Fosamax Plus D
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Questions & Answers
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FDA Labeling Changes
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Uses
FOSAMAX® PLUS D is indicated for:
For the treatment of osteoporosis, FOSAMAX PLUS D increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).
FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency.
The safety and effectiveness of FOSAMAX PLUS D for the treatment of osteoporosis are based on clinical data of four years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.
History
There is currently no drug history available for this drug.
Other Information
FOSAMAX PLUS D contains alendronate sodium, a bisphosphonate, and cholecalciferol (vitamin D3).
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 C4H12NNaO7P2•3H2O 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.
Cholecalciferol (vitamin D3) is a secosterol that is the natural precursor of the calcium-regulating hormone calcitriol (1,25 dihydroxyvitamin D3).
The chemical name of cholecalciferol is (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3-ol. The empirical formula of cholecalciferol is C27H44O and its molecular weight is 384.6. The structural formula is:
Cholecalciferol is a white, crystalline, odorless powder. Cholecalciferol is practically insoluble in water, freely soluble in usual organic solvents, and slightly soluble in vegetable oils.
FOSAMAX PLUS D for oral administration contains 91.37 mg of alendronate monosodium salt trihydrate, the molar equivalent of 70 mg of free acid, and 70 or 140 mcg of cholecalciferol, equivalent to 2800 or 5600 International Units (IU) vitamin D, respectively. Each tablet contains the following inactive ingredients: microcrystalline cellulose, lactose anhydrous, medium chain triglycerides, gelatin, croscarmellose sodium, sucrose, colloidal silicon dioxide, magnesium stearate, butylated hydroxytoluene, modified food starch, and sodium aluminum silicate.
Sources
Fosamax Plus D Manufacturers
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Physicians Total Care, Inc.
![Fosamax Plus D (Alendronate Sodium And Cholecalciferol) Tablet [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Fosamax Plus D | Physicians Total Care, Inc.
2.1 Treatment of Osteoporosis in Postmenopausal WomenThe recommended dosage is one 70 mg alendronate/2800 IU vitamin D3 or one 70 mg alendronate/5600 IU vitamin D3 tablet once weekly. For most osteoporotic women, the appropriate dose is FOSAMAX PLUS D (70 mg alendronate/5600 IU vitamin D3) once weekly.
2.2 Treatment to Increase Bone Mass in Men with OsteoporosisThe recommended dosage is one 70 mg alendronate/2800 IU vitamin D3 or one 70 mg alendronate/5600 IU vitamin D3 tablet once weekly. For most osteoporotic men, the appropriate dose is FOSAMAX PLUS D (70 mg alendronate/5600 IU vitamin D3) once weekly.
2.3 Dosing InstructionsFOSAMAX PLUS D must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only [see Medication Guide]. 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 FOSAMAX PLUS D with food, beverages (other than plain water) or other medications will lessen the effect of alendronate by decreasing its absorption into the body.
To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, FOSAMAX PLUS D should only be swallowed upon arising for the day with a full glass of water (6-8 oz) and patients should not lie down for at least 30 minutes and until after their first food of the day. FOSAMAX PLUS D 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); Medication Guide].
2.4 Recommendations for Calcium and Vitamin D SupplementationPatients should receive 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 additional 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.
The recommended intake of vitamin D is 400 IU-800 IU daily. FOSAMAX PLUS D 70 mg/2800 IU and 70 mg/5600 IU are intended to provide seven days’ worth of 400 and 800 IU daily vitamin D in a single, once-weekly dose, respectively.
Causes of osteoporosis other than estrogen deficiency, aging, and glucocorticoid use should be considered.
2.5 Dosing in Elderly and Renal InsufficiencyNo dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). FOSAMAX PLUS D is not recommended for patients with more severe renal insufficiency (creatinine clearance <35 mL/min) due to lack of experience.
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Merck Sharp & Dohme Corp.
Fosamax Plus D | Merck Sharp & Dohme Corp.
2.1 Treatment of Osteoporosis in Postmenopausal WomenThe recommended dosage is one 70 mg alendronate/2800 international units vitamin D3 or one 70 mg alendronate/5600 international units vitamin D3 tablet once weekly. For most osteoporotic women, the appropriate dose is FOSAMAX PLUS D (70 mg alendronate/5600 international units vitamin D3) once weekly.
2.2 Treatment to Increase Bone Mass in Men with OsteoporosisThe recommended dosage is one 70 mg alendronate/2800 international units vitamin D3 or one 70 mg alendronate/5600 international units vitamin D3 tablet once weekly. For most osteoporotic men, the appropriate dose is FOSAMAX PLUS D (70 mg alendronate/5600 international units vitamin D3) once weekly.
2.3 Important Administration InstructionsInstruct patients to do the following:
Take FOSAMAX PLUS D 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 FOSAMAX PLUS D with food, beverages (other than plain water) or other medications will lessen the effect of alendronate by decreasing its absorption into the body. Take FOSAMAX PLUS D upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, a FOSAMAX PLUS D tablet should be swallowed with a full glass of water (6-8 ounces). Patients should not lie down for at least 30 minutes and until after their first food of the day. FOSAMAX PLUS D 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)]. 2.4 Recommendations for Calcium and Vitamin D SupplementationInstruct 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 additional 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.
The recommended intake of vitamin D is 400-800 international units daily. FOSAMAX PLUS D 70 mg/2800 international units and 70 mg/5600 international units are intended to provide seven days' worth of 400 and 800 international units daily vitamin D in a single, once-weekly dose, respectively.
2.5 Administration Instructions for Missed DosesIf a once-weekly dose of FOSAMAX PLUS D is missed, instruct patients to take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.
![Fosamax Plus D (Alendronate Sodium And Cholecalciferol) Tablet [Merck Sharp & Dohme Corp.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c0ec7e75-03b9-4b5b-ca8b-58cb0f65b5d9&name=fosamax-plus-d-06.jpg)
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