SOLARAZE

What it is

SOLARAZE is a gel containing diclofenac sodium 3% . Diclofenac sodium is a non-steroidal compound that exhibits pronounced antirheumatic, anti-inflammatory, analgesic, and antipyretic properties .

Approved indications

The product information provided does not contain approved indications specific to the topical gel formulation. The available documentation covers oral tablet formulations only.

Key safety warnings

Non-selective NSAIDs may be associated with an increased risk of serious cardiovascular events including myocardial infarction and stroke, which may increase with dose or duration of use, particularly in patients with cardiovascular disease or cardiovascular risk factors . The lowest effective daily dose should be used for the shortest duration possible . Close medical surveillance is imperative in patients with symptoms indicative of gastrointestinal disorders or with a history of gastro-intestinal ulceration, bleeding or perforation. Upper GI ulcers, gross bleeding or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3–6 months and in about 2–4% of patients treated for one year, with higher risk with increasing doses, longer duration of use, and in elderly patients with a history of ulcer . Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, bullous fixed drug eruption and toxic epidermal necrolysis, have been reported very rarely and are idiosyncratic and independent of dose or duration of use, with patients at highest risk early in the course of therapy, typically within the first month . NSAIDs inhibit prostaglandin synthesis and when given during the latter part of pregnancy may cause closure of the foetal ductus arteriosus, oligohydramnios, and foetal renal impairment. Use of diclofenac during the third trimester of pregnancy is contraindicated owing to the possibility of uterine inertia, fetal renal impairment with subsequent oligohydramnios and/or premature closure of the ductus arteriosus .

Contraindications

SOLARAZE is contraindicated in patients with gastric or duodenal ulcer, gastro-intestinal bleeding or perforation; hypersensitivity to diclofenac or any excipients; last trimester of pregnancy; severe hepatic impairment; renal failure; severe cardiac failure; treatment of perioperative pain in coronary artery bypass surgery; and in patients in whom diclofenac, aspirin or other NSAIDs induce asthma, angioedema, urticaria or other allergic-type reactions .

PBS listing

SOLARAZE gel containing diclofenac sodium 30 mg per g in 25 g tubes is listed on the PBS as 1 item with authority required restriction, at an ex-manufacturer price of A$46.09 .

Regulatory history

SOLARAZE diclofenac sodium 3% gel was first listed on the ARTG on 15 May 2007 .