Ibandronic Acid + Algae Calcium + Vitamin D3

This kit contains Ibandronic Acid (a bisphosphonate that inhibits osteoclast-mediated bone resorption), Algae Calcium (plant-based calcium from hand-harvested, sun-dried algae that draws calcium and other minerals from seawater) 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 1-10: Take one Calcium & Vitamin D3 tablet daily after meal
• Day 11: Take one Ibandronic Acid tablet on empty stomach (1 hour before breakfast with plain water); do not lie down or take food/liquid (except water) for 1 hour
• Day 11-30: Take one Calcium & Vitamin D3 tablet daily 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

Common Side Effects:

• Back pain
• Dyspepsia
• Pain in extremity
• Diarrhea
• Flatulence
• Constipation
• Headache
• Myalgia
• 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
• Discontinue ibandronic acid if severe bone, joint and muscle pain develops
• If osteonecrosis of the jaw develops, consider discontinuing bisphosphonate therapy
• Not recommended in severe renal impairment (CrCl <30 ml/min)
• Calcium & Vitamin D3: Monitor plasma calcium and urinary calcium excretion in mild to moderate renal failure or mild hypercalciuria
• Increase fluid intake if history of kidney stones

Contraindications:

• Hypersensitivity to ibandronic acid, calcium, vitamin D3 or any components
• Ibandronic Acid: Esophageal abnormalities (stricture or achalasia), inability to stand/sit upright for 60 minutes, hypocalcemia
• Calcium & Vitamin D3: Hypercalcemia, hyperparathyroidism, hypercalciuria, nephrolithiasis, severe renal insufficiency, concomitant digoxin therapy, renal calculi, Zollinger-Ellison syndrome

Drug Interactions:

• Ibandronic Acid: Calcium and other multivalent cations (aluminium, magnesium, iron) interfere with absorption; caution with aspirin or NSAIDs
• Calcium & Vitamin D3: Interactions with digoxin, antacids, tetracycline, fluoride; 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: No adequate and well-controlled studies in pregnant women; not indicated for use in women of reproductive potential; use only if potential benefit justifies potential risk to mother and fetus.

Use in Lactation: No information on presence of ibandronate in human milk, effects on breastfed infant or milk production; should not be used during lactation.

Renal Impairment: Ibandronic acid not recommended in severe renal impairment (CrCl <30 ml/min); monitor plasma and serum calcium in mild to moderate renal impairment.

Hepatic Impairment: No dosage adjustment necessary.

Overdose: Ibandronic acid: hypocalcemia, hypophosphatemia, upper GI events (upset stomach, dyspepsia, esophagitis, gastritis, ulcer); give milk or antacids. Calcium & Vitamin D3: nausea, vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, unconsciousness, diarrhea, weakness, headache, constipation, dizziness, irritability; discontinue therapy and adequate rehydration.