Usage
This combination medication is primarily prescribed for the management and prevention of deficiencies in vitamin D, calcium, magnesium, and zinc. It is also used in the treatment of osteoporosis, osteomalacia, rickets, latent tetany, and hypoparathyroidism. It is sometimes used as an adjunct in managing secondary hyperparathyroidism in patients undergoing renal dialysis. This combination falls under the pharmacological classification of vitamins and minerals, or more accurately, as a dietary supplement.
The mechanism of action involves several components working synergistically:
- Calcitriol, the active form of vitamin D3, enhances intestinal absorption of calcium and phosphate. It also stimulates osteoclasts for calcium reabsorption from bone and promotes renal calcium reabsorption.
- Calcium citrate malate is a readily absorbed calcium salt crucial for bone mineralization and various biochemical functions.
- Magnesium regulates calcium levels and is vital for energy production and muscle function.
- Vitamin K2-7 (menaquinone-7) activates proteins like osteocalcin and matrix Gla protein, which facilitate calcium incorporation into bones and prevent vascular calcification.
- Zinc contributes to cell growth, immune function, and wound healing.
Alternate Names
No specific alternate names for this exact combination are mentioned in the sources. Individual components may be referred to by their chemical names (e.g., cholecalciferol for vitamin D3) or by other forms of vitamin K2 (menaquinone). Brand names vary depending on the manufacturer. Some mentioned include Bone C Max K2 Tablet and Bonultra Tablet 10, though these don’t necessarily contain all five components.
How It Works
Pharmacodynamics: This combination exerts its effects by influencing calcium and phosphate homeostasis, bone metabolism, muscle and nerve function, and immune function. Calcitriol regulates calcium absorption and utilization, while calcium and magnesium are crucial for bone structure and function. Vitamin K2-7 directs calcium towards bone deposition and prevents its deposition in soft tissues. Zinc supports immune function and various enzymatic processes.
Pharmacokinetics:
- Absorption: Calcitriol is absorbed in the small intestine. Calcium citrate malate is also absorbed in the small intestine. Magnesium absorption occurs primarily in the small intestine and colon. Zinc absorption takes place primarily in the small intestine. Vitamin K2-7 absorption follows the path of fats.
- Metabolism: Calcitriol undergoes hepatic metabolism. The other components are not significantly metabolized.
- Elimination: Calcitriol and its metabolites are primarily excreted via bile and feces, with some renal excretion. Calcium is excreted mainly through urine and feces. Magnesium is excreted mainly in urine. Zinc is primarily excreted in feces. Vitamin K2-7 is primarily excreted in bile and feces.
Mode of Action: Calcitriol binds to and activates vitamin D receptors in the intestine, kidneys, parathyroid gland, and bone. This leads to increased calcium absorption and reabsorption. Calcium and magnesium contribute to bone mineralization, while vitamin K2-7 activates proteins that incorporate calcium into the bone matrix. Zinc participates in numerous enzymatic reactions.
Receptor Binding/Enzyme Inhibition/Neurotransmitter Modulation: Calcitriol acts through vitamin D receptors. The other components do not exhibit specific receptor binding, enzyme inhibition, or neurotransmitter modulation.
Dosage
Standard Dosage
Children: Safety and efficacy have not been established for children younger than 12 years.
Special Cases: Dosage adjustments based on age and underlying medical conditions are not explicitly available for this specific combination in the given sources. Individual components may require adjustments based on renal or hepatic impairment. It’s best to consult dosing recommendations for individual components.
Clinical Use Cases
Specific dosage recommendations for this combination in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations are not available in the given sources.
Dosage Adjustments
Adjustments might be necessary based on individual patient factors, especially renal and hepatic function, comorbid conditions, and potential drug interactions.
Side Effects
Common Side Effects
Common side effects include stomach upset, diarrhea, constipation, gas, nausea, headache, and fatigue.
