クロファジミン
Clofazimine
別名: Lamprene · Clofozine · Hansepran · Lamcoin · B-663 · G-30320 · NSC-141046 · Chlofazimine · Clofazimina · Clofaziminum
VetSheet 獣医チームが監修更新日 2026年4月5日エビデンスに基づく獣医学リファレンス
用量は獣医専門家向けの臨床参考資料です。必ず最新の医薬品情報および個別症例に基づいて確認してください。
動物種別用量
🌎 NA — North America🌍 EU — Europe
犬
| 適応 | 用量 | 経路 | 頻度 | 期間 | 地域 |
|---|---|---|---|---|---|
| Mycobacterium avium complex (MAC) as part of a multi-drug regimen | 4 mg/kg PO once daily | PO | q24h | — | 🌎 NA |
| M. avium intracellularae complex infections, leprosy, or opportunistic mycobacteriosis | 4-8 mg/kg PO once a day | PO | q24h | 4 weeks | 🌎 NA |
| Mycobacterial infections | 4-8 mg/kg | PO | q24h | 2-6 months | 🌍 EU |
- Mycobacterium avium complex (MAC) as part of a multi-drug regimen: Other drugs that may be used in combination include doxycycline, clarithromycin, and/or enrofloxacin.
- M. avium intracellularae complex infections, leprosy, or opportunistic mycobacteriosis: Usually as part of a multi-drug protocol.
- Mycobacterial infections: Generally used in combination therapy with other antimicrobials including fluoroquinolones and clarithromycin.
猫
| 適応 | 用量 | 経路 | 頻度 | 期間 | 地域 |
|---|---|---|---|---|---|
| Treatment of feline leprosy | 25-50 mg once per day or 50 mg every other day | PO | q24h or q48h | — | 🌎 NA |
| Treatment of localized atypical mycobacterial infections | 8 mg/kg PO once daily | PO | q24h | At least 4 weeks beyond complete clinical resolution | 🌎 NA |
| M. avium intracellularae complex infections, leprosy or opportunistic mycobacteriosis | 4-8 mg/kg PO once a day | PO | q24h | 4 weeks | 🌎 NA |
| Mycobacterial infections (including feline leprosy) | 4-8 mg/kg | PO | q24h | 2-6 months | 🌍 EU |
- Treatment of feline leprosy: Using a regimen of either two or three drugs (with clarithromycin and/or rifampin).
- Treatment of localized atypical mycobacterial infections: Perform wide surgical excision of lesion if possible. Base antibiotic selection on culture and susceptibility results.
- M. avium intracellularae complex infections, leprosy or opportunistic mycobacteriosis: Usually as part of a multi-drug protocol.
- Mycobacterial infections (including feline leprosy): Generally used in combination therapy with other antimicrobials including fluoroquinolones and clarithromycin.
鳥
| 適応 | 用量 | 経路 | 頻度 | 期間 | 地域 |
|---|---|---|---|---|---|
| Avian mycobacteriosis | 6 mg/kg PO once daily | PO | q24h | — | 🌎 NA |
| Avian mycobacteriosis (recommended regime for raptors) | 1.5 mg/kg PO q24h | PO | q24h | — | 🌎 NA |
- Avian mycobacteriosis: Protocol 1: with rifampin 45 mg/kg and ethambutol 30 mg/kg.
- Avian mycobacteriosis (recommended regime for raptors): Protocol 2: with ethambutol 20 mg/kg, cycloserine 5 mg/kg, enrofloxacin 15 mg/kg q12h.
用量は獣医専門家向けの臨床参考資料です。必ず最新の医薬品情報および個別症例に基づいて確認してください。
概要
クロファジミンは、脂溶性が極めて高いフェナジン系色素の抗抗酸菌性抗生物質です。獣医学においては、主に猫ハンセン病や犬ハンセン病様肉芽腫などのハンセン病様症候群、およびマイコバクテリウム・アビウムコンプレックス（MAC）感染症の治療において、多剤併用療法の一部として使用されます。
臨床上のポイント:
- 併用療法: 抗酸菌は根絶が非常に困難であり、耐性を獲得しやすいため、クロファジミンが単独療法として使用されることはほとんどありません。
- 脂溶性: 極めて高い脂溶性を持つため、脂肪組織や網内系（マクロファージ）に大量に蓄積します。
- 着色作用: この薬は色素としての性質を持つため、皮膚、眼、体液の顕著で長期的な変色という特徴的な副作用を引き起こします。
- 入手の難しさ: 獣医師が小動物用に正確な用量を入手・調剤することは非常に困難な場合があり、多くの場合、調剤薬局の支援が必要となります。
作用機序
Clofazimine exerts a slowly bactericidal effect against susceptible mycobacteria (M. leprae, M. tuberculosis, M. avium complex, M. bovis, M. chelonei).
