Fosamax: FOSAMAX (alendronate sodium) is indicated for: The treatment of osteoporosis in postmenopausal women.
For the treatment of osteoporosis, FOSAMAX increases bone mass and prevents fractures, including those of the hip and spine (vertebral compression fractures).
Osteoporosis may be confirmed by the finding of low bone mass (for example, at least 2.0 standard deviations below the premenopausal mean) or by the presence or history of osteoporotic fracture.
The treatment of osteoporosis in men to reduce the incidence of fractures.
Fosamax Plus: FOSAMAX PLUS (alendronate sodium/colecalciferol) is indicated for: Treatment of osteoporosis in postmenopausal women.
The treatment of osteoporosis in men.
For the treatment of osteoporosis, the alendronate sodium component of FOSAMAX PLUS increases bone mass and can prevent fractures, including those of the hip and spine (vertebral compression fractures).
Osteoporosis may be confirmed by the finding of low bone mass (for example, at least 2.5 standard deviations below the premenopausal mean) or by the presence or history of osteoporotic fracture.
Patients suffering from osteoporosis are at an increased risk for vitamin D insufficiency, especially those over the age of 70 years, home bound, or chronically ill, and may need to receive vitamin D supplementation in addition to that provided in FOSAMAX PLUS (see Dosage & Administration).
An adequate calcium intake is also required.
Patients with gastrointestinal malabsorption may not adequately absorb vitamin D3 and will also require further supplementation.
FOSAMAX PLUS alone should not be used to treat vitamin D deficiency (commonly defined as 25-hydroxyvitamin D <22.5 nmol/L or 9 ng/mL).
Geriatrics (≥65 years of age): Alendronate Sodium: In clinical studies, there was no age-related difference in the efficacy or safety profiles of FOSAMAX.
Colecalciferol: Fosamax Plus: Daily requirements of vitamin D3 may be increased in the elderly.
Pediatrics (<18 years of age): Fosamax: FOSAMAX is not indicated for use in children.
Fosamax Plus: FOSAMAX PLUS has not been studied in patients <18 years of age and should not be given to them.
Important limitations of use: The optimal duration of use has not been determined. Patients should have the need for continued therapy re-evaluated on a periodic basis (see DOSAGE & ADMINISTRATION).