medicalmeds.eu Medicines Non-steroidal anti-inflammatory drug (NPVP). Instant 400

Instant 400

Препарат Миг 400. Berlin-Chemie AG/ Menarini Group (Берлин-Хеми АГ/ Менарини Групп) Германия

Producer: Berlin-Chemie AG/Menarini Group (Berlin-Hemi AG/Menarini Group) Germany

Code of automatic telephone exchange: M01AE01

Release form: Firm dosage forms. Tablets.

Indications to use: Hyper thermal syndrome (Fever). Mialgiya. Neuralgia. Dentagra. Migraine. Headache. Algodismenorey.

General characteristics. Structure:

Active ingredient: an ibuprofen - 400,0 mg.

Excipients: starch corn - 215,00 mg, sodium carboxymethylstarch (type A) - 26,00 mg, silicon dioxide colloid - 13,00 mg, magnesium stearate - 5,60 mg.

Cover: a gipromelloza (viscosity of 6 MPas • c) - 2,940 mg, povidone (value K = 30) - 0,518 mg, a macrogoal of 4000 - 0,560 mg, titanium dioxide (Е 171) - 1,918 mg.

Pharmacological properties:

Pharmacodynamics. Possesses analgetic, febrifugal and antiinflammatory action. The ibuprofen is derivative propionic acid. The mechanism of action is connected with inhibition of enzyme (TsOG) 1 and 2 cyclooxygenase of types that leads to oppression of synthesis of prostaglandins.

Analgetic action is most expressed at pains of inflammatory character. Suppresses
aggregation of thrombocytes.

Pharmacokinetics. Absorption: the ibuprofen is well absorbed from digestive tract. The maximum concentration (Cmax) of an ibuprofen in a blood plasma after administration of drug inside in a dose of 400 mg is reached in 1-2 hours and makes about 30 mkg/ml.

Distribution: communication with proteins of plasma about 99%. It is distributed in synovial fluid (Cmax of 2-3 h) where creates big concentration, than in plasma.

Metabolism: it is metabolized in a liver mainly by a hydroxylation and a carboxylation of isobutyl group. Metabolites pharmacological are inactive.

Removal: has two-phase kinetics of elimination. The elimination half-life (T1/2) makes 1,8-3,5 hours. It is removed by kidneys (in an invariable look no more than 1%) and, to a lesser extent, with bile.

Indications to use:

• headache,
• migraine,
• dentagra,
• neuralgia,
• muscle and joints pain,
• menstrual pain,
• a feverish syndrome at catarrhal diseases and flu.

Route of administration and doses:

Inside. To accept ^{the drug МИГ® 400} without chewing, washing down with enough water, in time or after food.
The dosage for children and teenagers depends on the body weight and age and averages 7-10 mg/kg of body weight.
The mode of dosing is specified in the table:

Body weight and age	Single dose	Maximum daily dose
Children: 6-9 years (20-29 kg)	1/2 tablets (200 mg)	1/2 tablets (600 mg)
Children: 10-12 years (30-39 kg)	1/2 tablets (200 mg)	2 tablets (800 mg)
Children are more senior than 12 years (≥ 40 kg)	Adult 1/2-1 tablets (200-400 mg)	3 tablets (1200 mg)

Repeated administration of drug earlier, than in 6 hours is not recommended.

No more than four days are recommended to use the drug МИГ® 400.

Patients of advanced age with an abnormal liver function easy and moderate severity, and at patients with a renal failure of easy severity have drug dose adjustments
it is not required.

It is necessary to use a minimal effective dose minimum possible short course.

Features of use:

During treatment control of indicators of peripheral blood and a functional condition of a liver and kidneys is necessary.

At emergence of symptoms of a gastropathy the careful control including carrying out an ezofagogastroduodenoskopiya, blood test with definition of hemoglobin, a hematocrit, the analysis a calla on the occult blood is shown.

