CLOFAZIMINE
DOSAGE
Adults: Recommend 100mg to 200mg once daily (oral).
Doses of 200mg daily for two months, then 100mg daily have been used. (Doses up to 300mg once daily have been used in leprosy).
Children: 2-5 mg/kg once daily. (Dose should be rounded to the nearest full capsule. This may require alternate day dosing if the dose in mg/kg/day is too high.)
Clofazimine should be taken with meals or with milk to maximise absorption and reduce gastrointestinal adverse effects.
PREPARATIONS
Oral: 100mg capsules (unlicensed medicine).
DRUG LEVEL MONITORING
ADVERSE EFFECTS
COMMON:
Dermatological: Pink to brownish-black skin discoloration (resembling sun-tanning) within 1-4wks in 75-100% of patients. It gradually disappears within 6-12 months after stopping treatment. It is important to advise patients of this prior to commencing treatment.
Ichthyosis & dry skin (8-38%), pruritis (5%), rash (1-5%), photosensitivity reactions (wear protective clothing and sunscreens).
Gastrointestinal: (up to 50% of patients): Abdominal pain, nausea, vomiting, diarrhoea, weight loss.
SERIOUS:
Gastrointestinal: (<1%): bowel obstruction, GI haemorrhage.
Ophthalmic: Conjunctival pigmentation (38-57%), subjective dimness of vision (12.3%), and dry eyes, burning, and other ocular irritation (24.6%).
Psychiatric: Reactive depression due to skin discolouration.
Other: Splenic infarction, discolouration of body fluids.
ADVERSE EFFECTS: MONITORING
Risk of QT prolongation and ventricular tachyarrhythmias (thought to be torsades de pointes) has been highlighted in case reports.
ECG: Baseline, 2 weeks then every 3 months and after the addition of any new medication that is known to prolong QT.
Routine tests as per generic MDR-TB treatment monitoring guidelines.
INTERACTONS
May reduce the absorption rate of rifampicin, but is unlikely to be clinically significant.
Isoniazid may increase plasma and urinary concentrations of clofazimine and decrease skin concentrations.
Increased risk of prolonged QTc with other drugs that prolong QTc including fluoroquinolones and bedquiline.
This information is not inclusive of all drug interactions. Please discuss with a pharmacist.
CONTRA-INDICATIONS & CAUTIONS
Contraindications:
Hypersensitivity: To clofazimine.
Hypersensitivity: To peanuts or soya, as clofazimine capsules contain soybean oil.
Cautions:
Pregnancy & Breast-feeding
Renal Disease: Use with caution. Dose reductions are not necessary.
Liver Disease: Use with caution. Metabolised by the liver, therefore may require dose adjustment in severe liver disease.
LABORATORY INFORMATION
Please find up to date information at www.assayfinder.com regarding individual providers of drug level monitoring tests. Click on the provider to discover contact details. Turnaround time varies depending on the test and whether it is run locally or sent to an external lab. By contacting laboratories in advance, turnaround time can significantly be reduced.
Not currently available in the UK.
Adults: Recommend 100mg to 200mg once daily (oral).
Doses of 200mg daily for two months, then 100mg daily have been used. (Doses up to 300mg once daily have been used in leprosy).
Children: 2-5 mg/kg once daily. (Dose should be rounded to the nearest full capsule. This may require alternate day dosing if the dose in mg/kg/day is too high.)
Clofazimine should be taken with meals or with milk to maximise absorption and reduce gastrointestinal adverse effects.
PREPARATIONS
Oral: 100mg capsules (unlicensed medicine).
DRUG LEVEL MONITORING
- Drug levels need not be routinely measured.
ADVERSE EFFECTS
COMMON:
Dermatological: Pink to brownish-black skin discoloration (resembling sun-tanning) within 1-4wks in 75-100% of patients. It gradually disappears within 6-12 months after stopping treatment. It is important to advise patients of this prior to commencing treatment.
Ichthyosis & dry skin (8-38%), pruritis (5%), rash (1-5%), photosensitivity reactions (wear protective clothing and sunscreens).
Gastrointestinal: (up to 50% of patients): Abdominal pain, nausea, vomiting, diarrhoea, weight loss.
SERIOUS:
Gastrointestinal: (<1%): bowel obstruction, GI haemorrhage.
Ophthalmic: Conjunctival pigmentation (38-57%), subjective dimness of vision (12.3%), and dry eyes, burning, and other ocular irritation (24.6%).
Psychiatric: Reactive depression due to skin discolouration.
Other: Splenic infarction, discolouration of body fluids.
ADVERSE EFFECTS: MONITORING
Risk of QT prolongation and ventricular tachyarrhythmias (thought to be torsades de pointes) has been highlighted in case reports.
ECG: Baseline, 2 weeks then every 3 months and after the addition of any new medication that is known to prolong QT.
Routine tests as per generic MDR-TB treatment monitoring guidelines.
INTERACTONS
May reduce the absorption rate of rifampicin, but is unlikely to be clinically significant.
Isoniazid may increase plasma and urinary concentrations of clofazimine and decrease skin concentrations.
Increased risk of prolonged QTc with other drugs that prolong QTc including fluoroquinolones and bedquiline.
This information is not inclusive of all drug interactions. Please discuss with a pharmacist.
CONTRA-INDICATIONS & CAUTIONS
Contraindications:
Hypersensitivity: To clofazimine.
Hypersensitivity: To peanuts or soya, as clofazimine capsules contain soybean oil.
Cautions:
Pregnancy & Breast-feeding
Renal Disease: Use with caution. Dose reductions are not necessary.
Liver Disease: Use with caution. Metabolised by the liver, therefore may require dose adjustment in severe liver disease.
LABORATORY INFORMATION
Please find up to date information at www.assayfinder.com regarding individual providers of drug level monitoring tests. Click on the provider to discover contact details. Turnaround time varies depending on the test and whether it is run locally or sent to an external lab. By contacting laboratories in advance, turnaround time can significantly be reduced.
Not currently available in the UK.