Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment is an effective once-daily treatment

Significant improvement in plaque psoriasis was seen in a clinical trial as early as Week 1

Taclonex® Ointment has a unique combination formula that may allow most patients to see improvement by Week 4. In fact, in a clinical trial, most patients had absent or very mild plaque psoriasis after using Taclonex® Ointment for 4 weeks. Many patients may see results as early as Week 1.

INDICATIONS 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.

Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment is approved for use on the skin to treat psoriasis vulgaris (plaque psoriasis) in adults 18 years of age and older and should be applied to affected areas once daily for up to 4 weeks. Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension is approved to treat moderate to severe psoriasis vulgaris of the scalp in adults 18 years and older and should be applied to affected areas on the scalp once a day for 2 weeks or until cleared. If the affected area is not cleared, Taclonex Scalp® Topical Suspension may be continued for up to 8 weeks. Do not exceed the recommended weekly dose of 100 grams for either product. Neither product is recommended for use on children.

IMPORTANT SAFETY INFORMATION ABOUT TACLONEX® TOPICAL SUSPENSION, TACLONEX® OINTMENT, AND TACLONEX SCALP® TOPICAL SUSPENSION

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.

FOR TOPICAL USE ONLY. Do not use Taclonex® Ointment or Taclonex Scalp® Topical Suspension on your face, under your arms, or on your groin. Do not get either product in your eyes, mouth, or vaginal area. Do not swallow Taclonex® Ointment or Taclonex Scalp® Topical Suspension.

You should not use Taclonex® Ointment or Taclonex Scalp® Topical Suspension if you are allergic to any of their ingredients, have thin skin (atrophy) at the treatment site, have known or suspected calcium metabolism disorders (too much or too little calcium in your blood or urine), have erythrodermic, exfoliative, or pustular psoriasis, or have severe kidney or severe liver disease. Avoid excessive exposure to either natural or artificial sunlight if you apply Taclonex® Ointment to exposed portions of your body or use Taclonex Scalp® Topical Suspension. Tell your doctor if you have a skin infection, are getting phototherapy treatments for your psoriasis, are pregnant, or planning to become pregnant, or are breastfeeding. Also tell your doctor about other medicines you are taking, especially other corticosteroids, products containing calcipotriene, or medicines for your psoriasis.

Taclonex® Ointment and Taclonex Scalp® Topical Suspension may cause serious side effects if you use too much, use it for too long, or use it with other medicines that contain corticosteroids or calcipotriene. Taclonex® Ointment and Taclonex Scalp® Topical Suspension contain the same medicine to treat psoriasis vulgaris. If you use both medicines to treat your psoriasis vulgaris, be sure to follow your doctor’s directions carefully so that you do not use too much of one or both of these medicines. Taclonex® Ointment and Taclonex Scalp® Topical Suspension can pass through your skin. Serious side effects may include too much calcium in your blood or urine or adrenal gland problems. Your doctor may do special blood and urine tests to check your calcium levels and adrenal gland function while you are using Taclonex® Ointment or Taclonex Scalp® Topical Suspension.

The most common side effects of Taclonex® Ointment are itching and rash. Other less common side effects with Taclonex® Ointment include redness of the skin, inflamed hair pores (folliculitis), psoriasis, skin irritation, skin burning, change of skin color (at the site of application), rash with pus-filled papules, thinning of the skin, and swollen fine blood vessels (this makes your skin appear red at the site of application).

The most common side effects of Taclonex Scalp® Topical Suspension are inflamed hair pores (folliculitis) and burning sensation of the skin. Other side effects include itching, worsening of psoriasis, redness of the skin, and skin pain or irritation.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm or call 1-800-FDA-1088.

Please see full Prescribing Information for Taclonex® Topical Suspension, Taclonex® Ointment, and Taclonex Scalp® Topical Suspension.

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