MIG 400, 400mg pills, 20pcs

Composition

Core:

Active ingredient:  ibuprofen – 400.0 mg.

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

Film shell:  hypromellose (viscosity 6 MPa • s), macrogol 4000, povidone (value K = 30), titanium dioxide (E 171).

Pharmacological action

Pharmacotherapy group: Nonsteroidal anti-inflammatory drug (NSAID)

ATX code:  M01AE01

Pharmacological properties

Pharmacodynamics

The mechanism of action of ibuprofen, a propionic acid derivative from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), is due to inhibition of prostaglandin synthesis – mediators of pain, inflammation and hyperthermic reaction. It selectively blocks cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2), thereby inhibiting prostaglandin synthesis. It has a rapid 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 – high, 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 blood plasma is reached in 45 minutes.

Taking the drug together with food can increase the time to reach the maximum concentration (TCmax) to 1-2 hours. Binding to plasma proteins is 90%. Slowly penetrates the joint cavities, lingers in the synovial fluid, creating higher concentrations in it than in the blood plasma. Lower concentrations of ibuprofen are found in the 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 elimination half-life (T 1/2) is 2 hours. It is excreted by the kidneys (no more than 1% unchanged) and, to a lesser extent, with bile.

In limited studies, ibuprofen has been detected in breast milk at very low concentrations.

Indications

MIG ® 400 is used for headache and toothache, migraines, painful menstruation, neuralgia, back pain, joint pain, muscle and rheumatic pain, as well as for fever, flu and colds.

Use during pregnancy and lactation

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

Avoid using the drug in the first-second trimesters of pregnancy, if necessary, take the drug should consult a doctor.

There is evidence that ibuprofen in small amounts can enter breast milk without any negative consequences for the health of the infant, so usually with short-term use, there is no need to stop breastfeeding. If long-term use of the drug is necessary, you should consult a doctor to decide whether to stop breastfeeding for the period of use of the drug.

Contraindications

• hypersensitivity to ibuprofen or any of the ingredients of the medication;
• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance of acetylsalicylic acid or other NSAIDs (including in the anamnesis);
• erosive and ulcerative diseases of the gastrointestinal tract (including stomach ulcer and duodenal ulcer, Crohn’s disease, ulcerative colitis) ulcer or bleeding in the active phase or in history (two or more episodes of confirmed peptic ulcer or ulcer bleeding);
• a bleeding or perforated ulcer of the gastrointestinal tract in history, triggered by the use of NSAIDs;
• severe heart failure (class IV according to the classification of new York heart Association (NYHA);
• severe liver failure or liver disease in the active phase;
• renal failure of severe degree of impairment (creatinine clearance < 30 ml/min);
• confirmed hyperkalemia;
• decompensated heart failure; after the coronary artery bypass surgery;
• cerebrovascular or other bleeding;
• hemophilia and other blood clotting (including anticoagulation), hemorrhagic diathesis;
• pregnancy (III trimester);
• body weight less than 20 kg;
• children up to age 6 years.

With caution

If you have any of the conditions listed in this section, you should consult your doctor before using the drug.

Concomitant use of other NSAIDs, a history of a single episode of gastric ulcer or ulcerative bleeding of the gastrointestinal tract; gastritis, enteritis, colitis, Helicobacter pylori infection, allergic diseases in the acute stage or in the anamnesis – possible development of bronchospasm; systemic lupus erythematosus or mixed connective tissue disease (Sharp’s syndrome) – increased risk of aseptic meningitis; chickenpox; renal failure, including with dehydration (creatinine clearance 30-60 ml/min), nephrotic syndrome, liver failure, cirrhosis of the liver with portal hypertension, hyperbilirubinemia, arterial hypertension and/or heart failure, cerebrovascular diseases, blood diseases of unknown etiology (leukopenia and anemia), severe somatic diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral artery diseases, smoking, frequent alcohol consumption, phenylketonuria or phenylalanine intolerance, concomitant use of medications that may increase the risk of ulceration or bleeding, in particular, oral glucocorticoids (including prednisone), anticoagulants (including warfarin), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline) or antiplatelet agents (including acetylsalicylic acid, sertraline). clopidogrel), pregnancy I-II trimester, breast-feeding period, elderly age, children under 12 years of age.

