Idrofos Kit

• Postmenopausal Osteoporosis: Treatment and prevention to reduce vertebral fracture risk.
• Senile Osteoporosis: Management of age-related bone loss in elderly patients.
• Glucocorticoid-Induced Osteoporosis: Prevention and treatment in patients receiving long-term corticosteroids.
• Osteoporosis in Men: Off-label use for men at increased fracture risk.
• Calcium and Vitamin D Deficiency: Supplementation in individuals with inadequate intake or absorption, especially in postmenopausal women and elderly.
• Bone Metastases (Ibandronic Acid, IV form): To reduce skeletal complications in cancer patients.

• Ibandronic Acid: 150 mg orally once monthly on the same date each month.
• Coral Calcium: Typically 500–750 mg elemental calcium daily, divided doses.
• Vitamin D3: 400–1000 IU daily, adjusted per serum levels.

Administration Instructions:

• Take Ibandronic Acid with a full glass of plain water at least 60 minutes before food, drink, or other medications.
• Remain upright for at least 60 minutes after dosing to prevent esophageal irritation.
• Separate calcium and vitamin D supplements by at least 6 hours from Ibandronic Acid.
• Calcium and vitamin D may be taken with meals to enhance tolerance.

Special Populations:

• Elderly: No dose adjustment needed; monitor renal function.
• Renal impairment: Contraindicated if creatinine clearance <30 mL/min; use with caution if 30–50 mL/min.
• Hepatic impairment: No adjustment necessary.
• Pediatrics: Safety and efficacy not established.

Ibandronic Acid is a bisphosphonate that binds to bone mineral surfaces, inhibiting osteoclast-mediated bone resorption by inducing osteoclast apoptosis and reducing their activity. This action decreases bone turnover, increases bone mineral density, and reduces fracture risk. Coral calcium provides bioavailable elemental calcium along with trace minerals important for bone mineralization. Vitamin D3 enhances intestinal calcium absorption and maintains calcium and phosphate balance, supporting bone formation and remodeling.

• Absorption: Ibandronic Acid has low oral bioavailability (~0.6%) under fasting conditions. Coral calcium exhibits good absorption, especially with food. Vitamin D3 is fat-soluble and absorbed in the small intestine.
• Distribution: Ibandronic Acid preferentially accumulates in bone tissue. Calcium distributes to bones and teeth. Vitamin D3 circulates bound to carrier proteins and is metabolized to active forms.
• Metabolism: Ibandronic Acid is not metabolized. Vitamin D3 undergoes hepatic and renal hydroxylation to active metabolites. Calcium participates in physiological mineral exchange.
• Elimination: Ibandronic Acid is excreted unchanged by the kidneys. Excess calcium is eliminated renally and fecally. Vitamin D metabolites are excreted primarily via bile.

• Pregnancy: Ibandronic Acid is FDA category C; animal studies indicate potential fetal risk. Use only if benefits justify risks. Coral calcium and vitamin D3 are generally safe at recommended doses.
• Lactation: Unknown if Ibandronic Acid is excreted in breast milk; caution advised. Coral calcium and vitamin D3 are safe in breastfeeding at appropriate doses.

• Ibandronic Acid: Bisphosphonate, antiresorptive agent.
• Coral Calcium: Mineral supplement.
• Vitamin D3: Fat-soluble vitamin regulating calcium homeostasis.

• Known hypersensitivity to ibandronic acid, coral calcium, vitamin D3, or excipients.
• Untreated hypocalcemia.
• Severe renal impairment (creatinine clearance <30 mL/min).
• Esophageal abnormalities or inability to remain upright for 60 minutes post-dose.
• Hypercalcemia or vitamin D toxicity.

• Osteonecrosis of the jaw risk, especially in cancer patients or those undergoing dental procedures.
• Atypical femoral fractures with long-term bisphosphonate use.
• Esophageal irritation and ulceration; ensure proper administration technique.
• Monitor serum calcium and vitamin D levels to prevent hypo- or hypercalcemia.
• Regular renal function monitoring recommended.
• Avoid vitamin D overdose to prevent toxicity.

• Common: Gastrointestinal discomfort (nausea, abdominal pain, esophageal irritation), musculoskeletal pain, headache, fatigue.
• Serious (rare): Osteonecrosis of the jaw, atypical femoral fractures, severe hypocalcemia, hypersensitivity reactions.
• Vitamin D Overdose: Symptoms include hypercalcemia, nausea, vomiting, weakness.

• Calcium, magnesium, iron supplements, and antacids reduce ibandronic acid absorption; separate administration by at least 6 hours.
• NSAIDs may increase risk of gastrointestinal irritation.
• Thiazide diuretics may increase risk of hypercalcemia with calcium and vitamin D supplementation.
• Drugs inducing vitamin D metabolism (e.g., phenytoin, rifampin) may reduce vitamin D efficacy.
• Ibandronic acid is not metabolized by CYP450 enzymes, limiting hepatic drug interactions.

• Osteoporosis treatment duration reassessment recommended after 3–5 years to evaluate fracture risk and consider drug holidays.
• Increased awareness and monitoring for osteonecrosis of the jaw and atypical femoral fractures.
• Continued recommendation for combined calcium and vitamin D supplementation alongside bisphosphonate therapy.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture, heat, and direct sunlight.
• Keep ibandronic acid in original blister packaging until use.
• Store coral calcium and vitamin D supplements in tightly closed containers, away from humidity and excessive heat.
• Do not refrigerate or freeze.