Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ALFACALCIDOL
UNIMED SDN BHD
ALFACALCIDOL
100 Capsules
XL Laboratories Pvt. Ltd.
ALFOST 0.25MCG & 1.0MCG Alfacalcidol Capsules 1 _Consumer Medication Information Leaflet (RIMUP) _ WHAT IS IN THIS LEAFLET 1. What Alfost is used for 2. How Alfost works 3. Before you use Alfost 4. How to use Alfost 5. While you are using it 6. Side effects 7. Storage and disposal of Alfost 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ALFOST IS USED FOR Alfost contains Alfacalcidol and belongs to a group of medicines called vitamin D analogues. It is a type of vitamin D. Vitamin D controls the levels of two substances in your body. These substances are called calcium and phosphate. Your body needs both of these substances for healthy bones and teeth. • Low levels of calcium in the blood of newborn babies (hypocalcaemia). • Softening and deformity of the bones due to lack of calcium (rickets or osteomalacia). • Disorders of the parathyroid glands (Hypoparathyroidism) • Decrease in bone mass and density (Osteoporosis) • Kidney bone disease (Osteodystrophy) HOW ALFOST WORKS Alfacalcidol works by increasing the amount of vitamin D in your body. This means the levels of calcium and phosphate in your body will increase too. Alfacalcidol is used to treat diseases where the amount of calcium in your body needs changing. It is used to treat: • Changes in bone caused by kidney failure (osteodystrophy). • Changes to your parathyroid glands. These are small glands found in your neck. They make a substance called the parathyroid hormone. This changes the amount of calcium in your body. • The glands may make the amount of calcium in your blood too high. (hyperparathyroidism). • The glands may make the amount of calcium in your blood too low (hypoparathyroidism). BEFORE YOU USE ALFOST _-When you must not take it_ • If you are allergic (hypersensitive) to alfacalcidol or any of the other ingredients. • If you know you have a condition called hypercalcaemia. This means you have high levels of calcium in your blood. • If you know that you have a condition Read the complete document
Size: 165x120 mm COMPOSITION Each soft gelatin capsule contains: Alfacalcidol BP 0.25mcg Each soft gelatin capsule contains: Alfacalcidol BP 0.5mcg Each soft gelatin capsule contains: Alfacalcidol BP 1.0mcg PHARMACOLOGICAL PROPERTIES: PHARMACODYNAMIC PROPERTIES: Pharmacotherapeutic group: Vitamin D and analogues, ATC code A11CC03. Alfacalcidol is converted rapidly in the liver to 1,25-dihydroxyvitamin D. This is the metabolite of vitamin D which acts as a regulator of calcium and phosphate metabolism. Since this conversion is rapid, the clinical effects of Alfacalcidol Capsules and 1,25-dihydroxyvitamin D are very similar. Impaired 1α-hydroxylation by the kidneys reduces endogenous 1,25-dihydroxyvitamin D production. This contributes to the disturbances in mineral metabolism found in several disorders, including renal bone disease, hypoparathyroidism, neonatal hypocalcaemia and vitamin D dependent rickets. These disorders, which require high doses of parent vitamin D for their correction, will respond to small doses of Alfacalcidol Capsules. The delay in response and high dosage required in treating these disorders with parent vitamin D makes dosage adjustment difficult. This can result in unpredictable hypercalcaemia which may take weeks or months to reverse. The major advantage of Alfacalcidol Capsules is the more rapid onset of response, which allows a more accurate titration of dosage. Should inadvertent hypercalcaemia occur it can be reversed within days of stopping treatment. PHARMACOKINETIC PROPERTIES: In patients with renal failure, 1-5 µg/day of 1α-hydroxyvitamin D (1α-OHD3) increased intestinal calcium and phosphorus absorption in a dose-related manner. This effect was observed within 3 days of starting the drug and conversely, it was reversed within 3 days of its discontinuation. In patients with nutritional osteomalacia, increases in calcium absorption were noted within 6 hours of giving 1 µg 1α- OHD3 orally and usually peaked at 24 hours. 1α-OHD3 also produced increases in plasma inorganic p Read the complete document