Side effects

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

In the elderly, there is an increased frequency of adverse reactions associated with NSAID use, especially gastrointestinal bleeding and perforation, in some cases with a fatal outcome.

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

The following adverse reactions were observed with short-term use of ibuprofen in doses not exceeding 1200 mg / day (3 tablets). In the treatment of chronic conditions and with prolonged use, other adverse reactions may occur.

Assessment of the frequency of adverse reactions was made 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 (

Disorders of the blood and lymphatic system

Very rare:  hematopoietic disorders (anemia, leukopenia, aplastic anemia, hemolytic anemia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms of such disorders are fever, sore throat, superficial ulcers in the oral cavity, “flu-like” symptoms, severe weakness, nosebleeds and subcutaneous hemorrhages, bleeding and bruising of unknown etiology.

Immune system disorders

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

Skin and subcutaneous tissue disorders

Frequency unknown:  acute generalized exanthematous pustulosis (AGEP).

Disorders of the gastrointestinal tract

Infrequently:  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 fatal, especially in elderly patients, ulcerative stomatitis, gastritis. Frequency unknown:  exacerbation of colitis and Crohn’s disease.

Liver and biliary tract disorders

Very rare:  liver function disorders, increased activity of “hepatic” transaminases, hepatitis and jaundice.

Kidney and urinary tract disorders

Very rarely: acute renal failure (compensated and decompensated), especially with prolonged use, in combination with increased urea concentration in blood plasma and the appearance of edema, hematuria and proteinuria, nephritic syndrome, nephrotic syndrome, papillary necrosis, interstitial nephritis, cystitis.

Nervous system disorders

Infrequently: headache. Very rarely: aseptic meningitis.

Cardiovascular disorders

Frequency unknown: heart failure, peripheral edema, prolonged use increases the risk of thrombotic complications (for example, myocardial infarction), increased blood pressure.

Respiratory and mediastinal disorders

Frequency unknown: bronchial asthma, bronchospasm, shortness of breath.

Laboratory parameters

• : hematocrit or hemoglobin (may decrease);
• bleeding time (may increase);
• plasma glucose concentration (may decrease);
• creatinine clearance (may decrease);
• plasma creatinine concentration (may increase);
• activity of “hepatic” transaminases (may increase).

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

Interaction

Concomitant use of ibuprofen with the following medications should be avoided:

Acetylsalicylic Acid: with the exception of low doses of acetylsalicylic acid (no more than 75 mg per day) prescribed by a doctor, since simultaneous use may increase the risk of side effects. When used concomitantly, ibuprofen reduces the anti-inflammatory and antiplatelet effects of acetylsalicylic acid (after starting ibuprofen, patients receiving small doses of acetylsalicylic acid as an antiplatelet agent may increase the incidence of acute coronary insufficiency).

Other NSAIDs, in particular selective COX-2 inhibitors: Concomitant use of two or more NSAID medications should be avoided because of the possible increased risk of side effects.

Use with caution at the same time as the following medications::

Anticoagulants and thrombolytic drugs: NSAIDs can increase the effect of anticoagulants, in particular, warfarin and thrombolytic drugs.

Antihypertensive agents (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 (for example, in patients with dehydration or in elderly patients with impaired renal function), the simultaneous use of ACE inhibitors or angiotensin II antagonists and cyclooxygenase inhibitors may lead to deterioration of renal function, including the 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, the simultaneous use of the above drugs should be prescribed with caution, especially in the elderly. Patients should be prevented from becoming dehydrated, and renal function monitoring should be considered after starting this combination treatment and periodically thereafter. Diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs.

Glucocorticosteroids: increased risk of gastrointestinal ulcers and gastrointestinal bleeding.

