Calcium + Ibandronic Acid + Vitamin D3

Usage

This combination medication is primarily prescribed for the treatment and prevention of osteoporosis in postmenopausal women. It is also used in other conditions characterized by low bone mineral density and increased risk of fractures, such as those induced by glucocorticoid therapy. Additionally, ibandronic acid can be used to treat hypercalcemia of malignancy. This drug’s pharmacological classifications include:

• Bisphosphonate: Ibandronic acid belongs to this class, known for inhibiting bone resorption.
• Calcium Supplement: Calcium carbonate provides this essential mineral for bone health.
• Vitamin Supplement: Vitamin D3 (cholecalciferol) aids in calcium absorption and bone mineralization.

Mechanism of Action: Ibandronic acid inhibits osteoclast activity, reducing bone resorption. Calcium and vitamin D3 work synergistically to maintain bone density and strength.

Alternate Names

While “Calcium + Ibandronic Acid + Vitamin D3” accurately represents the combination, it doesn’t have a distinct international nonproprietary name (INN) like the individual components.

Brand Names: Brand names vary regionally. Some examples include:

• Becoral Kit
• Bondrova Pro
• Cora Kit
• Coralcal-Kit
• Idrofos Kit
• Kalcoral Kit
• MarinCal Kit
• Reefcal Kit
• FABRICAL IBD3 KIT

How It Works

Pharmacodynamics: Ibandronic acid, a nitrogen-containing bisphosphonate, binds to hydroxyapatite in bone, particularly in areas of active bone resorption. It inhibits osteoclast activity, reducing bone breakdown. Calcium is essential for bone structure, nerve function, and muscle contraction. Vitamin D3 promotes calcium absorption in the gut and maintains serum calcium levels necessary for bone mineralization.

Pharmacokinetics: Ibandronic acid has limited oral bioavailability, improved by administration on an empty stomach with plain water. Absorption is reduced by food, calcium supplements, and other multivalent cations. It is not extensively metabolized and is primarily renally excreted. Calcium absorption is enhanced by vitamin D3. Vitamin D3 undergoes hepatic and renal metabolism.

Mode of Action: Ibandronic acid’s binding to hydroxyapatite disrupts osteoclast function at the cellular level, leading to decreased bone resorption. Calcium is integrated into the bone matrix, while vitamin D3 facilitates its absorption and utilization. Receptor binding, enzyme inhibition or neurotransmitter modulation are not directly involved in the primary mechanism of this combination therapy.

Dosage

Standard Dosage

Adults (Osteoporosis):

• Ibandronic Acid: 150 mg orally once a month, or 3 mg intravenously every 3 months.
• Calcium and Vitamin D3: Daily supplementation as needed to meet dietary requirements. Typical recommendations include 500-600 mg of elemental calcium and 400-800 IU of vitamin D3.

Children: This combination is not recommended for children and adolescents under 18.

Special Cases:

• Elderly Patients: No dose adjustment is typically necessary.
• Patients with Renal Impairment: Dosage adjustments of ibandronic acid are necessary based on creatinine clearance (CrCl).
• Patients with Hepatic Dysfunction: Generally, no dose adjustment is necessary for ibandronic acid. Monitor calcium and vitamin D3 levels.
• Patients with Comorbid Conditions: Consider individual patient factors.

Clinical Use Cases

The provided sources focus on osteoporosis treatment and do not describe specific dosage recommendations for intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.

Dosage Adjustments

Ibandronic acid dosage needs to be adjusted for renal impairment:

• Moderate Renal Impairment (CrCl 30-50 ml/min): 50 mg every other day.
• Severe Renal Impairment (CrCl <30 ml/min): 50 mg once weekly.

Side Effects

Common Side Effects:

• Gastrointestinal: Dyspepsia, heartburn, nausea, diarrhea, abdominal pain.
• Musculoskeletal: Bone pain, myalgia, back pain, arthralgia.
• General: Headache, asthenia.

Rare but Serious Side Effects:

• Osteonecrosis of the jaw (ONJ)
• Atypical femoral fractures
• Esophageal irritation and ulceration
• Hypocalcemia
• Severe allergic reactions

Long-Term Effects:

• Potential for ONJ and atypical femoral fractures with long-term use.

