Drug Catalog - Product Detail
ALENDRONATE SODIUM TB 35MG 4 UD
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 16252-0599-44 | ACTAVIS PHARMA | 4 | 35MG | TABLET |
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Description
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 4 H 12 NNaO 7 P 2 •3H 2 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. fosamax_structure
How Supplied
HOW SUPPLIED 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 # 16252-599-44 Unit-of-use Blister Package of 4 NDC # 16252-599-02 Unit-of-use Blister Package of 12 40 mg - white to off-white round tablet embossed with “AN" over “40”on one side and “>” on the other side. They are supplied as follows: NDC # 16252-600-30 Unit-of-use Bottle of 30 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 # 16252-601-44 Unit-of-use Blister Package of 4 NDC # 16252-601-02 Unit-of-use Blister Package of 12 Storage 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 for: Cobalt Laboratories Bonita Springs, Florida, U.S.A. 34134 Item Number: LFT0151AA Date: March 2009
Indications & Usage
INDICATIONS AND USAGE 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; 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 alendronate sodium tablets, USP 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 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
DOSAGE AND ADMINISTRATION Alendronate sodium tablets, USP 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 alendronate sodium tablets (see PRECAUTIONS, Drug Interactions ). Waiting less than 30 minutes, or taking alendronate sodium tablets with food, beverages (other than plain water) or other medications will lessen the effect of alendronate sodium tablets by decreasing its absorption into the body. Alendronate sodium tablets should only be taken upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, an alendronate sodium tablet should be swallowed with a full glass of water (6 - 8 oz). Patients should not lie down for at least 30 minutes and until after their first food of the day. Alendronate sodium tablets 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). Alendronate sodium tablets are 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 AND USAGE ) The recommended dosage is: one 70 mg tablet once weekly or one 10 mg tablet once daily Treatment to increase bone mass in men with osteoporosis The recommended dosage is: one 70 mg tablet once weekly or one 10 mg tablet once daily Prevention of osteoporosis in postmenopausal women (see INDICATIONS AND USAGE ) The recommended dosage is: one 35 mg tablet once weekly or one 5 mg tablet once daily The safety of treatment and prevention of osteoporosis with alendronate sodium tablets has been studied for up to 7 years. Treatment of glucocorticoid-induced osteoporosis in men and women The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily. Paget's disease of bone in men and women The recommended treatment regimen is 40 mg once a day for six months. Retreatment of Paget's disease In clinical studies in which patients were followed every six months, relapses during the 12 months following therapy occurred in 9% (3 out of 32) of patients who responded to treatment with alendronate sodium tablets. Specific retreatment data are not available, although responses to alendronate sodium tablets were similar in patients who had received prior bisphosphonate therapy and those who had not. Retreatment with alendronate sodium tablets may be considered, following a six-month post-treatment evaluation period in patients who have relapsed, based on increases in serum alkaline phosphatase, which should be measured periodically. Retreatment may also be considered in those who failed to normalize their serum alkaline phosphatase.