Mig instructions for use

pharmachologic effect

Ibuprofen is a derivative of propionic acid and has analgesic, antipyretic and anti-inflammatory effects due to the non-selective blockade of cyclooxygenase 1 and 2, as well as an inhibitory effect on the synthesis of prostaglandins.
The analgesic effect is most pronounced for inflammatory pain. The analgesic activity of the drug is not of the narcotic type. Like all NSAIDs, ibuprofen exhibits antiplatelet activity.

Pharmacokinetics

Suction: well absorbed from the stomach. The maximum concentration (Cmax) of ibuprofen in plasma is approximately 30 mcg/ml and is reached approximately 2 hours after taking the drug at a dose of 400 mg.
Distribution: ibuprofen is approximately 99% bound to plasma proteins. It is slowly distributed in and cleared from synovial fluid more slowly than from plasma.
Biotransformation: Ibuprofen is metabolized in the liver primarily by hydroxylation and carboxylation of the isobutyl group. Metabolites are pharmacologically inactive.
Removal: has two-phase elimination kinetics. The half-life (T/2) from plasma is 2-3 hours. Up to 90% of the dose can be found in urine in the form of metabolites and their conjugates. Less than 1% is excreted unchanged in urine and, to a lesser extent, in bile.

Indications

Headache, migraine, toothache, neuralgia, muscle and joint pain, menstrual pain, fever due to colds and flu.

Dosage regimen

MIG 400 is taken orally. The dosage regimen is set individually. Adults and children over 12 years of age are usually prescribed 400 mg 3 times a day (max. daily dose - 1200 mg). To achieve a rapid therapeutic effect, the dose can be increased to 400 mg 3 times a day. Upon achieving a therapeutic effect, the daily dose is reduced to 600 - 800 mg.
The drug should not be used for more than 7 days or in higher doses without consulting a doctor.
In patients with impaired renal, hepatic or cardiac function, the dose should be reduced

Side effect

Gastrointestinal tract (GIT)
NSAID 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); irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the gum mucosa, aphthous stomatitis, pancreatitis.
Hepato-biliary system
Hepatitis.
Respiratory system
Shortness of breath, bronchospasm.
Sense organs
Hearing impairment: hearing loss, ringing or tinnitus.
Central 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).
The cardiovascular system
Heart failure, tachycardia, increased blood pressure.
urinary system
Acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.
Allergic reactions
Skin rash (usually erythematous or urticarial), pruritus, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.
Blood-forming organs
Anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytoea, leukopenia.
Organs of vision
Toxic damage to the optic nerve, blurred vision or double vision, scotoma, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic origin). The risk of developing ulcerations of the gastrointestinal mucosa, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (impaired color vision, scotoma, optic nerve damage) increases with long-term use of the drug in large doses.

Laboratory indicators

• 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) .

Contraindications

• Hypersensitivity to any of the ingredients included in the drug.
• History of hypersensitivity to acetylsalicylic acid or other NSAIDs.
• Erosive and ulcerative diseases of the gastrointestinal tract (including peptic ulcer of the stomach and duodenum in the acute stage, Crohn's disease, ulcerative colitis).
• "Aspirin" asthma.
• Hemophilia and other bleeding disorders (including hypocoagulation), hemorrhagic diathesis.
• Bleeding of any etiology.
• Glucose-6-phosphate dehydrogenase deficiency.
• Pregnancy.
• Lactation period.
• Children's age up to 12 years.
• Diseases of the optic nerve.

Caution is required in the following cases:

• elderly age;
• heart failure;
• arterial hypertension;
• liver cirrhosis with portal hypertension;
• liver and/or renal failure, nephrotic syndrome, hyperbilirubinemia;
• peptic ulcer of the stomach and duodenum (history), gastritis, enteritis, colitis;
• blood diseases of unknown etiology (leukopenia and anemia);

Pregnancy and lactation

There is currently no sufficient experience regarding the safety of using ibuprofen during pregnancy. Therefore, the drug should not be used in the first six months of pregnancy. Ibuprofen is contraindicated in the last trimester of pregnancy.

