Generic name: alendronate sodium
(ah len‘ dro nate)
Brand name: Fosamax
Pregnancy Category C
- Calcium regulator
Slows normal and abnormal bone resorption without inhibiting bone formation and mineralization.
- Treatment and prevention of osteoporosis in postmenopausal women
- Treatment of men with osteoporosis
- Treatment of glucocorticoid-induced osteoporosis
- Treatment of Paget’s disease of bone in patients with alkaline phosphatase at least two times upper limit of normal, those who are symptomatic, those at risk for future complications
Contraindications and cautions
- Contraindicated with allergy to biphosphonates; hypocalcemia.
- Use cautiously with renal dysfunction, upper GI disease, pregnancy, lactation.
Tablets—5, 10, 35, 40, 70 mg
- Postmenopausal osteoporosis: 10 mg/day PO in AM with full glass of water, at least 30 min before the first beverage, food, or medication of the day, or 70 mg PO once a week. Avoid lying down for 30 min after taking drug.
- Males with osteoporosis: 10 mg/day PO.
- Prevention of osteoporosis: 5 mg/day PO or 35 mg PO once a week.
- Paget’s disease: 40 mg/day PO in AM with full glass of water, at least 30 min before the first beverage, food, or medication of the day for 6 mo; may retreat after 6-mo treatment-free period.
- Glucocorticoid-induced osteoporosis: 5 mg/day PO with calcium and vitamin D.
Safety and efficacy not established.
PATIENTS WITH RENAL IMPAIRMENT
Dosage adjustment not necessary for creatinine clearance 35–60 mL/min; not recommended if creatinine clearance < 35 mL/min.
Metabolism: Not metabolized; T1/2: More than 10 yr
Distribution: Crosses placenta; may enter breast milk
- CNS: Headache
- GI: Nausea, diarrhea, GI irritation, pain, esophageal erosion
- Skeletal: Increased or recurrent bone pain, focal osteomalacia
- Increased risk of GI distress with aspirin
- Decreased absorption if taken with antacids, calcium, iron, multivalent cations; separate dosing by at least 30 min
- Significantly decreased absorption and serum levels if taken with food; separate dosing from food and beverage by at least 30 min
CLINICAL ALERT!Name confusion has occurred between Fosamax (alendronate) and Flomax (tamsulosin); use caution.
- History: Allergy to bisphosphonates, renal failure, upper GI disease, lactation, pregnancy
- Physical: Muscle tone, bone pain; bowel sounds; urinalysis, serum calcium
- WARNING: Give in AM with full glass of water at least 30 min before the first beverage, food, or medication of the day. Patient must stay upright for 30 min.
- Monitor serum calcium levels before, during, and after therapy.
- Ensure 6-mo rest period after treatment for Paget’s disease if retreatment is required.
- Ensure adequate vitamin D and calcium intake.
- Provide comfort measures if bone pain returns.
- Take drug in morning with a full glass of plain water (not mineral water), at least 30 min before any beverage, food, or medication, and stay upright for 30 min and until after the first food of the day.
- You may experience these side effects: Nausea, diarrhea; bone pain, headache (analgesic may help).
- Report twitching, muscle spasms, dark-colored urine, severe diarrhea.