Richcal-D

Approved and Clinically Accepted Uses:

• Calcium and Vitamin D Deficiency:
• Supplementation in patients with low dietary intake or increased requirements of calcium and vitamin D, including postmenopausal women, elderly patients, and those on long-term corticosteroid therapy.
• Osteoporosis (Prevention and Adjunctive Treatment):
• Used in combination with other anti-osteoporotic agents to maintain bone mineral density and reduce fracture risk.
• Osteopenia:
• Adjunct in patients with low bone mass, particularly in older adults or perimenopausal women.
• Rickets and Osteomalacia:
• Supportive therapy in the management of vitamin D- or calcium-deficient bone softening disorders.
• Pregnancy and Lactation:
• Supplementation during pregnancy and breastfeeding to support maternal bone health and fetal/infant skeletal development.
• Hypoparathyroidism:
• Adjunct in managing chronic hypocalcemia related to parathyroid hormone deficiency.
• Calcium Supplementation in Children:
• Support growth and bone development in children with dietary deficiencies or increased demands.

Adults (including elderly):

• Typical dose:
• Calcium (as eggshell calcium): 500–600 mg elemental calcium once or twice daily
• Vitamin D3: 400–1000 IU once daily
• Dose may vary based on clinical need (e.g., osteoporosis may require up to 1200 mg calcium and 800–2000 IU vitamin D3 daily)

Pregnancy and Lactation:

• Calcium: 1000–1300 mg elemental calcium per day
• Vitamin D3: 600–2000 IU daily depending on serum 25(OH)D levels

Pediatric Dosing (under medical supervision):

• Calcium: 200–1000 mg/day depending on age and dietary intake
• Vitamin D3: 400–800 IU/day; higher doses for deficiency states

Hepatic/Renal Impairment:

• Use with caution in severe renal impairment due to risk of hypercalcemia and hyperphosphatemia; monitor calcium and phosphate levels closely
• In liver disease, vitamin D3 activation may be impaired; calcitriol or other active forms may be needed in some cases

Route of Administration:

• Oral (tablet, chewable, or capsule formulations)
• Should be taken with meals to enhance calcium absorption
• Ensure adequate fluid intake when using calcium supplements

Eggshell calcium provides bioavailable elemental calcium, essential for the development and maintenance of bone structure, neuromuscular function, vascular contraction, and other metabolic processes. Vitamin D3 (cholecalciferol) is a fat-soluble vitamin that is hydroxylated in the liver and kidneys to its active form (calcitriol), which enhances intestinal absorption of calcium and phosphate. The combination increases serum calcium levels, suppresses parathyroid hormone overactivity, and promotes mineralization of bone tissue, thus preventing or treating calcium-deficient bone disorders.

• Absorption:
• Calcium absorption is highest when administered in divided doses (<500 mg per dose) and in the presence of food and gastric acid
• Vitamin D3 is absorbed in the small intestine with the help of bile salts
• Bioavailability:
• Eggshell calcium is highly bioavailable, comparable to or better than calcium carbonate
• Vitamin D3 has high oral bioavailability when taken with fatty meals
• Distribution:
• Calcium is distributed in bones (99%) and extracellular fluid
• Vitamin D3 and its metabolites circulate bound to vitamin D-binding protein
• Metabolism:
• Vitamin D3 is converted in the liver to 25(OH)D (calcifediol), then in the kidney to active 1,25(OH)2D (calcitriol)
• Elimination:
• Calcium is excreted primarily via feces; small amounts via urine and sweat
• Vitamin D3 metabolites are excreted via bile and feces
• Half-life:
• Calcium: Not applicable as it is a mineral
• 25(OH)D: ~15 days; 1,25(OH)2D: ~4–6 hours

• Pregnancy:
• Vitamin D3 is generally considered safe during pregnancy (Category A or C depending on region).
• Calcium supplementation is essential during pregnancy to meet increased maternal and fetal skeletal demands.
• Lactation:
• Both calcium and vitamin D are excreted into breast milk in small amounts.
• Supplementation is safe and beneficial during breastfeeding.
• Monitor calcium intake to avoid hypercalcemia.
• General:
• Supplement within recommended dietary allowances unless treating documented deficiency.

• Primary Class: Nutritional Supplement
• Subclass: Calcium and Vitamin D Combination (Bone Health Supplement)

• Hypersensitivity to calcium, vitamin D3, or any excipient
• Hypercalcemia (e.g., due to malignancy or hyperparathyroidism)
• Hypervitaminosis D
• Severe renal impairment with hyperphosphatemia or risk of soft tissue calcification
• Nephrolithiasis (calcium-containing kidney stones)
• Sarcoidosis or other granulomatous disorders with increased vitamin D activation

• Hypercalcemia and Hypercalciuria:
• Monitor serum calcium levels, especially in the elderly or those with renal impairment
• Renal Calculi:
• Use with caution in individuals with a history of kidney stones
• Vitamin D Toxicity:
• High doses of vitamin D3 may lead to toxicity (nausea, vomiting, polyuria, confusion, arrhythmias)
• Drug Interactions:
• Consider potential interactions with digitalis, thiazide diuretics, or bisphosphonates
• Clinical Monitoring:
• Monitor serum calcium, phosphate, and 25(OH)D levels during long-term use

Gastrointestinal:

• Nausea, constipation, bloating, flatulence, abdominal pain

Metabolic:

• Hypercalcemia (fatigue, muscle weakness, confusion, polyuria, polydipsia)
• Hypercalciuria
• Vitamin D toxicity in overdose

Renal:

• Kidney stones (especially with high-dose calcium)

Rare/Serious:

• Arrhythmias (in severe hypercalcemia)
• Anaphylaxis (extremely rare)

• Thiazide Diuretics:
• May reduce urinary calcium excretion, increasing hypercalcemia risk
• Digitalis Glycosides:
• Increased risk of digitalis toxicity in hypercalcemia
• Tetracyclines, Fluoroquinolones, Levothyroxine, Bisphosphonates:
• Calcium may impair absorption; separate administration by at least 2 hours
• Glucocorticoids:
• Decrease calcium absorption and antagonize vitamin D action
• Anticonvulsants (e.g., phenytoin, phenobarbital):
• May accelerate vitamin D metabolism, reducing efficacy
• Enzyme Systems Involved:
• Vitamin D3 metabolism involves CYP2R1, CYP27A1 (liver), CYP27B1 (kidney)

• International Osteoporosis Foundation (IOF) and Endocrine Society Guidelines:
• Continue to recommend 1000–1200 mg/day calcium and 800–2000 IU/day vitamin D3 in older adults and at-risk populations
• Recent Research:
• Eggshell calcium shown to be as effective and better tolerated than other forms (e.g., carbonate or citrate)
• No recent safety warnings or label changes from FDA, EMA, or WHO

• Temperature:
• Store below 25°C (77°F)
• Humidity & Light Protection:
• Protect from excessive moisture and direct sunlight
• Keep in original container with desiccant (if present)
• Handling Precautions:
• Keep out of reach of children
• Do not use past expiration date
• No refrigeration or reconstitution required