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

Cardiac Glycosides: concomitant use of NSAIDs and cardiac glycosides may worsen heart failure, reduce glomerular filtration rate, and increase the concentration of cardiac glycosides in blood plasma.

Lithium preparations: there is evidence of the likelihood of an increase in the concentration of lithium in blood plasma against the background of NSAID use.

Methotrexate: there is evidence for the likelihood of an increase in the concentration of methotrexate in blood plasma against the background of NSAID use.

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

Mifepristone: NSAIDs should be started no earlier than 8-12 days after taking mifepristone, as NSAIDs may reduce the effectiveness of mifepristone.

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

Zidovudine: concomitant use of NSAIDs and zidovudine may lead to increased hematotoxicity. There is evidence of an increased risk of hemarthrosis and hematomas in HIV-positive patients with hemophilia treated concomitantly with zidovudine and ibuprofen.

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

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

Caffeine: enhances the analgesic effect.

How to take, course of use and dosage

For oral use. Patients with hypersensitivity of the stomach are recommended to take the drug with meals. Only for short-term use. Tablets should be washed down with water. Please read the instructions carefully before taking the drug.

Adults and children over 12 years of age

200 mg (1/2 tablet) 3-4 times a day.

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

Children aged 6-12 years (with a body weight of more than 20 kg)

200 mg (1/2 tablet) 3-4 times a day.

The interval between taking tablets should be at least 6 hours.

Taking 400 mg of the drug is not allowed 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 after taking the drug for 2-3 days, you should stop treatment and consult a doctor.

Overdose

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

Symptoms: nausea, vomiting, epigastric pain or less commonly, diarrhea, tinnitus, headache, and gastrointestinal bleeding. In more severe cases, there are manifestations of the central nervous system: 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 can develop. Patients with bronchial asthma may have an exacerbation of this disease.

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

If ibuprofen has already been absorbed, an alkaline drink may be prescribed to remove the acidic ibuprofen derivative by the kidneys, forced diuresis. Frequent or prolonged seizures should be stopped by intravenous use of diazepam or lorazepam. In case of worsening of bronchial asthma, the use of bronchodilators is recommended.

Description

Oval film-coated tablets, white or almost white in color, with a double-sided border for dividing and embossing on one of the sides “E “and” E ” on both sides of the border.

Special instructions

It is recommended to take the drug in the shortest possible course and in the minimum effective dose necessary to eliminate symptoms.

In patients with acute bronchial asthma or allergic disease, 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.

During long-term 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 is indicated, including esophagogastroduodenoscopy, a general blood test (determination of hemoglobin), and a fecal occult blood test. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. During the treatment period, it is not recommended to take ethanol. Patients with renal insufficiency should consult a doctor before using the drug, as there is a risk of deterioration of the functional state of the kidneys.

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

Patients with uncontrolled hypertension, NYHA class II-III congestive heart failure, coronary artery 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 were fatal) have been reported with NSAIDs, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Patients seem to be at the greatest risk at the beginning of treatment, as most patients developed these reactions in the first month of therapy. There are reports of cases of acute generalized exanthematous pustulosis (AGEP) associated with the use of ibuprofen-containing medications. At the first appearance of skin rash, mucosal lesions, or any other signs of hypersensitivity, the use of MIG® 400 should be discontinued.

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

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

Influence on the ability to drive vehicles and mechanisms

Patients who experience dizziness, drowsiness, lethargy, or visual disturbances while taking ibuprofen should avoid driving vehicles and mechanisms.

Form of production

Pills.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep the medicine out of the reach of children!

Shelf

life is 3 years. Do not use after the expiration date of the drug indicated on the package.

Active ingredient

Ibuprofen

Dosage form

Tablets

Purpose

For adults, Pregnant women in the first and second trimester as prescribed by a doctor, Children over 6 years of age

Indications

Osteoarthritis, Neuritis, Sore Throat, Migraine, Cold, Myositis, Osteoarthritis and Arthritis, Periarthritis, Sciatica, Flu, Lumbago