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Alendronate Sodium 35mg Tablets 1X4 Each Unit Dose Package By Watson Labs

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Alendronate Sodium 35mg Tablets 1X4 Each Unit Dose Package By Watson Labs

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Alendronate Sodium 35mg Tablets 1X4 Each Unit Dose Package By Watson Labs Item No.:This Item Requires A Valid Order From A Physician Licensed in USA. RXD4100210/RXB10022502 Item Profile
Generic For Fosamax
NDC No. 00591317104
Generic Name: Alendronate Sodium
Additional Description: Bpk
Strength: 35mg
Form Tabs
Size 4 Each. Unit of Measure Each
Unit of Sale Each
Unit Dose Uu
Schedule No. 0
Private Label 999
Multi-Source Y
Active Status Active
Generic Ind.

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ALENDRONATE SODIUM TABLETS 35 mg
NDC: 00591-3171-04
*Compare to: Fosamax?

Color/Shape: White / Capsule Shaped
Inscription: WPI 3171

CLICK HERE FOR Prescribing Information /a>


Brand Name: FOSAMAX?
(alendronate sodium) Tablets and Oral solution

DRUG DESCRIPTION

FOSAMAX* (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.

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%.

INDICATIONS

FOSAMAX is indicated for:

* Treatment and prevention of osteoporosis in postmenopausal women
o 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.)
o 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 deviation below the mean for healthy young adult women) thin body build Caucasian or Asian race and family history of osteoporosis. The presence of such risk factors may be important when considering the use of FOSAMAX for prevention of osteoporosis.
* Treatment to increase bone mass in men with osteoporosis
* Treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density (see PRECAUTIONS, Glucocorticoid-induced osteoporosis). Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
* Treatment of Paget's disease of bone in men and women
o Treatment is indicated in patients with Paget's disease of bone having alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.

DOSAGE AND ADMINISTRATION

FOSAMAX must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only (see PRECAUTIONS, Information for Patients). Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of FOSAMAX (see PRECAUTIONS: DRUG INTERACTIONS). Waiting less than 30 minutes, or taking FOSAMAX with food, beverages (other than plain water) or other medications will lessen the effect of FOSAMAX by decreasing its absorption into the body.

FOSAMAX should only be taken upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, a FOSAMAX tablet should be swallowed with a full glass of water (6-8 oz). To facilitate gastric emptying FOSAMAX oral solution should be followed by at least 2 oz (a quarter of a cup) of water. Patients should not lie down for at least 30 minutes and until after their first food of the day. FOSAMAX should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences (see WARNINGS, PRECAUTIONS, Information for Patients).

Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate (see PRECAUTIONS, General).

No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). FOSAMAX is not recommended for patients with more severe renal insufficiency (creatinine clearance < 35 mL/min) due to lack of experience.
Treatment of osteoporosis in postmenopausal women

(see INDICATIONS)

The recommended dosage is:

* one 70 mg tablet once weekly
or