Usual Adult Dose for Osteoporosis

• 70 mg alendronate-2800 IU cholecalciferol orally once a week or
• 70 mg alendronate-5600 IU cholecalciferol orally once a week

• Refer to administration advice for details on how to take this drug.
• Reevaluate bisphosphonate therapy periodically.

• Treatment to increase bone mass and reduce the incidence of fractures, including those of the hip and spine (vertebral compression fractures) in postmenopausal women
• Treatment to increase bone mass in men with osteoporosis

Renal Dose Adjustments

CrCl 35 to 60 mL/min: No adjustment recommended.
CrCl less than 35 mL/min: Not recommended.

Liver Dose Adjustments

No adjustment recommended.

Precautions

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

Consult WARNINGS section for additional precautions.

Dialysis

In case of overdosage, dialysis to remove this drug would not be beneficial.

Other Comments

Administration advice:

• Take this drug on an empty stomach, with a full glass of plain water (6 to 8 ounces), upon arising for the day, and 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.
• Waiting less than 30 minutes, or taking this drug with food, beverages (other than plain water) or other medications will decrease drug's absorption and lessen its therapeutic effect.
• This drug should not be taken at bedtime or before arising for the day; failure to follow these instructions may increase the risk of esophageal adverse reactions.

• Supplemental calcium should be taken 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 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 to 800 IU daily; this drug is intended to provide seven days' worth of 400 and 800 IU daily vitamin D in a single, once-weekly dose.

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

• This drug alone should not be used to treat vitamin D deficiency.
• The optimal duration of use has not been determined.
• All patients on bisphosphonate therapy should be reevaluated for continued therapy on a periodic basis.
• Patients at low-risk for fracture should consider drug discontinuation after 3 to 5 years of use.
• Reevaluate risk for fractures periodically after discontinuing therapy.

• Metabolic: Serum calcium and symptoms of hypocalcemia
• Renal: Urine calcium levels

• Report any side effect that bothers or that does not go away.
• Failure to follow administration instructions for this drug may increase the risk of esophageal adverse reactions.
• Discontinue this drug and seek medical attention if dysphagia, odynophagia, retrosternal pain or new or worsening heartburn develop.