Alfacalcidol


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Hypoparathyroidism; Renal osteodystrophy; Hyperparathyroidism; Nutritional and malabsorptive, hypophosphataemic vitamin D-resistant, and pseudo-deficiency (D-dependent) rickets and osteomalacia As cap/oral drops: Initial: 1 mcg/day, adjust subsequent doses according to individual biochemical (e.g. plasma Ca levels), radiographic, or histological response. Dose increases may be done in increments of 0.25-0.5 mcg daily. Usual maintenance dose: 0.25-1 mcg/day. IV Hypoparathyroidism; Renal osteodystrophy; Hyperparathyroidism; Nutritional and malabsorptive, hypophosphataemic vitamin D-resistant, and pseudo-deficiency (D-dependent) rickets and osteomalacia Initial: 1 mcg/day via bolus inj over approx 30 seconds, may be adjusted thereafter according to individual biochemical (e.g. plasma Ca levels), radiographic, or histological response. Usual maintenance dose: 0.25-1 mcg/day. Dose discontinuation may be required if hypercalcaemia occurs. Refer to detailed product guideline for further indication specific therapeutic measures.
Administration
Should be taken with food.
Contraindications
Hypercalcaemia, hyperphosphataemia, vitamin D toxicity, metastatic calcification.
Special Precautions
Patient with pulmonary tissue calcification, granulomatous diseases (e.g. sarcoidosis), nephrolithiasis, hypermagnesaemia. Concomitant treatment with digitalis glycosides; barbiturates and other anticonvulsants. Renal impairment. Children and elderly. Pregnancy and lactation. Monitoring Parameters Monitor serum Ca and phosphate levels regularly, such as at least twice weekly, during treatment initiation and dose adjustments (particularly in children, patients with renal impairment, or taking high doses); PTH, alkaline phosphatase, and Ca x phosphate product as clinically indicated. Measurement frequency may be dependent on the presence and magnitude of abnormalities, and rate of disease progression.
Adverse Reactions
Significant: Hypercalcaemia (when prolonged may cause generalised vascular and soft tissue calcification, and exacerbated nephrolithiasis, arteriosclerosis or cardiac valve sclerosis); over suppression of PTH, hypercalciuria, hyperphosphataemia, adynamic bone disease; transient or long-lasting decreased kidney function. Ear and labyrinth disorders: Vertigo. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain and discomfort, constipation. General disorders and administration site conditions: Lassitude, asthenia, malaise, calcinosis. Investigations: Increased plasma and urinary concentrations of Ca and phosphate, weight loss. Metabolism and nutrition disorders: Anorexia, thirst. Musculoskeletal and connective tissue disorders: Myalgia. Nervous system disorders: Headache. Rarely, dizziness. Psychiatric disorders: Confusional state. Renal and urinary disorders: Polyuria, acute renal failure, nephrocalcinosis. Skin and subcutaneous tissue disorders: Rash (e.g. maculo-papular, erythematous, pustular), pruritus, sweating, urticaria.
Drug Interactions
Increased risk of hypercalcaemia with thiazide diuretics, Ca-containing or other vitamin D-containing preparations. May precipitate cardiac arrhythmias with digitalis glycosides. Intestinal absorption may be impaired by colestyramine, colestipol, sucralfate, Al-based antacids (high dose), and mineral oil (prolonged use). May increase serum levels of Al in aluminium hydroxide, sucralfate or other Al-containing preparations. May increase metabolism with anticonvulsants (e.g. phenytoin, phenobarbital, carbamazepine, primidone). May cause hypermagnesaemia with Mg-based antacids or laxatives in dialysis patients.
ATC Classification
A11CC03 - alfacalcidol ; Belongs to the class of vitamin D and analogues. Used as dietary supplements.
Disclaimer: This information is independently developed by CIMS based on alfacalcidol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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