One-Alpha

One-Alpha

alfacalcidol

Manufacturer:

CHEPLAPHARM Arzneimittel GmbH

Distributor:

DKSH
Concise Prescribing Info
Contents
Alfacalcidol (1-α-hydroxyvit D3)
Indications/Uses
Diseases caused by disturbances in the Ca metabolism in consequence of reduced endogenous production of 1.25-dihydroxyvit D3. Renal osteodystrophy, post-op or idiopathic hypoparathyroidism, pseudohypoparathyroidism, as an adjunct to the management of tertiary hyperparathyroidism, vit D-resistant rickets or osteomalacia, vit D-dependent rickets, neonatal hypocalcaemia or rickets, malabsorption of Ca, osteoporosis, malabsorptive & nutritional rickets & osteomalacia.
Dosage/Direction for Use
Adult & childn >20 kg Initially 1 mcg daily. Maintenance dose: 0.25-2 mcg daily. Childn >1 mth & <20 kg Initially 0.05 mcg/kg/day. Neonates <1 mth 0.1 mcg/kg/day. Patients undergoing hemodialysis Initially 1 mcg/dialysis. Max: 6 mcg/dialysis & not >12 mcg/wk.
Administration
Should be taken with food.
Contraindications
Special Precautions
Monitor serum Ca & serum phosphate levels regularly; PTH, alkaline phosphatase, & Ca phosphate product. Avoid prolonged hypercalcaemia in arteriosclerosis, cardiac valve sclerosis or nephrolithiasis. Patients w/ calcification of pulmonary tissue, granulomatous diseases eg, sarcoidosis; renal bone disease or severely reduced renal function. Concurrent use of digitalis glycosides in the presence of hypercalcaemia. Sesame oil allergy. May affect the ability to drive & use machines. Pregnancy & lactation.
Adverse Reactions
Hypercalcemia, hyperphosphatemia; abdominal pain & discomfort; erythematous, maculopapular & pustular rash, pruritus; hypercalciuria.
Drug Interactions
Enhanced risk of hypercalcemia w/ thiazide diuretics, Ca-containing & vit D prep. Increased metabolism w/ anticonvulsants (eg, barbiturates, phenytoin, carbamazepine or primidone). Increased risk of hypermagnesemia w/ Mg-containing antacids. Increase serum conc of Al. Impaired intestinal absorption w/ bile acid sequestrants eg, cholestyramine.
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
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