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 administration), activated charcoal, alkaline drinking, forced diuresis, symptomatic therapy (correction of acid-base status, blood pressure).

special instructions

If signs of bleeding from the gastrointestinal tract occur, ibuprofen should be discontinued (see contraindications section).
Ibuprofen may mask objective and subjective signs of infection, so ibuprofen therapy should be used with caution in patients with infection.
The occurrence of bronchospasm is possible in patients suffering from bronchial asthma or allergic reactions in history or in the present.
Side effects can be reduced when using the minimum effective dose. With long-term use of analgesics, there is a possible risk of developing analgesic nephropathy.
The use of ibuprofen may negatively affect female fertility and is not recommended for women planning pregnancy.
Patients who experience visual disturbances during ibuprofen therapy should discontinue treatment and undergo an ophthalmological examination.
Ibuprofen may increase liver enzyme levels.
During treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary.
When symptoms of gastropathy appear, careful monitoring is indicated, including esophago-gastroduodenoscopy, a blood test to determine hemoglobin, hematocrit, and a stool test for occult blood. To prevent the development of NSAID gastropathy, it is recommended to combine it with prostaglandin E drugs (misoprostol).
If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. Patients should refrain from all activities that require increased attention, rapid mental and motor reactions. During the treatment period, ethanol intake is not recommended.

Drug interactions

The effectiveness of furosemide and thiazide diuretics may be reduced due to sodium retention associated with inhibition of renal prostaglandin synthesis.

Ibuprofen may enhance the effect of oral anticoagulants, so the simultaneous use of ibuprofen and oral anticoagulants is not recommended.

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

Ibuprofen may reduce the effectiveness of antihypertensive medications.

Isolated cases of increased plasma concentrations of digoxin, phenytoin and lithium while taking ibuprofen have been described in the literature.

Ibuprofen (like other NSAIDs) should be used with caution in combination with acetylsalicylic acid or other NSAIDs and glucocorticosteroids (this increases the risk of adverse effects of the drug on the gastrointestinal tract).

Ibuprofen may increase plasma concentrations of methotrexate.

Combination treatment 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 nephrotoxicity due to decreased synthesis of prostaglandins in the kidneys.

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

Storage conditions and periods

List B.: In a place protected from light, at a temperature not exceeding 30 °C. Shelf life: 3 years.

• - Descriptions and photographs in product cards may differ from what is presented in the pharmacy. Please check information with operators before placing an order.
• - This product cannot be exchanged or returned on the basis of Resolution 55 of January 19, 1998.

Active ingredient: ibuprofen - 400.0 mg.

Excipients: corn starch - 215.00 mg, sodium carboxymethyl starch (type A) - 26.00 mg, 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.

Pharmacodynamics. It has analgesic, antipyretic and anti-inflammatory effects. Ibuprofen is a propionic acid derivative. The mechanism of action is associated with inhibition of the enzyme cyclooxygenase (COX) types 1 and 2, which leads to inhibition of prostaglandin synthesis.

The analgesic effect is most pronounced for inflammatory pain. Suppresses
platelet aggregation.

Pharmacokinetics. Absorption: Ibuprofen is well absorbed from the gastrointestinal tract. The maximum concentration (Cmax) of ibuprofen in the blood plasma after taking the drug orally at a dose of 400 mg is reached after 1-2 hours and is about 30 mcg/ml.

Distribution: binding to plasma proteins about 99%. Distributed in synovial fluid (Cmax 2-3 hours), where it creates higher concentrations than in plasma.

Metabolism: Metabolized in the liver mainly by hydroxylation and carboxylation of the isobutyl group. Metabolites are pharmacologically inactive.

Elimination: has two-phase elimination kinetics. The half-life (T1/2) is 1.8-3.5 hours. It is excreted by the kidneys (no more than 1% unchanged) and, to a lesser extent, with bile.

