Composition
Each tablet contains: Active ingredient: ibuprofen – 200 mg; excipients: potato starch, magnesium stearate, calcium stearate, povidone, opadray II (contains polyvinyl alcohol, partially hydrolyzed, talc, macrogol 3350, lecithin, titanium dioxide (E 171)).
Pharmacological action
Pharmacodynamics
Ibuprofen is a nonsteroidal anti-inflammatory drug for external use. Ibuprofen has anti-inflammatory and analgesic effects. Suppresses the production of inflammatory mediators. It inhibits cyclooxygenase and blocks prostaglandin biosynthesis.
The anti-inflammatory effect is due to the normalization of increased vascular permeability, improvement of microcirculation, a decrease in the liberation of histamine, bradykinin and other inflammatory mediators, inhibition of the formation of ATP, which leads to a decrease in the energy supply of the inflammatory process. The analgesic effect of ibuprofen is associated with a decrease in the intensity of inflammation, a decrease in the production and weakening of bradykinin algogenicity. Dimethyl sulfoxide has a local non-specific anti-inflammatory, analgesic effect, promotes better and deeper penetration of ibuprofen into the tissues.
Ibuprofen ointment has a rapid and pronounced analgesic effect-it eases pain, including arthralgia at rest and when moving. Reduces swelling and hyperemia. Reduces morning stiffness and limited mobility in the joints.
Pharmacokinetics
Absorption – high, half-life (Ti / 2) -2 hours, plasma protein binding -90%. Excretion – by the kidneys, with bile. Slowly penetrates the joint cavity, lingers in the synovial fluid, creating higher concentrations in it than in plasma. Absorption decreases slightly when the drug is taken after a meal.
The time to reach the maximum concentration when taken on an empty stomach is 45 minutes, when taken after meals,1.5-2.5 hours. After absorption, about 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. It is metabolized. It is excreted by the kidneys (no more than 1% unchanged) and, to a lesser extent, with bile. It has two-phase elimination kinetics.
Indications
Ibuprofen is used as an analgesic and anti-inflammatory agent in the treatment of rheumatoid arthritis( including juvenile rheumatoid arthritis or Still’s disease), ankylosing spondylitis, osteoarthritis and other non-rheumatoid (seronegative) arthropathies. Ibuprofen is indicated : for the treatment of non-rheumatic inflammatory processes of periarticular tissues, such as “frozen” shoulder (inflammation of the joint shell), bursitis, tendinitis, tendovaginitis and low back pain. Ibuprofen can also be used to relieve pain from soft tissue injuries, such as sprains. Ibuprofen is also indicated as an analgesic to relieve mild to moderate pain in conditions such as dysmenorrhea, dental or postoperative pain, and for symptomatic relief of headaches, including migraines.
Use during pregnancy and lactation
Contraindicated in the third trimester of pregnancy.
The use of the drug in the first and second trimesters of pregnancy should be carefully monitored by a doctor.
Contraindications
Ibuprofen is contraindicated in patients with hypersensitivity to the active or auxiliary substances of the drug. Ibuprofen should not be used in patients who have previously experienced hypersensitivity reactions (for example, asthma, urticaria, angioedema, or rhinitis) after taking ibuprofen, aspirin, or other NSAIDs. Ibuprofen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation associated with previous ibuprofen therapy. Ibuprofen should not be used in patients with recurrent peptic ulcer disease or gastrointestinal bleeding (two or more episodes of proven ulceration or bleeding). Ibuprofen should not be prescribed to patients with conditions that are accompanied by an increased tendency to bleeding. Ibuprofen is contraindicated in patients with severe heart failure, hepatic and renal insufficiency. Ibuprofen is contraindicated during the last trimester of pregnancy.
Side effects
- : heartburn, abdominal pain, nausea, vomiting, diarrhea, flatulence, anorexia, NSAIDs-gastropathy, gastrointestinal bleeding.
- headache, dizziness, insomnia or drowsiness, agitation, depression, tinnitus, visual acuity disorders (color vision disorders, scotoma, amblyopia).
- allergic skin reactions, urticaria, angioedema, erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), aseptic meningitis, bronchospasm.
- heart failure, tachycardia, increased blood pressure,
- edematous syndrome, impaired renal function, allergic nephritis.
- anemia, thrombocytopenia, agranulocytosis, leukopenia.
- increased sweating.
Interaction
Ibuprofen may increase plasma concentrations of methotrexate, lithium, and digoxin when co-administered with these drugs.
Ibuprofen, like other nonsteroidal anti-inflammatory drugs (NSAIDs), can reduce the effect of diuretics, calcium channel blockers, ACE inhibitors and other antihypertensive drugs, which is associated with impaired prostaglandin synthesis in the kidneys. Concomitant use with potassium-sparing diuretics may lead to an increase in the level of potassium in the blood (if necessary, such a combination of drugs should monitor the level of potassium in the plasma).
There are reports of an increased risk of bleeding in the case of combined use of ibuprofen and anticoagulants, fibrinolytic drugs.
When combined with antidepressants, barbiturates, zixorin, rifampicin, phenylbutazone, and phenytoin, the risk of severe intoxication increases due to increased production of hydroxylated active metabolites of ibuprofen.
