Idrofos Kit 150 mg+500 mg+200 IU (Tablet)

Indications

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

Pharmacology

• Contains Ibandronic Acid (Ibandronate Sodium Monohydrate)
• Inhibits osteoclast-mediated bone resorption
• Affinity for hydroxyapatite in bone tissue
• Reduces bone resorption and turnover
• Contains Coral Calcium and Colecalciferol
• Ensures better absorption than Calcium of other Calcium Carbonate origin
• Vitamin-D aids in the absorption of Calcium

Dosage & Administration

• Take one tablet of Ibandronic Acid 150 mg once monthly
• Take two tablets of Calcium 500 mg and Vitamin D3 200 IU per day
• Take Ibandronic Acid tablet on an empty stomach at least 60 minutes before food
• Swallow tablet whole with a glass of plain water while standing or sitting in an upright position
• Avoid lying down for 60 minutes after taking the tablet
• One tablet of Calcium and Vitamin D should be taken at the morning and evening after meal
• Pediatric patient safety and effectiveness not established

Interaction

• Ibandronic Acid could be interfered by calcium and other multivalent cations
• Interaction with H2 blockers such as Ranitidine
• Oral Calcium can reduce the absorption of tetracycline & fluoride preparations
• Thiazide diuretics reduce the renal excretion of Calcium
• Concomitant intake of certain foods may reduce the intestinal uptake of Calcium

Contraindications

• Ibandronic Acid contraindicated in esophageal abnormalities, inability to stand or sit upright, Hypocalcemia, known hypersensitivity
• Calcium & Vitamin D3 contraindicated in hypersensitivity, hypercalcemia, hyperparathyroidism, hypercalciuria, severe renal insufficiencies, concomitant Digoxin therapy, renal calculi, Zollinger Ellison syndrome

Side Effects

• Ibandronic Acid side effects include Hypertension, Dyspepsia, Nausea, Diarrhea, Abdominal Pain, Arthralgia, Back Pain, Myalgia, Skin rash, Insomnia, etc.
• Calcium & Vitamin D3 side effects include flatulence, diarrhea, constipation, upper GI discomfort, Hypercalciuria, hypercalcemia with prolonged use

Pregnancy & Lactation

• Pregnancy category C
• Should be used during pregnancy if potential benefit justifies potential risk
• Caution when administered to a nursing woman

Precautions & Warnings

• Ibandronic Acid may cause upper gastrointestinal adverse reactions
• Treat hypocalcemia and other disturbances of mineral metabolism before starting therapy
• Severe musculoskeletal pain reported
• Osteonecrosis primarily in the jaw reported
• Calcium and Vitamin-D: Monitor plasma and serum Calcium level, Increase fluid intake for patients with renal stone history

Overdose Effects

• Oral over dosage may result in hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events

Therapeutic Class

• Bisphosphonate preparations

Storage Conditions

• Do not store above 30°C
• Keep away from light and out of the reach of children

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