Incepta Pharma


Concise Prescribing Info
Hydroxychloroquine sulphate
RA, juvenile chronic arthritis, discoid lupus erythematosus, SLE, sunlight-caused or -aggravated dermatological conditions.
Dosage/Direction for Use
Adult including elderly 200 or 400 mg daily. Min effective dose: Not to exceed 6.5 mg/kg daily. Patient able to receive 400 mg daily Initially 400 mg daily in divided doses, may be reduced to 200 mg if no further improvement or increased to 400 mg daily as maintenance if response lessens. Childn Min effective dose: Not to exceed 6.5 mg/kg daily.
Should be taken with food.
Hypersensitivity to hydroxychloroquine or 4-aminoquinoline compd. Preexisting eye maculopathy. Pregnancy.
Special Precautions
Sensitivity to quinine. Discontinue use if pigmentary abnormality, visual field defect, unexplainable abnormalities by difficulty in accommodation or presence of corneal opacities, visual disturbances including abnormal colour vision develops; anaemia, aplastic anaemia, agranulocytosis, decreased WBC & thrombocytopenia occur. Increased risk of retinopathy & hypoglycaemia. Severe GI, neurological or blood disorders; porphyria cutanea tarda, psoriasis. Perform ophth exam prior to initiation & repeat at least every 12 mth. Periodic exam of skeletal muscle function & tendon reflexes in long-term use. Concomitant use w/ drugs causing adverse ocular or skin reactions. G6PD deficiency. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. May affect ability to drive or operate machinery. Hepatic or renal disease. Not to be used during pregnancy. Lactation. Small childn.
Adverse Reactions
Corneal changes eg, oedema & opacities, haloes, blurred vision, photophobia; skin rashes, pigmentary skin & mucous membrane changes, hair bleaching, alopecia; nausea, diarrhoea, anorexia, abdominal pain; skeletal muscle myopathy or neuromyopathy; anaemia, aplastic anaemia, agranulocytosis, decreased WBC, thrombocytopenia; urticaria, angioedema, bronchospasm.
Drug Interactions
Increased plasma digoxin levels. Potentiated direct blocking action at neuromuscular junction by aminoglycosides. Inhibited metabolism by cimetidine. Antagonized effect of neostigmine & pyridostigmine. Reduced Ab response to primary immunisation w/ intradermal human-diploid cell rabies vaccine. Reduced absorption w/ antacids. Enhanced hypoglycaemic effects of insulin or antidiabetics.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
ATC Classification
P01BA02 - hydroxychloroquine ; Belongs to the class of aminoquinoline antimalarials.
Uniquin FC tab 200 mg
6 × 10's
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