Composition: Risedronate sodium 5mg and 30mg.
Presentation: Film-coated, yellow (5mg) and white (30mg) tablets .
Action: Pyridinyl bisphosphonate.
Indications: 5mg tablets, treatment of established postmenopausal osteoporosis to reduce the risk of vertebral 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 three months) systemic corticosteroid treatment at doses of 7.5mg/day or higher prednisone (or equivalent). 30mg tablets, treatment of Paget's disease of the bone.
Contraindications: Known sensitivity to risedronate sodium or any of its excipients. Hypocalcaemia, pregnancy and lactation, severe renal impairment.
Dosage and administration: Adults and elderly, treatment or prevention of osteoporosis, 5mg daily; treatment of Paget's disease, 30mg daily for two months. If re-treatment for Paget's disease is necessary (at least two months post-treatment), a new treatment with the same dose and duration of therapy can be given. Tablets should be taken either at least 30 minutes before the first food or drink (other than water) of the day, or at least two hours from any food or drink at any other time of the day, and at least 30 minutes before going to bed. The tablets must be swallowed whole and not sucked or chewed. Tablets should 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.
Children, safety and efficacy not established.
Overdosage: Decreases in serum calcium may be expected following substantial overdose. Milk or antacids containing magnesium, calcium or aluminium should be given to bind risedronate and reduce absorption of the drug. Gastric lavage may be considered in cases of substantial overdose.
Precautions: Use with caution in patients with a history of oesophageal disorders which delay oesophageal transit or emptying and in patients who are unable to stay in the upright position for at least 30 minutes after taking the tablet. Hypocalcaemia should be treated before starting risedronate. Other disturbances of bone and mineral metabolism should be treated at the time of starting risedronate therapy.
Drug interactions: No clinically relevant interactions with other drugs were found during clinical trials. Concomitant ingestion of medicines containing polyvalent cations will interfere with the absorption of risedronate.
Side effects: At the dose used for treatment of osteoporosis, possible or probable adverse reactions (incidence between 1 and 10 per cent) included dyspepsia, abdominal pain, constipation, diarrhoea, flatulence, gastritis, musculoskeletal pain, headache and rash. For less common adverse events and for events seen at the dose used for treatment of Paget's disease, see SPC.
Net price: 28 tablets, 5mg £21.83, 30mg £152.81.
Supplier: Actonel will be jointly marketed by Proctor & Gamble Pharmaceuticals, Lovett House, Lovett Road, Staines, Middlesex TW18 3AZ (tel 01784 495000, fax 01784 495253) and Aventis Pharma, Aventis House, 50 Kings Hill Avenue, Kings Hill, West Malling, Kent ME19 4AH (tel 01732 584000, fax 01732 584080).
Legal class: POM.