Calcitriol + Calcium citrate + L-Methyl Folate + Magnesium Oxide + Methylcobalamin + Vitamin K2-7 + Zinc Oxide

Usage

This combination medication is primarily prescribed for the treatment and prevention of nutritional deficiencies, particularly those related to bone health, calcium absorption, and overall metabolic function. It is commonly used in conditions like:

• Vitamin D deficiency: Calcitriol, the active form of vitamin D3, addresses this deficiency directly.
• Hypocalcemia: Calcium citrate helps restore normal calcium levels.
• Osteoporosis and Osteomalacia (Rickets): The combination supports bone health and density, reducing fracture risk.
• Hypoparathyroidism: Calcitriol helps regulate calcium and phosphorus levels in patients with underactive parathyroid glands.
• Postmenopausal Osteoporosis: The combination is frequently prescribed to mitigate bone loss in postmenopausal women.
• Nutritional Deficiencies: This combination addresses deficiencies in Vitamin D, calcium, magnesium, zinc, vitamin K2-7, methylcobalamin (vitamin B12), and L-methylfolate (vitamin B9).

Pharmacological Classification: This is a combination of vitamins, minerals, and a vitamin D hormone analog. It doesn’t fit neatly into a single pharmacological class, as it encompasses multiple therapeutic actions. It could be considered a bone health agent, calcium regulator, and nutritional supplement.

Mechanism of Action: This combination works synergistically to achieve several effects:

• Calcitriol increases calcium absorption in the intestines and kidneys, regulates calcium and phosphate homeostasis, and supports bone mineralization.
• Calcium Citrate provides a readily absorbable source of calcium to support bone health.
• Vitamin K2-7 helps direct calcium to the bones and prevents its deposition in arteries.
• Methylcobalamin supports nerve function and red blood cell production.
• Zinc Oxide and Magnesium Oxide play vital roles in immune function, enzyme activity, and protein synthesis.
• L-methylfolate is crucial for DNA synthesis and red blood cell formation.

Alternate Names

There is no single official alternate name for this specific multi-nutrient combination. The name is usually derived from the individual ingredients listed. Different pharmaceutical companies market this combination under various brand names, some examples include:

• Acro D3 Strong Softgel Capsule
• Boncal Super Tablets
• Semitrol-K27 Softgel Capsule
• Osteo Plus Soft Gelatin Capsule

How It Works

Pharmacodynamics: This combination exerts its effects through a variety of mechanisms. Calcitriol binds to vitamin D receptors, modulating gene expression to increase calcium absorption in the intestines and kidneys, and also impacting bone metabolism. Calcium citrate provides the necessary building blocks for bone mineralization. Vitamin K2-7 activates osteocalcin, a protein crucial for bone formation, while also inhibiting arterial calcification. Methylcobalamin acts as a cofactor for various enzymes involved in nerve function and red blood cell production. Zinc and magnesium are essential cofactors for numerous enzymes involved in a wide range of metabolic processes. L-methylfolate is the active form of folic acid, crucial for DNA synthesis and red blood cell maturation.

Pharmacokinetics:

• Absorption: Calcitriol and vitamin K2-7 are fat-soluble and are absorbed along with dietary fats. Calcium citrate absorption can vary depending on factors like stomach acid and vitamin D levels. The other components are generally well-absorbed.
• Metabolism: Calcitriol is metabolized in the liver and kidneys. Methylcobalamin is converted into its active coenzyme forms within cells. The other components undergo minimal metabolism.
• Elimination: Calcitriol metabolites are primarily excreted in bile and feces, with some renal excretion. Excess calcium is eliminated through the kidneys. The other components have varied elimination pathways, mostly renal.

Mode of Action (Cellular/Molecular): Calcitriol’s action is primarily genomic, binding to intracellular receptors that regulate gene transcription. Calcium citrate acts as a source of calcium ions for cellular processes and bone mineralization. Vitamin K2-7 post-translationally modifies osteocalcin and matrix Gla protein, impacting calcium deposition. Methylcobalamin acts as a coenzyme for methionine synthase and methylmalonyl-CoA mutase. Zinc and magnesium are cofactors for numerous enzymes. L-methylfolate participates in one-carbon metabolism and nucleotide synthesis.

Receptor binding/Enzyme inhibition/Neurotransmitter Modulation: Calcitriol binds to vitamin D receptors. Vitamin K2-7 does not directly inhibit enzymes but modifies proteins that influence calcium binding. Methylcobalamin modulates enzymatic activity.

Dosage

Dosage is highly dependent on individual patient needs, the specific formulation, and the targeted deficiency. Consulting the product information and a physician is crucial for appropriate dosing.

Standard Dosage

Adults: Common regimens range from one tablet or capsule once or twice daily, usually taken with meals to improve absorption and minimize gastrointestinal discomfort. Some formulations may have different dosages depending on the concentrations of ingredients.

Children: Dosage in children should be determined by a pediatrician based on the child’s age, weight, and specific needs.

