Ciclopirox (Penlac) Contraindications and Precautions
- breast-feeding
- children
- corticosteroid therapy
- diabetes mellitus
- human immunodeficiency virus (HIV) infection
- immunosuppression
- infants
- ocular exposure
- onychomycosis
- organ transplant
- peripheral vascular disease
- pregnancy
- seizure disorder
- skin abrasion
Ciclopirox (Penlac) Contraindications and Precautions
Ciclopirox products are contraindicated in individuals who have shown hypersensitivity to any of its components. If a reaction suggesting sensitivity or chemical irritation occurs during therapy, discontinue the use of ciclopirox treatment and institute appropriate therapy. Caution should be used in applying ciclopirox to patients with a skin abrasion; application to these areas could worsen skin irritation.
Avoid ocular exposure when applying ciclopirox. Ciclopirox is not for ophthalmic, oral, or intravaginal use. Loprox® shampoo, cream or lotion is for topical dermal application only. Penlac™ is for use on nails and immediately adjacent skin only.
As with many other topical antifungal drugs, ciclopirox creams and lotions are not effective for onychomycosis. This condition usually requires treatment with ciclopirox nail lacquer (Penlac™) or an oral (systemic) antifungal drug.
Due to the lack of safety and efficacy data, ciclopirox is not recommended in patients with a history of a seizure disorder or immunosuppression, including patients receiving corticosteroid therapy (e.g., oral, topical or inhaled corticosteroids). The clinical trials of ciclopirox excluded patients who had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex, human immunodeficiency virus (HIV) infection, or received an organ transplant). Patients who required medication to control epilepsy, or patients with severe plantar (moccasin) tinea pedis were also excluded.
There is no safety and efficacy data with ciclopirox nail solution in patients with insulin dependent diabetes mellitus, diabetic neuropathy, or peripheral vascular disease. The risk of removal of the unattached, infected nail, by the health care professional and trimming by the patient, should be carefully considered before prescribing Penlac™ nail solution to patients with a history of insulin dependent diabetes mellitus.
Clinical studies of ciclopirox did not include sufficient numbers of elderly subjects to determine whether they respond differently from younger subjects.
Ciclopirox is classified as an FDA pregnancy category B drug. There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. Ciclopirox should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral reproduction studies in rats of ciclopirox at doses equivalent to approximately 1.4 times the potential exposure at the maximum recommended human topical dose did not reveal any specific effects on fertility or other reproductive parameters.
It is not known whether ciclopirox is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when ciclopirox is administered to a woman who is breast-feeding.
Safety and efficacy use of ciclopirox nail solution (Penlac™) in children < 12 years have not been established. The safe and effective use of ciclopirox 1% cream or lotion has not been established in infants or children < 10 years old. The safe and effective use of ciclopirox 1% shampoo for seborrheic dermatitis has not been established in infants or children < 16 years old.
[ Last revised: 6/23/2006 12:52:00 PM ]
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