Prescription Risedronate Drug Information

The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of risedronate sodium on an individual patient basis, particularly after 5 or more years of use. The recommended dose in adults is one 35 mg tablet orally once a week. The tablet should be taken on the same day each week. Method of administration The absorption of risedronate sodium is affected by food, thus to ensure adequate absorption patients should take Risedronate 35 mg: Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. Patients should be instructed that if a dose is missed, one Risedronate 35 mg tablet should be taken on the day that the tablet is remembered. Patients should then return to taking one tablet once a week on the day the tablet is normally taken. Two tablets should not be taken on the same day. The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach Risedronate 35 mg is to be taken while in an upright position with a glass of plain water. Patients should not lie down for 30 minutes after taking the tablet. Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate. Older people No dosage adjustment is necessary. This has also been shown in the very elderly, 75 years old and above postmenopausal population. Renal Impairment No dosage adjustment is required for those patients with mild to moderate renal impairment. The use of risedronate sodium is contraindicated in patients with severe renal impairment . Hepatic impairment No studies have been performed to assess safety or efficacy of risedronate sodium in this population. Risedronate sodium is not metabolised via the liver, therefore dosage adjustment is unlikely to be needed in patients with hepatic impairment. Paediatric population Risedronate sodium is not recommended for use in children below age 18 due to insufficient data on safety and efficacy. Contraindications - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Hypocalcaemia. - Pregnancy and lactation. - Severe renal impairment. Special warnings and precautions for use Foods, drinks (other than plain water) and medicinal products containing polyvalent cations (such as calcium, magnesium, iron and aluminium) interfere with the absorption of bisphosphonates and should not be taken at the same time as risedronate sodium. 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 sodium in very elderly . 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 e.g. stricture or achalasia In patients who are unable to stay in the upright position for at least 30 minutes after taking the tablet. If risedronate sodium is given to patients with active or recent oesophageal or upper gastrointestinal problems (including known Barrett's oesophagus). Prescribers should emphasise 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 such as dysphagia, pain on swallowing, retrosternal pain or new/worsened heartburn.