Special Cases:

• Elderly Patients: Dose adjustments may be necessary based on kidney function and other age-related physiological changes.
• Patients with Renal Impairment: Careful dose adjustments are crucial due to altered calcitriol metabolism and calcium excretion.
• Patients with Hepatic Dysfunction: Dose adjustments may be needed for patients with severe liver disease due to calcitriol metabolism occurring in the liver.
• Patients with Comorbid Conditions: Patients with certain conditions (e.g., sarcoidosis, hypercalcemia, hypervitaminosis D) may require specific monitoring and dosage adjustments.

Clinical Use Cases

The combination isn’t specifically dosed differently for clinical procedures like intubation, surgical procedures, mechanical ventilation, or ICU use. Dosages are adjusted based on individual patient needs and underlying deficiencies, which may be more prevalent in critically ill patients.

Dosage Adjustments

Dose modifications should be considered for renal or hepatic dysfunction, hypercalcemia, hypervitaminosis D, and any condition affecting the metabolism of the individual components. Genetic polymorphisms affecting drug metabolism are not typically considered for this combination.

Side Effects

Common Side Effects:

• Gastrointestinal upset (nausea, vomiting, constipation, diarrhea, abdominal pain)
• Headache
• Increased thirst
• Gas and bloating

Rare but Serious Side Effects:

• Hypercalcemia (high blood calcium levels) - can lead to serious complications if not addressed promptly.
• Allergic reactions (rash, itching, swelling, difficulty breathing).

Long-Term Effects: Long-term inappropriate use (particularly excessive doses of vitamin D and calcium) can contribute to kidney stones or other calcium-related complications.

Adverse Drug Reactions (ADR): Serious ADRs are uncommon but can include hypercalcemia and allergic reactions, requiring immediate medical intervention.

Contraindications

• Hypersensitivity to any of the components
• Hypercalcemia
• Hypercalciuria
• Hypervitaminosis D
• Severe renal impairment
• Certain metabolic bone diseases

Drug Interactions

• Thiazide diuretics: May increase calcium levels.
• Digoxin: Calcium can potentiate digoxin toxicity.
• Corticosteroids: May reduce calcium absorption.
• Bile acid sequestrants: May reduce vitamin D and K absorption.
• Some antibiotics (tetracyclines, quinolones): May chelate with calcium and reduce absorption.
• Antacids containing aluminum or magnesium: May interfere with calcium absorption.

Pregnancy and Breastfeeding

The safety of this specific combination during pregnancy and breastfeeding hasn’t been fully established. Individual component risks and benefits should be assessed by a physician. Pregnant or breastfeeding women should consult their doctor before using this combination.

Drug Profile Summary

See previous sections for details.

Popular Combinations

This combination itself is a popular one. Additional ingredients like Omega-3 fatty acids, Boron, Lycopene, and additional folic acid are sometimes added for broader nutritional support.

Precautions

• Pre-screening for pre-existing conditions like hypercalcemia, hypervitaminosis D, renal impairment, and hypersensitivity is essential.
• Monitor calcium, phosphate, and vitamin D levels.
• Evaluate medication history for potential drug interactions.
• Caution advised for pregnant and breastfeeding women.
• Dosage adjustments may be needed in elderly patients and those with renal or hepatic impairment.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for this combination?

A: Dosage varies widely based on the specific product and individual patient needs. Consult the product information and a physician. A common regimen is one tablet or capsule once or twice daily, usually with meals.

Q2: Can this combination be used during pregnancy and breastfeeding?

A: Consult a physician before use during pregnancy or breastfeeding. While the individual components are often necessary, the safety of this specific combination hasn’t been definitively established.

Q3: What are the common side effects?

A: Common side effects are generally mild and may include gastrointestinal issues (nausea, vomiting, constipation, diarrhea, abdominal pain), headache, increased thirst, and gas.

Q4: Are there any serious side effects?

A: Hypercalcemia and allergic reactions are rare but serious side effects. Seek immediate medical attention if these occur.

Q5: What are the contraindications for this combination?

A: Contraindications include hypersensitivity, hypercalcemia, hypercalciuria, hypervitaminosis D, severe renal impairment, and some metabolic bone diseases.

Q6: Does this combination interact with other medications?

A: Yes, it can interact with thiazide diuretics, digoxin, corticosteroids, bile acid sequestrants, some antibiotics (tetracyclines and quinolones), and antacids.

Q7: How should this combination be stored?

A: Store in a cool, dry place, away from direct sunlight, typically below 25°C or as directed on the product label.

Q8: What should I do if I miss a dose?

A: If a dose is missed, take it as soon as remembered, unless it’s close to the next scheduled dose. Do not double the dose to catch up.

Q9: Can this combination be used in children?

A: Consult a pediatrician for appropriate dosing and safety considerations in children.

Q10: How does this combination differ from taking individual supplements?

A: This combination provides a convenient way to address multiple nutritional deficiencies simultaneously. However, it’s crucial to ensure the dosage of each component aligns with individual patient needs, which may be better addressed through individualized supplementation in some cases.

Please note that this information is intended for qualified Indian doctors and healthcare professionals. It is essential to refer to the specific product information and consult with a physician for appropriate patient care.