CAPITROL
Clinical safety rating
cautionComprehensive clinical and safety monograph for CAPITROL (CAPITROL).
Ciclopirox is a hydroxypyridine antifungal agent that inhibits the uptake of essential elements and amino acids, disrupts fungal cell membrane integrity, and chelates polyvalent cations (e.g., Fe3+, Al3+), inhibiting metal-dependent enzymes such as cytochromes and catalase.
| Metabolism | Ciclopirox is primarily metabolized via glucuronidation, with less than 2% excreted unchanged in urine. The major metabolite is ciclopirox glucuronide. |
| Excretion | Primarily renal (approximately 60-70% as unchanged drug); biliary/fecal elimination accounts for about 20-30%. |
| Half-life | Terminal elimination half-life is 20-40 hours; clinically, steady-state is achieved within 5-7 days. |
| Protein binding | >99% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.3 L/kg; indicates distribution primarily into extracellular fluid. |
| Bioavailability | Oral: 70-80%; Topical: approximately 5-10%. |
| Onset of Action | Oral: 2-4 hours; Topical: 2-6 hours. |
| Duration of Action | Approximately 24-36 hours after oral administration; topical effects may persist 12-24 hours. |
| Molecular Weight | 268.3 |
Apply 1 mL of 1% shampoo twice weekly for 4 weeks, then weekly for maintenance. Use on wet hair, lather for 2-3 minutes, rinse thoroughly.
| Dosage form | SHAMPOO |
| Renal impairment | No adjustment required as systemic absorption is negligible. |
| Liver impairment | No adjustment required as systemic absorption is negligible. |
| Pediatric use | Safety and efficacy not established in children under 12 years; use same as adult for ages 12 and above. |
| Geriatric use | No specific dose adjustment; caution with dry or aged skin due to potential irritation. |
| 1st trimester | Limited data in pregnant women; animal studies show no evidence of teratogenicity at clinically relevant doses. Caution advised. |
| 2nd trimester | No known risks, but use only if clearly needed due to lack of robust human data. |
| 3rd trimester | Avoid use near term due to theoretical risk of neonatal hypotension or respiratory depression if absorbed systemically. |
Clinical note
Comprehensive clinical and safety monograph for CAPITROL (CAPITROL).
| Placental transfer | Ciclopirox has a molecular weight of 268.3 Da, suggests limited passive diffusion across placenta; no specific data on placental transfer in humans. |
| Breastfeeding | Topical application of Capitrol (ciclopirox) is unlikely to result in significant systemic absorption. However, due to lack of data in breastfeeding women, apply to smallest area possible and avoid contact with infant's skin. |
| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | No adequate human studies; animal studies not available. Only minimal systemic absorption occurs with topical scalp application; theoretical risk low. First trimester: unlikely to cause harm due to negligible absorption; however, avoid elective use. Second and third trimesters: no known risks. |
| Fetal Monitoring | No specific monitoring required. General prenatal care. |
| Fertility Effects | No known effects on fertility. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to ciclopirox or any component of the formulationKnown hypersensitivity to any other antifungal agent of the pyridone class
| Precautions | Avoid contact with eyes, If irritation or sensitization occurs, discontinue use, Not for oral, ophthalmic, or intravaginal use |
| Food/Dietary | No known food interactions when applied topically. However, avoid applying immediately before consuming food to minimize accidental ingestion. |
| Clinical Pearls | Capitrol (chloroxine) is a topical antibacterial shampoo indicated for dandruff and seborrheic dermatitis. It is generally used twice weekly for 2 weeks, then as needed. Avoid contact with eyes and mucous membranes. Discontinue if local irritation or allergic reaction occurs. |
| Patient Advice | Use exactly as directed; do not use more often than prescribed. · Wet hair and scalp thoroughly before applying shampoo. · Massage into scalp and leave on for 2-3 minutes before rinsing. · Avoid contact with eyes; if occurs, rinse thoroughly with water. · Use caution to avoid staining of clothing or jewelry; rinse shampoo off completely. · Consult healthcare provider if condition persists or worsens after 2 weeks. · Inform doctor if you are pregnant, planning to become pregnant, or breastfeeding. |
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