Plenura (clobetasol propionate/calcipotriene)

Safety and efficacy of calcipotriene alone or in fixed combination with betamethasone dipropionate in pediatric patients have not been established.

For the management of plaque psoriasis, calcipotriene 0.005% cream is applied as a thin film and rubbed gently and completely into the affected area twice daily. Safety and efficacy of calcipotriene cream have been demonstrated in patients receiving the drug for 8 weeks.

For the topical treatment of plaque psoriasis, the fixed-combination ointment containing calcipotriene 0.005% and betamethasone 0.05% should be applied and rubbed gently into the affected area(s), until absorbed, once daily. The fixed-combination ointment should not be applied to greater than 30% of body surface area. The manufacturer states that dosage of the fixed-combination ointment should not exceed 100 g of ointment per week, and duration of therapy should not exceed 4 consecutive weeks. Occlusive dressings should not be used with the fixed-combination preparation, unless directed by a clinician. The fixed-combination ointment should not be used in patients with erythrodermic, exfoliative, and pustular psoriasis or in patients with preexisting skin atrophy at the treatment site.

For chronic, moderately severe psoriasis of the scalp, the hair should be combed to remove scaly debris and, after the hair has been parted to reveal the affected area, the 0.005% solution should be applied only to the affected area and rubbed gently and completely into the scalp twice daily. Care should be taken to avoid contact of the drug with the forehead or uninvolved scalp margins. The solution should not be used in patients with acute psoriatic eruptions of the scalp.

For the topical treatment of moderate to severe plaque psoriasis of the scalp, the fixed-combination suspension containing calcipotriene 0.005% and betamethasone 0.05% should be applied to the affected area(s) on the scalp once daily for 2 weeks or until clearing of psoriatic lesions occurs. The bottle should be shaken prior to each use. The manufacturer states that dosage of the combination suspension should not exceed 100 g of suspension per week, and duration of therapy should not exceed 8 weeks. Occlusive dressings should not be used with the combination preparation, unless directed by a clinician. In addition, the combination suspension should not be used in patients with preexisting skin atrophy at the treatment site.

Most patients with psoriasis received topical calcipotriene 0.005% cream or solution in adequate well-controlled clinical trials of 8 weeks' duration. Results of controlled clinical studies indicate that twice-daily topical application of calcipotriene 0.005% cream or solution usually results in apparent improvement within 2 weeks; after 8 weeks of therapy, continued improvement was observed in 50 or 31% of patients receiving the cream or solution, respectively, while only 4 or 14% of patients showed complete clearing of lesions receiving calcipotriene cream or solution, respectively.

In a multicenter, double-blind, controlled study in patients with mild to very severe plaque psoriasis, absent or very mild disease after 4 weeks of treatment was reported in 48, 16.5, 26.3, and 7.6%, respectively, of patients receiving fixed-combination ointment containing calcipotriene and betamethasone dipropionate, calcipotriene alone, betamethasone dipropionate alone, and vehicle alone. In multicenter, randomized, double-blind studies in patients with moderate to very severe scalp psoriasis, clear or almost clear disease after 8 weeks of once-daily treatment was observed in 67.2-70, 59.6-63.1, and 36.7-41%, of patients receiving fixed-combination suspension containing calcipotriene and betamethasone dipropionate, betamethasone dipropionate monotherapy, and calcipotriene monotherapy, respectively.

Topically applied calcipotriene may be absorbed in sufficient amounts to produce systemic effects; elevated serum calcium concentrations have been observed with use of topical calcipotriene. If elevations in serum calcium concentration occur, use of calcipotriene preparations should be discontinued until normal serum calcium concentrations have been restored. Preparations containing calcipotriene should not be used in patients with demonstrated hypercalcemia or evidence of vitamin D toxicity (hypervitaminosis D) or in patients with known or suspected disorders of calcium metabolism.

