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Clofazimine

    Brands

    DEA Class; Rx

    Common Brand Names; Lamprene

    • Antitubercular Agents

    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

    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

    Contraindicated in patients with known hypersensitivity to clofazimine or any of the excipients of clofazimine

    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

    Skin dryness and ichthyosis may occur; apply oil to skin may relieve this effect

    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

    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

    Clofazimine

    capsule

    • 50mg