Ibandren Special Precautions

Upper Gastrointestinal Adverse Reactions: IBANDREN 150 mg Film Coated Tablet, like other biphosphates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when IBANDREN 150 mg Film Coated Tablet is given to patients with active upper gastrointestinal problems. Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral biphosphates. In some cases, these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue IBANDREN 150 mg Film Coated Tablet and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (6-8 oz) of water, and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient. In patients who cannot comply with dosing instructions due to mental disability, therapy with IBANDREN 150 mg Film Coated Tablet should be used under appropriate supervision. There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and within complications, although no increased risk was observed in controlled clinical trials.
Hypocalcemia and Mineral Metabolism: Hypocalcemia has been reported in patients taking IBANDREN 150 mg Film Coated Tablet. Treat hypocalcemia and other disturbances of bone and mineral metabolism before starting IBANDREN 150 mg Film Coated Tablet therapy. Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate.
Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking IBANDREN 150 mg Film Coated Tablet and other bisphosphonates. The time to insert of symptoms varied from one day to several months after starting the drug. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when re-challenged with the same drug or another bisphosphonate. Consider discontinuing use if severe symptoms develop.
Jaw Osteonecrosis: Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including IBANDREN 150 mg Film Coated Table. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, diagnosis of cancer, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders. The risk for ONJ may increase with duration of exposure to bisphosphonates. For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Clinical judgement of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit/risk assessment. Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment.
Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Atypical, low-energy, or low-trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patient. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without the evidence of comminution. Casualty has not been established as these fractures also occur in osteoporotic patients who have not been treated with bisphosphonates. Atypical femur fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to month before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g., prednisone) at the time of fracture. Any patient with a history of bisphosphonate exposure at the time of fracture. Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out incomplete femur fracture. Patients presenting with an atypical fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of bisphosphonate therapy should be considered, pending a risk/benefit assessment, on an individual basis.
Severe Renal Impairment: IBANDREN 150 mg Film Coated Tablet is not recommended for use in patients with severe renal impairment (creatinine clearance of less than 30 mL/min).
Effects on ability to drive and use machine (if applicable): On the basis of pharmacodynamic and pharmacokinetic profile and reported adverse reactions, it is expected that Ibandronic acid has no or negligible influence on the availability of to drive and use machines.
Use in Children: Safety of administration of IBANDREN 150 mg Film Coated Tablet is not demonstrated for children under 18 years old.
Use in the Elderly: No dose adjustment needed for Elderly.