- DNA Binding: It binds directly to mycobacterial DNA (preferentially at guanine base sequences) → blocks template function → inhibits DNA replication and cell growth.
- Intracellular Accumulation: It is heavily taken up by macrophages, concentrating the drug exactly where intracellular mycobacteria reside.
- Immunomodulation: Exhibits anti-inflammatory and immunosuppressive properties, likely by inhibiting T-lymphocyte activation and proliferation, though the exact mechanism remains poorly understood.
安全性・警告
禁忌
- Use with caution in patients with pre-existing gastrointestinal conditions (diarrhea, abdominal pain)
- Known hypersensitivity to clofazimine
有害事象
- Skin, eye, and body fluid discoloration (pink to brownish-black)
- Gastrointestinal pain, nausea, vomiting, diarrhea (dose-limiting)
- Hepatotoxicity (reported in a dog receiving concurrent rifampin)
- Photosensitization (reported in a cat)
- Diarrhoea
- Discoloration of skin, eyes, and body fluids (red-brown/orange)
- Renal impairment
- Hepatic impairment
注意事項
Use with caution in patients with pre-existing gastrointestinal conditions such as diarrhea or abdominal pain. The drug is highly lipophilic and has an extremely long half-life, meaning adverse effects (like skin discoloration) can persist for months to years after discontinuation. It may be difficult to obtain and accurately dose for small animals.
医薬品相互作用
May reduce clofazimine levels in the skin and increase amounts in plasma and urine; clinical significance is unclear.
May reduce the anti-inflammatory effects of clofazimine; clinical significance is unclear.
監視
- Efficacy against mycobacterial disease
- Adverse effects (primarily gastrointestinal)
- Hepatic function (especially in dogs)
- Hepatic function (ALT, AST, ALP, Bilirubin)
- Renal function (BUN, Creatinine, SDMA)
- Clinical signs of photosensitization
- Gastrointestinal tolerance
薬物動態
吸収
Variably absorbed after oral administration (bioavailability 45-70% in humans). Food enhances absorption, but increasing the dosage decreases the percentage absorbed.
分布
Highly lipid soluble; distributes primarily to lipid tissue and the reticuloendothelial system. Taken up by macrophages throughout the body. Crosses the placenta and distributes into milk, but does not apparently cross into the CNS or CSF.
代謝
Not well defined in veterinary species.
消失
Retained in the body for a long period. Bile excretion may be responsible for the majority of excretion, but sputum, sebum, and sweat may also contribute.
過剰投与
Very limited data is available. The LD50 for rabbits is 3.3 g/kg and is greater than 5 g/kg in mice, rats, and guinea pigs. Treatment, if required, would include gut emptying and supportive care. Contact an animal poison control center for additional guidance.
製品
製剤
- Oral capsules (micronized form in a wax matrix base)
- 100 mg oral capsule
ヒト用医薬品
- Lamprene (restricted availability via Investigational New Drug [IND] protocols only)
- Lamprene 100 mg capsules
規制ステータス
POM (Prescription Only Medicine). Human drug used off-label under the cascade.
POM (Prescription Only Medicine). Human drug used off-label under the cascade.
規制データなし: 🇺🇸 US · 🇭🇰 HK · 🇹🇼 TW · 🇯🇵 JP · 🇰🇷 KR · 🇦🇺 AU
保管・安定性
Clofazimine oral capsules should be stored in tight containers, protected from moisture at temperatures less than 30°C.
飼主向け情報
投与方法:
- 獣医師からの特別な指示がない限り、吸収を高め、胃腸の不調を軽減するために、この薬は食事と一緒に与えてください。
重要な警告:
変色について: この薬は色素です。ペットの皮膚が変色する可能性が高くなります（通常はピンク色ですが、赤、オレンジ、茶色になることもあります）。また、涙、尿、便、その他の体液が茶褐色から黒色に変色することもあります。
- この変色は薬の正常かつ予期される効果であり、有害ではありませんが、布地を汚す可能性があり、治療終了後も数ヶ月間続くことがあります。
治療期間:
- 抗酸菌感染症の治療は非常に長期にわたります（通常は数ヶ月）。ペットの症状が改善したように見えても、獣医師の指示がない限り、自己判断で投薬を中止しないでください。
VetSheet医薬品リファレンスは獣医専門家の臨床意思決定支援を目的としており、専門的判断または製造業者の最新医薬品情報の代替にはなりません。