Piroxicam 0.5% Gel
SUMMARY 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
Posology
Adults: Apply 1 g of gel (about 3 cms or W* 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.
Paediatric population: dosage recommendations and indications for use of Piroxicam Gel in children have not been established.
Older people: No special precautions are necessary.
Method of administration
For external use only.
Piroxicam Gel is for external use only. Occlusive dressings should not be used.
4.3 Contraindications
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 or to any excipients (see section 6) . 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
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 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.
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
Incompatibilities: none known.
Interactions: none known
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 postimplantation loss. Therefore Piroxicam Gel during pregnancy is not recommended.
Breast-feeding
Piroxicam Gel is not recommended for use in breast-feeding mothers as clinical safety has not been established.
4.7 Effects on ability to drive and use machines
Effects on ability to drive: none known
4.8 Undesirable effects
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 section 4.3 ).
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 postmarketing 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
4.9. Overdose
Overdose is unlikely to occur with this topical preparation.
5 PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: non-steroidal anti-inflammatory,
ATC code: M02AA07
Piroxicam is a non-steroidal anti-inflammatory agent useful in the treatment of inflammatory conditions. Although the mechanism 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
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.
6.6 Special precautions for disposal
Apply 1 g of the gel (about 3 cms or DA inches) and rub into the affected area. Apply up to three or four times a day. Occlusive dressings should not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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
28/08/2015