Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
Alendronate sodium
Ranbaxy Australia Pty Ltd
Medicine Registered
Ossmax CMI V5 Mar 2010 Page 1 of 9 OSSMAX ® ALENDRONATE (AS ALENDRONATE SODIUM) 70 MG ONCE-WEEKLY TABLETS CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OSSMAX (alendronate). It 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 OSSMAX against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING/TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with this medicine. You may need to read it again. WHAT OSSMAX IS USED FOR OSSMAX contains alendronate. OSSMAX is used to treat osteoporosis. This condition is 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 an even faster rate. When bone loss is excessive, bones can become thinner and weaker, and therefore are more likely to break. _OSTEOPOROSIS _ _Osteo_ means bone, and _porosis _means something that has holes in it, like a sponge. Therefore, osteoporosis is a disease, which causes bones to become more porous, gradually making them weaker, more brittle and likely to break. Osteoporosis is common in postmenopausal women. The menopause occurs when the ovaries virtually stop producing the femal Přečtěte si celý dokument
OSSMAX PI V6 Mar 2010 Page 1 of 22 OSSMAX (ALENDRONATE TABLETS) OSSMAX 5 mg Tablets, OSSMAX 10 mg Tablets, OSSMAX 70 mg Tablets Alendronate sodium _CAS Number_:_ _129318-43-0. DESCRIPTION OSSMAX 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 OSSMAX contains either 5.442, 10.884 or 76.188 mg of alendronate sodium anhydrous, which is the molar equivalent to 5.0, 10.0 and 70 mg respectively of alendronic acid. OSSMAX tablets contain 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 OSSMAX PI V6 Mar 2010 Page 2 of 22 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 a Přečtěte si celý dokument