Clofazimine: Difference between revisions
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==Administration== | ==Administration== | ||
*Type: | *Type: [[Antibiotic]] | ||
*Dosage Forms: CAP 50mg | *Dosage Forms: CAP 50mg | ||
*Routes of Administration: Oral | *Routes of Administration: Oral | ||
| Line 6: | Line 6: | ||
==Adult Dosing== | ==Adult Dosing== | ||
===Hansen disease, | ===[[Hansen's disease]], multibacillary=== | ||
*50mg PO qd x 12mo in combination with [[rifampin]] and [[dapsone]] | *50mg PO qd x 12mo in combination with [[rifampin]] and [[dapsone]] | ||
**Give 300mg PO qmo x 12mo in addition to daily dose | **Give 300mg PO qmo x 12mo in addition to daily dose | ||
| Line 14: | Line 14: | ||
==Pediatric Dosing== | ==Pediatric Dosing== | ||
===Hansen disease, | ===[[Hansen's disease]], multibacillary=== | ||
*10-14 yo | *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]] | |||
*15 | |||
==Special Populations== | ==Special Populations== | ||
*[[Drug pregnancy categories|Pregnancy Rating]]: | *[[Drug pregnancy categories|Pregnancy Rating]]: C | ||
*Lactation risk: Caution advised | *Lactation risk: Caution advised | ||
*Renal dosing: not defined | |||
*Hepatic dosing: not defined | |||
* | |||
==Contraindications== | ==Contraindications== | ||
| Line 34: | Line 28: | ||
*Caution: | *Caution: | ||
**Electrolyte abnormality | **Electrolyte abnormality | ||
**Congenital long QT syndrome | **Congenital long QT syndrome, [[QT prolongation]] or family history of long QT | ||
**[[Torsades de pointes]], ventricular arrhythmias | |||
**[[Torsades de pointes]] | |||
**Bradycardia | **Bradycardia | ||
**Recent MI | **Recent MI | ||
| Line 45: | Line 37: | ||
==Adverse Reactions== | ==Adverse Reactions== | ||
===Serious=== | ===Serious=== | ||
* | *Severe abdominal symptoms | ||
*[[Hepatitis]] | *[[Hepatitis]], [[Jaundice]] | ||
*Intestinal obstruction | *Intestinal obstruction | ||
*[[GI Bleeding]] | *[[GI Bleeding]] | ||
*Splenic infarction | *Splenic infarction | ||
*[[Thromboembolism]] | *[[Thromboembolism]] | ||
*[[QT Prolongation]] | *[[QT Prolongation]], [[Torsades de pointes]] | ||
===Common=== | ===Common=== | ||
*Skin discoloration | *Skin discoloration | ||
*[[Nausea]]/[[Vomiting]] | *[[Nausea]]/[[Vomiting]], [[diarrhea]], abdominal/epigastric pain | ||
*Ichthyosis/xeroderma | *Ichthyosis/xeroderma | ||
*[[Pruritus]]/rash | *[[Pruritus]]/rash | ||
*Discolored urine/feces/sputum/sweat | *Discolored urine/feces/sputum/sweat | ||
*Ocular pigmentation | *Ocular pigmentation, ocular irritation | ||
*[[Hyperglycemia]] | *[[Hyperglycemia]] | ||
*ESR elevated | *ESR elevated | ||
| Line 81: | Line 68: | ||
==See Also== | ==See Also== | ||
*[[Hansen's disease]] | |||
==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] | |||
<references/> | <references/> | ||
[[Category:Pharmacology]] | [[Category:Pharmacology]] | ||
[[Category:ID]] | |||
Latest revision as of 17:40, 20 September 2019
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]
