Usage
This combination medication is primarily prescribed for the prevention and treatment of calcium and vitamin D deficiencies. It is also used in the management of conditions like:
- Postmenopausal osteoporosis: A condition characterized by weakened and brittle bones due to decreased bone density, common in women after menopause.
- 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.
- Renal osteodystrophy: Bone disease that occurs in people with chronic kidney disease.
- Nutritional deficiencies: To supplement dietary intake of calcium, vitamin D, vitamin K2-7, and zinc.
Pharmacological Classification: Vitamin and mineral supplement.
Mechanism of Action: This combination drug works synergistically to improve bone health. Calcitriol, the active form of vitamin D3, increases calcium absorption in the gut and regulates calcium and phosphate homeostasis. Calcium citrate malate provides a readily absorbable form of calcium, essential for bone mineralization. Vitamin K2-7 activates osteocalcin, a protein that helps incorporate calcium into the bones. Zinc oxide plays a supporting role in bone metabolism and enzyme function related to bone health.
Alternate Names
There are no officially recognized alternate names for this specific combination drug. However, it may be referred to by various brand names depending on the manufacturer.
Brand Names: Some examples of brand names include (this list may not be exhaustive and can vary by region):
- Avical
- Bonultra
- Calfirm Plus
- Nigcium
- Drocal Ct
- Xtracal Ct
- Venocal
- Z-CARE-K2
How It Works
Pharmacodynamics: Calcitriol binds to vitamin D receptors in the intestine, kidneys, and bone, promoting calcium absorption and regulating calcium and phosphate homeostasis. Vitamin K2-7 activates osteocalcin, which facilitates bone mineralization. Zinc supports enzyme function related to bone health. Calcium citrate malate provides a source of calcium for bone formation.
Pharmacokinetics:
- Absorption: Calcium citrate malate is absorbed in the gut. Calcitriol and Vitamin K2-7 are also absorbed through the intestines. Zinc is absorbed and distributed throughout the body.
- Metabolism: Calcitriol undergoes hepatic metabolism. Vitamin K2-7 is also metabolized in the liver.
- Elimination: Calcium is primarily excreted renally. Calcitriol metabolites are excreted in bile and urine. Vitamin K2-7 metabolites are also excreted through the biliary and renal routes. Zinc is mainly excreted in feces.
Mode of Action: Calcitriol modulates gene transcription by binding to vitamin D receptors. Vitamin K2-7 activates osteocalcin through carboxylation. Zinc acts as a cofactor for enzymes involved in bone metabolism.
Dosage
Standard Dosage
Dosage recommendations can vary depending on the specific product and individual patient needs. It’s crucial to follow the prescribing physician’s instructions.
Adults:
A typical dose might involve one or two capsules or tablets per day, usually taken with or after meals to enhance absorption and reduce gastrointestinal discomfort. However, the exact dose and frequency should be determined by a physician based on the patient’s specific condition and response to therapy.
Children:
Dosage in children must be carefully determined by a physician and will depend on factors such as age, weight, and the specific condition being treated. Pediatric safety and efficacy should be closely monitored.
Special Cases:
- Elderly Patients: Dose adjustments may be necessary based on kidney function and other comorbid conditions. Close monitoring of calcium levels is important.
- Patients with Renal Impairment: Dose modification is crucial, with careful consideration of creatinine clearance.
- Patients with Hepatic Dysfunction: Dose adjustments may be required. Close monitoring of calcium levels is recommended.
- Patients with Comorbid Conditions: Dosage adjustments may be needed in patients with conditions like diabetes, cardiovascular disease, or other relevant medical issues.
Clinical Use Cases
The combination of Calcitriol + Calcium Citrate Malate + Vitamin K2-7 + Zinc Oxide is not typically indicated for acute clinical situations like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Its primary use is in the long-term management of conditions related to calcium and vitamin D deficiency and bone health.
Dosage Adjustments
Dose modifications are often based on serum calcium and phosphate levels, renal function, and individual patient response to therapy. Monitoring of serum calcium, phosphorus, parathyroid hormone (PTH), and creatinine clearance is essential.
Side Effects
Common Side Effects:
- Gastrointestinal upset (constipation, diarrhea, gas, nausea, stomach upset)
- Headache
- Fatigue
- Dry mouth
Rare but Serious Side Effects:
- Hypercalcemia (high calcium levels): symptoms may include increased thirst, increased urination, nausea, vomiting, confusion, unusual weakness or fatigue, bone pain.
- Allergic reactions: Symptoms may include rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
Long-Term Effects:
With appropriate monitoring and dosage adjustment, long-term adverse effects are rare. However, chronic hypercalcemia can lead to kidney stones and other complications.
