Generic Name: alendronate sodium
Dosage Form: tablet, effervescent
Indications and Usage for Binosto
Treatment of Osteoporosis in Postmenopausal Women
Binosto effervescent tablet 70 mg is indicated for the treatment of osteoporosis in postmenopausal women. For the treatment of osteoporosis, alendronate sodium increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies (14.1).]
Treatment to Increase Bone Mass in Men With Osteoporosis
Binosto is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.2)].
Important Limitations of Use
The optimal duration of use has not been determined. The safety and effectiveness of Binosto for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-eva luated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-eva luated periodically.
Binosto Dosage and Administration
Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is one 70 mg effervescent tablet once weekly.
Treatment to Increase Bone Mass in Men With Osteoporosis
The recommended dosage is one 70 mg effervescent tablet once weekly.
Important Administration Instructions
Instruct patients to do the following to assure adequate drug absorption and to decrease the risk of esophageal adverse reactions: Waiting less than 30 minutes, or taking Binosto with food, beverages (other than plain water) or other medications will lessen the effect of Binosto by decreasing its absorption into the body [see Drug Interactions (7.1)].
Take Binosto upon arising for the day and at least 30 minutes before the first food, beverage, or medication of the day.
Dissolve the effervescent tablet in 4 ounces room temperature plain water only (not mineral water or flavored water).
Wait at least 5 minutes after the effervescence stops and then stir the solution for approximately 10 seconds and ingest.
Avoid lying down for at least 30 minutes after taking Binosto and until after their first food of the day.
Do not take Binosto at bedtime or before arising for the day.
Failure to follow these instructions may increase the risk of esophageal adverse reactions [see Warnings and Precautions (5.1)].
Recommendations for Calcium and Vitamin D Supplementation
Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate [see Warnings and Precautions (5.2)]. 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 and measurement of 25-hydroxyvitamin D should be considered.
Administration Instructions for Missed Doses
If the once-weekly dose is missed, instruct patients to take one dose on the morning after they remember. They should not take 2 doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.
Dosage Forms and Strengths
Binosto effervescent tablets are round, flat-faced, white to off-white tablets, 25 mm in diameter, with beveled e |
