Class: Musculoskeletal System
Dosage Form: Gel
Ketoprofen…………………2.5 g/100 g
Carbopol, Ethyl alcohol, Esters of p-hydroxybenzoic acid, Neroil oil, Lavendar oil, Diethanolamine to obtain pH 5.4, Distilled water q.s.
Well known is the marked antiphlogistic and pain antagonizing activity of 2-(3-benzoyl-phenyl) – propionic acid or ketoprofen, the most effective compound in this sense amongst the synthesized non-steroid drugs; this is the active substance of Fastum gel, which enables the topical percutaneous treatment of the painful, phlogistic or traumatic affections of the joints, the tendons, the ligaments and the muscles. It also contributes, in contingent association with the proper treatments by usual route, to the prompt recovery of the superficial inflammatory processes involving the skin, veins, lymphatic vessels and lymph glands. A suitable excipient ensures the trans-cutaneous penetration of the drug without provoking any systemic-like side effects; tolerability is excellent in the application site even for the most sensitive skin.
Painful, phlogistic or traumatic affections of the joints, tendons, ligaments and muscles (arthritis, periarthritis, arthrosynovitis, tendinitis, tenosynovitis, bursitis, contusions, sprains, luxations, lesions of the knee’s meniscus, torticollis lumbago).
Phlebitis, periphlebitis, lymphangitis, suerpficial lymphadenitis.
Erythemans and cutaneous phlogistic processes.
Known hypersensitivity to the product.
There have been reports of localized skin reactions which may subsequently spread beyond the application area and in isolated cases may be severe and generalized; erythema, burns, pruritus, allergic skin reactions, contact eczema, photosensitivity reactions, urticaria, and boil eruptions. The frequency and entity of such effects are sensibly reduced by avoiding exposure to sunlight (including solarium), during treatment and the two weeks thereafter. There have been reports of isolated cases of systemic adverse reactions such as renal disorders. The undesired effects are generally transitory. However, the patient is advised to consult the physician or pharmacist should they occur.
Dosage and Administration:
Apply the gel (3-5 cm or more, depending on the extend of the involved area) on the skin once or twice daily, gently rubbing it in to help absorption).
The use, especially if prolonged, of topical products may cause phenomena of sensitisation or local irriation. It is advisable not to apply Fastum 2.5% gel on open wounds or in any other case in which there has been loss of skin integrity. Fastum 2.5% gel does not cause habituation.
Tube of 50 g gel.
Store at room temperature.