Producer: CJSC Pharmaceutical Firm Darnitsa Ukraine
Code of automatic telephone exchange: M02AA10
Release form: Soft dosage forms. Gel.
General characteristics. Structure:
Active ingredient: 1 g of gel contains ketoprofen – 25 mg;
excipients: ethanol of 96%, methylparahydroxybenzoate (нипагин), carbomer 980, трометамол (трометамин), oil lavender, oil neroli, the water purified.
Ketoprofen has antiinflammatory, analgesic, anti-aggregation effect. Ketoprofen is derivative propionic acid. The mechanism of action is caused by inhibition of synthesis of prostaglandins at the level of cyclooxygenase-1. Has antibradikininovy activity, stabilizes lizosomalny membranes and release from them of the enzymes promoting destruction of fabrics at a chronic inflammation detains. Reduces release of cytokines, brakes activity of neutrophils. Concentration in blood dozozavisimy. Easily passes through gistogematichesky barriers and it is distributed in fabrics and bodies. It Biotransformirutsya in a liver (almost completely). Metabolites are removed with urine. Reduces morning constraint and a swelling of joints, increases the volume of movements, promotes reduction of degree of their functional insufficiency.
At topical administration in the form of gel it is soaked up extremely slowly and practically does not kumulirut in an organism. Bioavailability of gel – about 5%. The dose of 50 - 150 mg in 5–8 h creates level in plasma of 0,08-0,15 mkg/ml.
Indications to use:
Pain and hypostasis in muscles and joints owing to sports and other injuries (dislocations, stretchings, blows, ruptures of sheaves and sinews) or an excessive exercise stress; back pain; for reduction of pain and manifestations of an inflammation at degenerative rheumatic diseases.
Route of administration and doses:
Apply outwardly to adults and children 15 years are more senior.
Gel is applied, squeezing out from a tuba a strip about 3-5 cm long or more (depending on the size of a surface of the painful site) and distribute a uniform thin layer on an affected area, slightly rubbing in skin before full absorption of drug – 1–2 times a day. Duration of a course of treatment – no more than 10 days.
For the purpose of increase in efficiency of therapy use of occlusive bandages is possible.
Features of use:
To apply only outwardly. It is necessary to avoid hit of gel on open wound sites, and also in eyes and on mucous membranes. If after use of gel on skin changes are noted, treatment needs to be stopped temporarily. At the expressed skin reactions of treatment it is necessary to cancel.
It is necessary to avoid hit of a sunlight and ultraviolet rays on the affected skin during treatment Ф-гелем® and for 2 weeks after its termination.
After putting gel it is necessary to wash up hands diligently.
Patients who accept anticoagulants of a coumarinic row, diuretics and salts of lithium should appoint drug with care.
Use during pregnancy or feeding by a breast. Contraindicated at pregnancy. In І and ІІ trimesters it is applied only if the potential advantage for mother exceeds possible risk of negative effect on a fruit. During treatment it is necessary to stop feeding by a breast.
Ability to influence the speed of reactions at control of motor transport or work with other mechanisms. There are no data about способностивлиять on the speed of reactions at control of motor transport or work with other mechanisms.
Children. It is contraindicated to children age up to 15 years.
Asthmatic attacks, anaphylactic reactions, Stephens-Johnson's syndrome are very seldom observed.
Interaction with other medicines:
Despite insignificant extent of absorption of ketoprofen through skin at its use in the form of gel the possibility of interaction of drug with a methotrexate is not excluded (toxicity of a methotrexate increases).
Ketoprofen can reduce effect of diuretics and antigopertenzivny drugs, increases efficiency of peroral gipoglikemiziruyushchy drugs – sulfanylurea derivatives, and also some anticonvulsants (Phenytoinum). Simultaneous use of ketoprofen and diuretics or inhibitors of an angiotenzinkonvertaza increases risk of a renal failure.
Due to the increase in risk of bleeding at a concomitant use of ketoprofen and peroral anticoagulants or corticosteroids the patient has to be under constant medical control.
At a concomitant use of ketoprofen and cardiac glycosides, drugs of lithium, cyclosporine and a methotrexate their toxicity increases owing to decrease in excretion.
Ketoprofen can reduce effect of mifepristone therefore between a course of treatment mifepristone and the beginning of therapy by ketoprofen there have to pass not less than 8 days.
It is not necessary to appoint ketoprofen along with other non-steroidal anti-inflammatory drugs and salicylates.
- hypersensitivity to ketoprofen or excipients, salicylates and other non-steroidal anti-inflammatory drugs;
- digestive tract erosive cankers in an aggravation stage;
- chronic dyspepsia in the anamnesis;
- heavy abnormal liver functions and/or kidneys;
- tendency to bleedings;
- asthmatic attacks in the anamnesis after use of non-steroidal anti-inflammatory drugs;
System side effects can arise at prolonged use Ф-геля®, at use in high doses or its drawing on big sites of skin.
Period of validity. 2 years. To store in the place, unavailable to children, in original packaging at a temperature from 15 °C to 25 °C.
On 30 g in a tuba.