How Supplied:
3% gel,100 g
Indications and Usage:
Solaraze Gel is indicated for the treatment of actinic keratoses.
Prescribing Instructions:
Prescribing Information Instructions [PDF]
Side Effects and Contraindications:
Solaraze Gel is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 350 and/or hyaluronate sodium. Sun avoidance is indicated during Solaraze Gel therapy. As with other NSDAID s, anaphylactoid reactions may occur in patients without prior exposur to diclofenac. Diclofenac sodium should be given with caution to patients with the aspirin triad. The triad typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. In clinical trails, the most common adverse reactions involved in the skin and included contact dermatitis, rash, dry skin and exfoliation. The majority of these reactions were mild to moderate in severity, and resolved upon discontinuation of therapy. Solaraze Gel should be used with caution in patients with active gastrointestinal ulceration or bleeding and severe renal or hepatic impairments. Solaraze Gel should not be applied to open wounds, infections, or exfoliative dermatitis. It should not be allowed to come in contact with the eyes. The safety of concomitant use of sunscreens, cosmetics or other topical medications and Solaraze is unknown.
Company:
PharmaDerm, a division of Fougera Pharmaceuticals Inc.
866-337-6457
www.pharmaderm.com
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