Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ALENDRONATE SODIUM (UNII: 2UY4M2U3RA) (alendronic acid - UNII:X1J18R4W8P)
Dispensing Solutions Inc.
ALENDRONATE SODIUM
alendronic acid 70 mg
ORAL
PRESCRIPTION DRUG
Alendronate sodium tablets, USP are indicated for: - Treatment and prevention of osteoporosis in postmenopausal women For the treatment of osteoporosis, alendronate sodium tablets, USP increase bone mass and reduce the incidence of fractures, including those of the hip and spine (vertebral compression fractures). Osteoporosis may be confirmed by the finding of low bone mass (for example, at least 2 standard deviations below the premenopausal mean) or by the presence or history of osteoporotic fracture. (See CLINICAL PHARMACOLOGY, Pharmacodynamics.) For the prevention of osteoporosis, alendronate sodium tablets, USP may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of future fracture. Bone loss is particularly rapid in postmenopausal women younger than age 60. Risk factors often associated with the development of postmenopausal osteoporosis include early menopause; modera
Alendronate sodium tablets, USP for oral administration, are available as: 35 mg - white to off-white oval tablet embossed with “AN35" on one side and “>”on the other side. 40 mg - white to off-white round tablet embossed with “AN" over “40”on one side and “>” on the other side. 70 mg - white to off-white oval tablet embossed with “AN70" on one side and “>” on the other side. They are supplied by Dispensing Solutions Inc. as follows: This product was Manufactured By: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG06, Malta Manufactured for: Cobalt Laboratories, Bonita Springs, Florida, U.S.A. 34134 And Relabeled By: Dispensing Solutions Inc. 3000 West Warner Ave Santa Ana, CA 92704 United States Store at 20 to 25°C (68 to 77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature].
Abbreviated New Drug Application
ALENDRONATE SODIUM - ALENDRONATE SODIUM TABLET DISPENSING SOLUTIONS INC. ---------- ALENDRONATE SODIUM TABLETS, USP DESCRIPTION Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. The empirical formula of alendronate sodium is C H NNaO P •3H O and its formula weight is 325.12. The structural formula is: Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. Each tablet, for oral administration, contains 45.68 mg, 52.21 mg or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 35 mg, 40 mg and 70 mg, respectively, of free acid, and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Animal studies have indicated the following mode 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. Studies in mice on the localization of radioactive [ H]alendronate in bone showed about 10- fold higher uptake on osteoclast surfaces than on osteoblast surfaces. Bones examined 6 and 49 days after [ H]alendronate administration in rats and mice, respectively, showed that normal bone was formed on top of the alendronate, which was incorporated inside the matrix. While incorporated in bone matrix, alendronate is not pharmacologically active. Thus, alendronate must be continuous Přečtěte si celý dokument