Should be taken with food.
Administration
Should be taken with food.
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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. Patient Counselling Avoid prolonged exposure to sunlight. Contact lenses may be stained; remove contact lenses during treatment. Monitoring Parameters 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.
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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. |
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.
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CIMS Class
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ATC Classification
J04BA01 - clofazimine ; Belongs to the class of drugs used in the systemic treatment of lepra.
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