케토코나졸
Ketoconazole
Ketoconazolum
다른 이름: Nizoral · Fungiconazole · ketoconazolum · R-41400
VetSheet 수의사 팀 검수업데이트 2026년 4월 5일근거 기반 수의학 참고자료
용량은 수의사 전문가를 위한 임상 참고자료입니다. 반드시 최신 약물 정보 및 개별 환자에 따라 확인하시기 바랍니다.
동물 종별 용량
🌎 NA — North America🌍 EU — Europe
개
| 적응증 | 용량 | 경로 | 빈도 | 기간 | 지역 |
|---|---|---|---|---|---|
| Coccidioidomycosis (systemic form) | 5-10 mg/kg PO twice daily | PO | q12h | Minimum of 3-6 months | 🌎 NA |
| Coccidioidomycosis (CNS form) | 15-20 mg/kg PO twice daily | PO | q12h | Minimum of 3-6 months | 🌎 NA |
| Coccidioidomycosis (bony lesions or relapses) | 5 mg/kg PO every other day | PO | q48h | Lifelong | 🌎 NA |
| Coccidioidomycosis | 10-30 mg/kg PO divided twice a day | PO | q12h | 6-12 months | 🌎 NA |
| Blastomycosis | 10 mg/kg PO twice daily (15-20 mg/kg PO twice daily if CNS involvement) | PO | q12h | At least 3 months | 🌎 NA |
| Blastomycosis | 20 mg/kg/day PO once daily or divided twice daily; 40 mg/kg divided twice daily for ocular or CNS involvement | PO | q24h or q12h | At least 2-3 months or until remission | 🌎 NA |
| Histoplasmosis | 10 mg/kg PO once a day or twice a day | PO | q24h or q12h | At least 3 months | 🌎 NA |
| Histoplasmosis | 10-20 mg/day PO once daily or divided twice daily | PO | q24h or q12h | At least 2-3 months or until remission | 🌎 NA |
| Aspergillosis | 20 mg/kg PO | PO | Not specified | At least 6 weeks | 🌎 NA |
| Nasal aspergillosis | 10 mg/kg PO once daily (q24h) or 5 mg/kg PO q12h | PO | q24h or q12h | Many weeks; continue 1 month beyond last detection | 🌎 NA |
| Cryptococcosis | 10 mg/kg PO once daily or divided twice daily | PO | q24h or q12h | Maintenance | 🌎 NA |
| Fungal myocarditis | 10 mg/kg PO three times daily | PO | q8h | — | 🌎 NA |
| Candidiasis | 10 mg/kg PO once daily (q24h) or 5 mg/kg PO q12h | PO | q24h or q12h | Many weeks; continue 1 month beyond last detection | 🌎 NA |
| Sporotrichosis | 15 mg/kg PO q12h | PO | q12h | Many weeks; continue 1 month beyond last detection | 🌎 NA |
| Malassezia dermatitis (severe) | 5 mg/kg PO once daily to 10 mg/kg twice daily | PO | q24h to q12h | Until clinical signs abate and no organisms seen | 🌎 NA |
| Malassezia dermatitis | 5-10 mg/kg PO twice a day | PO | q12h | 30 days | 🌎 NA |
| Malassezia dermatitis | 5-10 mg/kg PO daily for 10 days, then every other day for an additional 10 days | PO | q24h then q48h | 20 days | 🌎 NA |
| Malassezia dermatitis | 5 mg/kg twice daily for 21-30 days, may increase to 10 mg/kg PO twice daily if poor response | PO | q12h | 21-30 days | 🌎 NA |
| Malassezia dermatitis | 2.5-10 mg/kg PO once daily (q24h) for 7-14 days; once a good response is seen taper to every other day (q48h) | PO | q24h then q48h | Until complete remission | 🌎 NA |
| Hyperadrenocorticism | 5-10 mg/kg PO twice daily initially; may increase to 15 mg/kg PO twice daily | PO | q12h | Long-term | 🌎 NA |
| Hyperadrenocorticism | 5 mg/kg q12h for 5-7 days, increase to 10 mg/kg q12h for 10-14 days; many require 15-20 mg/kg q12h | PO | q12h | Long-term | 🌎 NA |
| Hyperadrenocorticism (palliative) | 15 mg/kg PO q12h | PO | q12h | Long-term | 🌎 NA |
| Reduce cyclosporine dosage | 5-10 mg/kg PO per day | PO | q24h | Concurrent with cyclosporine | 🌎 NA |
| Perianal fistula (with cyclosporine) | 7.5 mg/kg PO twice daily | PO | q12h | — | 🌎 NA |
| Atopic dermatitis (with cyclosporine) | 5 mg/kg/day | PO | q24h | — | 🌎 NA |
| IMHA (with cyclosporine) | 10 mg/kg/day | PO | q24h | — | 🌎 NA |
- Blastomycosis: Used with amphotericin B
- Blastomycosis: Used with amphotericin B
- Histoplasmosis: Treat at least 30 days after complete resolution. Maintenance 5 mg/kg PO every other day indefinitely if relapse.
