Calcipotriene And Betamethasone Dipropionate

2 DOSAGE AND ADMINISTRATION Apply an adequate layer of Calcipotriene and Betamethasone Dipropionate Ointment to the affected area(s) once daily for up to 4 weeks. Calcipotriene and Betamethasone Dipropionate Ointment should be rubbed in gently and completely.

Patients should wash their hands after applying Calcipotriene and Betamethasone Dipropionate Ointment. Therapy should be discontinued when control is achieved. Patients 18 years and older should not use more than 100 g per week and patients 12 to 17 years should not use more than 60 g per week.

Treatment of more than 30% body surface area is not recommended. Calcipotriene and Betamethasone Dipropionate Ointment should not be used with occlusive dressings unless directed by a physician. Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.

Calcipotriene and Betamethasone Dipropionate Ointment is not for oral, ophthalmic, or intravaginal use. • Apply Calcipotriene and Betamethasone Dipropionate Ointment to affected area(s) once daily for up to 4 weeks. Discontinue therapy when control is achieved.

(2) • Adult patients should not use more than 100 g per week. (2) • Patients ages 12 to 17 years should not use more than 60 g per week. (2) • Treatment of more than 30% body surface area is not recommended. (2) • Do not use with occlusive dressings unless directed by a physician.

(2) • Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. (2) • Not for oral, ophthalmic, or intravaginal use. (2)

6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most common adverse reactions (≥1%) are pruritus and scaly rash. gov/medwatch. 1 Clinical Trials Experience Clinical Trials Conducted in Subjects 18 years and older with Plaque Psoriasis The data described below reflect exposure to calcipotriene and betamethasone dipropionate ointment in 2448 subjects with plaque psoriasis, including 1992 exposed for 4 weeks, and 289 exposed for 8 weeks.

Calcipotriene and betamethasone dipropionate ointment was studied primarily in placebo- and active-controlled trials (N = 1176, and N = 1272, respectively). The population was 15-97 years old, 61% males and 39% females, mostly white (97%) and had a baseline disease severity ranging from mild to very severe.

5 g. 4% in the vehicle group. 3) A lesional/perilesional adverse event was generally defined as an adverse event located ≤ 2 cm from the lesional border. 1) For subjects who reported lesional/perilesional adverse events, the median time to onset was 7 days for calcipotriene and betamethasone dipropionate ointment, 7 days for calcipotriene, 5 days for betamethasone dipropionate, and 3 days for vehicle.

1%) were, in decreasing order of incidence, folliculitis, rash papular, rash pustular, and skin hypopigmentation. 1%). In a separate trial, subjects (N = 207) with at least moderate disease severity were given calcipotriene and betamethasone dipropionate ointment intermittently on an “as needed” basis for up to 52 weeks.

4 g per week. The effects of calcipotriene and betamethasone dipropionate ointment on calcium metabolism were not studied and the effects on the HPA axis were not adequately studied. 0%). One case of serious flare-up of psoriasis was reported.

2 Postmarketing Experience The following adverse reactions associated with the use of calcipotriene and betamethasone dipropionate ointment have been identified post-approval: pustular psoriasis and rebound effect. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Postmarketing reports for local adverse reactions to topical corticosteroids may also include: striae, dryness, acneiform eruptions, perioral dermatitis, secondary infection and miliaria.

5 WARNINGS AND PRECAUTIONS • Hypercalcemia and hypercalciuria have been observed. If either occurs, discontinue treatment until parameters of calcium metabolism normalize. 1) • Calcipotriene and Betamethasone Dipropionate Ointment can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment.

Risk factors include the use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, concomitant use of more than one corticosteroid-containing product, altered skin barrier, liver failure, and use in pediatric patients.

Modify use should HPA axis suppression develop. 4) • Calcipotriene and Betamethasone Dipropionate Ointment may increase the risk of cataract and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. 1 Hypercalcemia and Hypercalciuria Hypercalcemia and hypercalciuria have been observed with use of calcipotriene and betamethasone dipropionate ointment.

If hypercalcemia or hypercalciuria develops, treatment should be discontinued until parameters of calcium metabolism have normalized. In the trials that included assessment of the effects of calcipotriene and betamethasone dipropionate ointment on calcium metabolism, such testing was done after 4 weeks of treatment.

2)] . 2 Effects on Endocrine System Calcipotriene and betamethasone dipropionate ointment can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment.

Factors that predispose a patient to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, concomitant use of more than one corticosteroid-containing product, use of occlusive dressings, altered skin barrier, liver failure, and young age.

2)]. In a trial evaluating the effects of calcipotriene and betamethasone dipropionate topical suspension and calcipotriene and betamethasone dipropionate ointment on the HPA axis, 32 adult subjects were treated with calcipotriene and betamethasone dipropionate topical suspension on the scalp and calcipotriene and betamethasone dipropionate ointment on the body.

2)] . The effects of calcipotriene and betamethasone dipropionate ointment on the HPA axis following treatment durations of longer than 4 weeks have not been adequately studied. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid.

Cushing's syndrome and hyperglycemia may also occur due to the systemic effects of topical corticosteroids. These complications are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids.

2)]. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. 3 Ophthalmic Adverse Reactions Use of topical corticosteroids, including Calcipotriene and Betamethasone Dipropionate Ointment, may increase the risks of glaucoma and posterior subcapsular cataract.

Glaucoma and cataracts have been reported in postmarketing experience with the use of topical corticosteroid products, including topical clobetasol products. Avoid contact of Calcipotriene and Betamethasone Dipropionate Ointment with eyes.

Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. 4 Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation.

Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing. 5 Allergic Contact Dermatitis with Topical Calcipotriene Allergic contact dermatitis has been observed with use of topical calcipotriene. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

6 Skin Irritation If irritation develops, treatment with Calcipotriene and Betamethasone Dipropionate Ointment should be discontinued and appropriate therapy instituted. 7 Risk of Ultraviolet Light Exposure Patients who apply Calcipotriene and Betamethasone Dipropionate Ointment to exposed skin should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc.

Physicians may wish to limit or avoid use of phototherapy in patients who use Calcipotriene and Betamethasone Dipropionate Ointment.

4 CONTRAINDICATIONS None. None.