1. Clinical & Scientific Overview
Magnesium Glycinate (Magnesium Bisglycinate) (TIP-MED-000630, Reference Code [SUP-06]) is classified under
Dietary Supplements & Nutraceuticals (FSSAI / ICMR-NIN) as a Clinical Nutrition & Nutraceutical Science • Chelated Intracellular Divalent Cation & ATP Coenzyme 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: 440 mg/day (adult men), 370 mg/day (adult women), 440 mg/day (pregnancy), 400 mg/day (lactation); Supplemental Elemental Magnesium Upper Limit (UL): 350 mg/day from supplements.
Clinical Nutrition, ICMR-NIN RDA & FSSAI Nutraceutical Profile
Magnesium Bisglycinate
Chelated Intracellular Divalent Cation & ATP Coenzyme Mineral
Pumpkin seeds, almonds, cashews, spinach, whole grains, millets, and black beans
ICMR-NIN 2024 Recommended Dietary Allowance (RDA) & Tolerable Upper Intake Limit (UL): ICMR-NIN 2024 RDA: 440 mg/day (adult men), 370 mg/day (adult women), 440 mg/day (pregnancy), 400 mg/day (lactation); Supplemental Elemental Magnesium Upper Limit (UL): 350 mg/day from supplements.
Deficiency Clinical Syndromes vs Chronic Excess / Hypervitaminosis Risks: Deficiency (often induced by loop/thiazide diuretics, PPIs, alcohol, or aminoglycosides): Muscle cramps, fasciculations, refractory hypokalaemia and hypocalcaemia (hypomagnesaemia impairs PTH release and renal ROMK channels — must correct Mg2+ before K+ or Ca2+ will normalise!), and Torsades de Pointes. Excess (in CKD eGFR <30 mL/min): Loss of deep tendon patellar reflexes, respiratory depression, and heart block.
Drug–Nutrient Chelation & Timing Interactions: Chelates oral bisphosphonates (alendronate), tetracyclines, fluoroquinolones, and integrase inhibitors (dolutegravir) — separate by at least 2 to 4 hours; long-term Proton Pump Inhibitors cause renal/intestinal TRPM6 hypomagnesaemia.
FSSAI Health Supplement vs Therapeutic Drug Distinction: FSSAI Health Supplement & Nutraceutical Regulation, 2022.
3. Mechanism of Action & Pharmacodynamics
Essential cofactor for >300 enzymatic reactions, including all Mg-ATP-dependent kinases, Na+/K+-ATPase, DNA/RNA polymerases, voltage-dependent blockade of NMDA glutamate receptors, and parathyroid hormone (PTH) secretion; glycine chelation prevents the osmotic diarrhoea seen with poorly absorbed Magnesium Oxide or Sulfate.
4. Therapeutic Indications & Evidence-Supported Uses
- Physiological & Biochemical Role: Essential cofactor for >300 enzymatic reactions, including all Mg-ATP-dependent kinases, Na+/K+-ATPase, DNA/RNA polymerases, voltage-dependent blockade of NMDA glutamate receptors, and parathyroid hormone (PTH) secretion; glycine chelation prevents the osmotic diarrhoea seen with poorly absorbed Magnesium Oxide or Sulfate.
- Dietary Sources: Pumpkin seeds, almonds, cashews, spinach, whole grains, millets, and black beans
- ICMR-NIN RDA & Upper Limits: ICMR-NIN 2024 RDA: 440 mg/day (adult men), 370 mg/day (adult women), 440 mg/day (pregnancy), 400 mg/day (lactation); Supplemental Elemental Magnesium Upper Limit (UL): 350 mg/day from supplements.
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: ICMR-NIN 2024 RDA: 440 mg/day (adult men), 370 mg/day (adult women), 440 mg/day (pregnancy), 400 mg/day (lactation); Supplemental Elemental Magnesium Upper Limit (UL): 350 mg/day from supplements.
Administration & Meal Timing: Chelates oral bisphosphonates (alendronate), tetracyclines, fluoroquinolones, and integrase inhibitors (dolutegravir) — separate by at least 2 to 4 hours; long-term Proton Pump Inhibitors cause renal/intestinal TRPM6 hypomagnesaemia.
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Salt-form and meal-timing dependent gastrointestinal absorption; see bioavailability and drug-nutrient chelation notes (Chelates oral bisphosphonates (alendronate), tetracyclines, fluoroquinolones, and integrase inhibitors (dolutegravir) — separate by at least 2 to 4 hours; long-term Proton Pump Inhibitors cause renal/intestinal TRPM6 hypomagnesaemia.).
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 (often induced by loop/thiazide diuretics, PPIs, alcohol, or aminoglycosides): Muscle cramps, fasciculations, refractory hypokalaemia and hypocalcaemia (hypomagnesaemia impairs PTH release and renal ROMK channels — must correct Mg2+ before K+ or Ca2+ will normalise!), and Torsades de Pointes. Excess (in CKD eGFR <30 mL/min): Loss of deep tendon patellar reflexes, respiratory depression, and heart block.
Key Clinical Precautions: Deficiency (often induced by loop/thiazide diuretics, PPIs, alcohol, or aminoglycosides): Muscle cramps, fasciculations, refractory hypokalaemia and hypocalcaemia (hypomagnesaemia impairs PTH release and renal ROMK channels — must correct Mg2+ before K+ or Ca2+ will normalise!), and Torsades de Pointes. Excess (in CKD eGFR <30 mL/min): Loss of deep tendon patellar reflexes, respiratory depression, and heart block.
8. Adverse Effects Profile
- Deficiency (often induced by loop/thiazide diuretics, PPIs, alcohol, or aminoglycosides): Muscle cramps, fasciculations, refractory hypokalaemia and hypocalcaemia (hypomagnesaemia impairs PTH release and renal ROMK channels — must correct Mg2+ before K+ or Ca2+ will normalise!), and Torsades de Pointes. Excess (in CKD eGFR <30 mL/min): Loss of deep tendon patellar reflexes, respiratory depression, and heart block.
- Deficiency (often induced by loop/thiazide diuretics, PPIs, alcohol, or aminoglycosides): Muscle cramps, fasciculations, refractory hypokalaemia and hypocalcaemia (hypomagnesaemia impairs PTH release and renal ROMK channels — must correct Mg2+ before K+ or Ca2+ will normalise!), and Torsades de Pointes. Excess (in CKD eGFR <30 mL/min): Loss of deep tendon patellar reflexes, respiratory depression, and heart block.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Chelates oral bisphosphonates (alendronate), tetracyclines, fluoroquinolones, and integrase inhibitors (dolutegravir) — separate by at least 2 to 4 hours; long-term Proton Pump Inhibitors cause renal/intestinal TRPM6 hypomagnesaemia.
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:
- Chelates oral bisphosphonates (alendronate), tetracyclines, fluoroquinolones, and integrase inhibitors (dolutegravir) — separate by at least 2 to 4 hours; long-term Proton Pump Inhibitors cause renal/intestinal TRPM6 hypomagnesaemia.
- 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.