Bon‑One Alfacalcidol Tablets

1. Indications and Usage
Osteoporosis: Indicated for the treatment of osteoporosis.
Vitamin D Metabolic Abnormalities: Indicated to improve various symptoms associated with vitamin D metabolic abnormalities caused by chronic renal failure, hypoparathyroidism, and vitamin D-dependent rickets.
2. Dosage and Administration
Osteoporosis and Chronic Renal Failure: Typically, 0.5 µg once daily orally in adults. Dosage should be adjusted appropriately according to age and symptoms.
Hypoparathyroidism and Other Vitamin D Metabolic Abnormalities: Typically, 1.0–4.0 µg once daily orally in adults. Dosage should be adjusted according to the disease, age, symptoms, and condition.
Monitoring: Dosage must be adjusted based on controlled normal serum calcium levels.
3. Mechanism of Action
Metabolic Conversion: Alfacalcidol is rapidly hydroxylated in the liver to 1α,25-dihydroxyvitamin D3, the active form of vitamin D.
Calcium and Bone Regulation: It increases intestinal absorption of calcium and phosphorus, promotes bone mineralization, inhibits parathyroid hormone (PTH) secretion, and reduces bone resorption.
4. Safety and Warnings
Hypercalcemia: Contraindicated in patients with hypercalcemia. Overdose or excessive dosing can lead to hypercalcemia and hypercalciuria, causing gastrointestinal, hepatic, and cardiovascular adverse effects.
Renal and Cardiac Monitoring: Renal function and serum calcium levels must be closely monitored. Extreme caution is required when used with cardiac glycosides (e.g., digoxin) due to the risk of arrhythmias.
Aluminum Toxicity: Aluminum-containing phosphate binders should be avoided during treatment to prevent aluminum toxicity.
5. Adverse Reactions and Clinical Research
Hypercalcemia-Related Symptoms: Common adverse reactions include anorexia, nausea, vomiting, diarrhea, pruritus, and headache.
Organ Function Abnormalities: Rare cases of elevated liver enzymes (AST, ALT), elevated blood urea nitrogen (BUN), renal function impairment, and hepatic dysfunction may occur.
Clinical Research: Clinical trials demonstrate significant improvement in bone mineral density and reduction in fracture risk.
6. Drug Interations
Calcium Supplements and Vitamin D Derivatives: May cause additive effects and increase the risk of hypercalcemia.
Cardiac Glycosides: Hypercalcemia induced by alfacalcidol may potentiate the effects of cardiac glycosides, increasing the risk of arrhythmias.
Magnesium-Containing Preparations: Concurrent use may occasionally cause hypermagnesemia.
Thiazide Diuretics: May increase serum calcium levels.
Barbiturates and Anticonvulsants: May reduce the efficacy of alfacalcidol.
7. Pharmaceutical Information
Active Ingredient: Alfacalcidol.
Excipients: Lactose, starch, magnesium stearate, and film-coating agents.
Appearance: White tablets.
Storage: Protect from light, seal, and store in a dry, cool place at or below 20°C.