- Histoplasmosis: Used with amphotericin B
- Aspergillosis: May require long-term/maintenance therapy
- Nasal aspergillosis: Itraconazole somewhat more effective
- Cryptococcosis: Used with amphotericin B
- Malassezia dermatitis: Often used with therapeutic shampoos
- Hyperadrenocorticism: Monitor with ACTH stimulation test
- Perianal fistula (with cyclosporine): Given with cyclosporine 0.5-0.75 mg PO twice daily
- Atopic dermatitis (with cyclosporine): Given with cyclosporine 2.5 mg/kg/day
- IMHA (with cyclosporine): Allows reduction of cyclosporine dose
고양이
| 적응증 | 용량 | 경로 | 빈도 | 기간 | 지역 |
|---|---|---|---|---|---|
| Coccidioidomycosis | 10-30 mg/kg PO divided twice a day | PO | q12h | 6-12 months | 🌎 NA |
| Coccidioidomycosis | 50 mg per cat PO once daily; or 25-75 mg per cat q12-48h | PO | q24h or q12-48h | 9-12 months on average | 🌎 NA |
| Blastomycosis | 10 mg/kg q12h PO | PO | q12h | At least 60 days | 🌎 NA |
| Cryptococcosis | 10 mg/kg twice daily | PO | q12h | — | 🌎 NA |
| Aspergillosis | 10 mg/kg PO q12h | PO | q12h | — | 🌎 NA |
| Dermatophytosis | 10 mg/kg PO once daily with an acidic meal | PO | q24h | Prolonged; 2 weeks beyond clinical cure and negative cultures | 🌎 NA |
| Sporotrichosis | 5-10 mg/kg PO q12-24h | PO | q12-24h | 2-4 months on average | 🌎 NA |
- Coccidioidomycosis: Use in cats is controversial
- Blastomycosis: Used with amphotericin B
- Cryptococcosis: Can produce anorexia and debility at this dosage
- Dermatophytosis: Reserved for when griseofulvin ineffective or not tolerated
소형 포유류
| 적응증 | 용량 | 경로 | 빈도 | 기간 | 지역 |
|---|---|---|---|---|---|
| Susceptible infections (Rabbits) | 10-40 mg/kg per day PO | PO | q24h | 14 days | 🌎 NA |
| Systemic mycoses/candidiasis (Hamsters, Gerbils, Mice, Rats, Guinea pigs, Chinchillas) | 10-40 mg/kg per day PO | PO | q24h | 14 days | 🌎 NA |
새
| 적응증 | 용량 | 경로 | 빈도 | 기간 | 지역 |
|---|---|---|---|---|---|
| Severe refractory candidiasis in Psittacines | 5-10 mg/kg as a gavage twice daily | PO (gavage) | q12h | 14 days | 🌎 NA |
| Susceptible fungal infections (most species) | 200 mg/L | PO (water) | Continuous | 7-14 days | 🌎 NA |
| Susceptible fungal infections (most species) | 10-20 mg/kg | PO (feed) | Daily | 7-14 days | 🌎 NA |
| Susceptible fungal infections (Moluccan Cockatoos) | 20-30 mg/kg PO twice daily | PO | q12h | — | 🌎 NA |
| Susceptible fungal infections (Ratites) | 5-10 mg/kg PO once daily | PO | q24h | — | 🌎 NA |
- Severe refractory candidiasis in Psittacines: Dissolve in 0.2 mL 1 N HCl and add 0.8 mL water
- Susceptible fungal infections (most species): Dissolve in acid prior to adding to water
- Susceptible fungal infections (most species): Add to favorite food or mash
파충류
| 적응증 | 용량 | 경로 | 빈도 | 기간 | 지역 |
|---|---|---|---|---|---|
| Susceptible infections (most species) | 15-30 mg/kg PO once daily | PO | q24h | 2-4 weeks | 🌎 NA |
| Fungal shell diseases in turtles/tortoises | 25 mg/kg PO once a day | PO | q24h | 2-4 weeks | 🌎 NA |
말
| 적응증 | 용량 | 경로 | 빈도 | 기간 | 지역 |
|---|---|---|---|---|---|
| Susceptible yeasts and Aspergillus spp | 5 mg/kg PO once daily | PO | q24h | — | 🌎 NA |
| Scopulariopsis pneumonia | 30 mg/kg q12h | NG tube | q12h | — | 🌎 NA |
- Susceptible yeasts and Aspergillus spp: Using commercial oral solution
- Scopulariopsis pneumonia: Administered via NG tube mixed with 0.2 Normal hydrochloric acid
용량은 수의사 전문가를 위한 임상 참고자료입니다. 반드시 최신 약물 정보 및 개별 환자에 따라 확인하시기 바랍니다.
