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Alfacalcidol

Generic Name
Alfacalcidol
Brand Names
One-alpha
Drug Type
Small Molecule
Chemical Formula
C27H44O2
CAS Number
41294-56-8
Unique Ingredient Identifier
URQ2517572

Overview

Alfacalcidol, or 1-alpha-hydroxycholecalciferol or 1-alpha-hydroxyvitamin D3, is a non-endogenous analogue of vitamin D. It plays an essential function in calcium homeostasis and bone metabolism. Alfacaldisol is activated by the enzyme 25-hydroxylase in the liver to mediate its effects in the body, or most importantly, the kidneys and bones. The pharmacological actions of alfacalcidol are prolonged than vitamin D because a negative feedback mechanism regulates the final activation step of vitamin D in the kidneys. Alfacalcidol is available in oral and intravenous formulations. In Canada, it is marketed as ONE-ALPHA, which manages hypocalcemia, secondary hyperparathyroidism, and osteodystrophy in adults with chronic renal failure. In approving European countries, alfacalcidol is also indicated for managing nutritional and malabsorptive rickets and osteomalacia, vitamin D-dependent rickets and osteomalacia, and hypophosphataemic vitamin D resistant rickets and osteomalacia.

Background

Alfacalcidol, or 1-alpha-hydroxycholecalciferol or 1-alpha-hydroxyvitamin D3, is a non-endogenous analogue of vitamin D. It plays an essential function in calcium homeostasis and bone metabolism. Alfacaldisol is activated by the enzyme 25-hydroxylase in the liver to mediate its effects in the body, or most importantly, the kidneys and bones. The pharmacological actions of alfacalcidol are prolonged than vitamin D because a negative feedback mechanism regulates the final activation step of vitamin D in the kidneys. Alfacalcidol is available in oral and intravenous formulations. In Canada, it is marketed as ONE-ALPHA, which manages hypocalcemia, secondary hyperparathyroidism, and osteodystrophy in adults with chronic renal failure. In approving European countries, alfacalcidol is also indicated for managing nutritional and malabsorptive rickets and osteomalacia, vitamin D-dependent rickets and osteomalacia, and hypophosphataemic vitamin D resistant rickets and osteomalacia.

Indication

Alfacalcidol is indicated in adult patients with chronic renal failure for the management of hypocalcemia, secondary hyperparathyroidism, or osteodystrophy. Alfacalcidol is indicated in the management of nutritional and malabsorptive rickets and osteomalacia, vitamin D-dependent rickets and osteomalacia, and hypophosphataemic vitamin D resistant rickets and osteomalacia.

Associated Conditions

  • Hypocalcemia
  • Hypophosphatemic Rickets
  • Nutritional Rickets
  • Osteodystrophy
  • Osteomalacia
  • Rickets
  • Secondary Hyperparathyroidism (SHPT)
  • Hypophosphatemic osteomalacia

FDA Approved Products

No FDA products found for this drug

Singapore Approved Products

ALFOST CAPSULES 0.25MCG
Manufacturer:XL LABORATORIES PVT.LTD.
Form:CAPSULE, LIQUID FILLED
Strength:0.25mcg
Online:Yes
Approved: 2022/05/05
Approval:SIN16483P
ALFOST CAPSULES 1.0MCG
Manufacturer:XL LABORATORIES PVT.LTD.
Form:CAPSULE, LIQUID FILLED
Strength:1mcg
Online:Yes
Approved: 2022/05/05
Approval:SIN16484P
ONE-ALPHA CAPSULE 0.25 mcg
Manufacturer:LEO Pharma A/S, Swiss Caps AG (encapsulation site)
Form:CAPSULE, LIQUID FILLED
Strength:0.25 mcg
Online:Yes
Approved: 1991/05/14
Approval:SIN05972P
ONE-ALPHA CAPSULES 0.5 mcg
Manufacturer:LEO Pharma A/S
Form:CAPSULE, LIQUID FILLED
Strength:0.5 mcg
Online:Yes
Approved: 1999/07/14
Approval:SIN11062P
ONE-ALPHA INJECTION 2 mcg/ml
Manufacturer:CENEXI
Form:INJECTION
Strength:2 mcg/ml
Online:Yes
Approved: 1991/06/20
Approval:SIN06140P

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