For the prevention of development of the NPVP-gastropathy it is recommended to combine with prostaglandin E drugs (for example, мизопростол).

For decrease in risk of development of the undesirable phenomena from a GIT it is necessary to use a minimal effective dose minimum possible short course.

In need of definition of 17 ketosteroids drug should be cancelled for 48 h prior to a research.

During treatment alcohol intake is not recommended.

Influence of drug on ability to driving of motor transport and to control of mechanisms

Îêâ® 400 in high doses can cause drowsiness and dizziness that in some cases can lead to reaction delay therefore it is necessary to be careful during the driving of vehicles and occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

Frequency is classified by headings, depending on occurrence of a case: very often (> 1/10), it is frequent (<1/10-> 1/100), infrequently (<1/100-> 1/1000), is rare (<1/1000-> 1/10000), is very rare (<1/10000), including separate messages.

Disturbances from digestive tract:

Often: NPVP - a gastropathy (heartburn, an abdominal pain, nausea, vomiting, a meteorism, diarrhea, a lock), insignificant gastrointestinal bleedings.

Infrequently: an ulcer of a stomach/duodenum (round ulcers), in certain cases with bleeding and perforation, ulcerations of a mucous membrane of a mouth (stomacace), an exacerbation of ulcer colitis or disease Krone.

Very seldom: a gullet inflammation (esophagitis) and a pancreas (pancreatitis), formation of cicatricial narrowings in a small and large intestine (an intestines stricture).

Disturbances from a liver and biliary tract:

Very seldom: abnormal liver functions (at long therapy), an acute liver failure, an acute inflammation of a liver (hepatitis).

Disturbances from cardiovascular system:

Very seldom: tachycardia, heart failure, myocardial infarction, increase in arterial pressure.

Disturbances from blood and lymphatic system:

Very seldom: anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis.

Disturbances from a nervous system:

Often: headache, dizziness, sleeplessness, excitement, irritability, fatigue.

Disturbances from sense bodys:

Infrequently: vision disorders.

Seldom: sonitus.

Disturbances from kidneys and urinary tract:

Very seldom: increase in a delay of liquid in cells (hypostases), especially at patients with a hypertension or with a renal failure, a nephrotic syndrome, intersticial nephrite, an acute renal failure. Defeats of renal fabric (necroses of renal nipples) and increase in concentration of uric acid in blood serum.

Disturbances from skin and hypodermic fabrics:

Very seldom: skin rash, skin itch, Stephens-Johnson's syndrome, toxic epidermal necrolysis.

Heavy skin infections and complications in soft tissues are in exceptional cases possible during an infection of chicken pox or an erysipelatous inflammation of face / shingles.

Disturbances from immune system:

Very seldom: heavy general reactions of hypersensitivity (Quincke's disease, anaphylactoid reactions, acute anaphylaxis, bronchospasm).

Disturbances of mentality:

Very seldom: psychotic reactions, depression.

Other instructions:

Very seldom: an aggravation of the inflammatory processes of an infectious origin connected using NPVP. Symptoms of aseptic meningitis (severe headaches, nausea, vomiting, fever, muscle tension of a nape or loss of consciousness). The increased risk is characteristic of the patients having autoimmune diseases (a system lupus erythematosus, mixed collagenoses).

At emergence of any side effects it is necessary to stop use of drug and to see a doctor.

Interaction with other medicines:

The concomitant use with other NPVP can increase risk of developing of gastrointestinal ulcers and bleedings. In this regard simultaneous use of the drug МИГ® 400 with other NPVP is not recommended.

Increases concentration in plasma of digoxin, Phenytoinum, methotrexate and drugs of lithium that can lead to strengthening of their toxicity.

Îêâ® 400 can reduce effect of diuretics and other anti-hypertensive drugs.

The ibuprofen weakens effect of APF inhibitors, the risk of functional disturbance of kidneys increases. Patients have to receive enough liquid, and renal function should be controlled carefully after the beginning of joint therapy.

