1. Clinical & Scientific Overview
Calcium Citrate Malate (CCM) (TIP-MED-000629, Reference Code [SUP-05]) is classified under
Dietary Supplements & Nutraceuticals (FSSAI / ICMR-NIN) as a Clinical Nutrition & Nutraceutical Science • Water-Soluble Organic Acid Calcium Salt (Bone & Cellular Mineral).
Within the Indian regulatory and compendial framework, it is governed under FSSAI Health Supplement & Nutraceutical Regulation, 2022..
FSSAI Licensed Health Supplement / Nutraceutical Formulations (RDA Compliant)
ICMR-NIN 2024 RDA: 1,000 mg/day (adult men, women, and pregnancy), 1,200 mg/day (lactating and postmenopausal women); Tolerable Upper Limit (UL): 2,500 mg/day (2,000 mg/day over age 50).
Clinical Nutrition, ICMR-NIN RDA & FSSAI Nutraceutical Profile
Calcium Citrate Malate
Water-Soluble Organic Acid Calcium Salt (Bone & Cellular Mineral)
Milk, curd, paneer, ragi (finger millet — 344 mg/100 g), sesame seeds (til), and calcium-set tofu
ICMR-NIN 2024 Recommended Dietary Allowance (RDA) & Tolerable Upper Intake Limit (UL): ICMR-NIN 2024 RDA: 1,000 mg/day (adult men, women, and pregnancy), 1,200 mg/day (lactating and postmenopausal women); Tolerable Upper Limit (UL): 2,500 mg/day (2,000 mg/day over age 50).
Deficiency Clinical Syndromes vs Chronic Excess / Hypervitaminosis Risks: Deficiency: Osteopenia, osteoporosis, secondary hyperparathyroidism, and tetany (Chvostek/Trousseau signs). Excess (>2,500 mg/day): Hypercalciuria, calcium oxalate/phosphate nephrolithiasis (CCM carries lower stone risk than carbonate as citrate inhibits urinary crystal aggregation), constipation, and vascular calcification.
Drug–Nutrient Chelation & Timing Interactions: Intestinal calcium absorption saturates at ~500 mg elemental calcium per dose (split doses >500 mg twice daily); chelates levothyroxine (separate by 4 hours), tetracyclines, fluoroquinolones, and oral iron (separate by 2 hours); thiazide diuretics reduce urinary calcium excretion (monitor serum Ca2+).
FSSAI Health Supplement vs Therapeutic Drug Distinction: FSSAI Health Supplement & Nutraceutical Regulation, 2022.
3. Mechanism of Action & Pharmacodynamics
Provides ionised Ca2+ (~21–24% elemental calcium) for hydroxyapatite bone mineralisation, neuromuscular excitability, cardiac excitation-contraction coupling, and coagulation cascade factor activation; unlike Calcium Carbonate (which requires gastric HCl and meals), CCM is well absorbed even in achlorhydria, elderly patients, and PPI users.
4. Therapeutic Indications & Evidence-Supported Uses
- Physiological & Biochemical Role: Provides ionised Ca2+ (~21–24% elemental calcium) for hydroxyapatite bone mineralisation, neuromuscular excitability, cardiac excitation-contraction coupling, and coagulation cascade factor activation; unlike Calcium Carbonate (which requires gastric HCl and meals), CCM is well absorbed even in achlorhydria, elderly patients, and PPI users.
- Dietary Sources: Milk, curd, paneer, ragi (finger millet — 344 mg/100 g), sesame seeds (til), and calcium-set tofu
- ICMR-NIN RDA & Upper Limits: ICMR-NIN 2024 RDA: 1,000 mg/day (adult men, women, and pregnancy), 1,200 mg/day (lactating and postmenopausal women); Tolerable Upper Limit (UL): 2,500 mg/day (2,000 mg/day over age 50).
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: ICMR-NIN 2024 RDA: 1,000 mg/day (adult men, women, and pregnancy), 1,200 mg/day (lactating and postmenopausal women); Tolerable Upper Limit (UL): 2,500 mg/day (2,000 mg/day over age 50).
Administration & Meal Timing: Intestinal calcium absorption saturates at ~500 mg elemental calcium per dose (split doses >500 mg twice daily); chelates levothyroxine (separate by 4 hours), tetracyclines, fluoroquinolones, and oral iron (separate by 2 hours); thiazide diuretics reduce urinary calcium excretion (monitor serum Ca2+).
