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Binosto

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Binosto

Indications
Dosage
How Supplied

INDICATIONS

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]

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].

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-evaluated 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 reevaluated periodically.

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].

  • 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.

HOW SUPPLIED

Dosage Forms And Strengths

BINOSTO effervescent tablets are round, flat-faced, white to off-white tablets, 25 mm in diameter, with beveled edges containing 91.37 mg of alendronate sodium, which is equivalent to 70 mg of free alendronic acid.

Storage And Handling

BINOSTO effervescent tablets are round, flat faced, white to off-white tablets with beveled edges. BINOSTO effervescent tablets, 70 mg are provided in blisters made of aluminum foil composite, as follows:

NDC 0178-0101-02 carton containing 4 units of use blisters
NDC 0178-0101-03 carton containing 12 units of use blisters

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F), [See USP Controlled Room Temperature.] Protect from moisture. Store tablets in original blister package until use.

Manufactured for: Mission Pharmacal Company, San Antonio, TX 78230-1355. Revised: 04/2013

Last reviewed on RxList: 5/6/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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