ILMODOL 1% Farmitalia Cream 120g

ILMODOL 1% Farmitalia Cream - Medical Device

Painful and inflammatory states of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.

INTERACTIONS

Based on bioavailability studies, piroxicam cream is extremely unlikely to displace other plasma protein-bound drugs. However, doctors will need to monitor patients treated with this cream and high protein binding drugs for any dose adjustments.

DOSAGE

Adults: apply on the skin 2-3 times at 3-5 cm of cream or more asecond of the extension of the interested part, massaging gently to favor its absorption.

ACTIVE PRINCIPLES

100 grams of cream contain: 1 g of piroxicam.

EXCIPIENTS

1% cream: polyethylene glycol cetyl ether, polyglycol esters with fatty acids, cetostearyl alcohol, propylene glycol, sodium citrate, citric acid, benzyl alcohol, purified water.

WARNINGS

The quantity of active principle absorbed through the skin does not normally reach concentrations in circulation such as to make the warnings valid and expose to the risk of side effects related to the administration of the drug systemically. The application of products for topical use, especially if prolonged, can give rise to sensitization phenomena. In the presence of hypersensitivity reactions, treatment must be interrupted and appropriate therapy instituted. Serious skin reactions, some of them life-threatening, such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of piroxicam for systemic use. These reactions have not been associated with topical piroxicamper use, however the possibility that they may occur with topical administration cannot be excluded. Patients should be informed of the signs and symptoms, and they should also be closely monitored for skin reactions. The highest risk of developing SJS and TEN occurs in the first weeks of treatment.If symptoms and signs of SJS or TEN occur (e.g. progressive rash often with blistering or mucosal lesions) treatment with pyroxi be suspended. The best results in the management of SJS and TEN are obtained with early diagnosis and immediate discontinuation of therapy with any suspect drug. Early withdrawal is associated with a better prognosis. If the patient has developed SJS or TEN with the use of this drug, the drug should no longer be reused in this patient. Non-steroidal anti-inflammatory drugs, including piroxicam, can cause interstitial nephritis, nephrotic syndrome and renal failure. There have also been reports of interstitial nephritis, nephrotic syndrome and renal failure with topical piroxicam, although a causal relationship with topical piroxicam treatment has not been established. Consequently, it cannot be excluded that these adverse events may be related to the use of topical piroxicam. The cream contains cetostearyl alcohol. This substance can cause local skin reactions (eg contact dermatitis).

FORMAT

120 g cream tube.