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BINOSTO® is the first and only prescription medicine that gives women diagnosed with osteoporosis proven fracture protection in a buffered, easy-to-swallow solution.
- BINOSTO is a once-weekly osteoporosis treatment that contains the same-strength ingredient (alendronate sodium 70 mg) as once-weekly Fosamax® therapy, the gold-standard osteoporosis medicine
- BINOSTO provides proven fracture protection at the hip and spine. It is also easy to prepare—and easy to take. Simply drop the BINOSTO effervescent tablet into a small glass of water to create a bubbly, strawberry-flavored solution
Fosamax is a registered trademark of Merck & Co., Inc.
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INDICATIONS AND IMPORTANT SAFETY INFORMATION
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).
Treatment to Increase Bone Mass in Men with Osteoporosis
BINOSTO is indicated for treatment to increase bone mass in men with osteoporosis.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
The use of BINOSTO is contraindicated for the following conditions: Abnormalities of the esophagus which delay emptying such as stricture or achalasia, inability to stand/sit upright for at least 30 minutes, patients at increased risk of aspiration, patients with hypocalcemia, or hypersensitivity to any component of this product.
WARNINGS AND PRECAUTIONS
Severe irritation of upper gastrointestinal mucosa can occur. Follow dosing instructions. Use caution in patients with active upper GI disease. Discontinue if new or worsening symptoms occur.
Hypocalcemia can worsen and must be corrected prior to use. Severe bone, joint, muscle pain may occur. Discontinue use if severe symptoms develop. Osteonecrosis of the jaw has been reported.
Atypical femur fractures have been reported. Evaluate new thigh or groin pain to rule out an incomplete femoral fracture. Each tablet contains 650 mg sodium, equivalent to 1650 mg NaCl. Use caution in patients on sodium restriction. Not recommended in patients with renal impairment.
ADVERSE REACTIONS
In clinical trials, the most common adverse reactions (incidence ≥3%) are abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain and nausea.
This material is intended to provide basic information and is not medical advice. All medical advice, diagnosis, and treatment should be obtained from your physician.
The product information provided in this site is intended for residents of the United States.
© 2013 Mission Pharmacal Company. All rights reserved.
Mission Pharmacal Company | San Antonio, TX 78230-1355 | Phone: 210.696.8400
