PIROXICAM Gel Ref.[7941] Active ingredients: Piroxicam

Piroxicam 0.5% Gel is not suitable for use in children under 12 years of age.

The gel should not be used for any condition other than those specified.

Skin reactions

Life-threatening cutaneous reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of systemic administration of piroxicam. These reactions have not been associated with topical piroxicam, but the possibility of occurring with topical piroxicam cannot be excluded.

Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first week of treatment.

If signs or symptoms of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, piroxicam treatment should be discontinued.

The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis.

If the patient has developed SJS or TEN with the use of piroxicam, piroxicam must not be re-started in this patient at any time.

Cases of fixed drug eruption (FDE) have been reported with piroxicam.

Piroxicam should not be reintroduced in patients with history of piroxicam-related FDE. Potential cross reactivity might occur with other oxicams.

Keep away from the eyes and mucosal surfaces. Do not apply to any sites affected by open skin lesions, dermatoses or infection.

NSAIDs, including piroxicam, may 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 the causal relationship to treatment with topical piroxicam has not been established. As a result, the possibility that these events may be related to the use of topical piroxicam cannot be ruled out.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

This medicinal product contains 150mg propylene glycol per gram and may cause skin irritation.

If local irritation develops, the use of the gel should be discontinued and appropriate therapy instituted as necessary. Because this medicine contains propylene glycol, Piroxicam Gel should not be used on open wounds or large areas of broken or damaged skin (such as burns).

Dose-dependent percutaneous absorption of piroxicam has been demonstrated in rabbits and there is theoretical possibility of systemic interactions/effects.

For example, oral piroxicam has been reported to potentiate the anticoagulant effect of dicumarol because of its effect on platelets. It can cause sodium, potassium and fluid retention and may interfere with the natriuretic action of diuretic agents and thus aggravate or precipitate heart failure.

Under conditions of solar or UV-irradiation of Piroxicam 0.5% Gel–treated exposed skin, phototoxic products may evolve which may induce cross-sensitivity reactions to Thimorosal (sodium ethylmercurithiosalicylate)or thiosalicylic acid in the case of relevant allergy. Sodium bisulphite (excipient) when used as a food additive, reduces the content of thiamine.

Fertility

Based on the mechanism of action, the use of NSAIDs, including piroxicam may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of NSAIDs, including piroxicam should be considered.

Pregnancy

There are no studies of the use of topical piroxicam in pregnant women. Studies in animals have shown reproductive toxicity with the systemic formulations (see section 5.3), but their relevance to the use of topical formulations in pregnant women is unknown. As a precautionary measure, it is preferable to avoid the use of topical piroxicam in pregnant women.

Inhibition of prostaglandin synthesis might adversely affect pregnancy. Data from epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post implantation loss. Therefore, the use of Piroxicam Gel during pregnancy is not recommended.

Breast-feeding

Piroxicam gel is not recommended for use in nursing mothers as clinical safety has not been established.

Not relevant.

Piroxicam Gel is well tolerated.

Mild to moderate local irritation, erythema, pruritus, and dermatitis may occur at the application site.

The systemic absorption of Piroxicam 0.5% Gel is very low. In common with other topical NSAIDs, systemic reactions occur infrequently.

Gastrointestinal: nausea, dyspepsia, abdominal pain and gastritis have been reported.

Respiratory, thoracic and mediastinal disorders: There have been isolated reports of bronchospasm and dyspnoea (see also section 4.3).

Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported very rarely (see section 4.4).

Contact dermatitis, eczema and photosensitivity skin reaction have also been observed from post-marketing experience.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The metabolism of Piroxicam is inhibited by cimetidine and it itself can inhibit antipyrine metabolism.