Dermatological Preparations : Analgesics and Antipruritics
TFOCU1 “Focus gel” 10mg/gm; 40gm/tube
適應症：骨關節炎、風濕性關節炎、關節黏連性脊椎炎、急性痛風、關節周圍炎、肌纖維炎。肌肉骨骼的不適（腱炎、黏液囊炎、外傷後疼痛）、手術後疼痛、原發性痛經。
適應症：類風濕性關節炎、骨關節炎（關節痛、退化性關節炎）、僵直性脊椎炎、急性肌肉骨骼損傷及急性痛風、肌肉痛外傷後之腫脹及疼痛。
Usual dose:
Apply appropriate amount of gel and rub into the affected site three to four times daily leaving to residual material on the skin.
Dose adjustment:
Use in Children: Dosage recommendations and indications for use of Piroxicam Gel in children have not been established.
Contraindication:
Piroxicam Gel should not be used in those patients who have previously shown hypersensitivity to piroxicam in any of its forms, or any of the other ingredients. 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.
Precaution:
Piroxicam Gel is not suitable for use in children under 12 years of age. The gel should not be used for any condition other than those specified.
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.
Keep away from the eyes and mucosal surfaces. Do not apply to any sites affected by open skin lesions, dermatoses or infection.
Adverse effect:
The systemic absorption of Piroxicam 0.5% Gel is very low. In common with other topical NSAIDs, systemic reactions occur infrequently. Mild to moderate local irritation, erythema, pruritus, and dermatitis may occur at the application site.
Common:
Mild to moderate local irritation：erythema, pruritus, and dermatitis may occur at the application site.
Gastrointestinal: nausea, dyspepsia, abdominal pain and gastritis have been reported.
Serious:
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Contact dermatitis, eczema and photosensitivity skin reaction have also been observed from post-marketing experience.
健保給付規範：限不適合口服非類固醇抗發炎製劑之軟組織風濕症或關節炎病患使用，每月至多以處方40gm為限(94/9/1)。