Headache,
.migraine,
.toothache,
.neuralgia,
.pain in muscles and joints,
.menstrual pain,
.febrile syndrome with colds and flu.

Inside. Take MIG ® 400 without chewing, with plenty of water, during or after meals.
The dosage for children and adolescents depends on body weight and age and averages 7-10 mg/kg body weight.
The dosage regimen is indicated in the table:

In elderly patients with mild to moderate hepatic impairment and in patients with renal impairment mild degree severity of drug dose adjustment
not required.

The minimum effective dose should be used for the shortest possible short course.

During treatment, monitoring of peripheral blood parameters and the functional state of the liver and kidneys is necessary.

Uncommon: stomach/duodenal ulcers (peptic ulcers), in some cases with bleeding and perforation, ulcerations of the oral mucosa (ulcerative), exacerbation of ulcerative or Crohn's disease.

Very rare: inflammation of the esophagus (esophagitis) and pancreas (pancreatitis), formation of scarring in the small and large intestines (intestinal strictures).

Disorders of the liver and biliary tract:

Very rare: liver dysfunction (with long-term therapy), acute inflammation of the liver (hepatitis).

Cardiovascular system disorders:

Nervous system disorders:

Renal and urinary tract disorders:

Very rare: increased fluid retention in cells (edema), especially in patients with hypertension or impaired renal function, nephrotic syndrome,. Damage to the renal tissue (necrosis of the renal papillae) and increased concentration of uric acid in the blood serum.

Disorders of the skin and subcutaneous tissues:

Immune system disorders:

Very rare: severe general hypersensitivity reactions (angioedema, anaphylactoid reactions,).

Mental disorders:

Very rare: psychotic reactions.

Other instructions:

Very rare: exacerbation of inflammatory processes of infectious origin associated with the use of NSAIDs. Aseptic symptoms (severe headaches, nausea, vomiting, fever, neck pain or loss of consciousness). An increased risk is typical for patients suffering from autoimmune diseases (systemic lupus erythematosus, mixed).

If any side effects occur, you should stop using the drug and consult a doctor.

Concomitant use with other NSAIDs may increase the risk of gastrointestinal ulcers and bleeding. In this regard, the simultaneous use of MIG® 400 with other NSAIDs is not recommended.

Increases plasma concentrations of digoxin, phenytoin, methotrexate and lithium preparations, which can lead to increased toxicity.

MIG® 400 may reduce the effect of diuretics and other antihypertensive drugs.

Ibuprofen weakens the effect of ACE inhibitors, increasing the risk of functional renal impairment. Patients should be kept adequately hydrated and renal function should be closely monitored after initiating concomitant therapy.

Glucocorticoids, platelet aggregation inhibitors and selective serotonin reuptake inhibitors when used simultaneously with ibuprofen increase the risk of developing gastrointestinal ulcers or bleeding.

Experimental data indicate that concomitant use of ibuprofen may inhibit the effect of low doses of acetylsalicylic acid on platelet aggregation.

Taking MIG® 400 within 24 hours before or after taking methotrexate may result in increased methotrexate concentrations and increased toxicity.

Cyclosporine increases the nephrotoxicity of ibuprofen.

Ibuprofen, like other NSAIDs, enhances the effect of indirect anticoagulants (for example, warfarin).

Enhances the hypoglycemic effect of insulin and oral hypoglycemic drugs.

When used concomitantly with tacrolimus, the risk of nephrotoxicity increases.

Probenecid or sulfinpyrazone may increase the time it takes for ibuprofen to be eliminated from the body.

Hypersensitivity to ibuprofen or any of the components included in the drug;
complete or incomplete combination of recurrent polynosis or paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history);
erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active (including rectal, cerebrovascular or other bleeding);
.period ;
hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis;
.inflammatory bowel diseases (Crohn's disease) in the acute phase;
severe impairment of liver or kidney function (creatinine clearance less than 30 ml/min);
.severe heart failure;
.pregnancy (III trimester);
.children under 6 years of age and children weighing less than 20 kg.

