Ciclopirox Topical Dosage

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Usual Adult Dose for Onychomycosis - Fingernail

8% topical solution: Apply once a day (preferably at bedtime or 8 hours before washing) to all affected nails with the applicator brush provided. Apply evenly over the entire nail plate and 5 mm of surrounding skin. If possible, the solution should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed.

The product should not be removed on a daily basis. Daily applications should be made over the previous coat and removed with alcohol every 7 days. This cycle should be repeated throughout the duration of treatment.

Up to 48 weeks of daily applications and professional removal, as frequently as monthly, of the unattached, infected nail are considered the full treatment to achieve a clear or almost clear nail. Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed.

Usual Adult Dose for Onychomycosis - Toenail

8% topical solution: Apply once a day (preferably at bedtime or 8 hours before washing) to all affected nails with the applicator brush provided. Apply evenly over the entire nail plate and 5 mm of surrounding skin. If possible, the solution should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed.

The product should not be removed on a daily basis. Daily applications should be made over the previous coat and removed with alcohol every 7 days. This cycle should be repeated throughout the duration of treatment.

Up to 48 weeks of daily applications and professional removal, as frequently as monthly, of the unattached, infected nail are considered the full treatment to achieve a clear or almost clear nail. Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed.

Usual Adult Dose for Seborrheic Dermatitis

0.77% topical gel: Apply to affected scalp areas twice a day (in the morning and evening) for 4 weeks.

1% topical shampoo: Wet hair and apply approximately 5 mL to the scalp. Up to 10 mL may be used for long hair. Lather and leave on hair and scalp for 3 minutes, then rinse off. Treatment should be repeated twice a week for 4 weeks, with at least 3 days between applications.

Usual Adult Dose for Cutaneous Candidiasis

0.77% topical cream, suspension (lotion): Gently massage into affected and surrounding skin areas twice a day (in the morning and evening). Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment.

Patients with tinea versicolor usually exhibit clinical and mycological clearing after 2 weeks of treatment.

Usual Adult Dose for Tinea Cruris

0.77% topical cream, suspension (lotion): Gently massage into affected and surrounding skin areas twice a day (in the morning and evening). Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment.

Patients with tinea versicolor usually exhibit clinical and mycological clearing after 2 weeks of treatment.

Usual Adult Dose for Tinea Versicolor

0.77% topical cream, suspension (lotion): Gently massage into affected and surrounding skin areas twice a day (in the morning and evening). Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment.

Patients with tinea versicolor usually exhibit clinical and mycological clearing after 2 weeks of treatment.

Usual Adult Dose for Tinea Corporis

0.77% topical cream, suspension (lotion): Gently massage into affected and surrounding skin areas twice a day (in the morning and evening). Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment.

0.77% topical gel: Gently massage gel into affected areas and surrounding skin twice a day (in the morning and evening) immediately after cleaning or washing areas to be treated. Interdigital tinea pedis and tinea corporis should be treated for 4 weeks.

Usual Adult Dose for Tinea Pedis

0.77% topical cream, suspension (lotion): Gently massage into affected and surrounding skin areas twice a day (in the morning and evening). Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment.

0.77% topical gel: Gently massage gel into affected areas and surrounding skin twice a day (in the morning and evening) immediately after cleaning or washing areas to be treated. Interdigital tinea pedis and tinea corporis should be treated for 4 weeks.

Usual Pediatric Dose for Onychomycosis - Fingernail

12 years or older:
8% topical solution: Apply once a day (preferably at bedtime or 8 hours before washing) to all affected nails with the applicator brush provided. Apply evenly over the entire nail plate and 5 mm of surrounding skin. If possible, the solution should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed.

The product should not be removed on a daily basis. Daily applications should be made over the previous coat and removed with alcohol every 7 days. This cycle should be repeated throughout the duration of treatment.

Up to 48 weeks of daily applications and professional removal, as frequently as monthly, of the unattached, infected nail are considered the full treatment to achieve a clear or almost clear nail. Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed.

Usual Pediatric Dose for Onychomycosis - Toenail

12 years or older:
8% topical solution: Apply once a day (preferably at bedtime or 8 hours before washing) to all affected nails with the applicator brush provided. Apply evenly over the entire nail plate and 5 mm of surrounding skin. If possible, the solution should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed.

The product should not be removed on a daily basis. Daily applications should be made over the previous coat and removed with alcohol every 7 days. This cycle should be repeated throughout the duration of treatment.