Calcipotriene may increase the effect of ultraviolet radiation to induce skin tumors; patients who apply calcipotriene to exposed areas of the body should minimize exposure to sunlight or artificial ultraviolet light (e.g., sunlamps, tanning booths). In addition, the manufacturer states that clinicians may want to limit or avoid use of phototherapy in patients using calcipotriene alone or in fixed combination with betamethasone dipropionate.

Topical clobetasol propionate cream, ointment, gel, lotion, and foam are applied sparingly in thin films and are rubbed gently into the affected area twice daily, preferably in the morning and evening. Clobetasol propionate solution is applied to affected areas of the scalp twice daily, in the morning and evening. Clobetasol propionate shampoo is applied in a thin film to affected areas of the dry (not wet) scalp once daily; the shampoo should be left in place for 15 minutes before lathering and rinsing. Because certain areas of the body may be more susceptible to atrophic changes than others following treatment with corticosteroids, clobetasol propionate cream, ointment, gel, lotion, foam, and shampoo should not be applied to the face or intertriginous areas (e.g., axilla, groin). Although there are no restrictions regarding use of clobetasol propionate solution on the face, axilla, or groin, the manufacturer states that patients receiving the solution should be observed frequently if these areas are to be treated.

When clobetasol propionate foam is applied, the canister containing the drug should be inverted and a small amount (up to a maximum of a golf-ball-sized dollop or 11/2 capfuls) of the preparation placed into the cap of the canister, onto a saucer, or other cool surface, or directly on the lesion, taking care to avoid contact with the eyes. The foam should not be dispensed directly to the hands (unless the hands are the affected area), since the foam will begin to melt immediately upon contact with warm skin. If the canister seems warm to the touch or the foam seems runny, the canister should be placed under cold running tap water. When applying clobetasol propionate foam to a hairy area, hair should be moved away from the affected area to allow application of the drug onto each affected area. The drug should be massaged gently with clean, dry fingertips into the affected area until the foam disappears; repeat until the entire affected area has been treated. Clobetasol propionate foam is flammable; therefore, exposure to flames or smoking should be avoided during and immediately after application.

When clobetasol propionate shampoo is applied to the dry scalp, hair should be moved away from the affected area to allow application of the drug directly onto each affected area. The bottle should be positioned over the affected area and gently squeezed so that a small amount of shampoo is released directly onto the affected area, avoiding any contact with the face, eyes, or lips; if accidental contact occurs, the area should be rinsed thoroughly with water. After application onto the scalp, the drug should be spread so that the entire affected area is covered with a thin uniform film. The drug should then be massaged gently into the affected area; the procedure should be repeated to treat additional affected areas. When all affected areas have been treated, the hands should be washed, and the shampoo should be left in place for 15 minutes. After 15 minutes, water should be added and the shampoo should be lathered, and then all parts of the scalp and body that came in contact with the shampoo (e.g., hands, face, neck, shoulders) should be rinsed thoroughly. Although no additional shampoo is necessary to cleanse the hair, a nonmedicated shampoo may be used if desired.

Some patients may respond initially to once-daily or intermittent therapy (e.g., twice daily 3 days per week). Clobetasol therapy should be discontinued and a less potent topical corticosteroid preparation substituted as soon as clinically feasible, but dosage should not exceed 50 g of clobetasol propionate 0.05% cream, foam, or ointment or 50 mL (50 g) of clobetasol propionate 0.05% lotion, solution, or shampoo per week. Use of clobetasol propionate cream, foam, gel, lotion, ointment, or solution generally should not exceed 14 days. Although clobetasol propionate 0.05% emollient cream or lotion (applied to no more than 10% of body surface area) may be used for up to 4 consecutive weeks in the management of plaque psoriasis, the manufacturers state that additional benefits of extended treatment (i.e., beyond 2 weeks) should be weighed against the risk of hypothalamic-pituitary-adrenal (HPA)-axis suppression. The manufacturer states that use of clobetasol propionate 0.05% shampoo should be limited to 4 consecutive weeks. If complete resolution is not achieved following 4 weeks of therapy, a less potent topical corticosteroid may be substituted for clobetasol propionate shampoo. If no improvement is seen within 4 weeks, reassessment of the diagnosis may be necessary.

