- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
- 11. Legal category
1. Name of the medicinal product
2. Qualitative and quantitative composition
Active ingredient: Piroxicam The Gel contains 5mg piroxicam in each gram in tubes of 60g and 112g.
3. Pharmaceutical form
Gel for topical application.
4. Clinical particulars
4.1 Therapeutic indications
Feldene Gel is a non-steroidal anti-inflammatory agent indicated for a variety of conditions characterised by pain and inflammation, or stiffness. It is effective in the treatment of osteoarthritis of superficial joints such as the knee, acute musculoskeletal injuries, periarthritis, epicondylitis, tendinitis, and tenosynovitis.
4.2 Posology and method of administration
Adults Feldene Gel is for external use only. No occlusive dressings should be employed. Apply 1g of Gel, corresponding to 3cm, 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.Use in Children Dosage recommendations and indications for the use of Feldene Gel in children have not been established.Use in the Elderly No special precautions are required.
Feldene Gel should not be used in those patients who have previously shown a hypersensitivity to the Gel or piroxicam in any of its forms. The potential exists for cross sensitivity to aspirin and other non-steroidal anti-inflammatory agents. 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.
4.4 Special warnings and precautions for use
Life-threatening cutaneous reactions (Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) have been reported with the 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 weeks of treatment. If symptoms or signs 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.If local irritation develops, the use of the Feldene Gel should be discontinued and appropriate therapy instituted as necessary. 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.
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
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: 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 Feldene Gel during pregnancy is not recommended.Lactation: Feldene Gel is not recommended for use in nursing mothers as clinical safety has not been established.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
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 (see also Contra-indications).Severe cutaneous adverse reactions (SCARs): 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.
Overdosage is unlikely to occur with this topical preparation.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Piroxicam is a non-steroidal anti-inflammatory agent useful in the treatment of inflammatory conditions. Although the mode of action for this agent is not precisely understood, piroxicam inhibits prostaglandin synthesis and release through a reversible inhibition of the cyclo-oxygenase enzyme. New data are presented on the anti-inflammatory and analgesic effects of Feldene Gel compared with its vehicle and indometacin 1% Gel in rats and guinea pigs. Using established animal models of pain and inflammation, Feldene Gel was as effective as oral Feldene and indometacin 1% Gel and significantly more effective than its vehicle.
5.2 Pharmacokinetic properties
On the basis of various pharmacokinetic and tissue distribution studies in animals, with piroxicam gel 0.5%, the highest concentrations of piroxicam were achieved in the tissues below the site of application with low concentrations being reached in the plasma. Piroxicam gel 0.5% was continuously and gradually released from the skin to underlying tissues, equilibrium between skin, and muscle or synovial fluid appeared to be reached rapidly, within a few hours of application. From a pharmacokinetic study in man, 2g of the Gel was applied to the shoulders of normal volunteers twice daily (corresponding to 20mg piroxicam/day) for 14 days, plasma levels of piroxicam rose slowly, reaching steady state after about 11 days. The plasma levels at this time were between 300-400 ng/ml, or one-twentieth of those observed in subjects receiving 20mg orally. The serum half-life of piroxicam is approximately 50 hours.
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
Propylene Glycol EP, Carbopol 980 EP, Ethyl Alcohol EP, Benzyl Alcohol EP, di-isopropanolamine NF, Hydroxyethyl Cellulose EP, Purified Water EP.
6.3 Shelf life
6.4 Special precautions for storage
Store below 30°C.
6.5 Nature and contents of container
Aluminium blind-ended tube incorporating epoxy-phenol internal lacquer with a polymer end seal, fitted with a polypropylene cap containing either 60g or 112g of Feldene Gel.
6.6 Special precautions for disposal and other handling
No special requirements.
7. Marketing authorisation holder
Pfizer Limited Ramsgate Road Sandwich Kent CT 13 9NJ United Kingdom
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
11. Legal category
Ramsgate Road, Sandwich, Kent, CT13 9NJ
+44 (0)1304 656 221
+44 (0)1304 616 161