Fosamax Indications and Dosage
hypercalcemia †
osteoporosis
osteoporosis prophylaxis
Paget’s disease
† non-FDA-approved indication
Fosamax Indications and Dosage
For the treatment of osteoporosis:
NOTE: The once daily, twice weekly, and once weekly administration regimens described below result in similar mean increases in lumbar spine, total hip, femoral neck, trochanter, and total body bone mineral density; all three regimens are shown to be equally effective.
once daily regimen:
Oral dosage (tablets):
Postmenopausal females: 10 mg PO once daily with supplemental calcium and vitamin D if dietary intake is inadequate. The safety and efficacy of alendronate in the treatment of osteoporosis has been studied for up to 7 years. Four years of alendronate therapy (5 mg/day for 2 years, then 10 mg/day for 2 years, compared to placebo) has been associated with increased bone mineral density at all sites evaluated, a 36% decrease in clinical fracture risk, and a 44% decrease of new vertebral fractures; increases in bone mineral density are significant only when baseline bone mineral density levels were >= 0.68 g/cm2.
Adult men: 10 mg PO once daily with supplemental calcium and vitamin D if dietary intake is inadequate; the safety and efficacy of alendronate in the treatment of osteoporosis has been studied for up to 7 years.
twice weekly regimen † :
Oral dosage (tablets):
Postmenopausal females: 35 mg PO twice weekly with supplemental calcium and vitamin D if dietary intake is inadequate; the safety and efficacy of alendronate in the treatment of osteoporosis has been studied for up to 7 years.
once weekly regimen:
Oral dosage (tablets):
Postmenopausal females: 70 mg PO once weekly with supplemental calcium and vitamin D if dietary intake is inadequate; the safety and efficacy of alendronate in the treatment of osteoporosis has been studied for up to 7 years.
Adult men: 70 mg PO once weekly may be considered as an alternative to a once daily administration regimen. Supplement calcium and vitamin D if dietary intake is inadequate.
Oral dosage (oral solution):
Postmenopausal females: 70 mg PO once weekly with supplemental calcium and vitamin D if dietary intake is inadequate.
Adult men: 70 mg PO once weekly may be considered as an alternative to a once daily administration regimen. Supplement calcium and vitamin D if dietary intake is inadequate.
for the treatment of glucocorticoid-induced osteoporosis in men and women who are taking systemic glucocorticosteroids (i.e., oral prednisone >= 7.5 mg/day or equivalent):
Oral dosage (tablets):
Adults: 5 mg PO once daily. For postmenopausal women who are not taking estrogen replacement, the dose is 10 mg PO daily. Supplement calcium and vitamin D if dietary intake is inadequate. Bone mineral density measurements should be made at baseline and repeated after 6 - 12 months of combined alendronate and glucocorticoid therapy; efficacy beyond 2 years has not been studied. Clinical trials show a significant increase in bone mineral density in patients with corticosteroid-induced osteoporosis who received alendronate 5 mg/day with calcium and vitamin D supplementation as compared to placebo. After two years of therapy, there was a significant decrease in the number of new vertebral fractures in patients treated with alendronate versus placebo; however, fractures mainly occurred in postmenopausal women.
For osteoporosis prophylaxis in postmenopausal women:
Oral dosage (tablets):
Adult females: 5 mg PO once daily or 35 mg PO once weekly. Supplement calcium and vitamin D if dietary intake is inadequate. The safety and efficacy of alendronate in the prevention of osteoporosis has been studied for up to 7 years.
For the treatment of Paget’s disease in symptomatic patients or patients with alkaline phosphatase levels at least twice the upper level of normal, or those at risk from complications:
Oral dosage (tablets):
Adults: 40 mg PO once daily for 6 months. Retreatment may be considered after a six-month post-treatment evaluation period, based on increases in serum alkaline phosphatase. Supplement calcium and vitamin D if dietary intake is inadequate. Treatment of Paget’s disease with alendronate for 6 months results in greater suppression of alkaline phosphatase than that achieved with etidronate. Investigation of bone structure after six months of alendronate therapy reveals normal lamellar bone formation where previously bone was woven and disorganized. A reduction in bone pain occurs in nearly all Paget’s disease patients treated with alendronate.
For the treatment of malignant hypercalcemia † :
Intravenous dosage (not available in the US) † :
Adults: In a randomized trial, patients with malignant hypercalcemia were treated with a single dose of alendronate (7.5 mg IV) or clodronate or were randomly allocated to a 2.5, 5, or 10 mg IV infusion of alendronate. In both groups, a second dose of alendronate 7.5 mg IV was given on the third day after infusion for plasma Ca > 2.70 mmol/L. Patients with relapsing hypercalcemia between days 6 and 22 after the first dose were given a single IV infusion of 12.5 mg of alendronate. Doses of 7.5 or 10 mg of alendronate IV appear to be effective. In another randomized trial of patients with malignant hypercalcemia, a single 2.5, 5, 10, or 15 mg IV infusion dose of alendronate was studied. Alendronate doses of 5 mg were effective in producing normocalcemia in most patients. At any time point over the initial 8 days posttreatment the 5- to 15-mg dose groups showed no significant differences in serum calcium concentrations, however 2.5 mg dose had significantly less effect.
Maximum Dosage Limits:
Adults: 10 mg/day PO or 70 mg/week PO for osteoporosis; 40 mg/day PO for Paget’s disease; maximum dosage for other indications/routes not available.
Elderly: 10 mg/day PO or 70 mg/week PO for osteoporosis; 40 mg/day PO for Paget’s disease; maximum dosage for other indications/routes not available.
Adolescents: Safe and effective use has not been established.
Children: Safe and effective use has not been established.
Patients with hepatic impairment:
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with renal impairment:
CrCl > 35 ml/min: No dosage adjustment needed.
CrCl <= 35 ml/min: Not recommended due to lack of experience in this patient population.
† non-FDA-approved indication
[ Last revised: 1/16/2006 5:45:00 PM ]
References
. Rizzoli R, Buchs B, Bonjour J-P. Effect of a single infusion of alendronate in malignant hypercalcemia; dose dependency and comparison with clodronate. Int J Cancer 1992;50:706 - 12.
. Nussbaum SR, Warrell Jr. RP, Rude R, et al. Dose-response study of alendronate sodium for the treatment of cancer-associated hypercalcemia. J Clin Oncol 1993;11:1618 - 23.
. chnitzer T, Bone HG, Crepaldi G, et al. Therapeutic equivalence of alendronate 70 mg once-weekly and alendronate 10 mg daily in the treatment of osteoporosis. Alendronate Once-Weekly Study Group. Aging (Milano) 2000;12:1 - 12.
. Saag KG, Emkey R, Schnitzer TJ et al. Alendronate for the prevention and treatment of glucocorticoid-induced osteoporosis. N Engl J Med 1998;339;292 - 9.
. Cummings SR, Black DM, Thompson DE, et al. Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures. JAMA 1998;280:2077 - 82.
Related entries
Syndicate
|
