CAPITROL
Clinical safety rating: caution
Comprehensive 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. |
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 | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CAPITROL (CAPITROL).
| Breastfeeding | Minimal systemic absorption; expected to be safe during breastfeeding. M/P ratio not determined. Avoid application to breast area. |
| 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 |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to ciclopirox or any component of the formulation"]
| 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. |
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| No specific monitoring required. General prenatal care. |
| Fertility Effects | No known effects on fertility. |
| 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. |