Osto Coral DX

Approved Indications:

• Prevention and treatment of calcium and vitamin D deficiency in adults, adolescents, and the elderly.
• Supportive therapy in osteoporosis, osteomalacia, and rickets.
• Adjunct therapy in postmenopausal women and elderly patients at risk of fractures.
• Calcium supplementation during pregnancy and lactation when dietary intake is insufficient.
• Adjunct in chronic kidney disease (CKD) for management of secondary hyperparathyroidism.

Clinically Accepted Off-label Uses:

• Muscle cramps or spasms related to hypocalcemia.
• Supportive care in conditions of impaired bone mineralization, such as long-term corticosteroid therapy or malabsorption syndromes.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Adults

• Usual dose: 1 tablet or capsule once or twice daily, preferably with meals.
• Each tablet generally contains about 500 mg elemental calcium (as coral calcium) and 200–400 IU vitamin D₃.
• The total daily intake of elemental calcium (from diet and supplements) should not exceed 2000 mg, and total vitamin D₃ intake should not exceed 4000 IU, unless directed by a physician.

Elderly

• 1 tablet or capsule once or twice daily with meals.
• Regular monitoring of serum calcium and renal function is advised due to reduced renal clearance and possible risk of hypercalcemia.

Pregnant and Lactating Women

• 1 tablet once or twice daily as prescribed by a physician.
• Adequate calcium and vitamin D₃ are essential during pregnancy and breastfeeding, but excessive doses should be avoided.

Children and Adolescents

• For children above 12 years: 1 tablet once daily with meals.
• For children below 12 years: use pediatric formulations; dosage should be adjusted by a physician according to age and dietary calcium intake.

Patients with Osteoporosis or Vitamin D Deficiency

• 1 tablet twice daily with meals, or as directed by a physician, to maintain optimal calcium and vitamin D₃ levels.

Patients with Renal Impairment

• Dose should be individualized.
• Avoid excessive calcium or vitamin D₃ supplementation.
• Regular monitoring of serum calcium, phosphate, and renal function is recommended.

Administration Instructions

• Take with or immediately after food for better absorption.
• Swallow the tablet or capsule whole with water; do not crush or chew.
• Maintain adequate hydration during supplementation.
• If a dose is missed, take it as soon as remembered—do not double the next dose.

রেজিস্টার্ড চিকিৎসকের নির্দেশনা অনুযায়ী ঔষধ সেবন করুন।

Coral Calcium serves as a natural source of elemental calcium, which is essential for neuromuscular function, skeletal strength, and enzymatic activity. It provides calcium in a bioavailable form, helping restore and maintain adequate calcium levels.
Vitamin D3 (Cholecalciferol) enhances intestinal absorption of calcium and phosphate by promoting the synthesis of calcium-binding proteins in the gut. It also helps regulate parathyroid hormone levels, facilitating proper bone remodeling. Together, these components help maintain bone mineral density and correct hypocalcemia.

Absorption:
Coral calcium is absorbed in the small intestine, primarily in the duodenum and jejunum. Absorption is enhanced when taken with Vitamin D₃ and food. Vitamin D₃ (cholecalciferol) is absorbed in the intestine along with dietary fat.

Distribution:
Approximately 99% of calcium is stored in bones and teeth, while the remaining circulates in plasma in ionized, protein-bound, and complexed forms. Vitamin D₃ binds to vitamin D–binding protein and is distributed to the liver, adipose tissue, and muscles.

Metabolism:
Calcium is not metabolized but its levels are regulated by parathyroid hormone (PTH), calcitonin, and calcitriol. Vitamin D₃ undergoes hydroxylation in the liver to form 25-hydroxycholecalciferol, and further hydroxylation in the kidney produces 1,25-dihydroxycholecalciferol (calcitriol), the biologically active form that promotes calcium absorption.

Excretion:
Calcium is excreted mainly through feces and urine. Vitamin D₃ metabolites are primarily eliminated in bile and feces, with minimal urinary excretion.

Half-life:

• 25-hydroxycholecalciferol: 2–3 weeks
• 1,25-dihydroxycholecalciferol: 6–8 hours

Pregnancy: Generally safe at recommended doses; supports fetal bone development. Avoid excessive intake.

Lactation: Safe during breastfeeding; supports maternal bone health and infant growth. Do not exceed recommended doses.

• Primary Class: Calcium and Vitamin D Supplement
• Subclass: Bone Health and Mineral Supplement (natural source-based calcium formulation)

• Known hypersensitivity to calcium salts, vitamin D3, or any formulation components
• Hypercalcemia (e.g., due to hyperparathyroidism, bone metastases)
• Hypervitaminosis D
• Severe renal impairment with risk of soft tissue calcification
• Nephrolithiasis (calcium-containing kidney stones)
• Sarcoidosis or other granulomatous diseases (increased vitamin D activation)

• Monitor serum calcium, phosphate, and vitamin D levels in long-term users, especially in elderly and renal-compromised patients.
• Risk of hypercalcemia and hypercalciuria with excessive doses.
• Caution in patients with a history of nephrolithiasis or chronic constipation.
• Avoid concurrent use with other calcium-containing supplements or high-dose vitamin D.
• Ensure adequate hydration to minimize renal side effects.
• Long-term use without monitoring can lead to vascular or soft tissue calcification.

• Gastrointestinal:
  – Constipation, bloating, flatulence, nausea
• Renal:
  – Hypercalciuria, nephrolithiasis with high or prolonged doses
• Metabolic:
  – Hypercalcemia (symptoms include fatigue, confusion, polyuria, polydipsia)
• Rare/Serious:
  – Arrhythmias, kidney dysfunction, calcium-alkali syndrome (from excessive intake)

• Calcium binding/reduction of absorption:
  – Tetracyclines, quinolones, bisphosphonates, levothyroxine, phenytoin
  – Space administration by 2–4 hours.
• Vitamin D3 metabolism interactions:
  – CYP450 inducers (e.g., rifampin, phenytoin) may reduce efficacy
  – Thiazide diuretics can increase risk of hypercalcemia
• Other considerations:
  – Concurrent use with digoxin may increase arrhythmia risk if hypercalcemia develops
  – Avoid use with other high-calcium supplements unless medically indicated

• Updated osteoporosis prevention guidelines (NICE, Endocrine Society) recommend calcium + vitamin D3 supplementation for all postmenopausal women at high fracture risk.
• KDIGO (Kidney Disease guidelines) caution use in advanced CKD due to risk of calcium loading.
• Emphasis on natural-source calcium (coral-derived) being well-tolerated, but clinical efficacy comparable to standard calcium carbonate.
• Guidelines stress monitoring serum 25(OH)D levels to guide ongoing dosing in long-term users.

• Store below 25°C (77°F) in a dry place.
• Protect from moisture and direct sunlight.
• Keep container tightly closed.
• Do not use after expiration date printed on the label.
• Keep out of reach of children.
• No refrigeration required. Shake powder or liquid suspension before use, if applicable.