Feldene Gel

1. Name Of The Medicinal Product

FELDENE GEL

FELDENE SPORTS GEL

FELDENE GEL STARTER PACK.

2. Qualitative And Quantitative Composition

Active ingredient: Piroxicam

The Gel contains 5mg piroxicam in each gram in tubes of 7.5g - Feldene Gel starter Pack, 30g - Feldene Sports Gel, 60g and 112g - Feldene Gel.

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

Dosage

Adults Feldene Gel, Feldene Sports Gel and Feldene Gel Starter Pack are for external use only. No occlusive dressings should be employed. Apply 1g of Gel, corresponding to 3cms, 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 (See under 'Special warnings and special precautions for use').

Use in the Elderly (See under 'Special warnings and special precautions for use').

4.3 Contraindications

Feldene Gel, Feldene Sports Gel and Feldene Gel Starter Pack 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, Feldene Sports Gel and Feldene Gel Starter Pack 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

If local irritation develops, the use of the 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.

Use in patients with impaired hepatic function

Use in patients with renal impairment

Use in the Elderly No special precautions are required.

Use in Children Dosage recommendations and indications for the use of Feldene Gel, Feldene Sports Gel and Feldene Gel Starter Pack in children under 12 years have not been established.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Use in pregnancy Although no teratogenic effects were seen when piroxicam was orally administered in animal testing, the use of Feldene Gel, Feldene Sports Gel and Feldene Gel Starter Pack during pregnancy or during lactation is not recommended.

Nursing mothers Feldene Gel, Feldene Sports Gel and Feldene Gel Starter Pack are not recommended for use in nursing mothers as clinical safety has not been established.

4.7 Effects On Ability To Drive And Use Machines

None known.

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).

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

4.9 Overdose

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 indomethacin 1% Gel in rats and guinea pigs. Using established animal models of pain and inflammation, Feldene Gel was as effective as oral Feldene and indomethacin 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.

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.

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

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 white vinyl pressure sensitive polyethylene end seal, fitted with a polypropylene cap containing either 7.5g, 30g, 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)

Feldene Gel, Feldene Sports Gel and Feldene Gel Starter Pack PL 0057/0284

9. Date Of First Authorisation/Renewal Of The Authorisation

13 January 2000

10. Date Of Revision Of The Text

February 2003

11. LEGAL CATEGORY

POM

Ref (UK): FE 3_1