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Five reasons to rethink your fracture protection choice. |
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The evidence for prescribing Actonel EC ® is stronger than ever. 1-8 |
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1. Supported by long-term data and real-world evidence. 1-4 2. Reduction in fracture risk from as early as 6 months. 5 3. No rebound effect on cessation of therapy. 6-8 4. Clinical monitoring of calcium levels not required before each dose. 6
Please see Product Information for monitoring requirements in special populations.
5. Enteric coated formula offers the convenience of morning dosing with or without food. 6
Does the treatment you’ re prescribing offer these benefits?
PROVEN FRACTURE PROTECTION 1-6
PBS Information: Restricted Benefit. Actonel EC Combi, Actonel EC Combi D. Authority Required( STREAMLINED). Refer to PBS schedule for full restricted and authority information.
PLEASE REVIEW PRODUCT INFORMATION BEFORE PRESCRIBING. FULL PRODUCT INFORMATION IS AVAILABLE FROM MEDICAL INFORMATION: 1800 AU TEVA( 1800 28 8382) OR ONLINE AT: HTTP:// WWW. GUILDLINK. COM. AU / GC / WS / TB / PI. CFM? PRODUCT = TBPACXEC10516
ACTONEL ® EC, ACTONEL ® EC COMBI & ACTONEL ® EC COMBI D. PRESENTATIONS: Actonel EC is available as 4 x 35mg risedronate sodium tablets. Actonel EC Combi contains: 4 Actonel EC 35 mg tablet and 24 calcium carbonate 1250mg( equivalent to 500mg elemental calcium) tablets. Actonel EC Combi D contains: 4 Actonel 35 mg tablets and 24 sachets containing 2500mg calcium carbonate and 22μg cholecalciferol, equivalent to 1000mg elemental calcium and 22μg( 880IU) vitamin D3 respectively. INDICATIONS: Actonel EC 35mg tablet, Actonel EC Combi, Actonel EC Combi D: Treatment of osteoporosis, treatment of glucocorticoid-induced osteoporosis, preservation of bone mineral density in patients on long term corticosteroid therapy. CONTRAINDICATIONS: Risedronate: Hypersensitivity to the drug or ingredients, hypocalcaemia, inability to stand or sit upright for at least 30 minutes. Calcium carbonate: Hypersensitivity to the drug or ingredients; hypercalcaemia; hypercalciuria; nephrolithiasis. Cholecalciferol: Hypercalcaemia; hypercalciuria; nephrolithiasis; hypervitaminosis D; diseases associated with hypercalcaemia and / or hypercalciuria; pregnancy and lactation; severe renal impairment. PRECAUTIONS: Risedronate: Hypocalcaemia; bone and mineral metabolism dysfunction; calcium and vitamin D if dietary intake is inadequate; severe renal impairment; oesophageal reaction, inflammatory bowel disease; osteonecrosis of the jaw; osteonecrosis of the external auditory canal; dental examination with preventive dentistry; avoid invasive dental procedures; atypical stress fractures; pregnancy( Category B3); certain medications( e. g. calcium supplements, antacids) should not be taken with Actonel EC; patients with a history of oesophagitis, gastritis, oesophageal ulcerations and gastroduodenal ulcerations. Calcium carbonate and / or Cholecalciferol: Impairment of renal functions; monitoring of serum calcium levels and renal function; other drugs containing vitamin D; sarcoidosis; immobilised patients due to the increased risk of hypercalcaemia; disease associated with unregulated overproduction of calcitriol; malabsorption. Actonel EC Combi / Actonel EC Combi D presentations only: for patients with mild-moderate renal impairment, absorptive or renal hypercalciuria, nephrocalcinosis, kidney stone formation, hypophosphataemia, renal function, serum and urinary calcium and phosphate should be monitored. INTERACTIONS: Risedronate does not induce or inhibit CYP450 enzymes. Calcium Carbonate / Cholecalciferol; serum calcium should be regularly monitored during concomitant use of thiazide diuretics; systemic corticosteroids reduce calcium absorption; may interfere with tetracycline absorption; may reduce bisphosphonate and sodium fluoride absorption; calcium absorption may be inhibited by oxalic acid and phytic acid; concomitant treatment with ion exchange resins( e. g. cholestyramine) or laxatives may reduce vitamin D absorption. Not recommended for concurrent use with antacids containing aluminium hydroxide in patients on haemodialysis. Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium combined with vitamin D. Such patients should be monitored with regard to electrocardiogram( ECG) and serum calcium levels. ADVERSE EVENTS: Risedronate: Very Common: nasopharyngitis. Common: abdominal and musculoskeletal pain, influenza, urinary tract infection, bronchitis, diarrhoea, constipation, vomiting, nausea, arthralgia, back pain, hypertension, hypercholesterolaemia. Uncommon: glossitis, iritis, and duodenitis, abnormal liver function tests. Postmarketing: vary rare: hypersensitivity and skin reactions, including angioedema, generalised rash and bulbous skin reaction, uveitis and osteonecrosis of the jaw. See full PI for others. Calcium carbonate and / or Cholecalciferol: Uncommon: hypercalcaemia, hypercalciuria. Rare: flatulence, constipation, nausea, abdominal pain, diarrhea, pruritus, rash and urticaria. DOSAGE AND ADMINISTRATION: Actonel EC 35mg tablets: take with a glass of plain water with or without food, Actonel EC should be taken in an upright position. Patient should avoid lying down for 30 minutes. Tablets must be swallowed whole. Actonel EC Combi: The recommended dose in adults is 1 Actonel EC 35mg tablet on the first day, then, beginning on the next day, 1 calcium 500 mg tablet daily for 6 days. This 7 day sequence is then repeated each week. Actonel EC Combi D: Intended for patients for whom the amount of calcium and cholecalciferol included is considered to provide adequate supplementation. The recommended dose is 1 Actonel EC 35mg tablet on the first day, followed by, beginning on the next day, 1 calcium carbonate / cholecalciferol sachet daily for 6 days. This 7 day sequence is then repeated each week starting with the Actonel EC 35mg tablet. See full PI for full information. STORAGE: store below 25 ° C. Sponsored in Australia by TEVA Pharma Australia Pty Ltd, ABN 41 169 715 664, Level 1, 37 Epping Road, Macquarie Park, Sydney, NSW 2113. Based on the PI last updated 11 May 2016.
REFERENCES: 1. Silverman SL et al. Osteoporos Int 2007; 18:25 – 34. 2. Harrington JT et al. Calcif Tissue Int 2004; 74:129 – 35. 3. Mellstrom DD et al. Calcif Tissue Int 2004; 75:462 – 68. 4. McClung MR et al. N End J Med 2001; 344:333-40. 5. Roux C et al. Curr Med Res Opin 2004; 20:433 – 39. 6. Actonel EC ® Product Information. 7. Adler RA et al. J Bone Miner Res 2016; 31:16 – 35. 8. Lamy O et al. J Clin Endocrinol Metab 2016 Oct 12 [ Epub ahead of print ].
TEVA Pharma Australia Pty Ltd, ABN 41 169 715 664. Level 1, 37 Epping Road, Macquarie Park, Sydney NSW 2113. P: 1800 AU TEVA( 1800 28 8382) F: + 61 2 8061 9999 www. tevapharma. com. au.
Date of preparation: May 2017. TEVA0118AD. ACTO-AU-00013.