Brand and Other Names:Lamprene
- Classes: Antitubercular Agents
Dosing & Uses
Dosage Forms & Strengths
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
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
- 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
Erythema nodosum leprosum reactions
- Treatment depends on the severity of symptoms
- Basic antileprosy treatment should be continued, and if nerve injury or skin ulceration is threatened, corticosteroids should be given
- Where prolonged corticosteroid therapy becomes necessary, clofazimine administered at dosages of 100 to 200 mg daily for up to 3 months may be useful in eliminating or reducing corticosteroid requirements
- Dosages >200 mg/day are not recommended
- Taper dose to 100 mg/day as quickly as possible after the reactive episode is controlled
No longer commercially available in the United States
Clofazimine can be obtained by submitting an IND through the National Hansen’s Disease (Leprosy) Program (NHDP)
The prescriber is considered to be an investigator and must submit an FDA form 1572 and curriculum vitae to the National Hansen’s Disease Program from the U.S. Department of Health and Human Services
The institutional review board is provided by the Centers for Disease Control and Prevention Consent forms and other documents will be provided to the prescriber upon request
For more information, visit www.hrsa.gov/hansensdisease/ or call 1-800-642-2477
Orphan designation for treatment of active tuberculosis
- Novartis Pharmaceuticals Corp; One Health Plaza, Bldg 135/409; East Hanover, NJ 07936-1080
Take with meals
Safety and efficacy not established; limit data are available from the National Hansen’s Disease (Leprosy) Program (NHDP)
Serious - Use Alternative
Significant - Monitor Closely
Well tolerated when dose does not exceed 100 mg/day
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
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
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
- Causes skin discoloration (pink-red to brownish-black) in most patients within a few weeks of treatment; this effect may result in depression (2 suicides reported)
- Discoloration of the conjunctivae, lacrimal fluid, sweat, sputum, urine, and feces also reported
- Skin discoloration, although reversible, may take several months or years to disappear after discontinuing clofazimine
Severe gastrointestinal symptoms
- Caution with GI problems (eg, abdominal pain and diarrhea)
- Dosages >100 mg daily should be given for as short a period as possible and only under close medical supervision
- Severe abdominal symptoms have necessitated exploratory laparotomies; rare reports have included splenic infarction, bowel obstruction, and GI bleeding; deaths reported with severe abdominal symptoms
- Autopsies have revealed crystalline deposits of clofazimine in various tissues including the intestinal mucosa, liver, spleen, and mesenteric lymph nodes
- If patient complains of colicky or burning pain in the abdomen, nausea, vomiting, or diarrhea, the dose should be reduced and/or interval between doses should be increased, or the drug should be discontinued
Pregnancy & 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
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
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
45-62% (PO): variable absorption rate in patients with leprosy
Serum concentration: 0.7-1 mcg/mL (100-300 mg/day)
Highly lipophilic and tends to be deposited predominantly in fatty tissue and in cells of the reticuloendothelial system; taken up by macrophages throughout the body
Half-life: 70 days (at steady state)
Excretion: Negligible in urine; small amount in feces and bile; small amount sputum, sebum, and sweat
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