Boncoral-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.

• Adults and Elderly:
  – Typical dose: 500–1500 mg elemental calcium (from coral calcium) + 400–1000 IU Vitamin D3 daily, in divided doses.
  – Frequency: 1 to 2 doses per day depending on severity of deficiency.
  – Form: Oral tablet, chewable tablet, capsule, or powder.
• Children (≥6 years):
  – Dose must be individualized based on calcium and vitamin D requirements; usually 250–500 mg calcium + 200–400 IU Vitamin D3 daily.
• Pregnancy & Lactation:
  – Safe when used within recommended daily intake (RDI). 1000–1300 mg elemental calcium + 600–800 IU Vitamin D3 daily.
• Renal Impairment:
  – Caution advised; adjust dose or avoid if risk of hypercalcemia or hyperphosphatemia exists. Regular monitoring is required.
• Administration Tips:
  – Best taken with meals to improve calcium absorption.
  – Avoid simultaneous use with high-oxalate or high-phytate meals (e.g., spinach, bran) to reduce calcium binding.

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:
  – Calcium is absorbed mainly in the small intestine (duodenum and jejunum); Vitamin D3 absorption occurs via passive diffusion and is fat-soluble.
• Distribution:
  – Calcium is distributed to bone and extracellular fluid. Vitamin D3 is bound to vitamin D-binding protein in plasma.
• Metabolism:
  – Vitamin D3 is converted in the liver to 25-hydroxyvitamin D3 and further in the kidneys to the active form, 1,25-dihydroxyvitamin D3 (calcitriol).
• Elimination:
  – Calcium is excreted mainly via feces (unabsorbed), and small amounts via urine and sweat.
  – Vitamin D and its metabolites are eliminated via bile and feces.
• Half-life:
  – Calcium has a short half-life; Vitamin D3 metabolites have a half-life ranging from days to weeks (25-OH-D3: ~15 days).

• Pregnancy:
  – Classified as Category A (generally safe). Essential for fetal skeletal development.
  – Avoid excessive intake above recommended dietary allowances to prevent fetal hypercalcemia or suppression of parathyroid function.
• Lactation:
  – Safe at recommended doses. Both calcium and vitamin D are excreted into breast milk but are not known to harm the infant when used appropriately.
  – Monitor maternal and infant calcium levels if high-dose supplementation is used.

• 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.