Combined use with kaliysberegayushchy diuretics (Spironolactonum, Triamterenum, amiloride), potassium drugs because of risk of emergence of a hyperpotassemia is not recommended.

Glucocorticoids, inhibitors of aggregation of thrombocytes and selective serotonin reuptake inhibitors at simultaneous use with an ibuprofen increase risk of development of gastrointestinal ulcers or bleedings.

Experimental data show that simultaneous use of an ibuprofen can inhibit action of small doses of acetylsalicylic acid on aggregation of thrombocytes.

Administration of drug МИГ® 400 within 24 hours to or after reception of a methotrexate can lead to increase in concentration of a methotrexate and increase in its toxic action.

Cyclosporine increases nephrotoxicity of an ibuprofen.

The ibuprofen, as well as other NPVP, strengthens effect of indirect anticoagulants (for example, warfarin).

Strengthens hypoglycemic effect of insulin and peroral hypoglycemic medicines.

At simultaneous use with takrolimusy the risk of nephrotoxicity increases.

Probenetsid or Sulfinpyrazonum can increase time of removal of an ibuprofen from an organism.

Contraindications:

• hypersensitivity to an ibuprofen or any of the components which are a part of drug;
• a full or incomplete combination of bronchial asthma, a recurrent pollinosis or okolonosovy bosoms and intolerance of acetylsalicylic acid or other NPVP (including in the anamnesis);
• erosive and ulcer changes of a mucous membrane of a stomach or 12-perstny gut, active gastrointestinal bleeding (including rectal, cerebrovascular or other bleeding);
• period of aortocoronary shunting;
• hemophilia and other disturbances of coagulability of blood (including hypocoagulation), hemorrhagic diathesis;
• inflammatory diseases of intestines (a disease Krone, nonspecific ulcer colitis) in an aggravation phase;
• heavy abnormal liver functions or kidneys (clearance of creatinine less than 30 ml/min.);
• heavy heart failure;
• pregnancy (III trimester);
• children up to 6 years and children with body weight less than 20 kg.

With care

Advanced age, heavy somatopathies, heart failure, arterial hypertension, liver failure, cirrhosis with portal hypertensia, a hyperbilirubinemia, a renal failure (clearance of creatinine less than 60 ml/min.), a nephrotic syndrome, gastritis, enteritis, colitis, a peptic ulcer of a stomach and duodenum (including in the anamnesis), existence of an infection of Helicobacter Pylori, a state after extensive surgical interventions, autoimmune diseases (a system lupus erythematosus), дислипидемия / a lipidemia, a diabetes mellitus, a disease of peripheral arteries, smoking, frequent alcohol intake, diseases of blood of not clear etiology (a leukopenia and anemia), prolonged use of NPVP, a concomitant use of peroral GKS (including Prednisolonum), anticoagulants (including warfarin), antiagregant (including acetylsalicylic acid, klopidogret), the selection inhibitors of neyronalny serotonin reuptake (including to tsitalopra, fluoxetine, пароксетин, sertraline).

Use at pregnancy and a lactation

It is allowed to use the drug МИГ® 400 in the first six months of pregnancy only after consultation with the doctor. In the last three months of pregnancy use of the drug МИГ® 400 is contraindicated because of the increased risk of complications for mother and a fruit.

The ibuprofen is allocated in breast milk in insignificant quantities. In need of prolonged use of the drug МИГ® 400 in the period of a lactation breastfeeding for administration of drug should be stopped.

Overdose:

Symptoms: headache, dizziness, block and loss of consciousness, abdominal pain, nausea, vomiting, lowering of arterial pressure, short wind, cyanosis. Gastrointestinal bleedings and abnormal liver functions and kidneys are possible.

Treatment: a gastric lavage (only within an hour after administration of drug), use of adsorbents, alkaline drink, an artificial diuresis, symptomatic therapy (correction of an acid-base state, arterial pressure). There is no specific antidote.