Ibuprofen increases the hypoglycemic effect of oral hypoglycemic agents, which requires dose adjustment of these drugs against the background of ibuprofen use.
Glucocorticoid and mineral corticoid hormones, colchicine enhance the anti-inflammatory effect of ibuprofen and increase the risk of developing gastrointestinal tract damage.
When combined with cefamandol, cefoperazone, cefotetane, valproic acid and plicamycin, the risk of hypoprothrombinemia increases.
Cyclosporine and gold preparations enhance the nephrotoxic effect of ibuprofen.
Ibuprofen increases the undesirable effect of estrogens when used together.
Ibuprofen weakens the effectiveness of the uricosuric action of anti-gouty drugs.
Colestyramine slows down the absorption of ibuprofen.
Caffeine enhances the analgesic effect of ibuprofen.
Ibuprofen increases the toxicity of ethanol.
When used together, acetylsalicylic acid weakens the effect of ibuprofen and increases its toxicity, this is due to the displacement of ibuprofen from protein binding and its metabolism with the formation of toxic hydroxylated metabolites.
How to take, course of use and dosage
For oral use. It is advisable to use during or after a meal, washed down with water. Tablets should be swallowed whole, not chewed, not broken, not crushed to avoid discomfort and irritation of the throat. Side effects can be minimized by applying the lowest effective dose for a short time. Adults: the recommended dosage of ibuprofen is 1200-1800 mg per day, in several doses. Some patients may take 600-1200 mg of ibuprofen daily. In severe or acute conditions, you can increase the dosage, provided that the total daily dose does not exceed 2400 mg, in several doses. Children: the daily dose of ibuprofen is 20 mg / kg of body weight, in several doses. In case of juvenile rheumatoid arthritis, the dose can be increased to 40 mg / kg of body weight, in several doses. It is not recommended for children weighing less than 7 kg. Elderly people: The elderly are at an increased risk of side effects. If nonsteroidal anti-inflammatory drugs (NSAIDs) are required, ibuprofen should be administered at a low effective dose for a short time. The patient should regularly check for gastrointestinal bleeding while taking NSAIDs. In the presence of renal or hepatic insufficiency, the dosage should be determined individually.
Overdose
Symptoms: a typical clinical picture of an ibuprofen overdose does not develop. Abdominal pain, nausea, vomiting, dizziness, lethargy, drowsiness, depression, headache, hypotension, convulsions, cardiac arrhythmias, acute renal failure, respiratory depression may occur.
Treatment: relief measures include drug withdrawal, maintenance and symptomatic therapy aimed at eliminating the resulting disorders, and correction of the acid-base state. It is possible to perform forced diuresis with simultaneous use of alkaline drinking, activated carbon, to reduce the reabsorption of ibuprofen. There is no specific antidote. Gastric lavage is effective only within an hour after taking the drug.
Special instructions
for people with gastrointestinal disorders. During the use of ibuprofen, careful medical monitoring is necessary for patients who have complaints from the gastrointestinal tract, a history of ulcerative lesions of the gastrointestinal tract, as well as non-specific ulcerative colitis or Crohn’s disease.When using ibuprofen, this group of patients may experience (for the first time or repeatedly) gastrointestinal bleeding or ulceration/perforation of the gastrointestinal tract, which may not be accompanied by harbinger symptoms. In all such cases, the drug should be discontinued.
Persons with pathology of the blood system. Ibuprofen temporarily inhibits platelet aggregation, so careful monitoring of appropriate laboratory parameters is necessary in patients with impaired hemostasis. With prolonged use of ibuprofen, systematic monitoring of peripheral blood is indicated.
Individuals with liver diseases. During the use of ibuprofen, a transient increase in the activity of liver enzymes is possible. Laboratory monitoring of liver function is indicated as a precautionary measure during long-term ibuprofen therapy. If functional disorders persist or worsen, or if there are clinical manifestations of other liver disorders, ibuprofen should be discontinued. It should be remembered that hepatitis with ibuprofen can occur without prodromal manifestations.
Persons with pathology of the cardiovascular system. Since prostaglandins play an important role in maintaining normal renal blood flow, special care is required when using ibuprofen in patients suffering from impaired renal function and chronic congestive heart failure, in people receiving diuretics, as well as in patients with a significant decrease in the volume of circulating plasma (for example, in the period before and after massive surgical interventions). In all these cases, monitoring of renal function is recommended as a precautionary measure. Discontinuation of the drug usually leads to the restoration of renal function to the initial level.
Influence on laboratory parameters. If it is necessary to determine 17-ketosteroids in the urine, ibuprofen should be discontinued 48 hours before the test.
Influence on the ability to drive motor vehicles and manage mechanisms. During the period of using ibuprofen, it is necessary to refrain from all activities that require increased attention, rapid mental and motor reactions.
During the treatment period, it is not recommended to take ethanol.
Cherry and currant juice, sugar syrup increase the rate of absorption of ibuprofen.
To reduce the risk of gastrointestinal adverse events, the minimum effective dose should be used in the shortest possible course.
Form of production
Coated tablets.
Storage conditions
In a place protected from light and moisture, at a temperature not exceeding 25 ° C.
Shelf
life is 3 years.
Active ingredient
Ibuprofen
Dosage form
Tablets
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