Clofazimine


Generic Medicine Info
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. 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.
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.
CIMS Class
Antileprotics
ATC Classification
J04BA01 - clofazimine ; Belongs to the class of drugs used in the systemic treatment of lepra.
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