Calcitriol + Calcium Carbonate + Soya Isoflavones

Usage

• This combination drug is primarily prescribed for the dietary management of postmenopausal osteoporosis (weak and brittle bones) and osteopenia (low bone mineral density). It may also be used to address calcium and vitamin D deficiency and alleviate menopausal symptoms.
• Pharmacological classification: This is a combination product containing a vitamin D analog (Calcitriol), a calcium supplement (Calcium Carbonate), and a phytoestrogen (Soya Isoflavones).
• Mechanism of action: Calcitriol enhances calcium absorption in the gut, Calcium Carbonate provides supplemental calcium, and Soya Isoflavones exert mild estrogenic effects that help maintain bone density.

Alternate Names

• No widely recognized alternate names for this specific combination exist.
• Brand names: Shelcal ISO, Calcimax ISO, Bio-D3 Fem, Nucifria-XT, Supracal ISO, Calorex-XL, Osteofit XT. Please note that formulations may vary slightly between brands and some brands may include additional ingredients such as magnesium, vitamin K2-7, and boron.

How It Works

• Pharmacodynamics: Calcitriol, the active form of vitamin D3, binds to vitamin D receptors, increasing calcium absorption from the gut and regulating bone metabolism. Calcium Carbonate directly increases calcium stores. Soya Isoflavones act as weak estrogens, influencing bone turnover by modulating osteoblast and osteoclast activity.
• Pharmacokinetics: Calcitriol is readily absorbed orally, undergoes hepatic metabolism, and is excreted primarily through the kidneys. Calcium Carbonate’s absorption varies depending on factors like vitamin D status and gastric pH. Soya Isoflavones are metabolized by gut bacteria and undergo hepatic conjugation. Elimination pathways are mainly renal and hepatic.
• Mode of action: Calcitriol interacts with vitamin D receptors (VDR) within cells. Calcium Carbonate releases calcium ions. Soya Isoflavones act as selective estrogen receptor modulators (SERMs), although their primary influence on bone health is less clear.
• Elimination pathways: Calcitriol: renal and hepatic. Calcium Carbonate: primarily fecal, some renal. Soya Isoflavones: hepatic and renal.

Dosage

Standard Dosage

Adults:

• The typical dosage is one capsule or tablet daily, taken with a meal. Dosage should be determined by a healthcare professional on the basis of individual patient requirements and serum vitamin D and calcium levels.

Children:

• This combination is generally not recommended for children under 18 years of age.

Special Cases:

• Elderly Patients: Dosage adjustments may be needed due to changes in renal function. Close monitoring of calcium levels is essential.
• Patients with Renal Impairment: Dose reduction or avoidance might be needed due to impaired calcitriol metabolism.
• Patients with Hepatic Dysfunction: Caution is recommended, although significant dosage adjustments are not usually required.
• Patients with Comorbid Conditions: Use with caution in patients with cardiovascular diseases, diabetes, hypercalcemia, hyperparathyroidism, kidney stones, certain cancers, or malabsorption syndromes.

Clinical Use Cases

The combination is not typically used in acute clinical settings like intubation, surgical procedures, mechanical ventilation, ICU, or emergency situations. Its primary use is in the long-term management of osteoporosis.

Dosage Adjustments

Dose modifications are based on renal function, vitamin D and calcium levels, and individual patient response.

Side Effects

Common Side Effects

• Constipation
• Flatulence
• Nausea
• Stomach upset
• Headache

Rare but Serious Side Effects

• Hypercalcemia (high blood calcium levels)
• Kidney stones
• Cardiac arrhythmias
• Allergic reactions

Long-Term Effects

• Potential for kidney problems with prolonged excessive intake.

Adverse Drug Reactions (ADR)

• Significant ADRs include hypercalcemia and its associated symptoms (e.g., nausea, vomiting, constipation, confusion).

Contraindications

• Hypercalcemia
• Hypercalciuria
• Hypervitaminosis D
• Hypersensitivity to any component of the medication
• Severe renal impairment
• Kidney stones
• Malabsorption syndrome
• Metastatic calcification
• Zollinger-Ellison syndrome

Drug Interactions

• Thiazide diuretics
• Digoxin
• Levothyroxine
• Bisphosphonates
• Antacids
• Corticosteroids
• Cholestyramine
• Antibiotics (tetracyclines, quinolones)
• Other vitamin D supplements
• Foods rich in vitamin D or calcium
• Alcohol (may affect calcium absorption)

Pregnancy and Breastfeeding

• Consult a doctor before use during pregnancy and breastfeeding. Use only if potential benefits outweigh risks.

Drug Profile Summary

(See information summarized above)

Popular Combinations

• This combination itself is commonly used.
• Some formulations include additional ingredients such as vitamin K2, magnesium, or boron for purported synergistic effects on bone health.

Precautions

• Pre-existing medical conditions (especially renal, hepatic, and cardiovascular) should be assessed before initiating therapy.
• Pregnancy and breastfeeding: Consult a doctor.
• Children and elderly: Dosage adjustments may be necessary.
• Alcohol consumption: Limit alcohol intake.

FAQs (Frequently Asked Questions)

• Q1: What is the recommended dosage for Calcitriol + Calcium Carbonate + Soya Isoflavones?

  • A: Typically, one capsule/tablet daily with a meal. Dosage needs to be individualized and should be determined by a healthcare professional.

• Q2: Can this combination be used in premenopausal women?

  • A: It is primarily indicated for postmenopausal osteoporosis. Its use in premenopausal women should be considered only if there’s a specific medical need for calcium or vitamin D supplementation.

• Q3: What are the common side effects?

  • A: Constipation, flatulence, nausea, and stomach upset.

• Q4: Are there any serious side effects?

  • A: Yes, hypercalcemia, kidney stones, and cardiac arrhythmias are rare but serious side effects.

• Q5: What are the contraindications?

  • A: Hypercalcemia, hypervitaminosis D, severe renal impairment, kidney stones, and hypersensitivity to the drug’s components.

• Q6: Does this combination interact with other medications?

  • A: Yes, interactions are possible with thiazide diuretics, digoxin, levothyroxine, bisphosphonates, antacids, and others. Consult a doctor or pharmacist about potential interactions.

• Q7: Can I take this with alcohol?

  • A: Excessive alcohol use can negatively affect bone health and interfere with calcium absorption. It is advisable to minimize alcohol consumption.

• Q8: What should I monitor while taking this medication?

  • A: Serum calcium, phosphate, vitamin D, and creatinine levels should be monitored, especially in patients with pre-existing conditions or when initiating therapy.

• Q9: Is it safe during pregnancy and breastfeeding?

  • A: Consult your doctor before use during pregnancy and breastfeeding. It should only be used if the benefits clearly outweigh the potential risks.

• Q10: How should this medication be stored?

  • A: Store in a cool, dry place away from direct sunlight and heat, out of the reach of children. Ensure that the container is tightly closed.