MIG 400,400 mg 10 pcs

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

ATC code: M01AE01

Pharmacological properties

Pharmacodynamics

The mechanism of action of ibuprofen, a derivative of propionic acid from the group of non-steroidal anti-inflammatory drugs (NSAIDs) is due to the inhibition of the synthesis of prostaglandins – mediators of pain, inflammation and hyperthermia. Indiscriminately blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), thereby inhibiting the synthesis of prostaglandins. It has a fast directed action against pain (analgesic), antipyretic and anti-inflammatory effect. In addition, ibuprofen reversibly inhibits platelet aggregation.

The analgesic effect of the drug lasts up to 8 hours.

Pharmacokinetics

Absorption is high and is quickly and almost completely absorbed from the gastrointestinal tract (GIT). After taking the drug on an empty stomach the maximum concentration (Cmax) of ibuprofen in plasma is reached after 45 minutes.

Ingestion of the drug with food may increase the time to reach the maximum concentration (TCmax) up to 1-2 hours. The binding to plasma proteins is 90%. Slowly penetrates into joint cavities, stays in synovial fluid, creating higher concentrations in it than in blood plasma. Lower concentrations of ibuprofen are found in cerebrospinal fluid compared to blood plasma. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. It is metabolized in the liver. The half-life (T1/2) is 2 hours. It is excreted by kidneys (not more than 1% unchanged) and, to a lesser extent, in bile.

In limited studies ibuprofen was found in very low concentrations in breast milk.

Indications

Active ingredient

Composition

Core:

The active ingredient: ibuprofen – 400.0 mg.

Excipients: corn starch, colloidal anhydrous silica, sodium carboxymethyl starch (type A), magnesium stearate.

The film coating: hypromellose (viscosity 6 mPa – s), macrogol 4000, povidone (K value = 30), titanium dioxide (E 171).

How to take, the dosage

For oral administration. Patients with hypersensitivity of the stomach are recommended to take the drug with meals. For short-term use only. The tablets should be washed down with water. Read the instructions carefully before taking this medicine.

Adults and children over 12 years of age

Take 200 mg (1/2 tablet) 3 to 4 times daily.

To achieve rapid therapeutic effect in adults, the single dose may be increased to 1 tablet (400 mg) 3 times daily. When taking 400 mg (1 tablet), the interval between doses should be at least 6 hours.

Children 6 to 12 years of age (body weight over 20 kg)

To 200 mg (1/2 tablet) 3 to 4 times daily.

The interval between taking the pills should be at least 6 hours.

The 400 mg dose is not approved for use in children under 12 years of age. The maximum daily dose for adults is 1200 mg.

The maximum daily dose for children from 6 to 18 years is 800 mg.

If symptoms persist or worsen when taking the drug for 2-3 days, you should stop treatment and see a doctor.

Interaction

Simultaneous use of ibuprofen with the following medicinal products should be avoided:

Acetylsalicylic acid: except in low doses of acetylsalicylic acid (no more than 75 mg per day) prescribed by a physician, because concomitant use may increase the risk of side effects. When concomitant use, ibuprofen reduces anti-inflammatory and antiaggregant effects of acetylsalicylic acid (after starting ibuprofen administration in patients receiving low doses of acetylsalicylic acid as antiaggregant medicine, the incidence of acute coronary failure may increase).

Other NSAIDs, particularly selective COX-2 inhibitors: Concomitant use of two or more drugs from the NSAID group should be avoided because of possible increased risk of side effects.

Cautiously use concomitantly with the following drugs:

Anticoagulants and thrombolytics: NSAIDs may increase the effect of anticoagulants, particularly warfarin and thrombolytics.

Antihypertensive drugs (ACE inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effectiveness of drugs in these groups. In some patients with impaired renal function (e.g., in patients with dehydration or elderly patients with impaired renal function), the simultaneous use of ACE inhibitors or angiotensin II antagonists and cyclooxygenase inhibitors may lead to worsening of renal function, including development of acute renal failure (usually reversible). These interactions should be considered in patients taking coxibs concomitantly with ACE inhibitors or angiotensin II antagonists. In this regard, concomitant use of the above drugs should be administered with caution, especially in the elderly. It is necessary to prevent dehydration in patients, and to consider monitoring renal function after the beginning of such combined treatment and periodically thereafter. Diuretics and ACE inhibitors may increase nephrotoxicity of NSAIDs.

