Classes
DEA Class; Rx
Common Brand Names; Lamprene
- Antitubercular Agents
Description
Exerts a slow bactericidal effect on Mycobacterium leprae (Hansen’s bacillus); inhibits mycobacterial growth and binds preferentially to mycobacterial DNA
Also exerts anti-inflammatory properties in controlling erythema nodosum leprosum reactions; however, its precise mechanisms of action are unknown
Indications
Indicated for treatment of lepromatous leprosy, including dapsone-resistant leprosy complicated by erythema nodosum leprosum
No longer commercially available in the United States; only available by obtaining an investigational new drug (IND), see Dosing Considerations
Preferably used in combination with 1 or more other antileprosy agents to prevent the emergence of drug resistance
Most patients today are treated with dapsone and rifampin, and, in multibacillary cases, clofazimine
Contraindications
Contraindicated in patients with known hypersensitivity to clofazimine or any of the excipients of clofazimine
Adverse Effects
Skin discoloration (75-100%)
Gastrointestinal: Abdominal and epigastric pain, diarrhea, nausea, vomiting, GI intolerance (40%-50%)
Ichthyosis and dry skin (8-28%)
Rash and pruritus (1-5%)
Ocular: Conjunctival and corneal pigmentation due to crystal deposits, dryness, burning, itching, irritation (>1%)
Discoloration of urine, feces, sputum, sweat (>1%)
Increased blood glucose (>1%) Increased ESR (>1%)
Skin: Phototoxicity, erythroderma, acneiform eruptions, monilial cheilosis
Body fluid discoloration and other skin reactions
Gastrointestinal: Bowel obstruction, GI bleeding, anorexia, constipation, weight loss, hepatitis, jaundice, eosinophilic enteritis, enlarged liver
Ocular: Diminished vision
Nervous: Dizziness, drowsiness, fatigue, headache, giddiness, neuralgia, taste disorder
Psychiatric: Depression secondary to skin discoloration
Laboratory: Elevated levels of albumin, serum bilirubin, and AST (SGOT), eosinophilia, hypokalemia
Ocular: Addition of maculopathy (bull’s eye retinopathy)
Other: Splenic infarction, thromboembolism, anemia, cystitis, bone pain, edema, fever, lymphadenopathy, vascular pain
Warnings
Skin dryness and ichthyosis may occur; apply oil to skin may relieve this effect
Pregnancy and Lactation
Pregnancy Category: C
Crosses the human placenta; the skin of infants born to women who had received the drug during pregnancy was found to be deeply pigmented at birth
Lactation: Distributed in human breast milk; do not administer to breastfeeding women unless clearly indicated
Maximum Dosage
Dapsone-sensitive multibacillary leprosy
- 50 mg PO qDay in combination with dapsone 100 mg/day and rifampicin 600 mg/day
- Administer for at least 2 years and continued, if possible, until negative skin smears are obtained
- At this time, monotherapy with an appropriate antileprosy drug can be instituted
- Well tolerated when dose does not exceed 100 mg/day
Dapsone-resistant leprosy
- 100 mg PO qDay in combination with 1 or more other antileprosy drugs for 3 years, followed by monotherapy with 100 mg of clofazimine daily
- Clinical improvement usually can be detected within 1-3 months of treatment and is usually clearly evident by the 6 months
How supplied
Clofazimine
capsule
- 50mg