Adverse Drug Reactions (ADR): ONJ, atypical femoral fractures, and severe allergic reactions require urgent medical attention.

Contraindications

• Hypocalcemia
• Abnormalities of the esophagus delaying emptying (e.g., stricture, achalasia)
• Inability to sit or stand upright for at least 60 minutes (for oral ibandronic acid)
• Hypersensitivity to ibandronic acid or any component of the formulation

Drug Interactions

• Multivalent cations (calcium, magnesium, iron, aluminum): Reduce ibandronic acid absorption.
• H2 blockers (ranitidine): May interfere with ibandronic acid absorption.
• Antacids: Avoid concurrent use with ibandronic acid.

Pregnancy and Breastfeeding

Ibandronic acid is contraindicated during pregnancy and breastfeeding. It is classified as Pregnancy Category C. The effects of calcium and vitamin D3 supplementation during pregnancy and breastfeeding should be considered individually.

Drug Profile Summary

• Mechanism of Action: Ibandronic acid inhibits osteoclast-mediated bone resorption. Calcium and vitamin D3 support bone mineralization.
• Side Effects: GI disturbances, musculoskeletal pain, ONJ (rare), atypical femoral fractures (rare).
• Contraindications: Hypocalcemia, esophageal abnormalities, inability to sit upright.
• Drug Interactions: Multivalent cations, H2 blockers, antacids.
• Pregnancy & Breastfeeding: Contraindicated.
• Dosage: See detailed section above.
• Monitoring Parameters: Serum calcium, vitamin D, creatinine, renal function.

Popular Combinations

The combination of ibandronic acid with calcium and vitamin D3 is itself a popular combination used in clinical practice.

Precautions

• Ensure adequate hydration before ibandronic acid administration, particularly intravenous.
• Correct hypocalcemia and other bone and mineral metabolism disorders before initiating therapy.
• Monitor renal function, serum calcium, phosphate, and magnesium.
• Advise patients on proper administration of oral ibandronic acid (empty stomach, upright position, full glass of water, avoid lying down for 60 minutes).
• Caution with a history of gastrointestinal issues.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Calcium + Ibandronic Acid + Vitamin D3?

A: Ibandronic acid: 150 mg orally once a month, or 3 mg intravenously every 3 months. Calcium and Vitamin D3 supplementation is individualized based on dietary intake and needs, generally 500–600mg calcium and 400-800 IU Vitamin D3 daily.

Q2: What are the common side effects?

A: Common side effects include gastrointestinal issues (dyspepsia, heartburn, nausea, diarrhea), musculoskeletal pain (bone pain, myalgia, back pain), and headache.

Q3: Who should not take this medication?

A: This medication is contraindicated in patients with hypocalcemia, esophageal abnormalities, an inability to stand or sit upright for 60 minutes after taking oral ibandronic acid, or hypersensitivity to any of the components.

Q4: Are there any drug interactions I should be aware of?

A: Avoid co-administration with multivalent cations (calcium, magnesium, iron, aluminum), H2 blockers, and antacids, as they can interfere with ibandronic acid absorption.

Q5: Can this combination be used during pregnancy or breastfeeding?

A: No, this combination is contraindicated during pregnancy and breastfeeding.

Q6: What are the monitoring parameters for this combination?

A: Monitor serum calcium, phosphorus, magnesium levels, renal function, creatinine clearance, and be vigilant for signs of osteonecrosis of the jaw.

Q7: What precautions are needed when administering ibandronic acid orally?

A: The tablet should be swallowed whole with a full glass of plain water on an empty stomach, at least 60 minutes before the first food or drink of the day. Patients must remain upright for at least 60 minutes after administration.

Q8: What is the role of Vitamin D3 in this combination?

A: Vitamin D3 aids in calcium absorption from the gut, which is crucial for maximizing the therapeutic effect of the combination in maintaining bone density and reducing fracture risk.

Q9: How long should this medication be taken?

A: The duration of ibandronic acid therapy for osteoporosis should be determined based on individual patient factors and reevaluated periodically. Three to five years is usual, after which the need for continued therapy should be assessed. Discuss with a specialist.