Producer: Mili Healthcare Ltd (Mili Helskere Ltd) Great Britain
Code of automatic telephone exchange: M01AH
Release form: Soft dosage forms. Gel for external use.
General characteristics. Structure:
Active ingredient: 1 g of a rofekoksib, 3 g of linseed oil, 10 g of methyl salicylate, 5 g of menthol, 1 g of phenoxyethanol.
Excipients: propylene glycol, carbomer 934, butyl hydroxytoluene (Е 321), polyethyleneglycol 400, isopropyl alcohol, dinatrium эдетат, the trietanolamine, the castor oil polyethoxylated, hydrogenated the water purified.
The medicine in the form of gel having anesthetics, febrifugal, antiinflammatory properties at topical administration.
Pharmacodynamics. Denebol contains gel рофекоксиб - non-steroidal anti-inflammatory drug - the high-selection inhibitor of cyclooxygenase-2. It has anesthetics, febrifugal, antiinflammatory properties at topical administration. TsOG-2 becomes more active in response to inflammatory process. It leads to synthesis and accumulation of mediators of an inflammation, in particular E2 prostaglandin that causes an inflammation, hypostasis and pain. Antiinflammatory action to a rofekoksib is carried out due to oppression of synthesis of prostaglandins by TsOG-2 inhibition.
In therapeutic concentration drug does not suppress cyclooxygenase-1 (TsOG-1). Thus, it does not influence prostaglandins which are synthesized due to activation of TsOG-1, and owing to it does not interfere with the normal physiological processes connected with TsOG-1 in fabrics, especially in a stomach, an intestinal path and thrombocytes.
Linseed oil is the diemulsified drug and a component for mitigation which is a part of drugs for topical administration. Linseed oil consists of alpha linolic acid which is important fatty acid for functioning of a human body.
Menthol causes a cryesthesia and renders medical effect in a scope, renders therapeutic effect thanks to stimulation of cold receptors, stabilizing a flow of calcium ions of neuronew membranes.
Methyl salicylate as рубефациент should be applied locally to treatment of muscular pain, a joint pain and at damage of soft tissues. It also has soothing and antiinflammatory effect due to the ability to stabilize cyclooxygenase enzyme, and also owing to transformation into an active form – salicylic acid.
Pharmacokinetics. Absorption of the drug applied on skin in the general blood stream happens very slowly. Even when drawing a large number does not lead a rofekosiba on skin to increase in concentration of active ingredient in a blood plasma.
Menthol after absorption biotransformirutsya in a liver and is removed with urine in the form of glyukoronid. Methyl salicylate quickly gets into deep layers of skin, is soaked up, hydrolyzed, turns into anion of salicylic acid and is removed with urine. The clearance of salicylates substantially depends from рН urine. Fenoksietanol is adsorbed in insignificant quantities and allocated with kidneys in the form of phenoxyacetsilt acid.
Indications to use:
Topical treatment of inflammatory reaction and reduction of a pain syndrome at adults at an acute and chronic osteoarthritis, a pseudorheumatism, a periarthritis, a bursitis, a tendinitis, at musculoskeletal system injuries, osteochondrosis, an osteoarthrosis, neuralgia, a lumbago, posttraumatic inflammations of sinews, communication, muscles and joints, for example owing to stretchings, retension and bruises.
Route of administration and doses:
Drug is used the adult. To apply on skin 3-4 times a day and to rub slightly. The necessary amount of drug depends on the size painful the site. After putting drug of a hand it is necessary to wash up. Duration of treatment is determined by the doctor according to indications and the reached effect.
Children. There is no sufficient experience of use of drug to children.
Features of use:
Denebol gel should be applied only on the unimpaired skin. It is necessary to avoid contact with eyes, a mucous membrane and the affected skin. At accidental hit of drug on mucous membranes to wash out a large amount of water.
Drug contains propylene glycol that can cause irritation. At strong irritation of skin of rubbing in it is necessary to stop. At prolonged use on big sites of skin systemic action of drug is not excluded.
Use during pregnancy or feeding by a breast. Clinical experience of use for pregnant women is limited therefore during pregnancy or feeding the breast does not recommend use of this drug. Drug is contraindicated during the third trimester of pregnancy in connection with a possibility of development of weakness of patrimonial activity and/or premature closing of an arterial channel.
It is unknown whether it is allocated рофекоксиб in breast milk therefore the doctor has to make the decision concerning the feeding termination by a breast or drug withdrawals, considering need of use of drug by mother.
Ability to influence speed of response at control of motor transport or other mechanisms. Drug does not influence speed of response at control of motor transport or work with other mechanisms.
At use Denebol of gel can arise a local cryesthesia, then it is warm, irritation of skin, a burning sensation, prickings in a site of application, hypersensitivity reactions, including erubescence, rash, feeling of an itch, urticaria, contact dermatitis.
Interaction with other medicines:
At topical administration of the recommended dose systematic absorptions of components are lower, than risk of undesirable clinical interaction with the drugs incorporating рофекоксиб.
Hypersensitivity to drug components.
Existence in the anamnesis of attacks of bronchial asthma, Quincke's disease, the small tortoiseshell or acute rhinitis, polyps of a nose or other allergic reactions caused by reception of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
Diseases of skin, damage, wound of skin in a drug site of application.
Overdose cases perhaps strengthening of manifestations of side reactions were not registered.
To store at a temperature not above 25 °C in original packaging and the place, unavailable to children. Not to freeze! Period of validity 2 years.
On 30 g of gel in a tuba, on 1 tuba together with the instruction on a medical use in a cardboard box.