Carefully

Old age, severe somatic diseases, heart failure, liver failure, with portal hypertension, hyperbilirubinemia, renal failure (creatinine clearance less than 60 ml/min), nephrotic syndrome, colitis, and duodenum (including a history), presence Helicobacter Pylori infections, conditions after major surgical interventions, autoimmune diseases (systemic lupus erythematosus), dyslipidemia/hyperlipidemia, peripheral arterial disease, smoking, frequent alcohol consumption, unknown etiology (leukopenia and anemia), long-term use of NSAIDs, simultaneous use of oral corticosteroids (in including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective inhibitors of neuronal serotonin uptake (including citalopram, fluoxetine, paroxetine, sertraline).

Use during pregnancy and lactation

The use of MIG® 400 in the first six months of pregnancy is permitted only after consultation with a doctor. In the last three months of pregnancy, the use of MIG® 400 is contraindicated due to the increased risk of complications for the mother and fetus.

Ibuprofen is excreted into breast milk in small quantities. If long-term use of the drug MIG® 400 is necessary during lactation, breastfeeding should be stopped while taking the drug.

Symptoms: headache, dizziness, lethargy and loss of consciousness, abdominal pain, nausea, vomiting, decreased blood pressure, cyanosis. Gastrointestinal bleeding and impaired liver and kidney function are possible.

Treatment: (only within an hour after taking the drug), use of adsorbents, alkaline drinking, symptomatic therapy (correction of acid-base status, blood pressure). There is no specific antidote.

Product: MIG ® 400
Active substance: ibuprofen
ATX code: M01AE01
KFG: NSAIDs
Reg. number: LS-002211
Registration date: 03.11.06
Owner reg. cred.: BERLIN-CHEMIE AG/MENARINI GROUP (Germany)

DOSAGE FORM, COMPOSITION AND PACKAGING

? Film-coated tablets white or almost white, oval, with a double-sided scoring line and an “E” and “E” embossed on both sides of the scoring line on one side.

Excipients: corn starch, sodium carboxymethyl starch type A, highly dispersed silicon dioxide, magnesium stearate.

Shell composition: hypromellose, titanium dioxide (E171), povidone K30, macrogol 4000.

10 pieces. - blisters (1) - cardboard packs.
10 pieces. - blisters (2) - cardboard packs.

DESCRIPTION OF THE ACTIVE SUBSTANCE.
The scientific information provided is general and cannot be used to make a decision about the possibility of using a particular drug.

PHARMACHOLOGIC EFFECT

NSAIDs, a derivative of phenylpropionic acid. It has anti-inflammatory, analgesic and antipyretic effects.

The mechanism of action is associated with inhibition of the activity of COX, the main enzyme in the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever. The analgesic effect is due to both peripheral (indirectly, through suppression of prostaglandin synthesis) and central mechanisms (due to inhibition of prostaglandin synthesis in the central and peripheral nervous system). Suppresses platelet aggregation.

When applied externally, it has an anti-inflammatory and analgesic effect. Reduces morning stiffness and helps increase range of motion in joints.

PHARMACOKINETICS

When taken orally, ibuprofen is almost completely absorbed from the gastrointestinal tract. Concomitant food intake slows down the rate of absorption. Metabolized in the liver (90%). T 1/2 is 2-3 hours.

80% of the dose is excreted in the urine mainly in the form of metabolites (70%), 10% - unchanged; 20% is excreted through the intestines in the form of metabolites.

INDICATIONS

Inflammatory and degenerative diseases of the joints and spine (including rheumatic and rheumatoid arthritis, ankylosing spondylitis, osteoarthritis), articular syndrome with exacerbation of gout, psoriatic arthritis, ankylosing spondylitis, tendinitis, bursitis, radiculitis, traumatic inflammation of soft tissues and musculoskeletal apparatus. Neuralgia, myalgia, pain syndrome due to infectious and inflammatory diseases of the ENT organs, adnexitis, algodismenorrhea, headache and toothache. Fever in infectious and inflammatory diseases.

