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Alendronate sodium
Alendronate sodium (Fosamax)
Alendronate sodium
(ay-LEN-droh-nayt)
Pregnancy Category: C
Fosamax (Rx)
Classification:
Bone growth regulator (biphosphonate)
Action/Kinetics:
Binds to bone hydroxyapatite and inhibits osteoclast activity, thereby preventing bone resorption. Appears to reduce fracture risk and reverse the progression of osteoporosis. Does not inhibit bone mineralization. Well absorbed orally and initially distributed to soft tissues, but then quickly redistributed to bone. Not metabolized; excreted through the urine. t1/2, terminal believed to be more than 10 years, due to slow release from the skeleton.
Uses:
Prevention and treatment of osteoporosis in postmenopausal women. Glucocorticoid-induced osteoporosis in men and women receiving daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density. Paget's disease of bone in those with alkaline phosphatase at least two times the upper limit of normal or for those who are symptomatic or at risk for future complications from the disease.
Contraindications:
In hypocalcemia. Severe renal insufficiency (CCR less than 35 mL/min). Use of hormone replacement therapy with alendronate for osteoporosis in postmenopausal women. Lactation.
Special Concerns:
Use with caution in those with upper GI problems, such as dysphagia, symptomatic esophageal diseases, gastritis, duodenitis, or ulcers. Safety and effectiveness have not been determined in children or for use in male osteoporosis.
Side Effects:
GI: Flatulence, acid regurgitation, esophageal ulcer, dysphagia, abdominal distention, gastritis, abdominal pain, constipation, diarrhea, dyspepsia, N&V.; Miscellaneous: Musculoskeletal pain, pain, headache, taste perversion, rash and erythema (rare), back pain, glaucoma, accidental injury, edema, flu-like symptoms.
Laboratory Test Alterations:
 Serum calcium and phosphate.
Overdose Management:
Symptoms: Hypocalcemia, hypophosphatemia, upset stomach, heartburn, esophagitis, gastritis, ulcer. Treatment: Administration of milk or antacids to bind the drug should be considered.
Drug Interactions:
- Antacids / Absorption of alendronate
- Aspirin /
 Risk of upper GI side effects
- Calcium supplements / Absorption of alendronate
- Ranitidine / Bioavailability of alendronate (significance not known)
How Supplied:
Tablet: 5 mg, 10 mg, 40 mg
Dosage
•Tablets
Prevention of osteoporosis in postmenopausal women.
5 mg once a day in the morning 1/2 hr before the first food, beverage, or medication of the day with 6-8 oz of plain water.
Treatment of osteoporosis or prevention of fractures in postmenopausal women with osteoporosis.
10 mg once a day in the morning 1/2 hr before the first food, beverage, or medication of the day with 6-8 oz of plain water. Safety of treatment for more than 4 years has not been determined.
Treatment of glucocorticoid-induced osteoporosis in men and women receiving daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density.
5 mg once daily for men or women with low bone mineral density and 10 mg once daily for treatment of low bone mineral density in postmenopausal women who are receiving glucocorticoid therapy but not estrogen.
Paget's disease of bone.
40 mg once a day for 6 months taken as for osteoporosis. |
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