Alfa-D 1.00mcg Capsule

Land: Malaysia

Sprog: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv bestanddel:

ALFACALCIDOL

Tilgængelig fra:

PAHANG PHARMACY SDN. BHD.

INN (International Name):

ALFACALCIDOL

Enheder i pakken:

500Capsule Capsules; 60Capsule Capsules; 10Capsule Capsules; 200Capsule Capsules; 30Capsule Capsules; 150Capsule Capsules; 250Capsule Capsules; 100Capsule Capsules

Fremstillet af:

PAHANG PHARMACY SDN. BHD.

Produktets egenskaber

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.
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
measurements may be taken every 2-4
weeks. Mos