MIG 400 - instructions for use, dose, side effects, contraindications

Excipients: starch corn, carboxymethyl starch sodium salt, type A, silicon dioxide highly dispersed, magnesium stearate. Sheath: hypromellose, titanium dioxide (E 171), povidone (K = 30), macrogol 4000.

Description:Oval tablets coated with a coat, white or almost white, having a two-sided risk for division and embossing on one side of the "E" and "E" on both sides of the risks.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).

ATX: & nbsp

M.01.A.E.01 Ibuprofen

Pharmacodynamics:

Ibuprofen is a derivative of propionic acid and has analgesic, antipyretic and anti-inflammatory effects due to an indiscriminate 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 pains. The analgesic activity of the drug does not apply to the narcotic type. Like all NSAIDs, ibuprofen exhibits antiaggregant activity.

Pharmacokinetics:

Suction: well absorbed from the stomach. The maximum concentration (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: ibuprofen approximately 99% is associated with plasma proteins. It is slowly distributed in the synovial fluid and is withdrawn from it more slowly than from the plasma.

Biotransformation: ibuprofen is metabolized in the liver mainly by hydroxylation and carboxylation of the isobutyl group. Metabolites are pharmacologically inactive.

Excretion: has a two-phase kinetics of elimination. The half-life period (T1 / 2) from the plasma is 2-3 hours. Up to 90% of the dose can be detected in the urine in the form of metabolites and their conjugates. Less than 1% is excreted unchanged in urine and, to a lesser extent, with bile.

Indications:Headache, migraine, toothache, neuralgia, pain in muscles and joints, menstrual pains, feverish condition with colds and flu.

Contraindications:

- Hypersensitivity to any of the ingredients that make up the drug.

- Hypersensitivity to acetylsalicylic acid or other NSAIDs in history.

- Erosive and ulcerative diseases of the gastrointestinal tract (including gastric ulcer and duodenal ulcer in the acute stage, Crohn's disease, nonspecific ulcerative colitis).

- "Aspirin" asthma.

- Hemophilia and other disorders of blood clotting (including hypocoagulation), hemorrhagic diathesis.

- Bleeding of any etiology.

- Deficiency of glucose-6-phosphate dehydrogenase.

- Pregnancy.

- Lactation period.

- Children under 12 years.

- Diseases of the optic nerve.

Carefully:

- elderly 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 the anamnesis), gastritis, enteritis, colitis;

- blood diseases of unclear etiology (leukopenia and anemia)

Pregnancy and lactation:With regard to the safety of the use of ibuprofen during pregnancy, there is no sufficient experience to date. Therefore, in the first six months of pregnancy, the drug should not be used. In the last trimester of pregnancy ibuprofen is contraindicated.

Dosing and Administration:

Inside. The dosage regimen is set individually, depending on the indications.

Adults and children over 12 years of age, the drug is usually prescribed in an initial dose of 200 mg 3-4 times a day. To achieve a rapid therapeutic effect, the dose can be increased to 400 mg three times a day.When the therapeutic effect is achieved, the daily dose is reduced to 600-800 mg.

The drug should not be used for more than 7 days or at higher doses without consulting a doctor.

In patients with impaired renal, hepatic or cardiac function, the dose should be reduced.

Side effects:

- Gastrointestinal tract (GIT)

NSAIDs-gastropathy (abdominal pain, nausea, vomiting, heartburn, decreased 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 gingival mucosa, aphthous stomatitis, pancreatitis.

- Hepatobiliary system

Hepatitis.

- Breathing 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 Reagents

Skin rash (usually erythematous or urticaria), itchy skin, Quincke's edema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea,

fever, multi-form exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.

- Organs of hematopoiesis

Anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, and leukopenia.

- The organs of sight

Toxic lesion of the optic nerve, blurred vision or double vision, scotoma dryness and irritation of the eyes, edema of the conjunctiva and eyelids (allergic genesis).

The risk of ulceration of the gastrointestinal mucosa, bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), visual impairment (color vision, scotoma, optic nerve damage) increases with prolonged use of the drug in large doses.

- Laboratory indicators:

- bleeding time (may increase)

- serum glucose concentration (may decrease)

- clearance of creatinine (may decrease)

- hematocrit or hemoglobin (may decrease)

- serum creatinine concentration (may increase)

- activity of "liver" transaminases (may increase)

Overdose:

Symptoms: abdominal pain, nausea, vomiting, retardation, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, lowering blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest.

Treatment: gastric lavage (only for an hour after ingestion), Activated carbon, alkaline drink, forced diuresis, symptomatic therapy (correction of acid-base state, blood pressure).

Interaction:

- The efficacy of furosemide and thiazide diuretics can be reduced due to a delay in sodium associated with inhibition of prostaglandin synthesis in the kidneys.

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

- With concomitant administration 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 antiplatelet agents).

- Ibuprofen may reduce the effectiveness of antihypertensive drugs.

- In the literature, single cases of an increase in plasma concentrations of digoxin, phenytoin and lithium with simultaneous administration of ibuprofen have been described.

- 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 drug effects on the gastrointestinal tract).

- Ibuprofen may increase the concentration of methotrexate in the plasma.

- Combined 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 developing nephrotoxic effects due to a decrease in the synthesis of prostaglandins in the kidneys.

- Ibuprofen enhances the hypoglycemic effect of oral hypoglycemic agents and insulin; may arisethe need for dose adjustment.

Special instructions:

When there are signs of bleeding from the gastrointestinal tract ibuprofen must be canceled (see section Contraindications).

Ibuprofen may mask objective and subjective signs of infection, so ibuprofen therapy in patients with infection should be administered with caution.

The occurrence of bronchospasm is possible in patients suffering from bronchial asthma or allergic reactions in the anamnesis or in the present.

Side effects can be reduced by applying the lowest effective dose. With prolonged use of analgesics, there is a risk of developing analgesic nephropathy.

The use of ibuprofen can adversely affect female fertility and is not recommended for women planning a pregnancy.

Patients who report visual impairment with ibuprofen therapy should stop treatment and undergo ophthalmic examination. Ibuprofen can increase the level of "liver" enzymes. During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys.

When symptoms of gastropathy appear, careful monitoring including esophagogastroduodenoscopy, a blood test with determination of hemoglobin, hematocrit, analysis of feces for latent blood is shown.

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

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

Patients should refrain from all activities requiring increased attention, rapid mental and motor reaction. During the period of treatment, ethanol is not recommended.

Effect on the ability to drive transp. cf. and fur:Patients should refrain from all activities requiring increased attention, rapid mental and motor reaction.

Form release / dosage:

The tablets covered with a cover, on 400 mg.

Packaging:

For 10 tablets in a blister of PVC / aluminum foil.

For 1 or 2 blisters together with instructions for use in a cardboard box.

Storage conditions:The drug is stored in a dark place at a temperature of no higher than 30 ° C. Keep the medicine out of the reach of children!

Shelf life:

3 years. Do not use after the expiration date of the product indicated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LS-002211

Date of registration:28.10.2011

The owner of the registration certificate:Berlin-Chemie / Menarini Pharma, GmbH Berlin-Chemie / Menarini Pharma, GmbH Germany

Manufacturer: & nbsp

BERLIN-CHEMIE AG / MENARINI GROUP Germany

Representation: & nbspBERLIN-CHEMI / MENARINI PHARMA GmbH BERLIN-CHEMI / MENARINI PHARMA GmbH Germany

Information update date: & nbsp28.10.2011

Illustrated instructions

Instructions

MIG® 400 (MIG 400)