CLOFAZIMINE

Antibacterial Activity

Used in the treatment of dapsone-resistant leprosy, multibacillary dapsone-sensitive leprosy, erythema nodosum leprosum and Mycobacterium avium-intracellulare (MAI) infections

Pregnancy Risk Factor

Category C

Contraindication/Precaution

Hypersensitivity to clofazimine or any component
Use with caution in patients with GI problems
Use with caution if nursing
Dosages of clofazimine of more than 100 mg daily should be given for as short a period as possible and only under close medical supervision
Safety and effectiveness in children have not been established

Mechanism of Action

Binds preferentially to mycobacterial DNA to inhibit mycobacterial growth; also has some anti-inflammatory activity through an unknown mechanism

Pharmacodynamics/Kinetics

Metabolism: 
liver, partially
Half-life: 
terminal: 8 days
in tissue: 70 days
Elimination: 
excreted in feces

Dosage

Children: 

Treatment of leprosy:

Safety and effectiveness in children have not been established
Several cases of children treated with clofazimine have been reported in the literature.
1 mg/kg PO qd in combination with dapsone and rifampin

Adults:  

Dapsone-resistant leprosy: 
100 mg PO qd in combination with one or more antileprosy drugs for 36 months then
100 mg PO qd as single drug
Dapsone-sensitive multibacillary leprosy: 
100 mg PO qd in combination with two or more antileprosy drugs for at least 24 months and continue until negative skin smears are obtained, then institute single drug therapy with appropriate agent
Erythema nodosum leprosum: 
100-200 mg PO qd for up to 3 months or longer then 
taper dose to 100 mg PO qd
Pyoderma gangrenosum: 
300-400 mg PO qd for up to 12 months

Dosage In Renal Failure

Creatinine clearance (ml/min):
N/A
Dialysis
Hemo: N/A
CAPD: N/A