Composition, form of production and packaging
? Tablets, film-coated 1 tab.
ibuprofen 200 mg
10 pieces. - Cellular outline packaging.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Ibuprofen is an NSAID, a derivative of phenylpropionic acid. The anti-inflammatory effect of ibuprofen is due to inhibition of synthesis and / or release of prostaglandins.
Ibuprofen reduces inflammatory pain, swelling and fever.
In patients with primary dysmenorrhea, ibuprofen reduces the increased content of prostaglandins in the menstrual fluid, reduces intrauterine pressure and the frequency of uterine contractions.
Like all NSAIDs, ibuprofen displays antiaggregant activity.
PHARMACOKINETICS
Suction
Ibuprofen is rapidly absorbed after ingestion, especially in the form of ibuprofen lysinate. C max in the blood is reached after 0.5 hours. It is absorbed quickly enough when taken on an empty stomach.
Distribution
Ibuprofen is rapidly distributed in the body; as well as other drugs of his group, to a large extent (90-99%) binds to plasma proteins.
Metabolism
Ibuprofen is rapidly metabolized to inactive metabolites (about 90% of the dose taken).
Excretion
It is excreted by the kidneys, while more than 90% of the dose is excreted within 24 hours in the form of metabolites or their conjugates, and about 10% in unchanged form. To a lesser degree is excreted with bile. Because of rapid metabolism, ibuprofen does not accumulate even with prolonged use. T 1/2 ibuprofen from plasma is about 2 hours and does not change significantly with increasing dosage. The isozyme CYP2C9 is involved in the metabolism of the drug.
INDICATIONS
Designed for symptomatic therapy, reducing pain and inflammation at the time of use, the progression of the disease is not affected.
- primary algodismenorea;
- symptomatic therapy of inflammatory and degenerative diseases of the musculoskeletal system (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, gouty arthritis, psoriatic arthritis);
- moderate pain syndrome of various etiologies (headache, migraine, toothache, neuralgia, myalgia, postoperative pain, post traumatic pains (soft tissue injuries, sprains);
- feverish conditions for colds and infectious diseases.
DOSING MODE
Ibuprofen is prescribed for adults and children over 12 years inside, in tablets of 200 mg 3-4 times / day. Tablets should be swallowed whole, washed down with water, preferably during or after meals (the morning dose taken before meals, washed down with sufficient water (for a faster absorption of the drug), the rest of the dose taken during the day after eating). Patients with gastrointestinal diseases (stomach ulcer and duodenal ulcer (in the anamnesis), gastritis, enteritis, colitis) it is recommended to take tablets with food.
Adults - 1-2 tablespoons. 3-4 times / day; if necessary (for rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, gouty arthritis, psoriatic arthritis, soft tissue injuries, sprains ) - 1 tab. every 4 hours. Do not take more than 4 hours. When the therapeutic effect is achieved, the daily dose of the drug is reduced to 600-800 mg.
With algodismenorea - 2 tab. 3 times / day (to achieve a rapid therapeutic effect). The interval between the two methods should be 4-6 hours. When used at regular time intervals, fluctuations in the intensity of pain are avoided.
The maximum daily intake for adults should not exceed 1200 mg (not more than 6 6tab for 24 hours). Do not exceed the indicated dose.
If the pain does not stop after 3 days of use, it is necessary to consult a doctor. The duration of the drug without a doctor's consultation is no more than 5 days.
Children over 12 years - 1 tab. 3 times / day. The maximum daily dose for children over 12 years old should not exceed 1000 mg (not more than 5 tablets within 24 hours). Do not exceed the indicated dose. The interval between taking the tablets is not less than 6 hours. The drug should be used only after consulting a doctor.
SIDE EFFECT
On the part of the digestive system: NSAID-gastropathy (nausea, vomiting, abdominal pain, heartburn, decreased appetite, diarrhea, flatulence, pain and discomfort in the epigastric region), ulceration of the gastrointestinal mucosa (in some cases complicated by perforation and bleeding), exacerbation of ulcerative colitis and Crohn's disease; irritation, dryness of the oral mucosa or pain in the mouth, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis, constipation, hepatitis.
On the part of the respiratory system: dyspnea, bronchospasm.
From the senses: hearing loss, ringing or noise in the ears, reversible toxic optic neuritis, blurred vision or diplopia, dryness and irritation of the eyes, edema of the conjunctiva and eyelids (allergic genesis), scotoma.
From the side of the central nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, aseptic meningitis (more often in patients with autoimmune diseases).
From the cardiovascular system: the development or worsening of heart failure, tachycardia, increased blood pressure.
From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.
Allergic reactions: skin rash (usually erythematous urticaria), skin itching, angioedema, anaphylactoid reactions, anaphylactic shock, bronchospasm, exacerbation of asthma, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (syndrome Lyell), eosinophilia, allergic rhinitis.
From the hemopoiesis: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, and leukopenia.
Other: increased sweating.