Glucocorticosteroids: increased risk of GI ulcers and gastrointestinal bleeding.

Antiaggregants and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.

Heart glycosides: Concomitant use of NSAIDs and cardiac glycosides may worsen heart failure, decrease glomerular filtration rate, and increase plasma concentrations of cardiac glycosides.

Lithium drugs: There is data on the likelihood of increased plasma lithium concentrations with NSAIDs.

Methotrexate: There is data on the likelihood of increased plasma concentrations of methotrexate with NSAIDs.

Cyclosporine: increased risk of nephrotoxicity with concomitant use of NSAIDs and cyclosporine.

Mifepristone: NSAIDs should not be started earlier than 8-12 days after mifepristone administration, because NSAIDs may reduce the effectiveness of mifepristone.

Tacrolimus: Simultaneous use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.

Zidovudine: Concomitant use of NSAIDs and zidovudine may increase hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia who have received concomitant treatment with zidovudine and ibuprofen.

Quinolone antibiotics: patients receiving concomitant treatment with NSAIDs and quinolone antibiotics may have an increased risk of seizures.

Myelotoxic drugs: increase the manifestation of hematotoxicity of the drug.

Caffeine: increases the analgesic effect.

Special Instructions

It is recommended that the drug be taken in as short a course as possible and in the lowest effective dose necessary to relieve symptoms.

In patients with bronchial asthma or allergic disease in the acute stage, as well as in patients with a history of bronchial asthma/allergic disease the drug may provoke bronchospasm. The use of the drug in patients with systemic lupus erythematosus or mixed connective tissue disease is associated with an increased risk of aseptic meningitis.

When using during long-term treatment it is necessary to monitor peripheral blood count and functional state of liver and kidneys. In case of gastropathy symptoms a thorough control is indicated, including esophagogastroduodenoscopy, general blood test (hemoglobin determination), fecal occult blood test. If it is necessary to determine 17-ketosteroids, the drug should be cancelled 48 hours before the study. Ethanol intake is not recommended during the treatment period. Patients with renal insufficiency should consult a physician before using the drug, because there is a risk of deterioration of the functional state of the kidneys.

Patients with hypertension, including a history of and/or chronic heart failure, should consult a physician before using the drug because the drug may cause fluid retention, increased blood pressure and edema.

Patients with uncontrolled arterial hypertension, NYHA class II-III congestive heart failure, coronary heart disease, peripheral artery disease and/or cerebrovascular disease should only be prescribed ibuprofen after careful benefit-risk assessment, and high doses of ibuprofen (≥2400 mg/day) should be avoided.

In rare cases serious skin reactions (some of which have been fatal), including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been observed with NSAIDs. Patients seem to be most at risk at the beginning of treatment, since most patients developed these reactions in the first month of therapy. There have been reports of cases of acute generalized exanthematous pustulosis (AGEP) associated with the use of drugs containing ibuprofen. The first occurrence of skin rash, mucosal lesions or any other signs of hypersensitivity should be discontinued with MIG® 400.

The use of NSAIDs in patients with chickenpox may be associated with an increased risk of severe suppurative complications of infectious and inflammatory skin and subcutaneous fat diseases (e.g., necrotizing fasciitis). In this regard, it is recommended to avoid using the drug in case of chicken pox.

Information for women planning pregnancy: these drugs inhibit cyclooxygenase and prostaglandin synthesis and affect ovulation, impairing female reproductive function (reversible after treatment withdrawal).

Influence on driving, operating machinery

Patients who have dizziness, somnolence, lethargy or visual disturbances while taking ibuprofen should avoid driving vehicles and operating machinery.

Synopsis

Oval film-coated tablets, white or almost white in color, having a bilateral mark for division and embossed on one side of the “E” and “E” on both sides of the mark.

Contraindications

Side effects

The risk of side effects can be minimized by taking the drug in a short course, at the lowest effective dose necessary to relieve symptoms.

The elderly have an increased incidence of adverse reactions with NSAIDs, especially gastrointestinal bleeding and perforations, in some cases fatal.

The side effects are predominantly dose-dependent. In particular, the risk of gastrointestinal bleeding depends on the dose range and the duration of treatment.