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Salt-form and meal-timing dependent gastrointestinal absorption; see bioavailability and drug-nutrient chelation notes (Intestinal calcium absorption saturates at ~500 mg elemental calcium per dose (split doses >500 mg twice daily); chelates levothyroxine (separate by 4 hours), tetracyclines, fluoroquinolones, and oral iron (separate by 2 hours); thiazide diuretics reduce urinary calcium excretion (monitor serum Ca2+).).
Incorporated into cellular coenzyme pools, metalloproteins, or membrane phospholipids.
Caution with magnesium, potassium, calcium, vitamin D, and high-dose vitamin C/collagen (oxalate) in Chronic Kidney Disease.
Caution with fat-soluble vitamins and concentrated lipophilic extracts in hepatobiliary disease.
7. Contraindications, Precautions & High-Risk Warnings
- Supratherapeutic megadosing above the ICMR-NIN Tolerable Upper Intake Level (UL) without medical indication
- Deficiency: Osteopenia, osteoporosis, secondary hyperparathyroidism, and tetany (Chvostek/Trousseau signs). Excess (>2,500 mg/day): Hypercalciuria, calcium oxalate/phosphate nephrolithiasis (CCM carries lower stone risk than carbonate as citrate inhibits urinary crystal aggregation), constipation, and vascular calcification.
Key Clinical Precautions: Deficiency: Osteopenia, osteoporosis, secondary hyperparathyroidism, and tetany (Chvostek/Trousseau signs). Excess (>2,500 mg/day): Hypercalciuria, calcium oxalate/phosphate nephrolithiasis (CCM carries lower stone risk than carbonate as citrate inhibits urinary crystal aggregation), constipation, and vascular calcification.
8. Adverse Effects Profile
- Deficiency: Osteopenia, osteoporosis, secondary hyperparathyroidism, and tetany (Chvostek/Trousseau signs). Excess (>2,500 mg/day): Hypercalciuria, calcium oxalate/phosphate nephrolithiasis (CCM carries lower stone risk than carbonate as citrate inhibits urinary crystal aggregation), constipation, and vascular calcification.
- Deficiency: Osteopenia, osteoporosis, secondary hyperparathyroidism, and tetany (Chvostek/Trousseau signs). Excess (>2,500 mg/day): Hypercalciuria, calcium oxalate/phosphate nephrolithiasis (CCM carries lower stone risk than carbonate as citrate inhibits urinary crystal aggregation), constipation, and vascular calcification.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Intestinal calcium absorption saturates at ~500 mg elemental calcium per dose (split doses >500 mg twice daily); chelates levothyroxine (separate by 4 hours), tetracyclines, fluoroquinolones, and oral iron (separate by 2 hours); thiazide diuretics reduce urinary calcium excretion (monitor serum Ca2+).
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Verify whether the patient requires physiological nutritional maintenance (<=1 RDA under FSSAI) or high-dose therapeutic deficiency correction (Schedule H/medical supervision), and check for multi-supplement stacking.
Pharmacist Patient Counselling Points:
- Intestinal calcium absorption saturates at ~500 mg elemental calcium per dose (split doses >500 mg twice daily); chelates levothyroxine (separate by 4 hours), tetracyclines, fluoroquinolones, and oral iron (separate by 2 hours); thiazide diuretics reduce urinary calcium excretion (monitor serum Ca2+).
- Check all multivitamin and wellness labels to avoid accidentally doubling up on fat-soluble vitamins (A, D, E, K), iron, or zinc.
- Health supplements support normal physiological nutrition and are NOT intended to diagnose, treat, cure, or prevent disease under Section 22 of the FSS Act, 2006.
Storage, Stability & Dispensing Safeguards: Store in a cool, dry place below 25°C away from moisture and direct sunlight; verify FSSAI License Number and Veg/Non-Veg symbol on packaging.
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: ICMR-NIN (National Institute of Nutrition) Nutrient Requirements and Recommended Dietary Allowances (RDA) for Indians (2020/2024); FSSAI (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2022.
Official Verification Portals: ICMR-National Institute of Nutrition (NIN) — Dietary Guidelines & Nutrient Requirements for Indians • FSSAI — Food Safety and Standards (Health Supplements and Nutraceuticals) Regulations
Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: VERIFIED_EDUCATIONAL_CONTENT
Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.