Fosamax Plus D (Alendronate Sodium & Cholecalciferol) Drug Information: Overdosage and Contraindications

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May 27, 2012

Fosamax Plus D

Menopause »

What is menopause?

Menopause is defined as the state of an absence of menstrual periods for 12 months. The menopausal transition starts with varying menstrual cycle length and ends with the final menstrual period. Perimenopause means "the time around menopause" and is often used to refer to the menopausal transitional period. It is not officially a medical term, but is sometimes used to explain certain aspects of the menopause transition in lay terms. Postmenopause is the entire period of time that comes after the last menstrual period.

Menopause is the time in a woman's life when the function of the ovaries ceases. The ovary (female gonad), is one of a pair of reproductive glands in women. They are located in the pelvis, one on each side of the uterus. Each ovary is about the size and shape of an almond. The ovaries produce eggs (ova) and female hormones such as estrogen. During each monthly menstrual cycle, an egg is released f...

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OVERDOSE

Alendronate Sodium

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.

Cholecalciferol

Significant lethality occurred in mice treated with a single high oral dose of calcitriol (4 mg/kg), the hormonal metabolite of Cholecalciferol.

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 IU 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.

CONTRAINDICATIONS

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].