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Film Coated Tablets
1 X 150 mg
Actonel Once a Month 150 mg tablets should be taken orally once a month. The tablet should be taken on the same date each month. The absorption of risedronate sodium is affected by food and polyvalent cations, thus to ensure adequate absorption patients should take Actonel Once a Month 150 mg before breakfast: at least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. Plain water is the only drink that should be taken with Actonel Once a Month 150mg tablet. Please note that some mineral water may have a higher concentration of calcium and therefore should not be used. Patients who miss a dose of Actonel Once a Month 150 mg should be instructed to take one Actonel Once a Month 150 mg tablet the morning after the day it is remembered, unless the time to the next month’s scheduled doses are within 7 days. If the next month’s scheduled doses of Actonel Once a Month 150 mg are within 7 days, patients should wait until their next month’s scheduled doses and then continue taking Actonel Once a Month 150 mg as originally scheduled. The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach Actonel Once a Month 150 mg is to be taken while in an upright position with a glass of plain water (>120 ml). 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. 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 Actonel on an individual patient basis, particularly after 5 or more years of use.
Elderly: No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (>60 years of age) compared to younger subjects. 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 2 patients with severe renal impairment (creatinine clearance lower than 30ml/min).
Children: Safety and efficacy of Actonel Once a Month 150mg have not been established in children and adolescents.
Treatment of postmenopausal osteoporosis. Prevention of postmenopausal osteoporosis.
– Known hypersensitivity to the drug or any of the ingredients.
– Pregnancy and lactation
– Severe renal impairment (creatinine clearance <30 ml/min).
– Inability to stand or sit upright for at least 30 minutes.
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 Actonel Once a Month 150mg. 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 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 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 is given to patients with active or recent oesophageal or upper gastrointestinal problem Prescribers should emphasise to patients the importance of paying attention to the dosing instructions and be alert to any signs or 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. Hypocalcaemia should be treated before starting Actonel Once a Month 150 mg therapy. Other disturbances of bone and mineral metabolism (e.g. parathyroid dysfunction, hypovitaminosis D) should be treated at the time of starting Actonel Once a Month 150 mg 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 intravenously 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 (e.g. 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, 3 there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw. Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Atypical fractures of the femur: Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. These transverse or short oblique, fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare. These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture. Fractures are often bilateral; therefore the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Poor healing of these fractures has also been reported. Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment. During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.
Mild to moderate in severity and usually did not require cessation of therapy. Common reactions: Musculoskeletal pain, dyspepsia, nausea, constipation, diarrhea, GI disorder, headache.
For full details see prescribing information.
No formal interaction studies have been performed, however no clinically relevant interactions with other medicinal products were found during clinical trials. In the risedronate sodium Phase III osteoporosis studies with daily dosing, acetyl salicylic acid or NSAID use was reported by 33% and 45% of patients respectively. In the Phase III study comparing 75mg on 2 consecutive days a month and 5 mg daily in postmenopausal women, acetyl salicylic acid/NSAID use was reported by 54.8% of patients. Similar percentages of patients experienced upper gastrointestinal adverse events regardless of NSAIDs and aspirin use. If considered appropriate risedronate sodium may be used concomitantly with oestrogen supplementation . Concomitant ingestion of medications containing polyvalent cations (e.g. calcium, magnesium, iron and aluminium) will interfere with the absorption of risedronate sodium. Risedronate sodium is not systemically metabolised, does not induce cytochrome P450 enzymes, and has low protein binding.
Pregnancy and Lactation
There are no adequate data from the use of risedronate sodium in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Studies in animals indicate that a small amount of risedronate sodium pass into breast milk. Risedronate sodium must not be used during pregnancy or by breast-feeding women.
No specific information is available on the treatment of acute overdose with risedronate sodium. Decreases in serum calcium following substantial overdose may be expected. Signs and symptoms of hypocalcaemia may also occur in some of these patients. Milk or antacids containing magnesium, calcium or aluminium should be given to bind risedronate and reduce absorption of risedronate sodium. In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed risedronate sodium.