Many clinicians indicate that more prolonged clobetasol therapy rarely may be necessary in patients with resistant conditions, but careful monitoring is essential. The risk of adverse systemic corticosteroid effects (e.g., HPA-axis suppression, Cushing's syndrome, hyperglycemia) associated with use of this potent corticosteroid must be carefully considered. Intermittent maintenance therapy, such as administration of the drug once- or twice-weekly for up to 6 months, has resulted in prolonged periods of remission from corticosteroid-responsive dermatoses in some patients.

Clobetasol propionate cream, foam, gel, lotion, ointment, solution, or shampoo should not be used with occlusive dressings and patients should be warned that treated areas of the skin should not be bandaged or otherwise covered or wrapped as to be occlusive.

Calcipotriene alone or in fixed combination with betamethasone dipropionate is applied topically to the skin as a cream or ointment, respectively; calcipotriene also is applied as a solution or as a fixed-combination suspension containing calcipotriene and betamethasone dipropionate to the scalp. The topical cream and solution are for external use only and should not be applied to the face, eyes, or mucous membranes. The topical fixed-combination ointment and suspension also are for external use onlyand should not be applied to the face, eyes, axillae, or groin area. The hands should be washed thoroughly after application of topical calcipotriene preparations.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

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• Hypervitaminosis D

• Hypercalcemia
• Hypercalcinuria

• Adrenocortical insufficiency
• Diabetes mellitus

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More Frequent

• Dermatitis due to topical drug
• Skin rash

Less Frequent

• Folliculitis
• Purpura
• Skin and skin structure infection
• Skin atrophy

Rare or Very Rare

• Adrenocortical insufficiency
• Bullous dermatitis
• Cataracts
• Central serous chorioretinopathy
• Folliculitis
• Glaucoma
• Growth failure
• Hypercalcemia
• Hypercalcinuria
• Hypothalamic-pituitary insufficiency
• Intracranial hypertension
• Ocular hypertension
• Skin atrophy
• Skin hypopigmentation
• Skin striae
• Skin ulcer
• Urticaria

More Frequent

• Abnormal desquamation
• Dry skin
• Erythema
• Erythema
• Pruritus of skin
• Skin irritation
• Stinging of skin

Less Frequent

• Acute pain at drug application site
• Acute pain at drug application site
• Blurred vision
• Drug-exacerbated psoriasis
• Headache disorder
• Paresthesia
• Pruritus of skin
• Skin rash
• Telangiectasia
• Treatment site sequelae

Rare or Very Rare

• Acneiform eruption
• Alopecia
• Blistering skin
• Blistering skin
• Contact dermatitis
• Dry skin
• Dyschromia
• Dyschromia
• Glycosuria
• Hirsutism
• Hypercortisolism
• Hyperesthesia
• Hyperglycemia
• Miliaria
• Miliaria
• Perioral dermatitis
• Skin hypopigmentation
• Skin irritation
• Skin photosensitivity
• Urticaria

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No enhanced messaging available.

The teratogenic potential of topical clobetasol propionate is not known; however, the drug appears to undergo percutaneous absorption, and reproduction studies in mice and rabbits using subcutaneous dosages of the drug as low as 30 mcg/kg (approximately 0.04 times the human topical dose) or 3 mcg/kg (approximately 0.02 times the human topical dose), respectively, have revealed evidence of substantial harm to the fetus (e.g., cleft palate, cranioschisis, skeletal abnormalities). Teratogenic effects of clobetasol were observed at subcutaneous dosages about one-fourth to one-twelfth those of betamethasone in these animals. In addition, although the teratogenic potential of topical clobetasol has not been studied, other potent corticosteroids have been shown to be teratogenic in animals following topical application.

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