ALENDRONATE SODIUM tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ALENDRONATE SODIUM (UNII: 2UY4M2U3RA) (alendronic acid - UNII:X1J18R4W8P)

Disponível em:

Dispensing Solutions Inc.

DCI (Denominação Comum Internacional):

ALENDRONATE SODIUM

Composição:

alendronic acid 70 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

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].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

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