Piroxicam 0.5% W/W Gel
1. NAME OF THE MEDICINAL PRODUCT
Piroxicam 0.5% w/w Gel Manxiflex 0.5% w/w 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 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 joint such as the knee, acute muscolskeletal injuries, periarthritis, epicondylitis, tendinitis and tenosynovitis.
4.2 Posology and method of administration
Adults: Apply 1 g of the gel (about 3 cms or 11/4 inches) and rub into the affected area until the gel completely disappears. Wash hands immediately after use. Apply three or four times a day. If the condition has not improved significantly in four weeks, treatment should be reviewed.
Occlusive dressings should not be used.
Children: Not recommended.
Elderly: No special precautions are necessary.
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. 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 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 discontinue use of the product.
Keep away from the eyes and mucosal surfaces. Do not apply to any sites affected by open skin lesions, dermatoses or infection.
Topical application of large amounts of piroxicam gel may result in increased systemic absorption of piroxicam with increased potential for systemic side effects.
Avoid excessive exposure to sunlight of the treated area to reduce the potential for development of photosensitivity reactions.
Piroxicam Gel should be used with caution in patients who have a history of serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens Johnson syndrome or toxic epidermal necrolysis.
Piroxicam Gel should be used with caution in patients who have a history of serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens Johnson syndrome or toxic epidermal necrolysis.
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 occurrence 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 a patient has developed SJS or TEN with the use of piroxicam, piroxicam must not be restarted in this patient at any time.
Use with caution in patients with impaired hepatic function.
Use with caution in patients with renal impairment.
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
The potential exists for cross-sensitivity to aspirin and other non-steroidal antiinflammatory agents.
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, the use of Piroxicam 0.5% w/w Gel during pregnancy is not recommended.
Lactation. Piroxicam 0.5% w/w 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
There should be no effect on the patient’s ability to drive and use machinery.
4.8 Undesirable effects
Mild to moderate local irritation, erythema, pruritus and dermatitis may occur at the application site. Contact dermatitis, eczema and photosensitivity skin reactions have been reported.
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.
Severe cutaneous adverse reactions. Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported very rarely (see section 4.4).
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.
PHARMACOLOGICAL PROPERTIES
5
5.1 Pharmacodynamic properties
Piroxicam is a cyclo-oxygenase (COX) inhibitor which has anti-inflammatory effects, in addition to having anti-pyretic and analgesic effects. Piroxicam’s main mechanism of action is by inhibition of the enzyme cyclo-oxygenase in the arachidonic acid metabolism pathway, resulting in reduced prostaglandin synthesis. Piroxicam inhibits prostaglandin (thromboxane) synthesis in the platelet, and thus inhibits the secondary phase of platelet aggregation.
5.2 Pharmacokinetic properties
Pharmacokinetic and tissue distribution studies have shown that the highest levels of piroxicam were achieved in tissues below the site of application with low levels in the plasma. A study in healthy human volunteers has shown that plasma concentrations following repeated topical application of a piroxicam 5% gel are about 5% of the level observed after equivalent doses of oral or intramuscular piroxicam.
5.3 Preclinical safety data
It is generally accepted that topical NSAID therapy provides a safer means of drug delivery than conventional routes. Clinical trials and post-marketing experience suggest that topical piroxicam is well-tolerated.
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 with a polypropylene cap containing 30g, 60g, 100g, or 112g.
6.6 Special precautions for disposal
Apply 1 g of the gel (about 3 cms or 11/4 inches) and rub into the affected area. Apply to three or four times a day. Occlusive dressings should not be used.
7 MARKETING AUTHORISATION HOLDER
Manx Healthcare Limited Taylor Group House Wedgnock Lane Warwick CV34 5YA United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 14251/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
08/12/2000 / 24/02/2009
10 DATE OF REVISION OF THE TEXT
26/05/2016