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Zanika

Zanika

hydroxychloroquine

Manufacturer:

Bafna Pharma

Distributor:

Corbridge
Concise Prescribing Info
Contents
Hydroxychloroquine sulfate
Indications/Uses
Acute attacks of malaria due to Plasmodium vivax, P. malariae, P. ovale, & susceptible strains of P. falciparum. RA, discoid lupus erythematosus, SLE, dermatological conditions caused or aggravated by sunlight in adults. Juvenile idiopathic arthritis (in combination w/ other therapies), discoid lupus erythematosus, SLE.
Dosage/Direction for Use
Adult including elderly Min effective dose should be employed. Should not exceed 6.5 mg/kg daily. Patient able to receive 400 mg daily Initially 400 mg daily in divided doses. Reduce to 200 mg when no further improvement is evident. Maintenance dose: Increase to 400 mg daily if response lessens. Paed patient Min effective dose should be employed. Should not exceed 6.5 mg/kg daily.
Administration
Should be taken with food: Taken w/ meal or glass of milk.
Contraindications
Hypersensitivity to 4-aminoquinoline compd.
Special Precautions
Discontinue immediately in any patient who develops pigmentary abnormality, visual field defect, or any other explainable by difficulty in accommodation or presence of corneal opacities; stop medication if vision disturbances including abnormal colour vision is noted. Severe hypoglycaemia including loss of consciousness. Discontinue treatment for rheumatic disease if no improvement by 6 mth. Reported cases of cardiomyopathy resulting in cardiac failure; discontinue if cardiomyopathy develops. Extrapyramidal disorders may occur. Increased risk of retinopathy & accelerated onset for administration of doses in excess of recommended max dose. All patients should have ophth exam before initiating treatment & at least every 12 mth thereafter. Exam should be more frequent in patients w/ daily dosage exceeding 6.5 mg/kg (absolute body wt used as guide to dosage could result in overdosage in obese), renal insufficiency, visual acuity <6/8, age >65 yr, cumulative dose >200 g. All patients on long-term therapy should undergo periodic exam of skeletal muscle function reflexes; w/draw drug if weakness occurs. Treatment should only be given during periods of max exposure to light in light-sensitive diseases. Consider chronic toxicity when conduction disorders (bundle branch block/AV heart block) as well as biventricular hypertrophy are diagnosed. Caution in patients w/ severe GI, neurological or blood disorders; sensitivity to quinine, G6PD deficiency; porphyria cutanea tarda; psoriasis; galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ medicines which may cause adverse ocular or skin reactions. Hepatic or renal disease (caution in concomitant use w/ drugs affecting those organs). Should not be used in pregnancy. Careful consideration during lactation. Small childn are sensitive to toxic effects. Not suitable for childn w/ ideal body wt <31 kg.
Adverse Reactions
Abdominal pain, nausea. Anorexia; affect lability; blurring of vision due to disturbance of accommodation; diarrhoea, vomiting; skin rash, pruritus.
Drug Interactions
Increased serum digoxin levels. Enhanced hypoglycemic treatment effects w/ insulin or antidiabetic drugs. Prolonged QT interval; should not be administered w/ drugs that have potential to induce cardiac arrhythmias. Increased risk of convulsion in concomitant use w/ other antimalarials known to lower convulsion threshold (eg, mefloquine). Impaired activity of antiepileptic drugs. Increased incidence of adverse effects w/ MTX. Increased plasma cyclosporin levels. Chloroquine phosphate (cannot be ruled out for hydroxychloroquine): Reduced bioavailability of praziquantel & ampicillin. Reduced absorption w/ antacids & kaolin. Avoid concomitant use w/ cimetidine.
MIMS Class
Antimalarials / Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
ATC Classification
P01BA02 - hydroxychloroquine ; Belongs to the class of aminoquinoline antimalarials.
Presentation/Packing
Form
Zanika 200 mg FC tab
Packing/Price
100's
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