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One-Alpha

One-Alpha

alfacalcidol

Manufacturer:

Cheplapharm

Distributor:

DKSH
Concise Prescribing Info
Contents
Alfacalcidol
Indications/Uses
Diseases caused by Ca metabolism disturbances in consequence of reduced endogenous production of 1,25-dihydroxyvit D3. Renal osteodystrophy, post-op or idiopathic hypoparathyroidism, pseudohypoparathyroidism. Adjunct to management of tertiary hyperparathyroidism, vit D-resistant rickets or osteomalacia, vit D-dependent rickets, neonatal hypocalcemia or rickets, Ca malabsorption, osteoporosis, malabsorptive & nutritional rickets, osteomalacia.
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Dosage/Direction for Use
Cap/oral drops Adult & childn >20 kg Initially 1 mcg daily. Maintenance: 0.25-2 mcg daily. Childn >1 mth, <20 kg Initially 0.05 mcg/kg daily. Oral drops Neonate <1 mth 0.1 mcg/kg daily. IV inj Adult Initially 1 mcg/dialysis slow IV inj. Max: 6 mcg/dialysis, not >12 mcg/wk.
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Overdosage
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Administration
May be taken with or without food: Cap: Swallow whole.
Contraindications
Hypersensitivity. Hypercalcemia.
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Special Precautions
Hypercalcaemia. Avoid prolonged hypercalcemia in arteriosclerosis, cardiac valve sclerosis, nephrolithiasis. Patients w/ pulmonary tissue calcification, granulomatous diseases eg, sarcoidosis. Regularly monitor serum Ca & phosphate levels, alkaline phosphatase. Concurrent use of digitalis glycosides in the presence of hypercalcaemia. May affect ability to drive & use machines. Renal bone disease or severe renal dysfunction. Severe hepatic insufficiency. Women of childbearing potential. Not to be used during pregnancy. Lactation. Cap: May cause allergic reactions due to sesame oil. Drops: May cause allergic reactions due to methyl parahydroxybenzoate; upset stomach & diarrhoea due to macrogolglycerol hydroxystearate. Not to be used w/ disulfiram or products w/ disulfiram-type effect. Not to be taken by patients w/ fructose intolerance. Drops/inj: Epilepsy. Alcoholism. Hepatic disease. Childn.
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Adverse Reactions
Hypercalcaemia, hyperphosphatemia; abdominal pain & discomfort; erythematous, maculopapular & pustular rash, pruritus; hypercalciuria.
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Drug Interactions
Enhanced risk of hypercalcemia w/ thiazide diuretics, Ca- & vit D-containing prep, multiple vit D analogues. Increased metabolism w/ anticonvulsants eg, barbiturates, phenytoin, carbamazepine, primidone. Enhanced absorption of Mg-containing antacids. Increased serum conc of Al. Cap/drops: Impaired intestinal absorption by bile acid sequestrants eg, cholestyramine.
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Storage
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Description
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Action
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MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
A11CC03 - alfacalcidol ; Belongs to the class of vitamin D and analogues. Used as dietary supplements.
Presentation/Packing
Form
One-Alpha cap 0.25 mcg
Packing/Price
100's
Form
One-Alpha cap 1 mcg
Packing/Price
100's
Form
One-Alpha oral drops 2 mcg/mL
Packing/Price
20 mL x 1's
Form
One-Alpha soln for inj 2 mcg/mL
Packing/Price
0.5 mL x 10 × 1's
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