Up to 48 weeks of daily applications and professional removal, as frequently as monthly, of the unattached, infected nail are considered the full treatment to achieve a clear or almost clear nail. Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed.

Usual Pediatric Dose for Seborrheic Dermatitis

16 years or older:
0.77% topical gel: Apply to affected scalp areas twice a day (in the morning and evening) for 4 weeks.

1% topical shampoo: Wet hair and apply approximately 5 mL to the scalp. Up to 10 mL may be used for long hair. Lather and leave on hair and scalp for 3 minutes, then rinse off. Treatment should be repeated twice a week for 4 weeks, with at least 3 days between applications.

Usual Pediatric Dose for Cutaneous Candidiasis

10 years or older:
0.77% topical cream, suspension (lotion): Gently massage into affected and surrounding skin areas twice a day (in the morning and evening). Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment.

Patients with tinea versicolor usually exhibit clinical and mycological clearing after 2 weeks of treatment.

Usual Pediatric Dose for Tinea Cruris

10 years or older:
0.77% topical cream, suspension (lotion): Gently massage into affected and surrounding skin areas twice a day (in the morning and evening). Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment.

Patients with tinea versicolor usually exhibit clinical and mycological clearing after 2 weeks of treatment.

Usual Pediatric Dose for Tinea Versicolor

10 years or older:
0.77% topical cream, suspension (lotion): Gently massage into affected and surrounding skin areas twice a day (in the morning and evening). Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment.

Patients with tinea versicolor usually exhibit clinical and mycological clearing after 2 weeks of treatment.

Usual Pediatric Dose for Tinea Corporis

10 years or older:
0.77% topical cream, suspension (lotion): Gently massage into affected and surrounding skin areas twice a day (in the morning and evening). Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment.

16 years or older:
0.77% topical gel: Gently massage gel into affected areas and surrounding skin twice a day (in the morning and evening) immediately after cleaning or washing areas to be treated. Interdigital tinea pedis and tinea corporis should be treated for 4 weeks.

Usual Pediatric Dose for Tinea Pedis

10 years or older:
0.77% topical cream, suspension (lotion): Gently massage into affected and surrounding skin areas twice a day (in the morning and evening). Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment.

16 years or older:
0.77% topical gel: Gently massage gel into affected areas and surrounding skin twice a day (in the morning and evening) immediately after cleaning or washing areas to be treated. Interdigital tinea pedis and tinea corporis should be treated for 4 weeks.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Patients should be advised to contact their physician if they experience increased irritation (redness, itching, burning, blistering, swelling, oozing). Treatment should be discontinued and appropriate therapy initiated if signs of sensitivity or local irritation occur.

There are no data on the use of ciclopirox topical solution in patients with insulin dependent diabetes or who have diabetic neuropathy. Prior to prescribing ciclopirox topical solution to such patients, the risk of removal of the unattached, infected nail by the health care professional and trimming by the patient should be carefully considered.

Efficacy of ciclopirox topical gel has not been established in immunosuppressed patients. Efficacy of ciclopirox topical gel in the treatment of plantar and vesicular types of tinea pedis has not been established. Seborrheic dermatitis associated with acne, atopic dermatitis, Parkinsonism, psoriasis, and rosacea has not been studied with ciclopirox topical gel.

There are no data on the use of ciclopirox topical shampoo in patients who have history of immunosuppression, who are immunocompromised, or who have diabetic neuropathy.

Safety and effectiveness of ciclopirox topical cream and suspension (lotion) have not been established in pediatric patients less than 10 years of age. Safety and effectiveness of ciclopirox topical gel and shampoo have not been established in pediatric patients less than 16 years of age. Safety and effectiveness of ciclopirox topical solution have not been established in pediatric patients less than 12 years of age.

Dialysis

Data not available

Other Comments

If a patient shows no clinical improvement after 4 weeks of treatment with ciclopirox topical cream, gel, shampoo, or suspension (lotion), the diagnosis should be reviewed.

Ciclopirox topical is not for ophthalmic, oral, or intravaginal use. Contact with eyes and mucous membranes should be avoided.

Ciclopirox topical solution is for use on nails and immediately adjacent skin only. Contact with skin other than skin immediately surrounding the treated nail(s) should be avoided.

Ciclopirox topical solution is flammable. Patients should be instructed to avoid use near heat or open flame.

The use of occlusive wrappings or dressings should be avoided with ciclopirox topical cream, gel, and suspension (lotion).

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