FizyCal-M

Approved Indications:

• Calcium and Vitamin D deficiency states, including dietary insufficiency and malabsorption syndromes.
• Prevention and treatment of osteoporosis, osteopenia, and osteomalacia, especially in:
• Postmenopausal women
• Elderly individuals at fracture risk
• Patients on long-term corticosteroid therapy
• Supportive treatment in rickets and delayed bone growth in children and adolescents.
• Supplementation during pregnancy and lactation, particularly in women with poor dietary intake.
• Prevention and correction of hypocalcemia in chronic illnesses, such as:
• Chronic kidney disease (pre-dialysis stages)
• Hypoparathyroidism
• Nutritional support in general debility, convalescence, and chronic illness, where calcium, vitamin D, and trace mineral requirements are elevated.
• Maintenance of bone and muscle health in older adults and individuals with low sun exposure.

Clinically Accepted Off-Label Uses:

• Preeclampsia prevention in high-risk pregnant populations with low calcium intake.
• Adjunct therapy in metabolic bone disease secondary to liver or kidney dysfunction.
• Correction of trace mineral deficiency in patients with poor oral intake, restricted diets, or gastrointestinal disorders (e.g., malabsorption, IBD).

Route of Administration: Oral

Adults and Elderly:

• General supplementation: 1–2 tablets or sachets daily (typically containing 500–1200 mg elemental calcium, 400–800 IU vitamin D3, and therapeutic levels of essential trace minerals).
• Osteoporosis/Osteomalacia: 1000–1500 mg elemental calcium + 800–1000 IU vitamin D3 per day in divided doses.
• Maintenance dose: 1 tablet per day or as directed by the physician.

Children and Adolescents:

• 6–12 years: 250–500 mg elemental calcium + 200–400 IU vitamin D3 daily with age-appropriate levels of minerals.
• 13–18 years: 500–1000 mg calcium + 400–800 IU vitamin D3 per day.

Pregnancy and Lactation:

• Recommended dose: 1000–1300 mg calcium + 400–800 IU vitamin D3 + iron, zinc, magnesium, and other trace elements, as per prenatal supplementation needs.

Renal Impairment:

• Use cautiously in mild-to-moderate renal dysfunction. Monitor serum calcium, phosphate, and vitamin D levels.
• Contraindicated in severe renal failure due to risk of soft tissue calcification and hypercalcemia.

Hepatic Impairment:

• No dose adjustment typically required.

Administration Instructions:

• Administer with meals to enhance calcium absorption.
• Tablets should be chewed or swallowed whole depending on formulation.
• Separate dosing from iron, thyroid hormones, tetracyclines, and certain minerals (e.g., zinc, magnesium) by at least 2–4 hours.

Calcium lactate gluconate and calcium carbonate are salt forms that provide essential elemental calcium for physiological functions such as bone mineralization, muscle contraction, nerve transmission, and blood coagulation. Vitamin D3 (cholecalciferol) is converted to calcitriol, its active form, in the body. Calcitriol enhances intestinal absorption of calcium and phosphate and regulates bone resorption and remodeling. The addition of multiminerals such as magnesium, zinc, copper, manganese, and selenium contributes to osteogenesis, cellular metabolism, and antioxidant defense mechanisms. Collectively, this combination helps maintain bone strength, corrects nutritional deficiencies, and supports musculoskeletal and immune health.

• Absorption:
• Calcium: Primarily absorbed in the duodenum and jejunum; vitamin D3 enhances absorption.
• Vitamin D3: Absorbed in the small intestine via fat-dependent mechanisms.
• Multiminerals: Vary in absorption; influenced by intestinal health and competing minerals.
• Bioavailability:
• Calcium carbonate: ~25–40% (enhanced when taken with food).
• Calcium lactate gluconate: More soluble, better tolerated.
• Vitamin D3: Increased bioavailability with fat-containing meals.
• Distribution:
• Calcium: Mainly in bone (99%) and teeth.
• Vitamin D3: Bound to plasma proteins; stored in liver, fat, and muscle tissues.
• Trace minerals: Widely distributed and stored in various tissues (e.g., liver, bones, RBCs).
• Metabolism:
• Vitamin D3: Converted in liver to 25(OH)D3 → activated in kidneys to 1,25(OH)2D3.
• Minerals like zinc and magnesium are metabolized via enzymatic systems or protein-binding pathways.
• Elimination:
• Calcium: Mostly excreted via feces (unabsorbed portion); minor urinary excretion.
• Vitamin D3: Bile and fecal excretion of metabolites.
• Trace minerals: Excreted in urine, sweat, or feces, depending on type.
• Half-life:
• Calcitriol: ~15 hours; 25(OH)D3: ~15 days.
• Minerals: Vary greatly depending on mineral and body status.

