Biocal Kit

• Postmenopausal Osteoporosis: Treatment and prevention to reduce the risk of vertebral fractures.
• Senile Osteoporosis: Management of age-related bone loss in elderly patients.
• Glucocorticoid-Induced Osteoporosis: Prevention or treatment in patients on long-term corticosteroid therapy.
• Osteoporosis in Men: Used off-label for men with low bone mineral density or increased fracture risk.
• Calcium and Vitamin D Deficiency: Correction of deficiencies in adults, especially in postmenopausal women and elderly patients.
• Supportive Treatment in Bone Metastases: Ibandronic Acid (IV form) reduces skeletal complications in metastatic bone disease.

• Ibandronic Acid: 150 mg orally once monthly, taken on the same date each month.
• Algae Calcium: Typically 500–750 mg elemental calcium daily in divided doses.
• Vitamin D3: 400–1000 IU daily, adjusted based on individual vitamin D status.

Administration Instructions:

• Take Ibandronic Acid first thing in the morning with a full glass of plain water.
• Remain upright for at least 60 minutes after dosing.
• Do not eat, drink, or take other medications for at least 60 minutes after Ibandronic Acid.
• Separate calcium and vitamin D intake by at least 6 hours from Ibandronic Acid to avoid absorption interference.
• Calcium and vitamin D supplements may be taken with meals to reduce gastrointestinal discomfort.

Ibandronic Acid is a potent bisphosphonate that binds to hydroxyapatite in bone, inhibiting osteoclast-mediated bone resorption by inducing osteoclast apoptosis. This reduces bone turnover, increases bone mineral density, and lowers fracture risk. Algae Calcium provides bioavailable calcium along with essential trace minerals, supporting bone mineralization. Vitamin D3 enhances intestinal calcium absorption and regulates calcium and phosphate metabolism, promoting bone health.

• Absorption: Ibandronic Acid oral bioavailability is approximately 0.6% when fasting. Algae Calcium has high bioavailability, especially when taken with food. Vitamin D3 is fat-soluble and absorbed in the small intestine.
• Distribution: Ibandronic Acid selectively binds bone tissue. Calcium distributes primarily to bones and teeth. Vitamin D3 is metabolized to active forms in liver and kidneys.
• Metabolism: Ibandronic Acid is not metabolized; Vitamin D3 undergoes hepatic and renal hydroxylation.
• Elimination: Ibandronic Acid is excreted unchanged by the kidneys. Unabsorbed calcium is eliminated via feces. Vitamin D3 metabolites are excreted primarily in bile.

• Pregnancy: Ibandronic Acid is FDA Category C (animal studies show risk; use only if benefit outweighs risk). Algae Calcium and Vitamin D3 are generally safe at recommended doses.
• Lactation: Unknown if Ibandronic Acid is excreted in breast milk; caution advised. Calcium and Vitamin D3 are safe in breastfeeding when used appropriately.

• Ibandronic Acid: Bisphosphonate, antiresorptive agent.
• Algae Calcium: Mineral supplement.
• Vitamin D3: Fat-soluble vitamin, calcium regulator.

• Hypersensitivity to any component.
• Hypocalcemia not corrected before therapy.
• Severe renal impairment (creatinine clearance <30 mL/min).
• Esophageal abnormalities or inability to remain upright.
• Hypercalcemia or vitamin D toxicity.

• Risk of osteonecrosis of the jaw, especially in cancer patients or with dental procedures.
• Possible atypical femoral fractures with prolonged use.
• Esophageal irritation; ensure correct administration.
• Monitor calcium and vitamin D status to avoid hypocalcemia.
• Renal function monitoring recommended.
• Avoid excessive vitamin D intake to prevent toxicity.

• Common: Gastrointestinal discomfort, nausea, abdominal pain, esophagitis, musculoskeletal pain.
• Serious (rare): Osteonecrosis of the jaw, atypical femoral fractures, severe hypocalcemia, allergic reactions.
• Vitamin D Overdose: Hypercalcemia, weakness, dehydration.

• Calcium, magnesium, iron supplements, and antacids reduce Ibandronic Acid absorption; separate dosing by at least 6 hours.
• NSAIDs may increase GI irritation.
• Thiazide diuretics may increase hypercalcemia risk.
• Drugs inducing vitamin D metabolism (e.g., phenytoin) may reduce Vitamin D efficacy.

• Osteoporosis treatment reassessment after 3–5 years of bisphosphonate therapy is recommended.
• Emphasis on monitoring for osteonecrosis of the jaw and atypical fractures.
• Combined therapy with calcium and vitamin D improves outcomes and adherence.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and direct sunlight.
• Keep Ibandronic Acid in original blister packaging until use.
• Do not freeze or refrigerate.