Diyra (ciclopirox olamine/clobetasol propionate/pyrithione zinc)

The labeled strengths of ciclopirox olamine creams and lotions are no longer expressed in terms of the olamine salt (i.e., 1% ciclopirox olamine), but instead are expressed in terms of the base, ciclopirox (i.e., 0.77% ciclopirox).

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.

Ciclopirox olamine is applied topically to the skin as a cream or lotion while ciclopirox is applied topically to the skin as a gel or shampoo and to nails as a solution (nail lacquer). The ciclopirox olamine lotion, which should be shaken vigorously before each use, may be particularly useful for infections involving relatively large areas or areas where a less viscous formulation might be preferred. Occlusive dressings or wrappings should not be used. Ciclopirox and ciclopirox olamine preparations should not be applied to the eye nor administered orally or intravaginally.

Patients should remove any loose nail or nail material (using nail clippers or nail files) before initiating therapy with ciclopirox solution (nail lacquer). Removal of unattached, infected nail(s) as frequently as once monthly by a qualified clinician in nail disorders, weekly self-trimming of infected nail(s) by the patient, and daily application of the topical solution (nail lacquer) are all essential components of the topical management of onychomycosis.

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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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There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• Adrenocortical insufficiency
• Diabetes mellitus
• No disease contraindications

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More Frequent

• Skin irritation

Less Frequent

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

Rare or Very Rare

• Adrenocortical insufficiency
• Bullous dermatitis
• Cataracts
• Central serous chorioretinopathy
• Glaucoma
• Growth failure
• Hypothalamic-pituitary insufficiency
• Intracranial hypertension
• Ocular hypertension
• Pruritus of skin
• Skin hypopigmentation
• Skin inflammation
• Skin irritation
• Skin striae
• Skin ulcer
• Urticaria

More Frequent

• Erythema
• Stinging of skin

Less Frequent

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

Rare or Very Rare

• Acneiform eruption
• Alopecia
• Blistering skin
• Contact dermatitis
• Dry skin
• Dyschromia
• Erythema
• Glycosuria
• Hair discoloration
• Hirsutism
• Hypercortisolism
• Hyperesthesia
• Hyperglycemia
• Miliaria
• Nail disorders
• Perioral dermatitis
• Skin irritation

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Reproduction studies in mice, rats, rabbits, and monkeys using ciclopirox olamine dosages (via various routes of administration) 10 or more times the topical human dosage have not revealed evidence of harm to the fetus. Reproduction studies in rats and rabbits using topical dosages of ciclopirox up to 120 and 100 mg/kg of body weight, respectively, (approximately 121 and 147 times the maximum recommended topical human dosage based on surface area, respectively), also have not revealed evidence of fetotoxicity. In addition, reproduction studies in mice, rats, rabbits, and monkeys using oral dosages of ciclopirox up to 100, 30, 30, and 50 mg/kg of body weight, respectively (approximately 37.5, 30, 44, and 77 times the maximum recommended topical human dosage based on surface area, respectively), have not revealed evidence of fetotoxicity. There are no adequate and controlled studies to date using topical ciclopirox or ciclopirox olamine in pregnant women; topical ciclopirox olamine cream and lotion and ciclopirox shampoo should be used during pregnancy only when clearly needed, while topical ciclopirox gel and solution (nail lacquer) should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

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.

It is not known whether ciclopirox or ciclopirox olamine is distributed in human milk. Because many drugs are distributed in human milk, ciclopirox or ciclopirox olamine preparations should be used with caution in nursing women.

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