DOSAGEAND 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 ].
- 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].
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]. 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
edges, with “M” debossed on one side, containing 91.37 mg of alendronate
sodium, which is equivalent to 70 mg of free alendronic acid.
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