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ACTONEL 5 mg Film-coated Tablets
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Drug Class Description
Bisphosphonates
Generic Name
Risedronate sodium
Drug Description
Film-coated tablets.Oval yellow film-coated tablet with RSN on one side and 5 mg on the other.
Presentation
Each film-coated tablet contains 5 mg risedronate sodium (equivalent to 4.64 mg risedronic acid).
Indications
Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures. Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis.To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months), systemic corticosteroid treatment at doses 7.5mg/day prednisone or equivalent.
Adult Dosage
The recommended daily dose in adults is one 5 mg tablet orally. The absorption of Actonel is affected by food, thus to ensure adequate absorption patients should take Actonel:• Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day.In the particular instance that before breakfast dosing is not practical, Actonel can be taken between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to ensure Actonel is taken on an empty stomach:• Between meals: Actonel should be taken at least 2 hours before and at east 2 hours after any food, medicinal product or drink (other than plain water). • In the evening: Actonel should be taken at least 2 hours after the last food, medicinal product or drink (other than plain water) of the day. Actonel should be taken at least 30 minutes before going to bed.If an occasional dose is missed, Actonel can be taken before breakfast, between meals, or in the evening according to the instructions above.The tablets must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach Actonel 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 (See Special Precautions). Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate.
Child Dosage
Safety and efficacy of Actonel have not been established in children and adolescents.
Elderly Dosage
Elderly: No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (>60 years of age) compared to younger subjects.
Contra Indications
Known hypersensitivity to risedronate sodium or to any of the excipients. Hypocalcaemia (See Special Precautions). Pregnancy and lactation. Severe renal impairment (creatinine clearance <30ml/min).
Special Precautions
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 (See Interactions) In order to achieve the intended efficacy, strict adherence to dosing recommendations is necessary (See Adult Dosage) Efficacy of bisphosphonates in the treatment of postmenopausal osteoporosis is related to the presence of low bone mineral density (BMD T-score at hip or lumbar spine -2.5 SD) and/or preva lent 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 Actonel in very elderly women (>80 years) is limited.Some bisphosphonates have been associated with oesophagitis and oesophageal ulcerations. Therefore patients should pay attention to the dosing instructions (See Adult Dosage). In patients who have a history of oesophageal disorders which delay oesophageal transit or emptying e.g. stricture or achalasia, or who are unable to stay in the upright position for at least 30 minutes after taking the tablet, risedronate sodium should be used with special caution because of limited clinical experience in these patients. Prescribers should emphasise the importance of the dosing instructions to these patientsHypocalcaemia should be treated before starting Actonel therapy. Other disturbances of bone and mineral metabolism (e.g. parathyroid dysfunction, hypovitaminosis D) should be treated at the time of starting Actonel 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 bisphophonates. 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, 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.This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Interactions
No formal interaction studies have been performed, however no clinically relevant interactions with other medicinal products were found during clinical trials. In the Actonel Phase III osteoporosis studies, acetyl salicylic acid or NSAID use was reported by 33% and 45% of patients respectively. If considered appropriate Actonel 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 Actonel (See Special Precautions).Actonel 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.Actonel must not be used during pregnancy or by breast-feeding women.
Adverse Reactions
Risedronate has been studied in phase III clinical trials involving more than 15,000 patients. The majority of undesirable effects observed in clinical trials were mild to moderate in severity and usually did not require cessation of therapy.Adverse experiences reported in phase III clinical trials in postmenopausal women with osteoporosis treated for up to 36 months with risedronate 5mg/day (n=5020) or placebo (n=5048) and considered possibly or probably related to risedronate are listed below using the following convention (incidences versus placebo are shown in brackets): very common (=1/10); common (=1/100; <1/10); uncommon (=1/1,000; <1/100); rare (=1/10,000; <1/1,000); very rare (<1/10,000).Nervous system disorders:Common: headache (1.8% vs. 1.4%)Eye disorders:Uncommon: iritis* Gastrointestinal disorders:Common: constipation (5.0% vs. 4.8%), dyspepsia (4.5% vs. 4.1%), nausea (4.3% vs. 4.0%), abdominal pain (3.5% vs. 3.3%), diarrhoea (3.0% vs. 2.7%)Uncommon: gastritis (0.9% vs. 0.7%), oesophagitis (0 |
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