Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
Alendronate sodium
Takeda Pharmaceuticals Australia Pty Ltd
Medicine Registered
_Steovess Approved PI_ _ _ _Version 1 _ _Page 1 _ PRODUCT INFORMATION STEOVESS ® EFFERVESCENT TABLETS NAME OF THE MEDICINE Alendronate sodium CHEMICAL STRUCTURE Chemical Name (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate, Molecular formula: C 4 H 12 NNaO 7 P 2 .3H 2 O, MW: 325.12. CAS NUMBER 121268-17-5 DESCRIPTION Alendronate sodium is a white or almost white crystalline powder. It is soluble in water, very slightly soluble in methanol and practically insoluble in methylene chloride. Each effervescent tablet of Steovess contains 91.37 mg of alendronate sodium, which is the molar equivalent to 70 mg alendronic acid. In addition to the active ingredients, Steovess contains the following inactive ingredients: monosodium dihydrogen citrate, anhydrous citric acid, sodium bicarbonate, sodium carbonate anhydrous, acesulfame potassium, sucralose and strawberry flavour PHS-132962. Steovess contains 26.2 mmol (or 602.54 mg) sodium per dose. PHARMACOLOGY PHARMACOKINETICS Absorption Relative to an intravenous (IV) reference dose, the mean oral bioavailability of alendronate in women was 0.64% for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardised breakfast. There was substantial variability both within and between patients, coefficient of variation 63% and 77%, respectively. Oral bioavailability in men (0.6%) was similar to that in women. Bioavailability was decreased similarly (by approximately 40%) whether alendronate was administered one or one-half hour before a standardised breakfast. In osteoporosis and Paget’s disease studies, alendronate was effective when administered at least 30 minutes before the first food or beverage of the day. Bioavailability was negligible whether alendronate Aqra d-dokument sħiħ