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ROCICAL (Calcitriol 0,25mcg)
Product Code: ROCI01
Made in: Korea
Description: Composition:
Each soft capsule contains:
Calcitriol (BP)………………………………………….0,25mcg
Excipient: Corn Oil, Butylated hydroxyanisole, Butylated hydroxytoluene, Gelatin, Concentrated glycerin, D-Sorbitol Solution (70%), Ethyl parahydroxybenzoate, Propyl parahydroxybenzoate, Titanium oxide, Iron oxide Red.
Appearance:
Orange-red, ovular soft capsules containing the yellowish oil phase.
Effects:
- Vitamin D3 derivative increases calcium and phosphorus absorption in gastrointestinal tract, assist calcium fixation in osteoplasty and increase phosphorus absorption in renal tract.
- Because of three above effects, the derivative regulates calcemia, also the concentration in serum of alkaline phosphatase and parathyroid hormone.
Indication:
- Menopausal Osteoporosis.
- Renal osteodystrophy, especially in patients undergoing haemodialysis.
- Hypoparathyroidism.
- Pseudohypoparathyroidism.
- Vitamin D resistant Osteomalacia, Vitamin D resistant Rickets with low phosphate blood.
Dosage and administration:
- The daily dose should be determined for each patient and increased slowly for to determine the minimum effect dose.
- Swallow up the soft capsule with purified water. The initial dose following:
• One soft capsule daily, for renal osteodystrophy in children.
• Two soft capsules daily, for renal osteodystrophy in adults or hypoparathyroidism.
• One soft capsule in children and two soft capsules in adults daily for Rickets, Osteomalacia and vitamin D resistant hypoparathyroidism.
- Should be frequently controlled the serum calcium and phosphorus levels, sometimes Should be quantified the urinary calcium levels during treatment period for determined a suitable dosage. After that, these examinations should be frequently controlled.
Contraindications:
- Hyperparathyroidism.
- All diseases related with hypercalcemia.
- Patients with evidence of vitamin D toxicity.
- Patients with a history of hypersensitivity to vitamin D.
- Not use in Pregnancy and Lactation, unless prescription of physician.
Precaution:
- To avoid possible adverse reactions by overdose, above exposed paraclinical examinations are essential.
- To avoid possible drug interactions, should be informed your physician of all used therapeutics.
Storage:
Storage in tight, light-resistant containers at a room temperature.
Keep out of reach of children.
Shelf life: 3 years.
Do not use this drug after the expiry date.
Specification: BP.
Packing: 10 soft capsules/blister; 6 blisters /box.
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