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Foods, drinks (other than plain water) and medicinal products containing polyvalent cations (eg, calcium, magnesium, iron and aluminium) interfere with the absorption of bisphosphonates and should not be taken at the same time as risedronate. In order to achieve the intended efficacy, strict adherence to dosing recommendations is necessary.
Efficacy of bisphosphonates in the treatment of osteoporosis is related to the presence of low bone mineral density and/or prevalent fracture.
High age or clinical risk factors for fracture alone are not sufficient reasons to initiate treatment of osteoporosis with a bisphosphonate.
The evidence to support efficacy of bisphosphonates including risedronate in the very elderly (>80 years) is limited.
Bisphosphonates have been associated with oesophagitis, gastritis, oesophageal ulcerations and gastroduodenal ulcerations.
Thus caution should be used in patients who have a history of oesophageal disorders which delay oesophageal transit or emptying eg, stricture or achalasia; in patients who are unable to stay in the upright position for at least 30 min after taking the tablet; if risedronate is given to patients with active or recent oesophageal or upper gastrointestinal problems.
Physicians should emphasize to patients the importance of paying attention to the dosing instructions and be alert to any signs and symptoms of possible oesophageal reaction. The patients should be instructed to seek timely medical attention if they develop symptoms of oesophageal irritation eg, dysphagia, pain on swallowing, retrosternal pain or new/worsened heartburn. Hypocalcaemia should be treated before starting risedronate therapy. Other disturbances of bone and mineral metabolism (ie, parathyroid dysfunction, hypovitaminosis D) should be treated at the time of starting risedronate therapy.
Osteonecrosis of the jaw generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer receiving treatment regimens including primarily IV administered bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (eg, cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Effects on the Ability to Drive or Operate Machinery: No effects on ability to drive and use machines have been observed.
Use in Children: Safety and efficacy of risedronate 35 mg have not been established in children and adolescents.
