These highlights do not include all the information needed to use Taclonex Scalp® Topical Suspension safely and effectively. See full prescribing information for Taclonex Scalp® Topical Suspension. Initial U.S. Approval: 2006
INDICATIONS AND USAGE
Taclonex Scalp® Topical Suspension is a vitamin D analog and corticosteroid combination product indicated for the topical treatment of moderate to severe psoriasis vulgaris of the scalp in adults 18 years and older (1.1)
Limitations of Use:
• Do not use on the face, axillae or groin (1.2)
• Do no use if atrophy is present at the treatment site (1.2)
DOSAGE AND ADMINISTRATION
Apply Taclonex Scalp® Topical Suspension to affected areas on the scalp once daily for 2 weeks or until cleared. Treatment may be continued for up to 8 weeks (2.1). The maximum weekly dose should not exceed 100 g (1.2). Shake before use (2).
Taclonex Scalp® Topical Suspension is not for oral, ophthalmic, or intravaginal use.
DOSAGE FORMS AND STRENGTHS
Suspension.
Each gram of Taclonex Scalp® Topical Suspension contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
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Hypercalcemia and hypercalciuria have been reported. If either occurs, discontinue until parameters of calcium metabolism normalize (5.1)
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Topical corticosteroids can produce reversible HPA axis suppression, Cushing's syndrome and unmask latent diabetes (5.2)
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Rate of adrenal suppression increased with treatment duration (5.2)
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Systemic absorption may require eva luation for hypothalamic-pituitary-adrenal (HPA) axis suppression (5.2)
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Modify use should HPA axis suppression develop (5.2)
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Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption (5.1)
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Local adverse reactions may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis and may be more likely with occlusive use or more potent corticosteroids (5.3, 6.1)
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Children may be more susceptible to systemic toxicity when treated with topical corticosteroids (5.2, 8.4)
ADVERSE REACTIONS
The most common adverse reactions (≥ 1%) are folliculitis and burning sensation of skin ( 6.1)
To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc at Phone 1-8877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 8/2010
