ALENDRONATE SODIUM tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

alendronate sodium (UNII: 2UY4M2U3RA) (alendronic acid - UNII:X1J18R4W8P)

제공처:

Rebel Distributors Corp

INN (국제 이름):

alendronate sodium

구성:

alendronic acid 35 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

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.  They are supplied as follows:  NDC # 21695-901-04   Unit-of-use Blister Package of 4 70 mg - white to off-white oval tablet embossed with “AN70" on one side and “>” on the other side. They are supplied as follows: NDC # 21695-902-04 Unit-of-use Blister Package of 4   Store at 20 to 25°C (68 to 77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]. Manufactured by: Cipla Ltd Verna, Goa INDIA

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ALENDRONATE SODIUM- ALENDRONATE SODIUM TABLET
REBEL DISTRIBUTORS CORP
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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
continuously