Ciclopirox

8% nail lacquer: part of comprehensive supervised management of mild/moderate fingernail/toenail onychomycosis due to Trichophyton rubrum in immunocompetent patients without lunula involvement. Removal of unattached infected nail by a trained professional, as often as monthly, is integral. Not established for every organism, extensive/lunula disease or immunosuppressed population.

Cream/lotion: labeled dermal tinea pedis, cruris and corporis, cutaneous Candida albicans infection and Malassezia-associated tinea versicolor. Gel: interdigital tinea pedis and tinea corporis due to designated dermatophytes, plus scalp seborrheic dermatitis; plantar/vesicular tinea pedis efficacy is unestablished. Shampoo: adult scalp seborrheic dermatitis. In-vitro activity is not an indication for every fungal site.

• Apply 8% lacquer once daily, preferably bedtime or ≥8 hours before washing, using supplied brush over entire nail plate and 5 mm surrounding skin; when free from nail bed, coat accessible underside/bed as directed. Allow about 30 seconds drying.
• Apply new layers over previous coats; remove with alcohol every 7 days, then file loose material/trim as directed. Professional removal of unattached infected nail as often as monthly. Diabetes/numbness requires clinician review before self-trimming.
• Up to 48 weeks of daily application plus professional nail care constitute the full program; safety/efficacy beyond 48 weeks daily are unestablished. Initial improvement may take 6 months; clear nail is not assured.

External local use only; no oral, intravaginal or ophthalmic substitution. Avoid occlusive dressings for skin vehicles. No numerical renal/hepatic adjustment or systemic mg/kg regimen is supplied. Product-specific pediatric boundaries appear in populations; the shampoo’s adult indication is distinct from trials enrolling≥16.

Lacquer, gel, cream and lotion: hypersensitivity to any component. Selected shampoo section 4 lists none; suspected sensitivity still requires stopping and review under its warnings. No universal age contraindication or permission to ignore allergy inferred.

No boxed warning appears in selected ciclopirox labels. They are prescription local products with route, population and treatment-duration boundaries. No systemic or OTC status inferred from the ingredient name.

Lacquer can cause periungual redness, local burning, irritation and nail shape/color changes. Gel can cause burning, stinging, dermatitis or itching; cream/lotion local reactions are generally uncommon in trials. Shampoo reports include itching, burning, redness, hair changes and alopecia. Trial rates differ by vehicle and cannot be pooled. No validated topical-overdose algorithm is supplied; accidental ingestion/serious exposure requires professional or Poison Control advice, not home decontamination.

The lacquer label does not recommend concomitant systemic antifungal therapy for onychomycosis because studies assessing whether lacquer reduces systemic treatment effectiveness were not conducted. This is a label-specific evidence limitation, not a claim that every antifungal combination is harmful.

Avoid nail cosmetics on lacquer-treated nails and occlusive wrappings with skin formulations. Selected other labels do not provide a quantified clinical drug-interaction algorithm. Low exposure is not proof every combination is safe; review topical corticosteroids, duplicate antifungals and vehicles with the clinician.

Lacquer

Label considers use safe at ≥12 based on adult safety; no pediatric trials. Below 12 not extrapolated.

Cream / lotion

Safety/effectiveness below 10 unestablished.

Gel

Safety/efficacy below 16 unestablished.

Shampoo

Adult indication; no trials below 16. Do not infer a universal pediatric scalp approval.

Older adults

Lacquer evidence≥65 limited. Shampoo tolerability comparable, but older-subgroup efficacy sample insufficient for statistical significance; greater sensitivity cannot be excluded.

No numerical organ/dialysis adjustment is established for these local products. Systemic absorption differs by formulation. Lacquer clinical exclusions and diabetes/neuropathy nail-care risk need review; do not equate low measured blood levels with established efficacy/safety in immunocompromised or advanced organ disease.

Adequate controlled pregnancy studies are absent; use only when benefit justifies potential fetal risk. Human milk excretion is unknown and nursing caution is advised. Lacquer efficacy trials excluded pregnancy/nursing. Older animal/letter-category text does not establish universal reproductive safety or a mandatory milk-discard interval.

A hydroxypyridone antifungal associated with polyvalent-cation chelation and inhibition of metal-dependent fungal enzymes. Relevance of antifungal activity to seborrheic-dermatitis benefit is not established by shampoo/gel labels. Nail clinical response cannot be predicted from an unvalidated in-vitro MIC breakpoint.

Lacquer long-term nail study estimated<5% absorbed dose. Shampoo study detected low serum levels in 6 of 18 subjects and<0.5% urinary dose excretion. Gel absorption exceeded cream in a comparative study; its reported renal elimination half-life about 5.5 hours differs from a 1.7-hour radiolabeled topical-solution study cited in cream/lotion labels. These are study-specific measurements, not a universal half-life or organ-dose formula. Glucuronidation is a principal metabolic pathway described in lacquer pharmacology.

Confirm nail diagnosis/extent and eligible immune context; plan professional nail removal and safe weekly care. Review diabetes/neuropathy before self-trimming. Follow local irritation, adherence and response; skin/scalp nonresponse after 4 weeks warrants diagnosis review. Lacquer may take 6 months before improvement. No routine blood-level or universal laboratory schedule is established.

Use exact vehicle schedule; shampoo rinses after 3 minutes, gel is not substituted as a wash, lacquer remains≥8 hours before washing and coats are removed weekly. Avoid eyes/mucosa, nail cosmetics and skin occlusion; keep lacquer away from flame and tightly closed. Continue prescribed treatment despite early symptom relief but stop/review serious irritation. Complete nail program may require 48 weeks with limited cure likelihood. Store away from children.

Strength

80 mg ciclopirox per gram; clear colorless to slightly yellowish lacquer.

Package

6.6 mL glass brush-cap bottle, Preferred NDC 68788-8755-6.

Status / route

Prescription nail/immediately adjacent skin product; not a skin-wide, eye or systemic preparation.

Cream / gel

0.77% ciclopirox base =7.70 mg/g; cream contains olamine salt, gel ciclopirox.

Current Padagis lotion

1.0% ciclopirox olamine salt =10 mg salt/g equivalent to 7.70 mg ciclopirox/g; shake suspension. Bottles 30/60 mL, NDC 45802-400-49/-46.

Shampoo

1% =10 mg/g, eachgram equivalent to 0.96 mL; 120 mL bottle NDC 21922-105-52. Not an assumed 10 mg/mL product.

Selected Glenmark packs

Cream 15/30/90 g; gel 30/45/100 g. Exact vehicles/excipients require package review.

Lacquer 20–25°C protected from light in carton, tightly closed and away from heat/flame. Selected cream/gel/lotion 20–25°C. Shampoo 15–30°C; discard unused product after initial treatment duration. Follow actual package expiration; shampoo discard guidance does not become a common period for other vehicles.