Fosamax Plus D
"The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis."...
Fosamax Plus D
Significant lethality after single oral doses with alendronate 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 alendronate. 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.
There is limited information regarding doses of cholecalciferol associated with acute toxicity, although intermittent (yearly or twice yearly) single doses of ergocalciferol (vitamin D2) as high as 600,000 international units have been given without reports of toxicity. Signs and symptoms of vitamin D toxicity include hypercalcemia, hypercalciuria, anorexia, nausea, vomiting, polyuria, polydipsia, weakness, and lethargy. Serum and urine calcium levels should be monitored in patients with suspected vitamin D toxicity. Standard therapy includes restriction of dietary calcium, hydration, and systemic glucocorticoids in patients with severe hypercalcemia.
Dialysis to remove vitamin D would not be beneficial.
FOSAMAX PLUS D 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]
- 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: 4/24/2015
This monograph has been modified to include the generic and brand name in many instances.
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