Calcitriol + Calcium Citrate Malate + Magnesium + Vitamin K2-7

Usage

This combination medication is primarily prescribed for the prevention and treatment of calcium and vitamin D deficiencies. It is also used in conditions like osteoporosis, osteomalacia, and hypoparathyroidism. It supports bone health, enhances calcium absorption, and promotes bone mineralization. It aids in regulating calcium levels and reducing fracture risk. It may also be prescribed to dialysis patients for renal osteodystrophy and secondary hyperparathyroidism.

• Pharmacological Classification: Vitamin and Mineral Supplement

• Mechanism of Action: This combination works synergistically to improve calcium homeostasis and bone health. Calcitriol, the active form of vitamin D3, increases intestinal calcium absorption and regulates calcium and phosphate levels. Calcium citrate malate provides a readily absorbable form of calcium, essential for bone mineralization. Magnesium plays a role in numerous enzymatic reactions, including those involved in bone formation. Vitamin K2-7 (menaquinone-7) activates osteocalcin, a protein that helps incorporate calcium into bones.

Alternate Names

There are no officially recognized alternate names for this specific combination. However, it may be referred to by different names based on specific brand formulations or regional variations.

• Brand Names: Several brand names market this combination with slight variations in composition. Some examples include (but are not limited to): Bonetuf, Strongcal-CM, Calday-C, Calwart K2, Glocal K2, and Z-Care-K2. Please note that formulations may differ slightly, so always refer to the specific product information.

How It Works

• Pharmacodynamics: Calcitriol binds to vitamin D receptors, increasing intestinal calcium and phosphate absorption and regulating bone metabolism. Calcium is crucial for bone mineralization, muscle function, and nerve transmission. Magnesium is a cofactor for enzymes involved in bone formation and many other physiological processes. Vitamin K2-7 activates osteocalcin, which binds calcium to the bone matrix, enhancing bone mineralization and reducing vascular calcification.

• Pharmacokinetics:

  • Absorption: Calcium citrate malate is well-absorbed orally. Calcitriol is absorbed in the small intestine. Magnesium absorption occurs in the small intestine and colon. Vitamin K2-7 is absorbed in the presence of dietary fats.
  • Metabolism: Calcitriol undergoes further hydroxylation in the kidney to its most active form. Magnesium is not extensively metabolized. Vitamin K2-7 is metabolized in the liver.
  • Elimination: Calcitriol is primarily excreted in bile and feces. Calcium is excreted through urine and feces. Magnesium is primarily excreted in urine. Vitamin K2-7 is eliminated through bile and urine.

Dosage

Dosage guidelines for this combination are not standardized and can vary significantly based on individual patient needs, the specific product formulation, and the treating physician’s judgment.

Standard Dosage

Adults: A common dosage is one tablet or capsule daily, typically taken with food. However, this can vary, and some formulations recommend two doses per day. The maximum daily dosage should not exceed the upper tolerable intake limits for individual components, particularly vitamin D and calcium.

Children: Pediatric dosing is not standardized and requires careful consideration of age, weight, and specific deficiencies. Always consult a pediatrician for appropriate pediatric dosing.

Special Cases:

• Elderly Patients: Dose adjustments may be necessary depending on renal function and other comorbidities.

• Patients with Renal Impairment: Careful dose adjustment is crucial due to altered calcium and vitamin D metabolism. Close monitoring of serum calcium, phosphate, and creatinine is essential.

• Patients with Hepatic Dysfunction: Dose modifications may be needed in severe hepatic impairment.

• Patients with Comorbid Conditions: Patients with conditions like sarcoidosis, hyperparathyroidism, or history of kidney stones require careful monitoring.

Clinical Use Cases

The specific use of this combination in acute clinical settings like intubation, surgery, mechanical ventilation, ICU, or emergency situations would be highly individualized and dependent on the specific patient’s needs and deficiencies. It is not routinely used in these acute settings.

Dosage Adjustments

Dosage adjustments are necessary based on serum calcium, phosphate, magnesium, and vitamin D levels. Genetic polymorphisms affecting drug metabolism are not routinely considered for this combination.

