Apo-Alendronate Dosage/Direction for Use

Administration: APO-ALENDRONATE (alendronate sodium) must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only. Other beverages (including mineral water), food, and some medications are known to reduce the absorption of APO-ALENDRONATE (see Interactions). Waiting less than 30 minutes will lessen the effect of APO-ALENDRONATE by decreasing its absorption into the body.
APO-ALENDRONATE should only be taken upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, an APO-ALENDRONATE tablet should be swallowed with a full glass of water (200-250 mL). Patients should not lie down for at least 30 minutes and until after their first food of the day. APO-ALENDRONATE should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences (see DOSAGE & ADMINISTRATION and PRECAUTIONS).
All patients must receive supplemental calcium and Vitamin D, if dietary intake is inadequate.
Although no specific studies have been conducted on the effects of switching patients on another therapy for osteoporosis or Paget's disease to alendronate, there are no known or theoretical safety concerns related to APO-ALENDRONATE in patients who previously received any other antiosteoporotic or antipagetic therapy.
Treatment with alendronate for longer than five years has not been studied; extension studies are ongoing.
Recommended Dose: Treatment of Osteoporosis in Postmenopausal Women and in Men: The recommended dosage is one 70 mg tablet once weekly or one 10 mg tablet once daily.
Prevention of Osteoporosis in Postmenopausal Women: The recommended dosage is 5 mg once a day.
Treatment and Prevention of Glucocorticoid-Induced Osteoporosis in Men and Women: The recommended dosage is 5 mg once a day, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is 10 mg once a day.
Paget's Disease of Bone in Men and Women: The recommended treatment regimen is 40 mg once a day for six months.
Retreatment of Paget's Disease: In clinical studies in which patients were followed every six months, relapses during the 12 months following therapy occurred in 9% (3 out of 32) of patients who responded to treatment with alendronate. Specific retreatment data are not available, although responses to alendronate were similar in patients who had received prior bisphosphonate therapy and those who had not.
Retreatment with APO-ALENDRONATE may be considered, following a six-month post-treatment evaluation period, in patients who have relapsed based on increases in serum alkaline phosphatase (which should be measured periodically). Retreatment may also be considered in those who failed to normalize their serum alkaline phosphatase.
Dosage Adjustment: No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency [creatinine clearance 0.58 to 1 mL/s (35 to 60 mL/min)]. APO-ALENDRONATE is not recommended for patients with more severe renal insufficiency (creatinine clearance <0.58 mL/s [<35 mL/min]) due to lack of experience.
Information to be Provided to the Patients: Patients must be instructed that the expected benefits of APO-ALENDRONATE may only be obtained when it is taken with plain water the first thing upon arising for the day at least 30 minutes before the first food, beverage or medication of the day. Even dosing with orange juice or coffee has been shown to markedly reduce the absorption of alendronate.
To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, patients should be instructed to swallow each tablet of APO-ALENDRONATE with a full glass of water. Patients should be instructed not to lie down for at least 30 minutes and until after their first food of the day. Patients should not chew or suck on the tablet because of a potential for oropharyngeal ulceration. Patients should be specifically instructed not to take APO-ALENDRONATE at bedtime or before arising for the day. Patients should be informed that failure to follow these instructions may increase their risk of esophageal problems. Patients should be instructed that if they develop symptoms of esophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn) they should stop taking APO-ALENDRONATE immediately and consult their physician.
Missed Dose: Patients should be instructed that if they miss a dose of APO-ALENDRONATE 70 mg once weekly, they should take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.
Patients should be advised with respect to adequate calcium and Vitamin D intake.