Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ALFACALCIDOL
PAHANG PHARMACY SDN. BHD.
ALFACALCIDOL
10Capsule Capsules; 100Capsule Capsules; 60Capsule Capsules; 200Capsule Capsules; 500Capsule Capsules; 30Capsule Capsules; 250Capsule Capsules; 150Capsule Capsules
PAHANG PHARMACY SDN. BHD.
ALFA-D CAPSULE COMPOSITION: Alfa-D 0.25mcg Capsule: Each vegetable capsule contains Alfacalcidol 0.25mcg. Alfa-D 1.00mcg Capsule: Each vegetable capsule contains Alfacalcidol 1.00mcg. PRODUCT DESCRIPTION: Alfa-D 0.25mcg Capsule -Two pieces, white, size ‘2’ hard vegetable capsules containing yellowish semisolid mass. Alfa-D 1.00mcg Capsule - Two pieces, brick red, size ‘2’ hard vegetable capsules containing yellowish semisolid mass. PHARMACOLOGY: Alfacalcidol is the metabolite of vitamin D and it acts as a regulator of calcium and phosphate metabolism. In the body, alfacalcidol is converted to calcitriol (1, 25- dihydroxyvitamin D3). The maintenance of normal calcium and phosphate concentrations is achieved by facilitation of intestinal calcium and phosphate absorption and reabsorption of calcium in the distal renal tubule. PHARMACOKINETICS: Alfacalcidol is well absorbed from the gastrointestinal tract. Alfacalcidol itself is inactive and must undergo 25-hydroxylation to 1, 25-dihydroxyvitamin D3 (Calcitriol) in the liver to elicit metabolites effects. The reported elimination half-life of alfacalcidol in serum is approximately 3 hours in normal subjects. Alfacalcidol is excreted mainly in the bile and feaces with only small amount appearing in urine. INDICATION: Disease caused by disturbances in the calcium metabolism as a consequence of reduced endogenous production of 1,25-dihydroxyvitamin D3. Renal osteodystrophy, postoperative or idiopathic hypoparathyroidism, pseudohypoparathyroidism, as adjunct to the management of tertiary hyperparathyroidism, vitamin D-resistant rickets or osteomalacia, vitamin D-dependent rickets, neonatal hypocalcaemia or rickets, malabsorptive of calcium, osteoporosis, malabsorptive and nutritional rickets, and osteomalacia. RECOMMENDED DOSE: ADULTS: Usual starting dose is 1 mcg/day. We would like to updated product description. The dose maybe adjusted by increments of 0.25-0.5mcg. Plasma levels should be measured at weekly intervals initially. When the dose is stabilized, the Baca dokumen lengkap