"March 7, 2013 -- An FDA panel voted to stop recommending calcitonin salmon for the treatment of osteoporosis in women who are at least five years past menopause.
The committee voted 12-9 against continued marketing of the drug, citing"...
Significant lethality after single oral doses was seen in female rats and mice at 552 mg/kg (3256 mg/m²) and 966 mg/kg (2898 mg/m²), respectively. In males, these values were slightly higher, 626 and 1280 mg/kg, respectively. There was no lethality in dogs at oral doses up to 200 mg/kg (4000 mg/m²).
No specific information is available on the treatment of overdosage with BINOSTO. Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage. Milk or antacids should be given to bind alendronate. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Dialysis would not be beneficial.
BINOSTO is contraindicated in patients with the following conditions:
- Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see WARNINGS AND PRECAUTIONS]
- Inability to stand or sit upright for at least 30 minutes [see DOSAGE AND ADMINISTRATION; WARNINGS AND PRECAUTIONS]
Do not administer BINOSTO to patients at increased risk of aspiration
- Hypocalcemia [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported [see ADVERSE REACTIONS].
Last reviewed on RxList: 5/6/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Binosto Information
- Binosto Drug Interactions Center: alendronate oral
- Binosto Side Effects Center
- Binosto FDA Approved Prescribing Information including Dosage
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