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Active ingredients
Ketoprofen
Release form
Gel
Composition
100 g contains ketoprofen lysine (ketoprofen lysine salt) 5 g, which corresponds to the content of ketoprofen 3.125 g. Auxiliary substances: carbomer - 1 g, trolamine - 1.9 g, polysorbate 80 - 0.8 g, ethanol 95% - 5 g, methyl parahydroxybenzoate - 0.1 g, lavender-non-cerium flavoring - 0.2 g, purified water - 86 ml.
Pharmacological effect
NSAIDs. It has anti-inflammatory, analgesic and antipyretic effects. When applied externally, artrosilene reduces the manifestations of inflammation and pain in the affected joints, tendons, ligaments, muscles. When articular syndrome causes a reduction in pain in the joints at rest and when moving, reducing morning stiffness and swelling of the joints. Ketoprofena lysine salt does not have a catabolic effect on articular cartilage
Pharmacokinetics
When skin application is absorbed slowly; a dose of 50-150 mg in 5-8 hours creates a plasma concentration level of 0.08-0.15 mcg / ml. The bioavailability of the drug is about 5%. The drug practically does not accumulate in the body.
Indications
Diseases of the musculoskeletal system (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of the peripheral joints and spine, rheumatic lesions of soft tissues); - muscle pain of rheumatic and non-rheumatic origin; - traumatic (including sports) damage to soft tissues. The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease
Contraindications
A complete or incomplete combination of asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including a history); - photosensitization reactions; - weeping dermatoses; - eczema; - violation of the integrity of the skin (infected wounds, - abrasion) in the place of intended application; - III trimester of pregnancy; - lactation period; - children's age up to 6 years; - hypersensitivity to ketoprofen or other components of the preparation; - hypersensitivity to acetylsal Icyl acid or other NSAIDs; - Hypersensitivity to fenofibrate; - Hypersensitivity to sunscreens. Exposure to sunlight, even on cloudy days,and a visit to the solarium is contraindicated during treatment and for 2 weeks after the last use of the drug. The drug should be prescribed with caution in exacerbation of hepatic porphyria, erosive and ulcerative lesions of the gastrointestinal tract, severe impairment of liver function and kidney, chronic heart failure, bronchial asthma, in I and II trimesters of pregnancy, as well as children aged 6 to 12 years and elderly patients
Use during pregnancy and lactation
The use of the drug in the third trimester of pregnancy is contraindicated. In the first and second trimesters of pregnancy, the use of the drug is possible only after consulting a doctor if the intended benefit to the mother exceeds the potential risk to the fetus. The use of the drug during lactation is not recommended
Dosage and administration
The drug is used externally. The gel should be applied to the skin surface 2 times / day. in accordance with the size of the affected area and the doctor's prescription, gently rubbing until completely absorbed. A single dose is 1-1.5 g of the drug (corresponds to the size of a cherry). When iontophoresis, the drug is applied to the negative pole. The dose in children aged 6 to 12 years corresponds to that in adults and depends on the site of application and doctor's recommendations. The duration of treatment varies from a few days to 3-4 weeks, because The drug is used in both acute and chronic diseases.
Side effects
Local reactions: erythema, rash, burning sensation, itching. Sometimes local reactions can spread beyond the area of application of the drug, very rarely can be serious and generalized. Allergic reactions: dermatitis, contact eczema, urticaria, bullous dermatitis, photosensitization reactions. Systemic adverse reactions, such as renal dysfunction, occur rarely. development of any adverse effects should consult a doctor
Overdose
Extremely low degree of systemic absorption of the active ingredients of the drug for external use makes overdosing almost impossible. If accidental ingestion of large quantities of the drug (more than 20 g), the occurrence of systemic adverse reactions characteristic of NPVS may occur. Treatment: gastric lavage, intake of activated carbon
Interaction with other drugs
The drug may enhance the effect of drugs that cause photosensitization. Although interaction with other drugs for local and systemic use is unlikely, in the case of prolonged treatment or drug treatment in high doses, it is necessary to take into account the possibility of competition for the binding of plasma proteins between absorbed ketoprofen and other drugs Patients taking coumarin anticoagulants are advised to regularly monitor INR
special instructions
The drug should be applied only to intact skin. Avoid contact with eyes and mucous membrane. In order to avoid manifestations of hypersensitivity and photosensitivity, it is recommended to avoid exposure of the sun to the treated areas of the skin during treatment and for 2 weeks after the end of therapy. hands should be washed thoroughly. An occlusive dressing should not be used. The drug should be stopped immediately in case of any skin reaction. Simultaneous use of sunscreen or other cosmetic products containing Octocrylene. Effect on the ability to drive vehicles and control mechanisms. There is no data on the negative effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities requiring increased concentration of attention and psychomotor speed.