Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
Alendronate sodium
Actavis Pty Ltd
Medicine Registered
Alendronate-GA CMI v4 100501 1 of 4 _ _ _ALENDRONATE-GA _ _70 mg Once Weekly _ _Alendronate sodium_ Consumer Medicine Information WHAT IS IN THIS LEAFLET This leaflet answers some common questions about _ALENDRONATE-_ _GA_. 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 _ALENDRONATE-GA_ 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 _ALENDRONATE-GA_ IS USED FOR _ALENDRONATE-GA_ is used to treat osteoporosis.It is also used to treat or prevent osteoporosis in people who are receiving corticosteroid medicines, such as prednisone and dexamethasone. In addition, _ALENDRONATE-GA_ is used to prevent osteoporosis in postmenopausal women who have low bone mass. 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 replaced. In women, after menopause, hormonal changes cause bone loss at a Soma hati kamili
Alendronate-GA V6 100913 Page 1 of 19 ALENDRONATE-GA (ALENDRONATE 70 MG TABLETS) NAME OF THE MEDICINE Alendronate sodium _CAS Number_:_ _129318-43-0. DESCRIPTION ALENDRONATE-GA tablets contain alendronate sodium anhydrous, which is described chemically as: (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt. The molecular formula of Alendronate sodium anhydrous is C 4 H 12 NO 7 P 2 Na and molecular weight is 271.1. Alendronate sodium anhydrous is a white or almost white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate is a bisphosphonate that acts as a potent, specific inhibitor of osteoclast-mediated bone resorption. STRUCTURAL FORMULA OF ALENDRONATE Each tablet of ALENDRONATE-GA contains 76.188 mg of alendronate sodium anhydrous, which is the molar equivalent to 70 mg of alendronic acid. ALENDRONATE-GA tablets contain the following inactive ingredients: Mannitol, Croscarmellose Sodium, Magnesium stearate, Purified Talc, Colloidal Anhydrous Silica. PHARMACOLOGY • PHARMACODYNAMIC PROPERTIES Alendronate is a bisphosphonate that, in animal studies, localizes preferentially to sites of bone resorption, specifically under osteoclasts, and inhibits osteoclastic bone resorption with no direct Alendronate-GA V6 100913 Page 2 of 19 effect on bone formation. Since bone formation and bone resorption are coupled, bone formation is also reduced, but less so than resorption, leading to progressive gains in bone mass. Following exposure to alendronate, normal bone is formed that incorporates alendronate into its matrix where it is pharmacologically i Soma hati kamili