Product Description.:
APO, IBA 150
tablet , film-coated , white , oval oblong
White to off-whiteBiconvex
Boniva Tablets are contraindicated in patients with uncorrected hypocalcemia, known hypersensitivity to any component of this product, or the inability to stand or sit upright for at least 60 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting therapy. Adequate intake of calcium and vitamin D is important in all patients. Boniva is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min).
Boniva, like other bisphosphonates administered orally, may cause upper gastrointestinal (GI) disorders such as dysphagia, esophagitis, and esophageal or gastric ulcers. As aspirin, NSAIDs, and bisphosphonates are associated with GI irritation, caution should be exercised when using them concomitantly. Boniva Tablets should be taken at least 60 minutes before any oral medication or supplementation including calcium, antacids, or vitamins. Rarely, patients have reported severe bone, joint, and/or muscle pain after taking bisphosphonate therapy for osteoporosis. Osteonecrosis of the jaw has been reported in patients treated with bisphosphonates most cases have been in cancer patients undergoing dental procedures. The overall adverse events profile of Boniva 2.5 mg once daily was similar to that of placebo. In a one-year study comparing Boniva 150 mg once-monthly and Boniva 2.5 mg daily, the overall incidence of adverse events with the two dosing regimens was similar. The most commonly reported adverse events (��%), regardless of causality, were abdominal pain (Boniva 150 mg 7.8% vs Boniva 2.5 mg 5.3%), hypertension (6.3% vs 7.3%), dyspepsia (5.6% vs 7.1%), arthralgia (5.6% vs 3.5%), nausea (5.1% vs 4.8%), and diarrhea (5.1% vs 4.1%).