DOSING REGIME

They are set individually, depending on the nosological form of the disease and the severity of clinical manifestations. When taken orally or rectally for adults, a single dose is 200-800 mg, frequency of administration is 3-4 times a day; for children - 20-40 mg/kg/day in several doses.

Apply externally for 2-3 weeks.

Maximum dose: for adults when taken orally or rectally - 2.4 g.

SIDE EFFECT

From the digestive system: often - nausea, anorexia, vomiting, epigastric discomfort, diarrhea; possible development of erosive and ulcerative lesions of the gastrointestinal tract; rarely - bleeding from the gastrointestinal tract; With long-term use, liver function disorders are possible.

From the central nervous system and peripheral nervous system: often - headache, dizziness, sleep disturbances, agitation, visual disturbances.

From the hematopoietic system: with long-term use, anemia, thrombocytopenia, and agranulocytosis are possible.

From the urinary system: With long-term use, renal dysfunction is possible.

Allergic reactions: often - skin rash, Quincke's edema; rarely - aseptic meningitis (more often in patients with autoimmune diseases), bronchospastic syndrome.

Local reactions: When used externally, skin hyperemia, burning or tingling sensations are possible.

CONTRAINDICATIONS

Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, diseases of the optic nerve, “aspirin triad”, hematopoietic disorders, severe renal and/or liver dysfunction; hypersensitivity to ibuprofen.

PREGNANCY AND LACTATION

Ibuprofen should not be used in the third trimester of pregnancy. Use in the first and second trimesters of pregnancy is justified only in cases where the expected benefit to the mother outweighs the possible harm to the fetus.

Ibuprofen is excreted in breast milk in small quantities. Use during lactation for pain and fever is possible. If long-term use or use in high doses (more than 800 mg/day) is necessary, the issue of stopping breastfeeding should be considered.

SPECIAL INSTRUCTIONS

Use with caution in case of concomitant diseases of the liver and kidneys, chronic heart failure, with dyspeptic symptoms before starting treatment, immediately after surgery, with indications in the anamnesis of bleeding from the gastrointestinal tract and gastrointestinal diseases, allergic reactions associated with taking NSAIDs.

During treatment, systematic monitoring of liver and kidney functions and peripheral blood patterns is necessary.

Should not be used externally on damaged skin areas.

DRUG INTERACTIONS

With simultaneous use, ibuprofen reduces the effect of antihypertensive drugs (ACE inhibitors, beta-blockers), diuretics (furosemide, hypothiazide).

When used simultaneously with anticoagulants, their effect may be enhanced.

When used simultaneously with GCS, the risk of side effects from the gastrointestinal tract increases.

When used simultaneously, ibuprofen can displace indirect anticoagulants (acenocoumarol), hydantoin derivatives (phenytoin), and oral hypoglycemic drugs, sulfonylurea derivatives, from compounds with blood plasma proteins.

When used simultaneously with amlodipine, a slight decrease in the antihypertensive effect of amlodipine is possible; with acetylsalicylic acid - the concentration of ibuprofen in the blood plasma decreases; with baclofen - a case of increased toxic effects of baclofen is described.

When used simultaneously with warfarin, an increase in bleeding time is possible; microhematuria and hematomas were also observed; with hydrochlorothiazide - a slight decrease in the antihypertensive effect of hydrochlorothiazide is possible; with captopril - the antihypertensive effect of captopril may be reduced; with cholestyramine - a moderately pronounced decrease in the absorption of ibuprofen.

When used simultaneously with lithium carbonate, the concentration of lithium in the blood plasma increases.

When used simultaneously with magnesium hydroxide, the initial absorption of ibuprofen increases; with methotrexate - the toxicity of methotrexate increases.