Edirol Eldecalcitol Soft Capsules

1. Indications and Usage
Osteoporosis: Indicated for the treatment of postmenopausal osteoporosis.
2. Dosage and Administration
Recommended Dose: Typically, adults are administered 0.75 μg orally once daily. The dose may be appropriately reduced to 0.5 μg once daily based on symptoms.
Administration: Regular monitoring of serum calcium levels is required. If hypercalcemia occurs, administration should be immediately discontinued.
Dose Adjustment: After serum calcium levels return to normal following discontinuation, 0.5 μg may be resumed. Dose increases should be considered based on patient status.
3. Mechanism of Action
Active Vitamin D3: Eldecalcitol is an active vitamin D3 derivative.
Bone Metabolism: It promotes intestinal calcium absorption and inhibits bone resorption while promoting new bone formation, thereby improving bone mineral density and reducing fracture risk.
4. Safety and Warnings
Hypercalcemia: Elevation of serum calcium may lead to hypercalcemia. If abnormal, administration must be stopped immediately.
Renal Impairment: Acute renal failure may occur due to elevated serum calcium. Renal function and serum calcium must be observed regularly.
Urolithiasis: Urolithiasis may occur; appropriate measures, including discontinuation, should be taken if detected.
5. Adverse Reactions and Clinical Research
Adverse Reactions: Common adverse reactions include elevated urinary calcium, elevated blood calcium, elevated blood uric acid (including hyperuricemia), and hypercalcemia.
Clinical Research: Clinical studies have demonstrated that eldecalcitol effectively improves bone mineral density and reduces fracture risk in postmenopausal osteoporosis.
6. Drug Interactions
Calcium Supplements: Concomitant use with calcium preparations may increase the risk of hypercalcemia.
Other Vitamin D Analogues: Concomitant use with other active vitamin D analogues is not recommended due to the cumulative effect on intestinal calcium absorption.
Thiazide Diuretics: May increase the risk of hypercalcemia.
7. Pharmaceutical Information
Composition: The active ingredient is eldecalcitol.
Appearance: 0.5 μg: tea-white opaque soft capsules; 0.75 μg: tea-brown transparent soft capsules. The contents are a colorless, clear, slightly viscous liquid.
Storage: Store in a tightly sealed container, protected from light, at a temperature not exceeding 25°C.