Piroxicam 0.5% Gel
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Piroxicam 0.5% Gel
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Piroxicam 0.5% w/w
3. PHARMACEUTICAL FORM
Topical Gel
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
Piroxicam Gel is a non-steroidal anti-inflammatory agent used for the treatment of 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 musculo-skeletal injuries, periarthritis, epicondylitis, tendinitis and tenosynovitis.
4.2 Posology and method of administration
For external use only.
Piroxicam Gel is for external use only. Occlusive dressings should not be used.
Adults: Apply 1 g of gel (about 3 cms or 1% inches) and rub into the affected area until the gel completely disappears. Apply up to three or four times a day. Therapy should be reviewed after 4 weeks use.
Use in children: dosage recommendations and indications for use of Piroxicam
Gel in children have not been established.
Elderly: No special precautions are necessary.
4.3. Contra-indications
Piroxicam gel should not be used in those patients who have previously shown a sensitivity to the Gel or to piroxicam in any of its forms. The potential exists for cross sensitivity to aspirin and other non-steroidal anti- inflammatory agents.
Piroxicam Gel should not be given to patients in whom aspirin and other nonsteroidal 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 discontinue use of the product. Appropriate therapy should be 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.
4.5 Interaction with other medicinal products and other forms of interaction
Incompatibilities: none known.
Interactions: none known
4.6 Pregnancy and lactation
Although no teratogenic effects have been seen when piroxicam has been administered orally to animals, the use of Piroxicam Gel during pregnancy or during lactation is not recommended
Nursing mothers:_Piroxicam 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
None known.
Undesirable effects
4.8
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 Gel is very low. In common with other topical NSAIDs, 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 section 4.3 Contraindications).
Contact dermatitis, eczema and photosensitivity skin reaction have also been observed from postmarketing experience.
4.9. Overdose
Overdose 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-6 oxygenase enzyme.
New data are presented on the anti-inflammatory and analgesic effects of Piroxicam Gel compared with its vehicle and indomethacin 1% Gel in rats and guinea pigs. Using established animal models of pain and inflammation, Piroxicam Gel was as effective as oral Piroxicam and indomethacin 1% Gel and significantly more effective than its vehicle.
5.2 Pharmacokinetic properties
Pharmacokinetic and tissue distribution studies have shown that the highest concentrations of piroxicam were achieved in tissues below the site of application with low concentrations in the plasma. Piroxicam 0.5% Gel has been shown to be continuously and gradually released from the skin to underlying tissues; equilibrium between skin and muscle or synovial fluid appeared to be reached 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
None relevant to the prescriber.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Propylene glycol, isopropyl alcohol, macrogol 7 glyceryl cocoate, hypromellose, sodium hydroxide, sodium metabisulphite, potassium dihydrogen phosphate, purified water.
6.2. Incompatibilities
None known.
6.3. Shelf Life
Three (3) years
6.4 Special Precautions for Storage
Do not store above 25°C.
6.5. Nature and Contents of Container
Aluminium tubes incorporating epoxy phenol internal lacquer with a membrane fitted with a polypropylene cap containing either 50g, 60g, 100g, or 112g of Piroxicam 0.5% Gel.
Instruction for Use/Handling
6.6.
Apply 1 g of the gel (about 3 cms or 1% inches) and rub into the affected area. Apply up to three of four times a day. Occlusive dressings should not be used.
7 MARKETING AUTHORISATION HOLDER
Pliva Pharma Limited Ridings Point, Whistler Drive, Castleford,
West Yorkshire, WF10 5HX
8. MARKETING AUTHORISATION NUMBER
PL 10622/0233
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
28 May 2004
10 DATE OF REVISION OF THE TEXT
03/07/2015