Rare but Serious Side Effects
Rare but serious side effects include hypercalcemia, hypercalciuria and hypermagnesemia. These are often associated with excessive intake and require medical attention.
Long-Term Effects
Long-term effects of this combination have not been extensively studied.
Adverse Drug Reactions (ADR)
Clinically significant ADRs associated with this combination include hypersensitivity reactions, severe gastrointestinal distress, and electrolyte imbalances.
Contraindications
Contraindications include hypersensitivity to any of the components, hypervitaminosis D, hypercalcemia, hypercalciuria, metastatic calcification, severe renal impairment, and hypermagnesemia.
Drug Interactions
This combination may interact with steroids, anticonvulsants, diuretics, antifungals, cholesterol-lowering medications, iron supplements, thyroid medications, painkillers, antidepressants, antibiotics (e.g., doxycycline, ciprofloxacin), anticoagulants, and other calcium or vitamin D supplements. Spinach, rhubarb, bran, and whole grains may reduce calcium absorption.
Pregnancy and Breastfeeding
Use during pregnancy and breastfeeding should be considered only if clearly needed and under the guidance of a healthcare professional.
Drug Profile Summary
- Mechanism of Action: Improves calcium and vitamin D levels, promotes bone health.
- Side Effects: Stomach upset, diarrhea, constipation, nausea, headache.
- Contraindications: Hypercalcemia, hypervitaminosis D, severe renal impairment.
- Drug Interactions: Steroids, anticonvulsants, certain antibiotics, anticoagulants.
- Pregnancy & Breastfeeding: Use with caution and under medical supervision.
- Dosage: Typically one tablet or capsule daily, adjust as needed.
- Monitoring Parameters: Serum calcium, magnesium, phosphate, vitamin D levels.
Popular Combinations
Specific popular combinations involving all five components are not mentioned in the provided sources. However, several combinations with some of these components are marketed for bone health.
Precautions
- General Precautions: Assess renal and hepatic function. Monitor serum calcium, magnesium, and phosphate levels.
- Specific Populations: Use cautiously in pregnancy and breastfeeding. Consult a doctor for pediatric use.
- Lifestyle Considerations: Limit alcohol intake as it can interfere with calcium absorption.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Calcitriol + Calcium Citrate Malate + Magnesium + Vitamin K2-7 + Zinc?
A: Standard dosage is generally one tablet or capsule daily, preferably taken with food. Individual needs vary; healthcare professional consultation is vital for optimal dosing.
Q2: What are the common side effects?
A: Common side effects are mild and include gastrointestinal issues like upset stomach, diarrhea, constipation, and gas. Headache, nausea, and fatigue may also occur.
Q3: What are the contraindications?
A: This combination should be avoided in individuals with hypercalcemia, hypervitaminosis D, severe renal impairment, hypercalciuria, and hypermagnesemia.
Q4: Can pregnant or breastfeeding women take this combination?
A: Consult a doctor before using it during pregnancy or while breastfeeding. Use only if clearly needed and with careful monitoring.
Q5: How does this combination interact with other medications?
A: It can interact with various drugs, including steroids, anticonvulsants, antibiotics, anticoagulants, and thyroid medication. A complete medication history is essential.
Q6: Are there any dietary restrictions while taking this supplement?
A: Foods like spinach, rhubarb, bran, and whole grains can decrease calcium absorption. Consult a doctor or dietitian for dietary recommendations.
Q7: What should be monitored while on this medication?
A: Monitoring serum calcium, magnesium, phosphate, vitamin D levels, and renal function is important, especially during the initial phase of treatment.
Q8: What if I miss a dose?
A: If a dose is missed, take it as soon as remembered. However, if it’s close to the next dose, skip the missed dose and resume the regular schedule. Do not double the dose.
Q9: How should this supplement be stored?
A: Store in a cool, dry, and dark place, away from direct sunlight and moisture, preferably below 25°C. Keep out of the reach of children.