Država: Filipini
Jezik: engleski
Izvor: FDA (Food And Drug Administration)
Alendronic Acid
Getz Pharma Phils., Inc.
Alendronic Acid
70mg
Tablet
Box of 1 Alu-Alu Blister pack x 4's, Alu-Alu Blister pack x 4's (box of 1's)
Getz Pharma (Pvt.)., Ltd., Pakistan
Anti-Osteoporotic
– In postmenopausal women for the treatment of osteoporosis to prevent fractures, including those of the hip and spine (vertebral compression fractures). – In postmenopausal women who are at risk of developing osteoporosis. – For the treatment of osteoporosis in men to prevent fractures. – For the treatment and prevention of glucocorticoid-induced osteoporosis in men and women. – For the treatment of Paget’s disease of bone in men and women.
2017-06-05
DESCRIPTION Alendronic Acid (Reventa ® ) is an aminobisphosphonate that acts as a potent inhibitor of bone resorption. Alendronic Acid is chemically described as (4-amino-1- hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The molecular formula is C 4 H 12 NNaO 7 P 2 •3H 2 O and the structural formula is FORMULATION Alendronic Acid (Reventa ® ) is available for oral administration as: Alendronic Acid (Reventa ® ) Tablets 70mg Each tablet contains: Alendronic Acid (as Alendronate sodium trihydrate) ... 70mg CLINICAL PHARMACOLOGY MECHANISM OF ACTION At the cellular level, alendronate shows preferential localization to sites of bone resorption, specifically under osteoclasts. The osteoclasts adhere normally to the bone surface but lack the ruffled border that is indicative of active resorption. Alendronate does not interfere with osteoclast recruitment or attachment, but it does inhibit osteoclast activity. While incorporated in bone matrix, alendronate is not pharmacologically active. Thus, alendronate must be continuously administered to suppress osteoclasts on newly formed resorption surfaces. PHARMACOKINETICS _Absorption_ Like other bisphosphonates, alendronate is poorly absorbed following oral administration. Absorption is decreased by food, especially by products containing calcium or other polyvalent cations. Bioavailability is about 0.4% when administered half an hour before food, reduced from 0.7% in the fasting state absorption is negligible when taken up to 2 hours after a meal. _Distribution_ The mean steady-state volume of distribution, exclusive of bone, is at least 28L in humans. Concentrations of drug in plasma following therapeutic oral doses are too low (less than 5ng/mL) for analytical detection. Protein binding in human plasma is approximately 78%. _Metabolism_ There is no evidence that alendronate is metabolized in animals or humans. _Elimination_ About half of the absorbed portion is excreted in the urine; the remainder is sequestered to bone for a prolonged period. The te Pročitajte cijeli dokument