Ibandronic Acid + Calcium + Vitamin D3

This kit contains Ibandronic Acid (a bisphosphonate that inhibits osteoclast-mediated bone resorption), Coral Calcium (calcium carbonate with small amounts of magnesium and trace minerals, with chemical structure similar to human bone calcium carbonate) and Vitamin D3 (aids in calcium absorption from the GI tract). This combination increases bone mass and reduces fracture risk.

• Treatment and prevention of osteoporosis
• Increases Bone Mineral Density (BMD)
• Reduces incidence of vertebral fractures

Dosing Schedule (Oral):

• Day 1: Take one Ibandronic Acid tablet on empty stomach (1 hour before breakfast with plain water); do not lie down for 60 minutes; do not chew or suck the tablet
• Day 2-31: Take one Calcium & Vitamin D3 tablet morning and evening after meal

Adult Dose: Ibandronic Acid 150 mg once monthly on same date each month; Calcium 500 mg & Vitamin D3 200 IU (2 tablets daily in divided doses)

Child Dose: Safety and efficacy in pediatric patients have not been established

Ibandronic Acid: Hypertension, Dyspepsia, Nausea, Diarrhea, Abdominal Pain, Arthralgia, Back Pain, Myalgia, Muscle Cramp, Influenza, Nasopharyngitis, Bronchitis, Urinary Tract Infection, Upper Respiratory Tract Infection, Headache, Dizziness, Skin rash, Insomnia

Calcium & Vitamin D3: Flatulence, diarrhea, constipation, upper GI discomfort; hypercalciuria and hypercalcemia (rare with prolonged use)

Precautions:

• Ibandronic Acid: Caution in active upper GI problems (Barrett's esophagus, dysphagia, gastritis, duodenitis, ulcers)
• Treat hypocalcemia and other bone/mineral disturbances before starting therapy
• Severe bone, joint and muscle pain reported
• Osteonecrosis of the jaw reported
• Calcium & Vitamin D3: Reduce dose in mild hypercalciuria; monitor plasma and serum calcium in mild to moderate renal impairment; increase fluid intake if history of kidney stones

Contraindications:

• Ibandronic Acid: Esophageal abnormalities (stricture or achalasia), inability to stand/sit upright for 60 minutes, hypocalcemia, hypersensitivity
• Calcium & Vitamin D3: Hypercalcemia, hyperparathyroidism, hypercalciuria, nephrolithiasis, severe renal insufficiency, concomitant digoxin therapy (requires careful monitoring), renal calculi, Zollinger-Ellison syndrome

Drug Interactions:

• Ibandronic Acid: Calcium and other multivalent cations interfere with absorption; interacts with H2 blockers (ranitidine)
• Calcium & Vitamin D3: Reduces absorption of tetracycline & fluoride (minimum 3 hours interval); thiazide diuretics reduce calcium excretion; phenytoin, barbiturates, glucocorticoids induce vitamin D metabolism
• Spinach, cereals, milk and derivatives may reduce intestinal calcium uptake

Use in Pregnancy: Category C; no adequate and well-controlled studies in pregnant women; use only if potential benefit justifies potential risk to mother and fetus.

Use in Lactation: It is not known whether this kit is excreted in human milk; caution should be exercised when administered to a nursing woman.

Renal Impairment: Not recommended in severe renal impairment; monitor calcium levels in mild to moderate renal impairment.

Hepatic Impairment: No dosage adjustment necessary.

Overdose: Oral overdose of Ibandronic acid may result in hypocalcemia, hypophosphatemia and upper gastrointestinal adverse events; milk or antacids should be given.