FOSAMAX- alendronate sodium tablet FOSAMAX- alendronate sodium tablet, coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

ALENDRONATE SODIUM (UNII: 2UY4M2U3RA) (ALENDRONIC ACID - UNII:X1J18R4W8P)

Dostupno od:

Physicians Total Care, Inc.

INN (International ime):

ALENDRONATE SODIUM

Sastav:

ALENDRONATE SODIUM 5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

FOSAMAX is indicated for: - Treatment and prevention of osteoporosis in postmenopausal women For the treatment of osteoporosis, FOSAMAX increases bone mass and reduces 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, FOSAMAX 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; moderately low bone mass (for example, at least 1 standard deviatio

Proizvod sažetak:

No. 3759 — Tablets FOSAMAX, 5 mg, are white, round, uncoated tablets with an outline of a bone image on one side and code MRK 925 on the other. They are supplied as follows: NDC 54868-4384-0 bottles of 30. No. 3797 — Tablets FOSAMAX, 10 mg, are white, oval, wax-polished tablets with code MRK on one side and 936 on the other. They are supplied as follows: NDC 54868-3857-0 bottles of 30. No. 3813 — Tablets FOSAMAX, 35 mg, are white, oval, uncoated tablets with code 77 on one side and a bone image on the other. They are supplied as follows: NDC 54868-4463-0 bottle of 4. No. 3814 — Tablets FOSAMAX, 70 mg, are white, oval, uncoated tablets with code 31 on one side and an outline of a bone image on the other. They are supplied as follows: NDC 54868-4462-0 bottle of 4 NDC 54868-4462-1 bottle of 12. FOSAMAX Tablets: Store in a well-closed container at room temperature, 15-30°C (59-86°F). FOSAMAX Oral Solution: Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Do not freeze. MERCK & CO., INC., Whitehouse Station, NJ 08889, USA Issued February 2008 Printed in USA 9635608 9636808

Status autorizacije:

New Drug Application

Svojstava lijeka

FOSAMAX - ALENDRONATE SODIUM TABLET
FOSAMAX - ALENDRONATE SODIUM TABLET, COATED
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
FOSAMAX1 (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.
Tablets FOSAMAX for oral administration contain 6.53, 13.05, 45.68,
52.21 or 91.37 mg of alendronate
monosodium salt trihydrate, which is the molar equivalent of 5, 10,
35, 40 and 70 mg, respectively, of
free acid, and the following inactive ingredients: microcrystalline
cellulose, anhydrous lactose,
croscarmellose sodium, and magnesium stearate. Tablets FOSAMAX 10 mg
also contain carnauba wax.
Each bottle of the oral solution contains 91.35 mg of alendronate
monosodium salt trihydrate, which is
the molar equivalent to 70 mg of free acid. Each bottle also contains
the following inactive ingredients:
sodium citrate dihydrate and citric acid anhydrous as buffering
agents, sodium saccharin, artificial
raspberry flavor, and purified water. Added as preservatives are
sodium propylparaben 0.0225% and
sodium butylparaben 0.0075%.
1
Registered trademark of MERCK & CO., Inc.
COPYRIGHT © 1995, 1997, 2000 MERCK & CO., Inc.
All rights reserved
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
4
12
7
2
2
adhere normally to the bone surface but lack the ruffled border that
i