Pregnancy:

• Not assigned a formal FDA category (per updated FDA labeling system).
• Safe at recommended dietary intakes.
• Excessive calcium and vitamin D may cause maternal hypercalcemia, fetal soft tissue calcification, or suppressed fetal parathyroid activity.

Lactation:

• Calcium, vitamin D3, and minerals are secreted into breast milk.
• Safe at standard doses.
• Monitor maternal intake to prevent infant exposure to high levels of fat-soluble vitamins or certain trace elements (e.g., selenium, copper) if megadosed.

• Primary Class: Bone Health Supplement / Nutritional Support
• Subclass: Calcium and Vitamin D Combination with Multiminerals

• Hypersensitivity to any component of the formulation.
• Hypercalcemia from any cause (e.g., hyperparathyroidism, malignancy).
• Hypervitaminosis D.
• Severe renal impairment (due to risk of hyperphosphatemia or tissue calcification).
• History or active calcium-containing kidney stones.
• Conditions involving excessive mineral storage (e.g., Wilson's disease if copper is present).

• Monitor serum calcium, phosphate, and renal function in patients on long-term therapy.
• Use cautiously in:
• Renal insufficiency
• Granulomatous diseases (e.g., sarcoidosis)
• Patients prone to nephrolithiasis
• Avoid high-dose vitamin D3 or calcium intake from multiple sources.
• Risk of milk-alkali syndrome with excessive calcium and alkali ingestion.
• Caution in patients receiving digitalis glycosides due to risk of arrhythmias with hypercalcemia.

Common:

• Gastrointestinal: Constipation, bloating, flatulence, nausea
• Musculoskeletal: Muscle cramps (in high calcium states)

Uncommon:

• Hypercalcemia: Weakness, vomiting, confusion, cardiac arrhythmias
• Nephrolithiasis in predisposed individuals

Rare:

• Hypersensitivity reactions (rash, pruritus)
• Milk-alkali syndrome
• Metallic taste or gastrointestinal upset with certain minerals (e.g., zinc, iron)

Severity and Onset:

• GI symptoms appear within days of initiation.
• Hypercalcemia or renal effects occur with overdose or preexisting kidney dysfunction.

• Iron, Zinc, Magnesium, Tetracyclines, Quinolones: Compete for absorption – separate by 2–4 hours.
• Levothyroxine: Calcium and iron reduce absorption – dose at least 4 hours apart.
• Thiazide diuretics: Increase calcium reabsorption – monitor serum calcium levels.
• Glucocorticoids: Decrease calcium and vitamin D absorption.
• Digitalis: Increased risk of arrhythmias with hypercalcemia.

Enzyme Pathways:

• Vitamin D3 metabolism involves CYP2R1, CYP27A1, and CYP27B1.
• Mineral excretion is non-CYP mediated but can be affected by renal transporter interactions.

• National Osteoporosis Guidelines continue to recommend calcium + vitamin D + mineral supplementation in postmenopausal women and the elderly.
• FDA and EMA alerts suggest careful monitoring of cumulative vitamin D intake to avoid toxicity, especially with multiple supplement sources.
• WHO supports calcium supplementation during pregnancy to reduce risk of preeclampsia in low-calcium populations.

• Temperature: Store at 20°C to 25°C (68°F to 77°F); acceptable range: 15°C–30°C.
• Humidity: Keep in a dry place; protect from moisture.
• Light: Store away from direct sunlight.
• Handling: Keep container tightly closed; do not remove desiccant if present.
• Refrigeration: Not required.
• Do not freeze. Use sachets or effervescent tablets immediately after opening.