Adult Dosing

Erythema nodosum leprosum

• 100-200 mg PO qd x 3 months
• Max: 200 mg/day
• Taper dose to 100 mg PO qd after the reactive episode is controlled

Note:

• Dose should be given with meals and in combination with antileprosy agents to prevent emergence of drug resistance

Dapsone-resistant leprosy

• 100 mg PO qd in combination with one or more antileprosy drugs x 3 yrs

Dapsone-sensitive multibacillary leprosy

• 100 mg PO qd in combination with two other antileprosy drugs for at least 2 years

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

• Treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustments

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustments

• Hepatic impairment: Dose adjustments not defined

• Death following severe abdominal symptoms has been reported with the use of clofazimine
• Rare cases of splenic infarction, bowel obstruction, and gastrointestinal bleeding have been reported in patients receiving clofazimine
• Use cautiously in patients with GI problems such as abdominal pain and diarrhea
• Daily doses of more then 100 mg should be given for shorter period of time with close medical supervision
• Consider a decrease in dose or an increased interval between doses, if patient experiences colicky or burning pain in abdomen; nausea, vomiting, and diarrhea
• Advise patient to apply oil in case of skin dryness and ichthyosis

Caution: Use cautiously in

• GI disorder

Pregnancy Category:C

Breastfeeding: Clofazimine appears in milk in relatively large amounts. Milk can be colored pink by the drug and breastfed infant's skin can be discolored. No serious or permanent toxicity has been reported in breastfed infants; however, an alternate drug might be considered. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 17 May 2011). Manufacturer recommends avoiding use of drug in nursing women unless clearly indicated.

• GI: Abdominal pain, epigastric pain, diarrhea, nausea, vomiting, gastrointestinal intolerance, intestinal obstruction, GI bleed
• DERM: Pigmentation from pink to brownish-black, ichthyosis, dryness, rash, pruritus
• HEMA: Splenic infarction
• EENT: Conjunctival and corneal pigmentation, ocular (dryness, burning, itching, irritation)
• HEPA: Hepatitis, jaundice
• LABTEST: Elevated blood sugar, elevated ESR
• MISC: Discoloration of (urine, feces, sputum, sweat), depression

• Antimycobacterial; inhibits mycobacterial growth and binds to mycobacterial DNA; also exerts anti-inflammatory effects in controlling erythema nodosum leprosum reactions
• Absorbed 45-62% following oral administration
• Metabolized in liver; CYP450: Unknown
• Excreted in feces
• Half-life: 70 days

US Trade Name(s)

• Lamprene

US Availability

Lamprene

• CAPS: 50 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• Lamprene

Australian Availability

Lamprene

• CAPS: 50 mg

Antimicrobials

Antibiotics

Leprostatics

Infectious Disease

Antibiotics

Leprostatics