Side Effects

Common Side Effects:

Constipation, stomach upset, nausea, vomiting, loss of appetite, weakness, tiredness, headache, hypercalcemia (high calcium levels), hypercalciuria (high calcium in urine).

Rare but Serious Side Effects:

Hypercalcemia leading to kidney stones, abnormal heart rhythms, and confusion.

Long-Term Effects:

Potential for kidney stones with prolonged excessive calcium intake.

Adverse Drug Reactions (ADR):

Severe hypercalcemia requiring immediate medical intervention.

Contraindications

• Hypercalcemia
• Hypervitaminosis D
• Hyperparathyroidism
• Kidney stones
• Hypersensitivity to any component of the formulation

Drug Interactions

• Thiazide diuretics (e.g., hydrochlorothiazide)
• Corticosteroids (e.g., prednisone)
• Digoxin
• Bile acid sequestrants (e.g., cholestyramine)
• Lipid-lowering agents (e.g., orlistat)
• Anticonvulsants (e.g., phenytoin, phenobarbital)
• Antibiotics (e.g., tetracyclines, quinolones)
• Iron supplements
• Thyroid medications (e.g., levothyroxine)
• Foods high in oxalates or phytates (may reduce calcium absorption)

Pregnancy and Breastfeeding

Consult with a healthcare provider before use during pregnancy or breastfeeding. While generally considered safe at recommended doses, potential fetal risks and neonatal exposure should be carefully evaluated.

Drug Profile Summary

• Mechanism of Action: Enhances calcium absorption, promotes bone mineralization, regulates calcium and phosphate homeostasis.
• Side Effects: Constipation, stomach upset, nausea, hypercalcemia.
• Contraindications: Hypercalcemia, hypervitaminosis D, kidney stones.
• Drug Interactions: Thiazide diuretics, corticosteroids, digoxin.
• Pregnancy & Breastfeeding: Consult a healthcare provider.
• Dosage: Varies; typically one tablet or capsule daily.
• Monitoring Parameters: Serum calcium, phosphate, creatinine, vitamin D levels.

Popular Combinations

This combination itself is a popular combination. Adding other vitamins and minerals, like vitamin D3, methylcobalamin (vitamin B12), zinc, or L-methylfolate, is sometimes seen in commercial formulations.

Precautions

• Assess for pre-existing hypercalcemia, hypervitaminosis D, or kidney stones.
• Monitor renal function, especially in patients with kidney disease.
• Caution in pregnancy and breastfeeding.
• Adjust dose in renal impairment.
• Limit alcohol intake.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Calcitriol + Calcium Citrate Malate + Magnesium + Vitamin K2-7?

A: The dosage varies depending on individual patient needs and product formulation. A common dosage is one tablet or capsule daily with food, but some formulations recommend twice-daily dosing. Consult the specific product information and physician recommendations.

Q2: What are the common side effects?

A: Common side effects include constipation, stomach upset, nausea, and headache.

Q3: Who should not take this combination?

A: Individuals with hypercalcemia, hypervitaminosis D, or kidney stones should not take this combination.

Q4: Can this combination be taken during pregnancy or breastfeeding?

A: Consult a healthcare provider before use during pregnancy or breastfeeding.

Q5: What are the signs of hypercalcemia?

A: Signs of hypercalcemia include nausea, vomiting, constipation, confusion, muscle weakness, and increased thirst.

Q6: How does this combination interact with other medications?

A: This combination can interact with several medications, including thiazide diuretics, corticosteroids, and digoxin. Consult your physician about potential drug interactions.

Q7: Are there any dietary restrictions while taking this medication?

A: Limit foods high in oxalates and phytates, as they may reduce calcium absorption.

Q8: What are the monitoring parameters for this combination?

A: Monitor serum calcium, phosphate, creatinine, and vitamin D levels regularly, especially in patients with renal impairment.

Q9: What is the role of each component in bone health?

A: Calcitriol improves calcium absorption, calcium strengthens bones, magnesium aids in bone formation enzymes, and vitamin K2-7 directs calcium to the bones.