Cora-DX Vita

Approved Indications:

• Calcium and vitamin D deficiency states, including:
• Nutritional deficiency
• Increased physiological need (e.g., pregnancy, lactation, adolescence)
• Adjunct therapy in osteoporosis, osteomalacia, and osteopenia to improve bone mineral density and reduce fracture risk.
• Treatment and prevention of rickets in children and adolescents.
• Hypocalcemia due to various etiologies such as:
• Post-parathyroidectomy
• Chronic kidney disease (non-dialysis-dependent stages)
• Hypoparathyroidism
• Supportive therapy in corticosteroid-induced bone loss.
• Supplementation in elderly populations at risk of falls and fractures.
• Prevention of calcium and vitamin D deficiency in long-term anticonvulsant or proton pump inhibitor therapy.

Important Off-Label or Clinically Accepted Uses:

• Prevention of preeclampsia in high-risk pregnant women (with low dietary calcium intake).
• Adjunct in chronic liver disease with metabolic bone disease.

Route of Administration: Oral

Adults and Elderly:

• General supplementation: 1–2 tablets or sachets per day (typically providing 500–1200 mg elemental calcium and 400–800 IU vitamin D3).
• Osteoporosis or osteopenia: 1000–1500 mg elemental calcium + 800–1000 IU vitamin D3 daily in divided doses.
• Long-term maintenance therapy: 1 tablet daily or as directed by physician.

Children:

• 6–12 years: 250–500 mg elemental calcium + 200–400 IU vitamin D3 daily.
• 13–18 years: 500–1000 mg elemental calcium + 400–800 IU vitamin D3 daily.
• Always under pediatric supervision.

Pregnancy and Lactation:

• Recommended daily intake: 1000–1300 mg elemental calcium + 400–800 IU vitamin D3.
• Divide the dose for better absorption and tolerance.

Renal Impairment:

• Mild-to-moderate impairment: Use cautiously; monitor calcium-phosphate balance.
• Severe renal impairment or end-stage renal disease: Contraindicated due to risk of hypercalcemia and soft tissue calcification.

Hepatic Impairment:

• No specific dosage adjustment required.

Administration Advice:

• Take with meals to enhance calcium absorption.
• Separate from iron, zinc, magnesium, thyroid hormones, and antibiotics by at least 2–4 hours.

Calcium lactate gluconate and calcium carbonate are salt forms that provide bioavailable elemental calcium, essential for skeletal development, neuromuscular activity, and cardiovascular function. Calcium carbonate is a concentrated source of calcium, while calcium lactate gluconate is more soluble and better tolerated. Vitamin D3 (cholecalciferol) is a fat-soluble prohormone that undergoes hepatic and renal activation to form calcitriol, the active form. Calcitriol enhances intestinal calcium absorption by increasing expression of calcium-binding proteins, facilitating serum calcium normalization. This combination ensures effective correction of calcium deficiency and supports bone remodeling and mineralization.

• Absorption:
• Calcium: Absorbed in the duodenum and proximal jejunum; enhanced by vitamin D3 and dietary fat.
• Vitamin D3: Absorbed from the intestine with the help of bile salts.
• Bioavailability:
• Calcium carbonate: ~25–40% (higher with food).
• Calcium lactate gluconate: Highly soluble and well tolerated.
• Vitamin D3: Absorption increases with fat-containing meals.
• Distribution:
• Calcium: 99% in bones/teeth; remaining in serum (ionized or bound).
• Vitamin D3: Stored in adipose and muscle tissue; bound to vitamin D-binding protein.
• Metabolism:
• Vitamin D3: Hydroxylated in liver (25-hydroxylase) → converted in kidneys to 1,25-dihydroxyvitamin D (active form).
• Elimination:
• Calcium: Primarily fecal (unabsorbed), partial urinary excretion.
• Vitamin D3: Metabolites excreted in bile and urine.
• Half-life:
• Vitamin D3 (25-OH): ~15 days; Calcitriol: ~15 hours.
• Calcium: Half-life not fixed (homeostatically regulated).

Pregnancy:

• Category Not Assigned (per updated FDA system).
• Safe at recommended dietary intake levels.
• High doses may cause maternal hypercalcemia, fetal soft tissue calcification, or suppressed fetal parathyroid function.
• Avoid exceeding tolerable upper limits unless clinically indicated.

Lactation:

• Both calcium and vitamin D3 are excreted into breast milk.
• No adverse effects expected in breastfed infants when used at recommended dosages.
• Monitor for signs of hypercalcemia if high doses are used by the mother.

• Primary Class: Calcium Supplement + Vitamin D Analog
• Therapeutic Subclass: Bone Health Supplement / Nutritional Therapy

• Hypersensitivity to calcium salts, vitamin D3, or formulation excipients.
• Hypercalcemia of any origin (e.g., hyperparathyroidism, malignancy).
• Hypervitaminosis D.
• Severe renal impairment or end-stage renal disease (risk of soft tissue calcification).
• Nephrolithiasis (active or history of calcium stones).

• Risk of hypercalcemia in high doses or prolonged use.
• Avoid concurrent use with other high-dose vitamin D or calcium supplements unless medically supervised.
• Use cautiously in patients with renal impairment, dehydration, sarcoidosis, or granulomatous disorders (increased vitamin D activation).
• Monitor serum calcium, phosphate, and renal function during long-term therapy.
• Increased risk of milk-alkali syndrome (metabolic alkalosis, hypercalcemia, renal failure) with excessive intake.

Common (≥1%):

• Gastrointestinal: Constipation, flatulence, nausea, abdominal bloating
• Musculoskeletal: Muscle cramps (rare)

Uncommon:

• Hypercalcemia: Weakness, confusion, arrhythmias, vomiting, polyuria, polydipsia
• Nephrolithiasis (especially with high fluid loss or inadequate hydration)

Rare but Serious:

• Milk-alkali syndrome (especially with chronic overuse)
• Hypersensitivity reactions: Rash, pruritus, urticaria, anaphylaxis (very rare)

Onset & Severity:

• GI effects appear within days of starting therapy.
• Hypercalcemia symptoms appear with cumulative overdose or renal impairment.

• Tetracyclines and Quinolones: Reduced absorption due to chelation – separate doses by 2–4 hours.
• Levothyroxine: Calcium reduces absorption – administer at least 4 hours apart.
• Iron, Zinc, Magnesium: Compete with calcium for absorption – separate intake times.
• Thiazide Diuretics: Reduce renal calcium excretion → increased risk of hypercalcemia.
• Phenytoin, Barbiturates: May reduce vitamin D activity by inducing hepatic metabolism.
• Glucocorticoids: Reduce calcium absorption and impair vitamin D metabolism.

Enzyme Systems Involved:

• Vitamin D3 is metabolized via CYP2R1, CYP27A1, and CYP27B1 enzymes.

• Recent bone health guidelines reaffirm calcium + vitamin D3 supplementation as standard in:
• Osteoporosis
• Chronic corticosteroid use
• Elderly with fall risk
• EMA and FDA reinforce the need to individualize calcium and vitamin D intake based on dietary habits and lab values to avoid over-supplementation.
• Routine screening for vitamin D status is advised in elderly and at-risk populations before initiating long-term supplementation.

• Store below 25°C (77°F) in a dry, cool place.
• Protect from light and moisture.
• Keep container tightly closed after use.
• Do not refrigerate or freeze.
• For sachets: Use immediately after opening.
• Chewable tablets should be kept in their original blister or bottle packaging.