Adverse Drug Reactions (ADR):
Clinically significant ADRs primarily involve hypercalcemia and hypersensitivity reactions. These require prompt medical attention.
Contraindications
- Hypercalcemia
- Hypercalciuria
- Hypervitaminosis D
- Metastatic calcification
- Hypersensitivity to any component of the formulation
- Severe renal impairment
Drug Interactions
- Thiazide diuretics
- Digoxin
- Corticosteroids
- Phosphate binders
- Antacids containing magnesium or aluminum
- Certain antibiotics (tetracyclines, quinolones)
- Anticonvulsants (phenytoin, phenobarbital)
- Cholesterol-lowering medications (cholestyramine)
- Iron supplements
- Thyroid medications (levothyroxine)
Pregnancy and Breastfeeding
Use during pregnancy and breastfeeding should be under strict medical supervision and only if clearly necessary. The potential risks and benefits should be carefully weighed. Consult a physician for guidance. The FDA pregnancy safety category is not specifically assigned for this combination product.
Drug Profile Summary
- Mechanism of Action: Calcitriol enhances calcium absorption and regulates calcium and phosphate homeostasis. Vitamin K2-7 activates osteocalcin, promoting bone mineralization. Zinc supports enzyme function related to bone health.
- Side Effects: Common side effects include gastrointestinal issues, headache, fatigue, and dry mouth. Serious side effects include hypercalcemia and allergic reactions.
- Contraindications: Contraindicated in hypercalcemia, hypercalciuria, hypervitaminosis D, metastatic calcification, hypersensitivity, and severe renal impairment.
- Drug Interactions: Interacts with various drugs, including thiazide diuretics, digoxin, corticosteroids, and certain antibiotics.
- Pregnancy & Breastfeeding: Use with caution under medical supervision if absolutely necessary.
- Dosage: Varies based on individual patient needs. Standard adult dose is typically one or two capsules or tablets daily.
- Monitoring Parameters: Serum calcium, phosphate, PTH, creatinine clearance.
Popular Combinations
This specific combination is already a widely used formulation for bone health. Other combinations may include additional vitamins and minerals like magnesium, methylcobalamin (vitamin B12), or L-methylfolate.
Precautions
- Monitor for hypercalcemia and adjust dosage accordingly.
- Assess renal function before and during treatment.
- Caution in patients with a history of kidney stones.
- Evaluate dietary calcium intake.
- Avoid or limit excessive exposure to natural or artificial sunlight and phototherapy while taking this medication as it contains Vitamin D.
- Avoid alcohol consumption as it may hinder calcium absorption.
- Inform your doctor about all other medications, supplements, and herbal products you are using.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Calcitriol + Calcium Citrate Malate + Vitamin K2-7 + Zinc Oxide?
A: The recommended dosage varies depending on individual patient needs and the specific product. A common adult dose is one or two capsules/tablets daily, taken with or after meals. A physician should determine the precise dosage and duration of treatment.
Q2: What are the common side effects of this medication?
A: Common side effects include gastrointestinal discomfort (constipation, diarrhea, gas), headache, fatigue, and dry mouth.
Q3: Who should not take this medication?
A: This medication is contraindicated in patients with hypercalcemia, hypercalciuria, hypervitaminosis D, metastatic calcification, hypersensitivity to any component, and severe renal impairment.
Q4: What are the signs of hypercalcemia?
A: Signs of hypercalcemia include increased thirst, increased urination, nausea, vomiting, confusion, weakness, fatigue, and bone pain.
Q5: Can this medication interact with other drugs?
A: Yes, it can interact with various medications, including thiazide diuretics, digoxin, corticosteroids, certain antibiotics, and others. It’s essential to inform your physician about all other medications you are taking.
Q6: Is it safe to take this medication during pregnancy or breastfeeding?
A: Use during pregnancy and breastfeeding should be under strict medical supervision and only if clearly necessary. The potential risks and benefits should be carefully evaluated by a physician.
Q7: How should this medication be stored?
A: Store in a cool, dry place, protected from light and moisture. Keep out of reach of children.
Q8: What should I do if I miss a dose?
A: If you miss a dose, take it as soon as you remember. If it is near the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Q9: Can I drive while taking this medication?
A: While this medication is not generally associated with impaired alertness, some individuals may experience side effects like fatigue or dizziness. Use caution when driving or operating machinery until you know how this medication affects you.
Q10: What should I monitor while taking this medication?
A: Regular monitoring of serum calcium, phosphorus, PTH, and creatinine clearance is recommended.
It is important to note that this information is intended for qualified Indian doctors and healthcare professionals. It should not be used for self-treatment or as a substitute for professional medical advice. Always consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.
