Usual Adult Dose for Osteoporosis

10 mg orally once a day or 70 mg orally once a week

For the Treatment of Glucocorticoid-Induced Osteoporosis: 5 mg orally once a day
For the Treatment of Glucocorticoid-Induced Osteoporosis in Postmenopausal Women Not Receiving Estrogen: 10 mg orally once a day

Comments:

• In postmenopausal women, this drug increases bone mass and reduces the incidence of fractures including those of the hip and spine (vertebral compression fractures).
• This drug increased bone mass in men with osteoporosis.
• The optimal duration of use has not been determined; data is based on clinical use of 4 years.
• Patients receiving therapy should have use re-evaluated on a periodic basis; patients with a low risk of fracture should consider stopping therapy after 3 to 5 years of use.
• Once therapy is discontinued, patients should have their fracture risk re-evaluated periodically.

Uses: For the treatment of osteoporosis in postmenopausal women, men with osteoporosis, and men and women with glucocorticoid-induced osteoporosis receiving glucocorticoids in a daily dose equivalent to 7.5 mg or greater of prednisone who have low bone mineral density.

Usual Adult Dose for Prevention of Osteoporosis

5 mg orally once a day or 35 mg orally once a week

Comments:

• The optimal duration of use has not been determined; data is based on clinical use of 4 years.
• Patients receiving therapy should have use re-evaluated on a periodic basis; patients with a low risk of fracture should consider stopping therapy after 3 to 5 years of use.
• Once therapy is discontinued, patients should have their fracture risk re-evaluated periodically.

Use: Prevention of osteoporosis in postmenopausal women

Usual Adult Dose for Paget's Disease

40 mg orally once a day for 6 months

Comments:

• Treatment is indicated in patients who have alkaline phosphatase at least 2 x the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.
• Retreatment may be considered, following a 6- month post-treatment evaluation period in patients who have relapsed, based on increases in serum alkaline phosphatase, which should be measured periodically.
• Retreatment may also be considered in patients who failed to normalize serum alkaline phosphatase.

Use: Treatment of Paget's disease of bone

Renal Dose Adjustments

CrCl 35 mL/min or more: No adjustment recommended
CrCl less than 35 mL/min: Not recommended

Liver Dose Adjustments

No adjustment recommended

Precautions

• Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia
• Inability to stand or sit upright for at least 30 minutes
• Hypocalcemia
• Hypersensitivity to active substance or any of the ingredients; hypersensitivity reactions have included urticaria and angioedema
• Increased risk of aspiration (oral solution)

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be taken at least 30 minutes before the first food, beverage, or medication of the day
• Avoid lying down for at least 30 minutes after taking this drug AND until after the first food of the day
• Take with plain water only: do not take with mineral water, coffee, tea, soda, or juice, etc.
• Tablets: Take with a full glass of plain water (6 to 8 ounces)
• Oral Solution: Follow with at least 2 ounces of water
• Effervescent Tablet: Dissolve effervescent tablet in 4 ounces of plain room temperature water; after effervescence stops, wait 5 minutes, then stir solution for 10 seconds, and consume

Recommendations for Calcium and Vitamin D Supplementation:

• Take supplemental calcium and vitamin D if dietary intake is inadequate
• 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; measurement of 25-hydroxyvitamin D should be considered
• Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D

Missed Doses:

• If the once-weekly dose is missed, take dose on the morning after remembering; two doses should not be taken on the same day; resume regular schedule

General:

• Optimal duration of use has not been determined; use should be reevaluated periodically.
• Patients at low-risk for fracture should consider drug discontinuation after 3 to 5 years of use.
• Patients who discontinue therapy should have their risk for fracture reevaluated periodically.

Monitoring:

• Metabolic: Monitor serum calcium and hypocalcemia symptoms in patients with disorders affecting mineral metabolism

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
• Patients should be instructed to take supplemental calcium and vitamin D if their daily dietary intake is inadequate.
• Patients should be instructed on proper administration instructions.