The following adverse reactions have been reported with short-term administration of ibuprofen in doses not exceeding 1200 mg/day (3 tablets). When treating chronic conditions and with long-term use, other adverse reactions may occur.

The frequency of adverse reactions has been evaluated based on the following criteria: very common (≥ 1/10), common (≥ 1/100 to < 1/10), infrequent (≥ 1/1000 to < 1/100), rare (≥ 1/10 000 to < 1/1000), very rare (< 1/10 000), frequency unknown (data for frequency evaluation are not sufficient).

Disorders of the blood and lymphatic system

Very rare: disorders of hematopoiesis (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of these disorders are fever, sore throat, superficial mouth ulcers, “flu-like” symptoms, marked weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology.

Immune system disorders

Infrequent: Hypersensitivity reactions – non-specific allergic reactions and anaphylactic reactions, reactions from the respiratory tract (bronchial asthma, including its exacerbation, bronchospasm, dyspnea), skin reactions (itching, urticaria, purpura, Quincke’s edema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome, erythema multiforme), allergic rhinitis, eosinophilia.
Very rare: severe general hypersensitivity reactions, including edema of the face, tongue and throat, shortness of breath, tachycardia, arterial hypotension (anaphylaxis, Quincke’s edema or severe anaphylactic shock).

Skin and subcutaneous tissue disorders

Prevalence unknown: Acute generalized exanthematous pustulosis (AGEP).

Gastrointestinal disorders

Infrequent: abdominal pain, nausea, dyspepsia (including heartburn, bloating).
Rarely : diarrhea, flatulence, constipation, vomiting.
Very rare: peptic ulcer, perforation or gastrointestinal bleeding, melena, bloody vomiting, in some cases with fatal outcome, especially in elderly patients, ulcerative stomatitis, gastritis.
Frequency unknown: exacerbation of colitis and Crohn’s disease.

Hepatic and biliary tract disorders

very rarely: liver function abnormalities, increased activity of “hepatic” transaminases, hepatitis and jaundice.

River and urinary tract disorders

Very rare: Acute renal failure (compensated and decompensated), especially with long-term use, combined with an increase in plasma urea concentration and the appearance of edema, hematuria and proteinuria, nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis.

Nervous system disorders

Infrequent: headache.
Very rare: aseptic meningitis.

Cardiovascular system disorders

Prevalence unknown: heart failure, peripheral edema, with prolonged use, increased risk of thrombotic complications (e.g., myocardial infarction), increased blood pressure.

Respiratory and mediastinal disorders

Area of unknown frequency: bronchial asthma, bronchospasm, dyspnea.

Laboratory measures

If side effects occur, discontinue the drug and seek medical attention.

Overdose

In children, overdose symptoms may occur after a dose greater than 400 mg/kg body weight. In adults, the dose-dependent effect of overdose is less pronounced. The half-life of the drug in overdose is 1.5-3 hours.

Symptoms: nausea, vomiting, epigastric pain or less frequently, diarrhea, tinnitus, headache and gastrointestinal bleeding. In more severe cases, manifestations of the central nervous system are observed: drowsiness, rarely – agitation, convulsions, disorientation, coma. In cases of severe poisoning metabolic acidosis and increased prothrombin time, renal failure, liver tissue damage, decreased blood pressure, respiratory depression and cyanosis may develop. In patients with bronchial asthma, exacerbation of this disease is possible.

The treatment: symptomatic, with mandatory provision of airway patency, ECG monitoring and basic vital signs until the patient’s condition normalizes. Oral administration of activated charcoal or gastric lavage within 1 hour after taking a potentially toxic dose of ibuprofen is recommended.

If ibuprofen is already absorbed, alkaline drinking may be prescribed in order to eliminate the acidic derivative of ibuprofen by the kidneys, forced diuresis. Frequent or prolonged seizures should be controlled with intravenous diazepam or lorazepam. In worsening bronchial asthma the use of bronchodilators is recommended.

Pregnancy use

The use of the drug in the III trimester of pregnancy is contraindicated.

The use of the drug in I-II trimesters of pregnancy should be avoided, if it is necessary to take the drug, consult a physician.

There is evidence that ibuprofen may pass into breast milk in small amounts without any adverse effect on the health of the infant, therefore usually with short-term use there is no need to stop breast-feeding. If long-term use of the drug is necessary, it is necessary to consult a physician to decide on stopping breastfeeding for the period of using the drug.

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