Clofazimine
Administration
- Type: Antibiotic
- Dosage Forms: CAP 50mg
- Routes of Administration: Oral
- Common Trade Names: Lamprene
Adult Dosing
Hansen's disease, multibacillary
- 50mg PO qd x 12mo in combination with rifampin and dapsone
- Give 300mg PO qmo x 12mo in addition to daily dose
Erythema nodosum leprosum
- 100mg PO bid x12wk, then 100mg PO qd 12-24wk
- Start 100mg PO tid x12wek
Pediatric Dosing
Hansen's disease, multibacillary
- 10-14 yo: 50mg PO qod AND 150mg PO qmo x12mo in combination with rifampin and dapsone
- >15 yo: 50mg PO qd AND 300mg PO qmo x 12mo in combination with rifampin and dapsone
Special Populations
- Pregnancy Rating: C
- Lactation risk: Caution advised
- Renal dosing: not defined
- Hepatic dosing: not defined
Contraindications
- Allergy to class/drug
- Caution:
- Electrolyte abnormality
- Congenital long QT syndrome, QT prolongation or family history of long QT
- Torsades de pointes, ventricular arrhythmias
- Bradycardia
- Recent MI
- CHF
Adverse Reactions
Serious
- Severe abdominal symptoms
- Hepatitis, Jaundice
- Intestinal obstruction
- GI Bleeding
- Splenic infarction
- Thromboembolism
- QT Prolongation, Torsades de pointes
Common
- Skin discoloration
- Nausea/Vomiting, diarrhea, abdominal/epigastric pain
- Ichthyosis/xeroderma
- Pruritus/rash
- Discolored urine/feces/sputum/sweat
- Ocular pigmentation, ocular irritation
- Hyperglycemia
- ESR elevated
Pharmacology
- Half-life: 70 days
- Metabolism: Unknown
- Excretion: Feces primarily
Mechanism of Action
- Bacteriostatic or bactericidal: Binds to mycobacterial DNA, inhibiting growth
Comments
See Also
References
- Lexicomp
- Aronoff GR, Bennett WM, Berns JS, et al, Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children, 5th ed. Philadelphia, PA: American College of Physicians; 2007.
- FDA Safety Alert. Med Watch. Lamprene (Clofazimine). Food and Drug Administration website. Available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm514749.htm. Accessed November 11, 2016.
- Freerksen E, Seydel JK. Critical comments on the treatment of leprosy and other mycobacterial infections with clofazimine. Arzneimittelforschung. 1992;42(10):1243-5. Review. [PubMed 1472145]
- Health Resources and Services Administration (HRSA). National Hansen's Disease (Leprosy) Program: Recommended Treatment Regimens. http://www.hansensdisease/diagnosis/recommendedtreatment.html. Accessed on March 31, 2016.
- Holdiness MR. Clinical pharmacokinetics of clofazimine. A review. Clin Pharmacokinet. 1989;16(2):74-85. [PubMed 2656045]
- Lamprene (clofazimine) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals; January 2019.
- Legendre DP, Muzny CA, Swiatlo E. Hansen's disease (Leprosy): current and future pharmacotherapy and treatment of disease-related immunologic reactions. Pharmacotherapy. 2012;32(1):27-37. [PubMed 22392826]
- Szeto W, Garcia-Buitrago MT, Abbo L, Rosenblatt JD, Moshiree B, Morris MI. Clofazimine enteropathy: a rare and underrecognized complication of mycobacterial therapy. Open Forum Infect Dis. 2016;3(3):ofw004. [PubMed 27800519]
- World Health Organization. Drugs Used in Leprosy. http://apps.who.int/medicinedocs/pdf/h2988e/h2988e.pdf. Accessed April 6, 2016.
- World Health Organization. WHO Expert Committee on Leprosy. World Health Organ Tech Rep Ser. 2012;(968):1-61, 1 p following 61. [PubMed 22970604]