Feldene Gel

/ Pfizer

Adults: No occlusive dressings should be employed. Apply 1g of Gel, corresponding to 5mg of piroxicam, and rub into the affected site three to four times daily leaving no residual material on the skin. Therapy should be reviewed after 4 weeks.
Paediatric population: Dosage recommendations and indications for the use of Feldene Gel in children have not been established.
Elderly: No special precautions are required.
Method of administration: Feldene Gel is for external use only.

Feldene Gel is indicated for a variety of conditions characterized by pain and inflammation such as osteoarthritis of superficial joints, acute musculoskeletal injuries, periarthritis, tendinitis and tenosynovitis.

Hypersensitivity to the active substance or to any of the excipients.
The potential exists for cross sensitivity to aspirin and other non-steroidal anti-inflammatory agents (NSAIDs). Feldene Gel should not be given to patients in whom aspirin and other non-steroidal anti-inflammatory agents induce the symptoms of asthma, nasal polyps, angioneurotic oedema or urticaria.

Life-threatening cutaneous reactionsincluding 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 rules out.
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.
This medicinal product contains propylene glycol and may cause skin irritation. If local irritation develops, the use of the Feldene Gel should be discontinued and appropriate therapy instituted as necessary. Because this medicine contains propylene glycol, Feldene Gel should not be used on open wounds or large areas of broken or damaged skin (such as burns).
This medicinal product contains benzyl alcohol which may cause mild local irritation.
Benzyl alcohol may cause allergic reactions.

Feldene Gel is well tolerated. Mild to moderate local irritation, erythema, pruritus and dermatitis may occur at the application site.
The systemic absorption of Feldene Gel is very low. In common with other topical non-steroidal anti-inflammatory agents, systemic reactions occur infrequently and have included minor gastro-intestinal side-effects such as nausea and dyspepsia. Cases of abdominal pain and gastritis have been reported rarely. There have been isolated reports of bronchospasm and dyspnoea.
Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome (SJS) Fixed drug eruption at an unknown frequency.
and toxic epidermal necrolysis (TEN) have been reported very rarely.
Contact dermatitis, eczema and photosensitivity skin reaction have also been observed from post-marketing experience.
See prescribing information for full details.

None known.

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, 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.
Lactation: Feldene Gel is not recommended for use in nursing mothers as clinical safety has not been established.
See prescribing information for full details.

Overdosage is unlikely to occur with this topical preparation.

Storage: Store below 25°C.
After first opening the preparation can be used within 6 months, no later than the expiration date.