Usage
This combination medication is prescribed for the management of conditions related to calcium deficiency and bone health. These include:
- Osteoporosis: A condition characterized by weak and brittle bones.
- Osteomalacia/Rickets: Softening of the bones due to vitamin D deficiency.
- Hypoparathyroidism: A condition in which the parathyroid glands do not produce enough parathyroid hormone, leading to low calcium levels.
- Hypocalcemia: Low calcium levels in the blood, which can occur in patients with chronic renal failure or after small bowel resection.
- Prevention of Osteoporosis: It can be prescribed to individuals at risk of developing osteoporosis.
Pharmacological Classification:
This drug is classified as a combination of:
- Calcium Supplement: Calcium carbonate is a mineral supplement.
- Vitamin D Analog: Calcitriol is the active form of vitamin D.
- Mineral Supplement: Zinc sulfate is a mineral supplement.
Mechanism of Action:
This combination works by:
- Increasing Calcium Absorption: Calcitriol enhances calcium absorption from the intestine.
- Supplementing Calcium Levels: Calcium carbonate provides a direct source of calcium to increase blood calcium levels.
- Enhancing bone mineralization: Zinc sulfate is involved in bone mineralization and plays a role in immune function. Calcitriol also helps to preserve bone health and improves muscle strength, which reduces the risk of falls.
Alternate Names
This combination medication does not have a universally recognized international nonproprietary name (INN). It is often referred to by the names of its components.
Brand Names: Several brand names exist depending on the manufacturer and region. Some examples include:
How It Works
Pharmacodynamics:
Calcitriol, the active form of vitamin D3, increases calcium and phosphate absorption from the gastrointestinal tract. It also regulates bone metabolism, stimulating bone formation and mineralization. Calcium carbonate directly supplements calcium levels, and zinc sulphate is essential for the activity of many enzymes. It is involved in protein synthesis and carbohydrate metabolism. It helps to maintain the integrity of the skin and plays a role in immune function.
Pharmacokinetics:
- Calcitriol: Administered orally, absorbed in the small intestine. Metabolized in the liver and kidneys. Excreted mainly in bile and feces, with a small amount eliminated in urine.
- Calcium Carbonate: Absorbed from the small intestine, requires vitamin D for optimal absorption. Excreted primarily through feces and urine.
- Zinc Sulfate: Absorbed in the small intestine. Excreted primarily in feces.
Dosage
Standard Dosage
Adults:
One capsule/tablet once or twice daily. The optimal daily dose needs to be determined individually based on serum calcium levels and patient response.
Children:
Dosage should be individualized based on age, weight, and the specific condition being treated. Pediatric safety considerations include careful monitoring of serum calcium levels due to the risk of hypercalcemia with calcitriol.
Special Cases:
- Elderly Patients: Dose adjustments may be necessary based on renal function and concomitant conditions.
- Patients with Renal Impairment: Close monitoring of serum calcium and phosphate levels is essential. Dose reduction or less frequent administration may be required.
- Patients with Hepatic Dysfunction: Caution is advised, and dose adjustment may be necessary.
- Patients with Comorbid Conditions: Dosage should be individualized based on specific comorbidities.
Clinical Use Cases
The provided sources do not specify dosages for intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. The standard dosage recommendations should be followed, with careful monitoring and adjustments as necessary based on the patient’s condition and response.
Dosage Adjustments
Dose modifications should be considered for renal/hepatic dysfunction, metabolic disorders, or genetic polymorphisms affecting drug metabolism. Close monitoring of serum calcium levels is essential for appropriate dosage adjustments.
Side Effects
Common Side Effects:
- Constipation
- Stomach upset
- Nausea
- Vomiting
- Headache
- Weakness
- Increased thirst
- Dry mouth
- Metallic taste
- Bone/muscle pain
Rare but Serious Side Effects:
- Hypercalcemia (high blood calcium levels) with symptoms such as nausea, vomiting, constipation, muscle weakness, confusion, and cardiac arrhythmias.
- Hypervitaminosis D (high vitamin D levels)
- Kidney stones
- Allergic reactions
Long-Term Effects:
Long-term excessive intake can lead to hypercalcemia, kidney stones, and other complications.
Adverse Drug Reactions (ADR):
Clinically significant ADRs include hypercalcemia, hypervitaminosis D, and allergic reactions, which require immediate intervention.
Contraindications
- Hypercalcemia
- Hypervitaminosis D
- Vitamin D toxicity
- Hypersensitivity to any of the components
- Severe renal impairment
- Kidney stones (in some cases)
Drug Interactions
- Thiazide diuretics
- Digoxin
- Cholestyramine
- Ketoconazole
- Phenytoin or phenobarbital
- Corticosteroids
- Phosphate binders (e.g., sevelamer, calcium acetate)
- Magnesium-containing antacids or supplements
- Food and lifestyle factors (alcohol, caffeine, soft drinks may affect Calcium absorption.)
Pregnancy and Breastfeeding
Calcitriol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. As calcitriol passes into breast milk, it is recommended to consult with a doctor before using this medication while breastfeeding. Higher doses of vitamin D than the recommended daily allowance during pregnancy should only be used under medical supervision.
Drug Profile Summary
- Mechanism of Action: Enhances calcium absorption, supplements calcium levels, regulates bone metabolism.
- Side Effects: Constipation, nausea, headache, hypercalcemia, hypervitaminosis D.
- Contraindications: Hypercalcemia, hypervitaminosis D, hypersensitivity.
- Drug Interactions: Thiazide diuretics, digoxin, cholestyramine, ketoconazole.
- Pregnancy & Breastfeeding: Use with caution if benefits outweigh risks.
- Dosage: Adult: One capsule/tablet once or twice daily. Pediatric: individualized.
- Monitoring Parameters: Serum calcium, phosphate, creatinine, and vitamin D levels.
Popular Combinations
This combination itself is a popular combination, especially for managing osteoporosis and calcium deficiency.
Precautions
- General Precautions: Monitor serum calcium and vitamin D levels, assess renal function.
- Specific Populations: As mentioned above.
- Lifestyle Considerations: Limit alcohol, caffeine, and soft drinks.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Calcitriol + Calcium Carbonate + Zinc Sulfate?
A: The standard adult dosage is one capsule/tablet once or twice daily. However, the optimal dose should be determined individually based on the patient’s specific condition, serum calcium levels, and response to treatment. Pediatric and special population dosing require adjustments as described above.
Q2: What are the common side effects?
A: Common side effects include constipation, stomach upset, nausea, vomiting, headache, and weakness.
Q3: What are the serious side effects?
A: Serious side effects can include hypercalcemia, hypervitaminosis D, and allergic reactions.
Q4: What are the contraindications?
A: Contraindications include hypercalcemia, hypervitaminosis D, vitamin D toxicity, and hypersensitivity to any components.
Q5: How does this combination interact with other medications?
A: It can interact with several medications, including thiazide diuretics, digoxin, cholestyramine, and ketoconazole. A full list is mentioned above.
Q6: Can this combination be used during pregnancy and breastfeeding?
A: Use during pregnancy and breastfeeding should be considered only if the potential benefits outweigh the risks. Consult a doctor before use.
Q7: How should I monitor a patient taking this medication?
A: Monitor serum calcium, phosphate, creatinine, and vitamin D levels regularly, especially during initial dose titration.
Q8: What should patients do if they miss a dose?
A: If a dose is missed, take it as soon as remembered, unless it is close to the time for the next dose. Do not double the dose.
Q9: What are the long-term implications of taking this medication?
A: Long-term use, especially at high doses, may increase the risk of hypercalcemia and kidney stones. Regular monitoring is crucial.
