Description

Ibandronic Acid is contraindicated in conditions like: abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. Inability to stand or sit upright for at least 60 minutes, Hypocalcemia, known hypersensitivity to Ibandronic Acid. Calcium & Vitamin D3: Hypersensitivity to any of the component of this preparation. It is also contraindicated in case of hypercalcemia, hyperparathyroidism, hypercalciuria, nephrolithiasis, severe renal insufficiencies, concomitant Digoxin therapy (requires careful monitoring of serum calcium level), renal calculi and Zollinger Ellison syndrome.

Ibandronic Acid: Common side effects include Hypertension, Dyspepsia, Nausea, Diarrhea, Abdominal Pain, Arthralgia, Back Pain, Localized Osteoarthritis, Myalgia, Muscle Cramp, Influenza, Nasopharyngitis, Bronchitis, Urinary Tract Infection, Upper Respiratory Tract Infection, Headache, Dizziness, Skin rash, Insomnia etc. Calcium & Vitamin D3: Most common side effects are flatulence, diarrhea, constipation, upper GI discomfort etc. Hypercalciuria and hypercalcemia due to prolong use has rarely been reported.

Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. This kit should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. Nursing mother: It is not known whether this kit is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this kit is administered to a nursing woman.

Ibandronic Acid: Upper Gastrointestinal Adverse Reactions: Ibandronic acid like other bisphosphonates administered orally may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects, caution should be used when Ibandronic acid is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers). Hypocalcaemia and Mineral Metabolism: Treat hypocalcemia and other disturbances of bone and mineral metabolism before starting therapy. Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Ibandronic acid and other bisphosphonates. Jaw Osteonecrosis: Osteonecrosis, primarily in the jaw, has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses. Calcium and Vitamin-D: In mild hypercalciuria reduction of dose is sufficient to return to normal serum Calcium concentration. Plasma and serum Calcium level should be monitored in mild to moderate renal impairment patients and also in case of long term use. Patients with renal stone or with such previous history should be recommended to increase their fluid intake.

No specific information is available on the treatment of over dosage of Ibandronic acid. However, based on knowledge of this class of compounds, oral over dosage may result in hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events.

Bisphosphonate preparations