CONTRAINDICATIONS
- complete or incomplete combination of bronchial asthma, recurrent polyposis of the nasal mucosa or paranasal sinuses and intolerance to acetylsalicylic acid (ASA) and other NSAIDs (including in the anamnesis);
- erosive and ulcerative changes in the gastric mucosa or duodenum, active gastrointestinal bleeding; cerebrovascular or other bleeding;
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the phase of exacerbation;
- hemophilia and other disorders of blood clotting;
Decompensated heart failure;
- severe hepatic impairment or any active liver disease;
- glucose-galactose malabsorption;
- severe renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease, confirmed hyperkalemia;
- period after aortocoronary shunting;
- pregnancy (III trimester);
- children's age till 12 years;
- Hypersensitivity to the active substance or auxiliary components.
With caution: bronchial obstruction, bronchospasm in the anamnesis (there is an increased risk of bronchospasm), allergies, IHD, cerebrovascular diseases, chronic heart failure, dyslipidemia / hyperlipidemia, diabetes, peripheral arterial disease, smoking, creatinine clearance 30-60 ml / min, ulcerative stomach and duodenal ulcer (history), gastritis, enteritis, colitis, hepatic and / or renal insufficiency, the presence of Helicobacter pylori infection, advanced age, prolonged use of NSAIDs, frequent use alcohol, severe somatic diseases, concomitant therapy with the following drugs (anticoagulants (eg, warfarin), antiaggregants (eg ASA, clopidogrel), oral GCS (eg, prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline).
PREGNANCY AND LACTATION
The drug is contraindicated in the III trimester of pregnancy. With caution should prescribe the drug in the I and II trimesters of pregnancy and in the period of lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated:
- marked renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease, confirmed hyperkalemia.
With caution: kidney failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated:
- severe hepatic insufficiency or any active liver disease.
With caution: liver failure.
APPLICATION FOR CHILDREN
The drug is contraindicated for children under 12 years .
SPECIAL INSTRUCTIONS
Gastrointestinal bleeding, ulcers and perforations can appear at any time of NSAID treatment, with or without warning symptoms and without taking into account previous history. In this case, the drug should be discontinued immediately.
When symptoms of NSAID-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 prostaglandin E preparations (misoprostol).
Serious skin reactions are very rare, but they can include exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis. In case of skin rash, damage to the mucous membrane or other symptoms of hypersensitivity, the drug should be discontinued immediately.
If there is a visual impairment during the treatment with ibuprofen, stop taking the drug.
If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.
During the period of treatment, ethanol is not recommended.
To reduce the risk of developing adverse events on the part of the gastrointestinal tract, a minimum effective dose should be used with the minimum possible short course.
During treatment, it is necessary to monitor the functional state of the liver and kidneys.
The drug is intended for children over 12 years.
Impact on the ability to drive vehicles and manage mechanisms
During the period of treatment, patients should avoid driving motor vehicles and other activities that require a high concentration of attention and speed of psychomotor reactions.
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 taking), reception of activated charcoal, alkaline drink, forced diuresis, symptomatic therapy (correction of acid-base state, blood pressure).
DRUG INTERACTION
Inductors of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of developing severe hepatotoxic reactions.
Inhibitors of microsomal oxidation reduce the risk of hepatotoxic action.
Reduces the hypotensive activity of vasodilators (including slow calcium channel blockers and ACE inhibitors), natriuretic and diuretic - furosemide and hydrochlorothiazide.
Reduces the effectiveness of uricosuric medicines, increases the effect of indirect anticoagulants (warfarin), antiplatelet agents, fibrinolytics (increased risk of hemorrhagic complications), ulcerogenic effects with bleeding mineralocorticosteroids, colchicine, estrogens, ethanol; enhances the effect of oral hypoglycemic drugs and insulin.
Antacids and colestyramine reduce the absorption of ibuprofen.
Increases the concentration in the blood of digoxin, lithium and methotrexate.
Caffeine increases the analgesic effect.
With simultaneous use, ibuprofen reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (ASA) (possibly increasing the incidence of acute coronary insufficiency in patients receiving low doses of ASA as an antiplatelet agent after taking ibuprofen). NSAIDs, ASA (only at a dose above 75 mg per day), increase the risk of gastrointestinal bleeding.
When prescribed with anticoagulant and thrombolytic drugs (AL) (alteplase, streptokinase, urokinase), the risk of bleeding increases at the same time.
Cefamandol, cefaperazone, cefotetan, valproic acid, plikamycin increase the frequency of hypoprothrombinemia.
Myelotoxic drugs increase the manifestation of hematotoxicity of the drug. Cyclosporine and gold preparations increase the effect of ibuprofen on prostaglandins in the kidneys, which is manifested by increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects.
LS, blocking tubular secretion, reduce excretion and increase the plasma concentration of ibuprofen.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
Store the drug at a temperature of no higher than 25 В° C. Keep out of the reach of children. Shelf life - 3 years. Do not use after expiration date
