Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
alendronate sodium
Accord Healthcare Pty Ltd
alendronate sodium
Registered
PHARMACOR ALENDRONATE 10 CONSUMER MEDICINE INFORMATION VERSION 1.0 2010 - 1 - PHARMACOR ALENDRONATE 10 ALENDRONATE SODIUM TABLETS 10 MG CONSUMER MEDICINE INFORMATION (CMI) _WHAT IS IN THIS LEAFLET _ This leaflet answers some common questions about PHARMACOR ALENDRONATE. It is particularly important that you read the sections “When to take it” and “How to take it” before you take this medicine. The leaflet does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking PHARMACOR ALENDRONATE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again . _WHAT IS PHARMACOR _ _ALENDRONATE USED _ _FOR _ PHARMACOR ALENDRONATE is used to treat osteoporosis. It is also used to treat and prevent osteoporosis in post menopausal women who are receiving corticosteroid medicines, such as prednisone and dexamethasone, if they are not receiving oestrogen. In addition, PHARMACOR ALENDRONATE is also indicated for prevention of Osteoporosis in post menopausal women with low bone mass (at least 1 standard deviation below the mean for young adults) not receiving oestrogen. Glucocorticoid- induced osteoporosis in those patients on long term corticosteroid therapy These conditions are caused by changes in the way bone is normally maintained. _UNDERSTANDING BONE _ Bone is living, growing tissue. Throughout life, our bodies are breaking down old bone and rebuilding new bone in a continuous cycle. Until our late 20s, while bones are still developing, we gain bone by building more than we lose. From then until about age 35 the process is usually in balance, so that the amount of bone lost is about equal to the amount that is replaced. After about age 35 this balance is disturbed, with bone loss occurring at a slightly faster rate than it can be Prečítajte si celý dokument
PRODUCT INFORMATION: PHARMACOR ALENDRONATE 10 (Alendronate Sodium Tablets 10 mg) Ver.1.0 2010 - 1 - PRODUCT INFORMATION PHARMACOR ALENDRONATE 10 (ALENDRONATE SODIUM TABLETS 10MG ) NAME OF THE MEDICINE Alendronate Sodium Chemical name: (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. Molecular formula: C 4 H 12 NNaO 7 P 2 •3H 2 O, The molecular weight is 325.12 CAS Registry Number is: 121268-17-5 The structural formula is DESCRIPTION Alendronate sodium, is a bisphosphonate that acts as a potent, specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. PHARMACOR ALENDRONATE (Alendronate Sodium) is available as 10 mg oral uncoated tablets. Each tablet of PHARMACOR ALENDRONATE 10 contains 13.05 mg of alendronate sodium, which is the molar equivalent to 10 mg of alendronic acid. In addition to the active ingredient alendronate sodium, each PHARMACOR ALENDRONATE 10 mg tablet contains the following inactive ingredients: Cellulose- microcrystalline, lactose anhydrous, croscarmellose sodium and magnesium stearate. PRODUCT INFORMATION: PHARMACOR ALENDRONATE 10 (Alendronate Sodium Tablets 10 mg) Ver.1.0 2010 - 2 - PHARMACOLOGY PHARMACOKINETIC PROPERTIES 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 osteop Prečítajte si celý dokument