Clofazimine


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Multibacillary leprosy Recommended regimen by WHO: As a 3-drug regimen: 300 mg clofazimine and 600 mg rifampicin, both given once a month with daily doses of 50 mg clofazimine and 100 mg dapsone. Treatment is given for 12 months. Refer to local treatment guidelines for other dosage regimen recommendations. Erythema nodosum leprosum (Type 2) In combination with baseline antileprosy treatment and corticosteroids (as clinically indicated): 100-200 mg daily for up to 3 months. Gradually taper the dose to 100 mg daily as soon as possible after the reactive episode is controlled. Dapsone-resistant leprosy 100 mg/day combined with 1 or more other antileprosy agents for 3 years, then continue as a monotherapy at 100 mg/day.
Dosage Details
Oral
Erythema nodosum leprosum (Type 2)
Adult: In combination with baseline antileprosy treatment and corticosteroids (as clinically indicated): 100-200 mg daily for up to 3 months. Gradually taper the dose to 100 mg daily as soon as possible after the reactive episode is controlled.

Oral
Multibacillary leprosy
Adult: Recommended regimen by World Health Organisation (WHO): As a 3-drug regimen: 300 mg clofazimine and 600 mg rifampicin, both given once a month with daily doses of 50 mg clofazimine and 100 mg dapsone. Treatment is given for 12 months. Refer to local treatment guidelines for other dosage regimen recommendations.
Child: 10-14 years Recommended regimen by WHO: As a 3-drug regimen: 150 mg clofazimine with 450 mg rifampicin and 50 mg dapsone once a month, taken with 50 mg dapsone daily and 50 mg clofazimine on alternate days. Treatment is given for 12 months. Refer to local treatment guidelines for other dosage regimen recommendations.

Oral
Dapsone-resistant leprosy
Adult: 100 mg daily in combination with 1 or more other antileprosy agents for 3 years, then continue as a monotherapy at 100 mg daily.
Administration
Should be taken with food.
Special Precautions
Patient with gastrointestinal disorders, including diarrhoea and abdominal pain; risk factors for QT prolongation; history of depression. Hepatic and severe renal impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Torsades de pointes with QT prolongation; accumulation of crystals in organs, including intestinal mucosa, spleen, and liver; discolouration of the skin, conjunctivae, and body fluids (e.g. sweat, tears, breast milk, sputum, urine, faeces); depression (due to skin discolouration); photosensitivity. Rarely, suicidal ideation.
Eye disorders: Burning sensation, dryness, pruritus, and irritation of eyes.
Gastrointestinal disorders: Abdominal or epigastric pain, nausea, vomiting, diarrhoea.
General disorders and administration site conditions: Fatigue.
Investigations: Increased blood glucose and erythrocyte sedimentation rate (ESR).
Nervous system disorders: Headache, dizziness, drowsiness.
Skin and subcutaneous tissue disorders: Ichthyosis, dry skin, pruritus, rash.
Potentially Fatal: Splenic infarction, gastrointestinal bleeding.
Patient Counseling Information
Avoid prolonged exposure to sunlight. Contact lenses may be stained; remove contact lenses during treatment.
MonitoringParameters
Perform pregnancy test before initiation of treatment. Monitor LFTs and serum creatinine periodically; ECG. Assess for gastrointestinal symptoms, skin discolouration, and depression or suicidal ideation.
Drug Interactions
Increased risk of additive torsades de pointes and QT prolongation with other agents known to prolong QT interval (e.g. bedaquiline). May increase the serum concentrations of CYP3A4/5 substrates.
Food Interaction
Absorption may be increased with food.
Action
Description: Clofazimine, an antimycobacterial agent with anti-inflammatory and immunosuppressive effects. Its exact mechanism is not yet known; however, it appears to inhibit mycobacterial replication and growth by binding into the DNA of Mycobacterium leprae.
Pharmacokinetics:
Absorption: Variably and incompletely (45-70%) absorbed from the gastrointestinal tract. Increased absorption with food.
Distribution: Primarily deposited into fatty tissues and reticuloendothelial cells, including macrophages. Distributed to most tissues and organs (except the brain and CSF). Crosses the placenta and enters breast milk.
Excretion: Mainly via faeces (as unchanged drug); urine (approx 1% as unchanged drug and metabolites); sebaceous or sweat glands and sputum (small amounts). Elimination half-life: Approx 25 (range: 6.5-160) days.
Chemical Structure

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Storage
Store at 25°C. Protect from moisture.
MIMS Class
ATC Classification
J04BA01 - clofazimine ; Belongs to the class of drugs used in the systemic treatment of lepra.
Disclaimer: This information is independently developed by MIMS based on Clofazimine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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