Usage
This combination medication is prescribed to prevent or treat calcium and vitamin D deficiencies, often during pregnancy, lactation, and childhood growth stages. It’s also used to address conditions arising from low calcium levels, such as osteoporosis (weakened bones), osteomalacia/rickets (soft bones), hypoparathyroidism (low parathyroid hormone), and latent tetany (muscle disease). This drug falls under the pharmacological classification of nutritional supplements and bone health agents.
The mechanism of action involves providing supplemental calcium necessary for bone health, while vitamin D3 facilitates calcium absorption and phosphorus regulation for enhanced bone mineralization. Folic acid plays a vital role in cell growth and division, especially crucial during pregnancy for fetal development and red blood cell formation.
Alternate Names
While the generic name is Calcium Citrate Malate + Folic Acid + Vitamin D3, no widely recognized alternate or international names exist. Brand names can vary regionally; examples include CCM Tablets and Adorcal CC Tablets.
How It Works
Pharmacodynamics: Calcium is vital for bone structure, nerve function, and muscle contraction. Vitamin D3 promotes calcium and phosphorus absorption in the gut, essential for bone mineralization and calcium homeostasis. Folic acid is a cofactor in DNA synthesis and crucial for cell growth, especially during rapid cell division like in pregnancy.
Pharmacokinetics: Calcium citrate malate is absorbed in the intestines, influenced by vitamin D3. It’s primarily excreted through the kidneys. Vitamin D3 is absorbed in the gut and undergoes hepatic and renal metabolism. Folic acid is absorbed in the small intestine and metabolized in the liver.
Mode of Action: Calcium strengthens bones. Vitamin D3 enhances calcium and phosphorus absorption, affecting gene transcription related to calcium transport. Folic acid acts as a cofactor for enzymes involved in DNA and amino acid synthesis.
Receptor Binding/Enzyme Inhibition: Vitamin D3 binds to vitamin D receptors, influencing gene expression. Folic acid interacts with enzymes in nucleotide synthesis.
Elimination Pathways: Calcium primarily undergoes renal excretion. Vitamin D3 is metabolized in the liver and kidneys and excreted in bile and urine. Folic acid is eliminated through renal and hepatic pathways.
Dosage
Standard Dosage
Adults:
Two tablets twice daily with meals.
Children:
Two tablets per day, administered in a single dose or divided doses. Consider the child’s ability to swallow tablets, particularly for younger children.
Special Cases:
- Elderly Patients: Similar to adult dosing, monitor for potential gastrointestinal side effects and adjust if needed.
- Patients with Renal Impairment: Contraindicated in severe renal impairment and renal failure.
- Patients with Hepatic Dysfunction: No specific dose adjustments required. Monitor closely for liver related issues.
- Patients with Comorbid Conditions: Caution advised for patients with heart disease, sarcoidosis, hypercalcemia, or hypervitaminosis D. Monitor regularly.
Clinical Use Cases
The provided sources primarily focus on general calcium and vitamin D supplementation and do not specify dosages for clinical use cases like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. In such situations, clinicians should consult specialist guidelines and consider patient-specific factors.
Dosage Adjustments
Dose adjustments are based on renal function, primarily. No adjustments are typically needed for hepatic impairment. Monitor serum calcium levels regularly, especially during long-term therapy.
Side Effects
Common Side Effects
Constipation, stomach upset, nausea, vomiting, loss of appetite, flatulence, abdominal pain, and diarrhea.
Rare but Serious Side Effects
Hypercalcemia, mental/mood changes, allergic reactions, and kidney stones.
Long-Term Effects
Kidney stones, hypercalcemia, and potential drug interactions with prolonged use.
Adverse Drug Reactions (ADR)
Severe allergic reactions, hypercalcemic crisis, and acute kidney injury.
Contraindications
Hypercalcemia, hypercalciuria, nephrocalcinosis, nephrolithiasis, hypervitaminosis D, severe renal impairment, renal failure, milk-alkali syndrome, and hypersensitivity to any components.
Drug Interactions
Tetracycline antibiotics, bisphosphonates (alendronate), estramustine, levothyroxine, quinolone antibiotics, digoxin, phosphate binders, phenytoin, barbiturates, antiepileptics, thiazide diuretics, antifungals (ketoconazole, itraconazole), glucocorticoids, and other calcium or vitamin D supplements. Food interactions may also occur; take calcium with food to enhance absorption, but avoid concomitant administration with iron supplements due to reduced iron absorption.
Pregnancy and Breastfeeding
Generally considered safe during pregnancy and breastfeeding when taken as directed. Adequate calcium and vitamin D intake are important during these periods. Excessive vitamin D should be avoided. Folic acid is particularly important for neural tube development in early pregnancy.
Drug Profile Summary
- Mechanism of Action: Calcium supports bone health, vitamin D3 facilitates calcium absorption, folic acid aids cell development.
- Side Effects: Constipation, stomach upset, nausea, hypercalcemia.
- Contraindications: Hypercalcemia, renal failure, hypersensitivity.
- Drug Interactions: Several drug interactions; see detailed section.
- Pregnancy & Breastfeeding: Generally safe; folic acid supplementation crucial.
- Dosage: Adults: Two tablets twice daily; Children: Two tablets daily; adjust for renal impairment.
- Monitoring Parameters: Serum calcium levels, renal function.
Popular Combinations
This combination itself is a popular one. Individual components may be combined with other medications depending on the specific clinical need, for instance, calcium with other bone health agents or folic acid with other prenatal vitamins.
Precautions
- General Precautions: Assess for allergies, pre-existing conditions, and concomitant medications. Monitor serum calcium and renal function.
- Specific Populations: Pregnant/breastfeeding women: Monitor vitamin D intake; Children/Elderly: Adjust dose as needed; Renal/hepatic impairment: Exercise caution.
- Lifestyle Considerations: Limit alcohol, avoid smoking.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Calcium Citrate Malate + Folic Acid + Vitamin D3?
A: Adults: Two tablets twice daily with meals. Children: Two tablets daily, in single or divided doses. Adjust for renal impairment.
Q2: Can this combination be used during pregnancy?
A: Yes, it’s generally safe and often beneficial for both maternal and fetal health. Folic acid is crucial for preventing neural tube defects. Avoid excessive vitamin D.
Q3: What are the most common side effects?
A: Constipation, stomach upset, nausea, and loss of appetite are common.
Q4: Are there any serious side effects to watch out for?
A: Rarely, hypercalcemia, mental/mood changes, or allergic reactions can occur. Seek medical attention if these happen.
Q5: What are the contraindications for this combination?
A: Hypercalcemia, severe renal impairment, renal failure, hypervitaminosis D, and hypersensitivity are contraindications.
Q6: Does this medication interact with other drugs?
A: Yes, several significant drug interactions exist. Refer to the detailed “Drug Interactions” section.
Q7: Should this combination be taken with food?
A: Yes, taking calcium with food can improve its absorption. However, avoid concomitant administration with iron supplements.
Q8: How should I monitor patients on this medication?
A: Monitor serum calcium levels and renal function, especially during long-term use. Watch for signs of hypercalcemia and other adverse effects.
Q9: Can I prescribe this combination to a patient with liver disease?
A: No specific dose adjustment is required for hepatic dysfunction, but close monitoring is necessary.
