INDICATION AND USAGE
Taclonex® Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 18 years and older. Apply Taclonex® Topical Suspension to affected areas once daily for up to 8 weeks. Treatment may be discontinued earlier, if cleared. Instruct patients not to exceed a maximum weekly dose of 100 g.
IMPORTANT SAFETY INFORMATION
FOR TOPICAL USE ONLY. Taclonex® Topical Suspension is not for oral, ophthalmic, or intravaginal use and should not be applied to the face, axillae, or groin. Do not use if atrophy is present at the treatment site.
Hypercalcemia and hypercalciuria have been observed with use of Taclonex® Topical Suspension. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. Use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression and calcium abnormalities. If HPA axis suppression is documented, attempt to withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.
In clinical trials, the most common adverse reactions that occurred in ≥1% of subjects treated with Taclonex® Topical Suspension and at a rate higher than in subjects treated with vehicle were folliculitis and burning sensation of skin. Other less common adverse reactions (<1% but >0.1%) were, in decreasing order of incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash. Local adverse reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria and may be more likely with occlusive use or more potent corticosteroids. Some local adverse reactions may be irreversible. Taclonex® Topical Suspension may cause eye irritation. Avoid eye exposures. Patients who apply Taclonex® Topical Suspension to exposed skin should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc. There are no adequate and well-controlled studies of Taclonex® Topical Suspension in pregnant women. Taclonex® Topical Suspension should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Because many drugs are excreted in human milk, caution should be exercised when Taclonex® Topical Suspension is administered to a nursing woman. The patient should be instructed not to use Taclonex® Topical Suspension on the breast when nursing. Safety and effectiveness of the use of Taclonex® Topical Suspension in pediatric patients have not been studied.
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