RECALBON 0.5mcg TAB

Description

Generic Name: Alfacalcidol
Brand Name: RECALBON
Strength: 0.5mg per tablet
Form: Oral tablet
Pack Size: Available in 30 tablets per pack
Pharmacological Class: Vitamin D Analog
Prescription Status: Prescription-only (Rx)

Overview:

RECALBON 0.5mg Tablet contains Alfacalcidol, a vitamin D analog that plays an essential role in regulating calcium and phosphate metabolism. Alfacalcidol is a prodrug, which means that once it is absorbed, it is converted in the liver to its active form, 1,25-dihydroxyvitamin D. This active form helps in promoting calcium absorption from the gastrointestinal tract and enhancing calcium retention in the bones, contributing to bone health and mineral balance.

RECALBON is primarily prescribed for the treatment of calcium and phosphate imbalances associated with chronic kidney disease (CKD), rickets, osteocalcin, and other conditions leading to vitamin D deficiency or impaired calcium metabolism.

Mechanism of Action:

Alfacalcidol, upon conversion to 1,25-dihydroxyvitamin D, acts by:

• Enhancing intestinal calcium absorption, helping to maintain adequate calcium levels in the bloodstream.
• Promoting calcium and phosphate retention in the bones, leading to improved bone density and strength.
• Regulating parathyroid hormone (PTH) levels in conditions like secondary hyperparathyroidism, often seen in chronic kidney disease.

Indications:

RECALBON 0.5mg Tablet is indicated for:

• Vitamin D deficiency and calcium imbalances
• Osteocalcin (softening of the bones due to inadequate calcium or vitamin D)
• Rickets (a bone disease in children caused by vitamin D deficiency)
• Hypoparathyroidism (insufficient parathyroid hormone)
• Secondary hyperparathyroidism associated with chronic kidney disease (CKD)
• Prevention and treatment of bone loss in osteoporosis and postmenopausal women

Dosage and Administration:

• Typical Adult Dose:
  • Initial dose: 0.5mcg to 1mcg daily, depending on the severity of the condition.
  • The dose can be gradually adjusted based on the serum calcium levels and patient response.
• For Chronic Kidney Disease (CKD): The dose may be adjusted to 0.5mcg to 1mcg daily or 3 times weekly, depending on calcium and phosphate levels.

Always follow the prescribed dosage and consult your healthcare provider before altering your treatment plan.

Side Effects:

Common:

• Hypercalcemia (elevated calcium levels in the blood)
• Nausea
• Vomiting
• Constipation
• Loss of appetite

Less common but serious:

• Hypercalciuria (high calcium in urine)
• Kidney stones
• Fatigue or weakness
• Confusion
• Arrhythmias (irregular heart rhythms) due to high calcium levels

Precautions:

• Hypercalcemia: Monitor calcium levels regularly, especially when starting treatment or adjusting the dose.
• Renal Impairment: Use with caution in patients with kidney dysfunction, as the drug is metabolized in the liver and can accumulate in cases of severe kidney disease.
• Pregnancy and Lactation: Consult a healthcare provider if pregnant or breastfeeding, as high doses of vitamin D can pose risks to the fetus or infant.
• Drug interactions: May interact with certain medications like thiazide diuretics or calcium supplements, increasing the risk of hypercalcemia.

Drug Interactions:

• Thiazide Diuretics: Can increase calcium levels, and should be used with caution when combined with Alfacalcidol.
• Calcium Supplements: Can increase the risk of hypercalcemia.
• Phenytoin or Phenobarbital: May reduce the effectiveness of Alfacalcidol by increasing its metabolism.

Storage Instructions:

• Store in a cool, dry place at room temperature (15°C to 25°C).
• Protect from light and moisture.
• Keep out of reach of children.

Packaging:

• 30 tablets in each bottle, each containing 0.5mg of Alfacalcidol.

Key Benefits:

• Enhances calcium absorption to support bone health and prevent bone diseases like osteocalcin and rickets.
• Provides an effective treatment option for secondary hyperparathyroidism in patients with chronic kidney disease.
• Safe and well-tolerated when taken as prescribed, helping manage calcium imbalances in the body.
• Helps to maintain mineral balance and prevent bone loss in patients at risk of osteoporosis or bone fragility.