Drug Catalog - Product Detail
ALENDRONATE SODIUM ORAL SOLUTION SOL 70MG/5ML 4X75ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 51224-0301-10 | TAGI PHARMA | 75 | 70MG/75ML | NA |
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Description
11 DESCRIPTION Alendronate Sodium Oral Solution 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 USP is a white powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. 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: citric acid (anhydrous), methylparaben, propylparaben, purified water, raspberry blend, saccharin sodium and sodium citrate. chem.jpg
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Alendronate Sodium Oral Solution 70 mg oral solution is supplied as a clear, colorless to pale pink solution with a raspberry flavor. NDC 51224-301-10 unit-of-use cartons of 4 single-dose bottles containing 75 mL each Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not freeze.
Indications & Usage
1 INDICATIONS AND USAGE Alendronate Sodium Oral Solution is a bisphosphonate indicated for: • Treatment of osteoporosis in postmenopausal women ( 1.1 ) • Treatment to increase bone mass in men with osteoporosis ( 1.3 ) Limitations of use: Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. ( 1.6 ) 1.1 Treatment of Osteoporosis in Postmenopausal Women Alendronate sodium is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures) [see Clinical Studies ( 14.1 ) ] . 1.3 Treatment to Increase Bone Mass in Men with Osteoporosis Alendronate sodium is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies ( 14.3 ) ] . 1.6 Important Limitations of Use The optimal duration of use has not been determined. The safety and effectiveness of alendronate for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • Treatment of osteoporosis in postmenopausal women and in men: 70 mg (oral solution) once weekly. ( 2.1 , 2.3 ) • Instruct patients to: ( 2.6 ) o Swallow oral solution followed by at least 2 ounces of water. o Not lie down for at least 30 minutes after taking alendronate sodium oral solution and until after food. 2.1 Treatment of Osteoporosis in Postmenopausal Women The recommended dosage is: • one bottle of 70 mg oral solution once weekly 2.3 Treatment to Increase Bone Mass in Men with Osteoporosis The recommended dosage is: • one bottle of 70 mg oral solution once weekly 2.6 Important Administration Instructions Instruct patients to do the following: • Take alendronate at least one-half hour before the first food, beverage, or medication of the day with plain water only [see Patient Counseling Information ( 17.2 ) ] . Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate [see Drug Interactions ( 7.1 ) ] . Waiting less than 30 minutes, or taking alendronate with food, beverages (other than plain water) or other medications will lessen the effect of alendronate by decreasing its absorption into the body. • Take alendronate upon arising for the day. To facilitate gastric emptying alendronate oral solution should be followed by at least 2 ounces (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. Alendronate 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 and Precautions ( 5.1 ) and Patient Counseling Information ( 17.2 ) ] . 2.7 Recommendations for Calcium and Vitamin D Supplementation Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions ( 5.2 ) ] . Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D. 2.8 Administration Instructions for Missed Doses If a once-weekly dose of alendronate sodium is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day .