Apocal-DM

Approved and Clinically Accepted Uses:

• Prevention and treatment of calcium and vitamin D deficiencies, especially in elderly or postmenopausal patients.
• Osteoporosis (including senile, postmenopausal, and corticosteroid-induced): Adjunctive treatment to strengthen bone mineral density.
• Osteomalacia and rickets: Nutritional support in vitamin D/calcium deficiency-related bone softening.
• Pregnancy and lactation: To meet increased demands for calcium and essential minerals.
• Hypocalcemia-related conditions, such as tetany and hypoparathyroidism (supportive therapy).
• Growth periods in children and adolescents: Ensures proper bone development and mineral balance.
• Supplementation in chronic illnesses (e.g., chronic kidney disease, malabsorption syndromes) that impair calcium/vitamin D absorption or utilization.
• Supportive therapy in fractures and bone healing.
• Prevention of mineral depletion in restrictive diets or prolonged illness.

Adults (including elderly):

• Typical dose: 1–2 tablets/capsules daily or as directed by a physician.
• Each tablet usually contains:
• Calcium (as carbonate/citrate): 500–1000 mg elemental calcium
• Vitamin D3 (Cholecalciferol): 400–1000 IU
• Multimineral complex: Contains magnesium, zinc, manganese, copper, selenium, and sometimes boron

Children (≥6 years):

• 250–500 mg calcium + 200–400 IU vitamin D3 daily depending on age and formulation.
• Multimineral inclusion adjusted to age-appropriate levels.

Pregnant and Lactating Women:

• Calcium: Up to 1200 mg/day
• Vitamin D3: 600–800 IU/day
• Adjusted depending on dietary intake.

Hepatic Impairment:

• No dosage adjustment generally required.

Renal Impairment:

• Use with caution; monitor for hypercalcemia and hyperphosphatemia.
• Avoid if eGFR <30 mL/min unless under supervision.

Administration:

• Preferably taken with meals to enhance absorption.
• Swallow whole with water; do not crush or chew unless chewable formulation.

Calcium is essential for numerous physiological functions including neuromuscular transmission, muscle contraction, blood clotting, and bone formation. Vitamin D3 (cholecalciferol) enhances intestinal absorption of calcium and phosphate, facilitating bone mineralization. The multimineral complex (magnesium, zinc, manganese, copper, selenium, etc.) works synergistically with calcium and vitamin D to support bone integrity, antioxidant defense, enzymatic reactions, and cellular metabolism. Together, this combination corrects nutritional deficiencies, promotes bone health, and reduces the risk of fractures.

• Calcium:
• Absorption: ~25–30% in the small intestine; enhanced by vitamin D
• Distribution: 99% stored in bones and teeth
• Metabolism: Not metabolized
• Elimination: Primarily via feces; minimal renal excretion
• Vitamin D3:
• Absorption: Fat-soluble; absorbed in the small intestine with dietary fat
• Metabolism: Converted in liver to 25(OH)D, then in kidney to active 1,25(OH)2D
• Half-life: ~15 days
• Excretion: Mainly in bile and feces
• Multiminerals:
• Each has specific absorption and excretion pathways (e.g., magnesium absorbed in jejunum; zinc via intestine, etc.)
• Excreted through urine and feces depending on mineral

• Pregnancy: Generally regarded as safe when used within recommended dietary allowances. Excessive calcium or vitamin D may cause fetal hypercalcemia or suppression of parathyroid function.
• Lactation: Safe in appropriate doses. Calcium and vitamin D are excreted in breast milk but not known to harm nursing infants.
• Caution: Avoid high doses; monitor total daily intake from all sources to prevent hypercalcemia or vitamin D toxicity.

• Therapeutic Class: Bone Health Supplement
• Subclass: Calcium Regulator with Vitamin D and Trace Minerals

• Hypersensitivity to calcium, vitamin D, or any excipients
• Hypercalcemia or hypervitaminosis D
• Severe renal impairment or kidney stones
• Sarcoidosis or other granulomatous diseases (risk of increased vitamin D activation)
• Malabsorption syndromes with poor vitamin D handling

• Renal insufficiency: Risk of hypercalcemia and nephrocalcinosis; monitor renal function.
• Long-term use: May contribute to vascular or soft tissue calcification if used inappropriately.
• Concomitant use with thiazide diuretics: Increases calcium levels.
• Monitor serum calcium, phosphate, and renal function in long-term users.
• Avoid excessive vitamin D supplementation from multiple sources.

Common (GI & systemic):

• Constipation
• Flatulence
• Nausea
• Abdominal pain

Less common:

• Hypercalcemia (lethargy, confusion, muscle weakness)
• Nephrolithiasis (kidney stones)
• Hyperphosphatemia (with phosphate-containing minerals)
• Metallic taste (from some minerals)

Rare:

• Hypersensitivity reactions (rash, itching)
• Vitamin D toxicity (with chronic overdose)

• Thiazide diuretics: May increase serum calcium levels.
• Corticosteroids: Reduce calcium absorption.
• Iron, tetracyclines, quinolones: Absorption reduced when taken with calcium; separate by at least 2 hours.
• Phenytoin, barbiturates: Increase vitamin D metabolism, reducing efficacy.
• Bisphosphonates and levothyroxine: Absorption decreased if taken with calcium—space by at least 4 hours.
• CYP enzymes: Vitamin D may interact with CYP3A4 substrates/inducers/inhibitors indirectly.

• WHO and national osteoporosis foundations reaffirm the importance of combined calcium + vitamin D in fracture prevention in elderly and osteoporotic patients.
• EMA advises close monitoring of cumulative daily calcium and vitamin D3 intake from all sources to prevent overdose.
• Some guidelines discourage routine supplementation in low-risk populations unless dietary intake is insufficient.

• Store at 25°C (77°F); excursions permitted between 15°C and 30°C.
• Protect from moisture and excessive heat.
• Keep container tightly closed.
• Do not freeze.
• Chewable and effervescent forms should be used immediately after reconstitution.
• Keep out of reach of children.