II. Indications
- Lepromatous Leprosy (including Dapsone resistant)
- Must be used as part of multi-drug regimen (high risk of developed Antibiotic Resistance)
- Lepromatous Leprosy Type 2 Reaction (Erythema Nodosum)
III. Mechanism
- Rimino-phenazine dye (red color) synthetically derived from lichen extracts (Buellia canescens)
- Anti-inflammatory properties (used in treatment of Leprosy type 2 reaction)
- Anti-Mycobacterial
- Preferentially binds Mycobacterial DNA, inhibiting DNA Replication and cell growth
- Activity against Mycobacterium leprae (as well as other Mycobacteria)
- Slowly bactericidal
IV. Medications
- Clofazimine (Lamprene) soft gel capsules: 50 mg
V. Dosing
- Precautions
- Clofazimine must be used in combination with other agents (risk of resistance)
- Decrease dose for significant gastrointestinal adverse effects
- Discontinue for significant QTc Prolongation
- Lepromatous Leprosy (in combination with other agents)
- Clofazimine 50 mg orally daily for 2 years
- FDA label dosing is 100 mg daily for 2 years (3 years if Dapsone resistance)
- Lepromatous Leprosy Type 2 Reaction (Erythema Nodosum)
- Other treatment regimens are preferred (e.g. Corticosteroids, Methotrexate)
- Clofazimine 100 to 200 mg orally daily for up to 3 months (taper to 100 mg as soon as possible)
VI. Adverse Effects
- Skin and body fluid reddish discoloration (40-50% of patients)
- Deposits in skin, mucosa and Conjunctiva
- Leprosy lesions treated with Clofazimine will appear tan or black
- Gastrointestinal (related to drug deposits in intestinal mucosa)
- Small Bowel Obstruction
- Gastrointestinal Hemorrhage
- Splenic infarction
- Cardiovascular
- QTc Prolongation (esp. dose >100 mg/day)
VII. Safety
- Unknown safety in Lactation
- Unknown safety in pregnancy
VIII. Resources
- Clofazimine (FDA drug insert)
IX. References
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Related Studies
| Definition (NCI) | A phenazine dye with anti-mycobacterial and anti-inflammatory activities. The exact mechanism through which clofazimine exerts its effect is unknown. However, it binds preferentially to mycobacterial DNA, thereby inhibiting DNA replication and cell growth. Clofazimine has a slow bactericidal effect on Mycobacterium leprae and is active against various other Mycobacteria. |
| Definition (MSH) | A fat-soluble riminophenazine dye used for the treatment of leprosy. It has been used investigationally in combination with other antimycobacterial drugs to treat Mycobacterium avium infections in AIDS patients. Clofazimine also has a marked anti-inflammatory effect and is given to control the leprosy reaction, erythema nodosum leprosum. (From AMA Drug Evaluations Annual, 1993, p1619) |
| Concepts | Pharmacologic Substance (T121) , Indicator, Reagent, or Diagnostic Aid (T130) , Organic Chemical (T109) |
| MSH | D002991 |
| SnomedCT | 387410004, 72924009 |
| LNC | LP18924-8, MTHU006900 |
| English | Clofazimine, 2-Phenazinamine, N,5-bis(4-chlorophenyl)-3,5-dihydro-3-((1-methylethyl)imino)-, clofazimine, 2-Phenazinamine, 3,5-dihydro-N,5-bis(4-chlorophenyl)-3-((1-methylethyl)imino)-, 3-(p-Chloranilino)-10-(p-chlorophenyl)-2,10-dihydro-2-(isopropylimino)-phenazine, clofazimine (medication), Clofazimine [Chemical/Ingredient], N,5-Bis(4-chlorophenyl)-3,5-dihydro-3-((1-methylethyl)imino)-2-phenazinamine, Clofazimine product, Clofazimine (product), Clofazimine (substance), CLOFAZIMINE |
| Swedish | Klofazimin |
| Czech | klofazimin |
| Finnish | Klofatsimiini |
| Russian | KLOFAZIMIN, LAMIREN, КЛОФАЗИМИН, ЛАМИРЕН |
| Japanese | クロファジミン |
| Polish | Riminofenazyna, Klofazymina |
| Spanish | Clofacimina, clofazimina (producto), clofazimina (sustancia), clofazimina, Clofazimina |
| French | Clofazimine |
| German | Clofazimin |
| Italian | Clofazimina |
| Portuguese | Clofazimina |
