the part of laboratory parameters: 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, an increase in the activity of hepatic transaminases are possible.

Long-term use of the drug in high doses increases the risk of ulceration of the gastrointestinal tract, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (color vision disorders, scotoma, optic nerve damage).

Application during pregnancy and lactation

There are no adequate and well-controlled studies on the safety of ibuprofen during pregnancy. 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 planning a pregnancy.

Application for violations of liver function

Ibuprofen can increase the activity of liver enzymes. During treatment, it is necessary to monitor the functional state of the liver.

Application for impaired renal function

During treatment, it is necessary to monitor the functional state of the kidneys.

special instructions

If signs of gastrointestinal bleeding occur, ibuprofen should be discontinued.

Ibuprofen can mask objective and subjective symptoms, therefore, the drug should be prescribed with caution in patients with infectious diseases.

The occurrence of bronchospasm is possible in patients with bronchial asthma or allergic reactions in history or in the present.

Side effects can be reduced by using the drug in the lowest effective dose. With prolonged use of analgesics, the risk of developing analgesic nephropathy is possible.

Patients who experience visual impairment during ibuprofen therapy should discontinue treatment and undergo an ophthalmologic examination.

Ibuprofen can increase the activity of liver enzymes.

During treatment, it is necessary to control the picture of peripheral blood and the functional state of the liver and kidneys.

When symptoms of gastropathy appear, careful monitoring is shown, including esophagogastroduodenoscopy, blood test with determination of hemoglobin, hematocrit, fecal occult blood test.

To prevent the development of NSAID gastropathy, ibuprofen is recommended to be combined with prostaglandin E (misoprostol).

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

During the period of treatment, it is not recommended to take ethanol.

Influence on the ability to drive vehicles and use mechanisms

Patients should refrain from all activities that require increased attention and speed of psychomotor reactions.

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 an hour after ingestion), activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy (correction of acid-base state, blood pressure).

Drug interactions

A decrease in the effectiveness of furosemide and thiazide diuretics is possible due to sodium retention associated with inhibition of prostaglandin synthesis in the kidneys.

Ibuprofen may increase the effect of oral anticoagulants (concomitant use is not recommended).

When administered simultaneously with acetylsalicylic acid, ibuprofen reduces its antiplatelet effect (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent).

Ibuprofen may reduce the effectiveness of antihypertensive drugs.

In the literature, isolated cases of an increase in plasma concentrations of digoxin, phenytoin and lithium have been described while taking ibuprofen.

Ibuprofen, like other NSAIDs, should be used with caution in combination with acetylsalicylic acid or other NSAIDs and GCS, because this increases the risk of developing adverse effects of the drug on the digestive tract.

Ibuprofen can increase the plasma concentration of methotrexate.

Combination therapy with zidovudine and ibuprofen may increase the risk of hemarthrosis and hematoma in HIV-infected patients with hemophilia.

The combined use of ibuprofen and tacrolimus may increase the risk of developing nephrotoxic effects due to impaired renal prostaglandin synthesis.

Ibuprofen enhances the hypoglycemic effect of oral hypoglycemic agents and insulin; dose adjustment may be necessary.