개요
케토코나졸은 1세대 이미다졸계 항진균제입니다. 안전성과 효능 면에서 더 우수한 새로운 트리아졸계(이트라코나졸, 플루코나졸 등)로 대체되는 추세이지만, 특정 전신성 진균 감염(예: 분아균증, 히스토플라스마증, 콕시디오이데스증, 말라세지아 피부염) 치료에 있어서는 여전히 비용 효율적인 선택지입니다.
임상 요점: 항진균 특성 외에도 케토코나졸은 포유류의 사이토크롬 P450 효소의 강력한 억제제입니다. 이러한 독특한 특성은 수의학에서 주로 두 가지 목적을 위해 허가 외(Off-label)로 활용됩니다:
- 약물 절약: 간 대사를 억제하여 사이클로스포린과 같은 고가의 약물 요구 용량(및 비용)을 줄이기 위해 사용됩니다.
- 내분비 치료: 부신 스테로이드 생성을 가역적으로 억제하여 개 부신피질기능항진증(쿠싱 증후군)의 내과적 관리 옵션으로 사용됩니다.
주의: 고양이의 경우 위장관 및 간 독성 발생 위험이 높아 케토코나졸 사용에 논란이 많으며, 많은 임상 수의사들은 고양이 환자에게 이트라코나졸을 선호합니다.
작용 기전
Antifungal Action: Ketoconazole inhibits lanosterol 14α-demethylase, a fungal cytochrome P450 enzyme → blocks the conversion of lanosterol to ergosterol → depletion of ergosterol in the fungal cell membrane → accumulation of toxic intermediate sterols → increased cellular membrane permeability and cell death. It is primarily fungistatic but can be fungicidal at high concentrations or prolonged exposures.
Endocrine/Metabolic Action: It reversibly inhibits mammalian cytochrome P450 enzymes (specifically CYP11A1 and CYP17) → blocks the synthesis of adrenal and gonadal steroids → decreases cortisol and testosterone production.
Immunomodulatory Action: Inhibits 5-lipooxygenase, providing mild anti-inflammatory effects, and suppresses T-lymphocyte proliferation.
안전성·주의사항
금기사항
- Known hypersensitivity to ketoconazole
- Controversial/Contraindicated in cats (due to toxicity risks)
- Concurrent use with cisapride or ivermectin (in dogs)
- Hepatic insufficiency
- Pregnancy (due to possible teratogenic effects)
부작용
- Anorexia (most common, especially in cats)
- Vomiting
- Diarrhea
- Hepatic toxicity (cholangiohepatitis, increased liver enzymes)
- Thrombocytopenia (rare)
- Reversible lightening of haircoat
- Transient suppression of gonadal and adrenal steroid synthesis
- Infertility in male dogs (reversible)
- Hepatotoxicity
- Alterations in hair-coat colour
- Thrombocytopenia (at high doses)
- Adrenal insufficiency (at high doses)
- Cataract development (in dogs)
- Teratogenic effects
주의
Use with caution in patients with hepatic disease or thrombocytopenia. Ketoconazole is a known teratogen and embryotoxin; weigh risks vs. benefits in pregnant animals. It may cause reversible infertility in male dogs by decreasing testosterone synthesis. Dogs undergoing high-dose antifungal therapy may need additional glucocorticoid support during periods of acute stress due to adrenal suppression.
