Aldren 70 Special Precautions

Alendronate sodium, like other bisphosphonates, may cause local irritation of the upper gastrointestinal mucosa. Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture, have been reported in patients receiving treatment with alendronate sodium. Patients should be instructed to discontinue alendronate sodium tablets and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking alendronate sodium and/or who fail to swallow it with a full glass (6-8 oz) of water, and/or who continue to take alendronate sodium after developing symptoms suggestive of esophageal irritation. Because of possible irritant effects of alendronate sodium on the upper gastrointestinal mucosa and a potential for worsening of the underlying disease, caution should be used when alendronate sodium tablets are given to patients with active upper gastrointestinal problems (such as dysphagia, esophageal diseases, gastritis, duodenitis, or ulcers). Hypocalcemia must be corrected before initiating therapy with alendronate sodium. Other disturbances of mineral metabolism (such as vitamin D deficiency) should also be effectively treated. Presumably due to the effects of alendronate sodium on increasing bone mineral, small, asymptomatic decreases in serum calcium and phosphate may occur, especially in patients with Paget's disease, in whom the pretreatment rate of bone turnover may be greatly elevated and in patients receiving glucocorticoids, in whom calcium absorption may be decreased. Ensuring adequate calcium and vitamin D intake is especially important in patients with Paget's disease of bone and in patients receiving glucocorticoids. Alendronate sodium tablets are not recommended for patients with renal insufficiency (creatinine clearance <35 mL/min).