약물 상호작용
May produce a disulfiram-like reaction (vomiting)
May reduce oral absorption of ketoconazole; administer at least 1 hour before or 2 hours after
Ketoconazole may reduce metabolism and increase adverse effects
Ketoconazole may increase levels
Plasma concentrations may be elevated
Ketoconazole may increase levels
Ketoconazole may increase levels
Ketoconazole may increase cisapride levels and possibility for toxicity; use together contraindicated
Ketoconazole may inhibit metabolism; potential for increased adverse effects
Ketoconazole may inhibit metabolism; potential for increased toxicity
Increased cyclosporine levels (often used therapeutically to reduce cyclosporine dose)
Ketoconazole may increase digoxin levels
Ketoconazole may increase fentanyl or alfentanil levels
Increased gastric pH may reduce ketoconazole absorption
Should be used cautiously together due to additive hepatotoxicity risk
May affect ketoconazole levels; concomitant use not recommended
Ketoconazole may increase risk for neurotoxicity; should never be used together in dogs
May increase ketoconazole concentrations
Not recommended together; adrenolytic effects of mitotane may be inhibited by ketoconazole
May decrease ketoconazole levels
Increased gastric pH may reduce ketoconazole absorption
Ketoconazole may increase quinidine levels
May decrease ketoconazole levels; ketoconazole may increase rifampin levels
May reduce absorption of ketoconazole
Ketoconazole may increase levels; hypoglycemia possible
Ketoconazole may decrease serum theophylline concentrations; monitor levels
Ketoconazole may inhibit vinca alkaloid metabolism and increase levels
Ketoconazole may cause increased prothrombin times
Ketoconazole increases blood levels of ciclosporin (used therapeutically to reduce ciclosporin dose requirements)
Used synergistically in systemic fungal disease, allowing for a reduced dose of amphotericin B
Increases gastric pH, which impairs the absorption of ketoconazole; stagger dosing
Increases gastric pH, which impairs the absorption of ketoconazole; stagger dosing
Increases gastric pH, which impairs the absorption of ketoconazole; stagger dosing
Ketoconazole extends the activity of methylprednisolone
Inhibits the metabolism of antihistamines (extrapolated from human data)
Inhibits the metabolism of oral hypoglycaemics (extrapolated from human data)
Inhibits the metabolism of antiepileptics (extrapolated from human data)
모니터링
- Liver enzymes with chronic therapy (at least every 1-2 months)
- CBC with platelets
- Clinical efficacy
- Adverse effects (GI signs, jaundice)
- Liver function tests (routine monitoring recommended)
- Platelet count (if high doses are used)
- Adrenal function/clinical signs of hypoadrenocorticism
약동학
반감기
흡수
Highly variable oral bioavailability in dogs (4-89%). Absorption is enhanced in an acidic environment and may be increased with food. Poor oral absorption of tablets in horses, but increases to 23% if given with hydrochloric acid, and 60% with oral solution.
분포
Distributed into bile, cerumen, saliva, urine, synovial fluid, and CSF (CSF levels <10% of serum). High levels in liver, adrenals, and pituitary gland. 84-99% bound to plasma proteins. Crosses the placenta and is found in milk.
대사
Extensively metabolized by the liver into several inactive metabolites.
배설
Metabolites are excreted primarily into the feces via the bile. About 13% is excreted into the urine (only 2-4% unchanged).
과다투여
No reports of acute toxicity associated with overdosage were located. The oral LD50 in dogs is >500 mg/kg. In the event of an acute overdose, employ supportive measures, including gastric lavage with sodium bicarbonate.
제품
제형
- Oral tablets
- Oral suspension (compounded)
- Topical preparations
- 200 mg oral tablet
동물용의약품
- None for systemic use
- Fungiconazole 200 mg tablet
인용의약품
- Ketoconazole Tablets: 200 mg (scored)
규제 현황
POM-V classification
POM-V (Prescription Only Medicine - Veterinarian)
규제 데이터 없음: 🇺🇸 US · 🇭🇰 HK · 🇹🇼 TW · 🇯🇵 JP · 🇰🇷 KR · 🇦🇺 AU
보관·안정성
Store tablets at room temperature in well-closed containers. Compounded oral suspensions (20 mg/mL) retain >95% potency for 60 days when stored at 5°C or 25°C and protected from light.
보호자 정보
- 투여 방법: 흡수를 높이고 위장 장애를 줄이기 위해 이 약을 음식과 함께 먹이세요. 반려동물이 구토를 하거나 식욕을 잃는 경우, 하루 복용량을 나누어 먹이는 것이 도움이 될 수 있습니다.
- 부작용: 식욕 부진, 구토 또는 설사가 있는지 관찰하세요. 이러한 증상이 나타나면 수의사에게 연락하세요. 고양이의 경우 이러한 부작용이 더 흔하게 나타납니다.
- 털 변화: 치료 기간 동안 반려동물의 털 색깔이 옅어지는 것을 발견할 수 있으나, 이는 약을 끊으면 회복됩니다.
- 치료 기간: 진균 감염은 보통 수개월의 지속적인 치료가 필요합니다. 반려동물의 상태가 좋아진 것 같더라도 감염이 쉽게 재발할 수 있으므로 일찍 약을 중단하지 마세요.
- 경고: 케토코나졸은 많은 약물과 상호작용하므로, 반려동물이 복용 중인 모든 다른 약물에 대해 수의사에게 알려주세요.
VetSheet 의약품 참고자료는 수의사 전문가의 임상 의사결정 지원을 위한 것이며, 전문적 판단이나 제조사의 최신 약물 정보를 대체할 수 없습니다.
