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Recommended Dose: Treatment of Osteoporosis in Postmenopausal Women and in Men: Fosamax: The recommended dosage is one 70 mg tablet once weekly.
The optimal duration of bisphosphonate treatment of osteoporosis has not been established.
The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of FOSAMAX on an individual patient basis.
Fosamax Plus: The recommended dosage is one tablet of FOSAMAX PLUS (70 mg/2800 IU) or FOSAMAX PLUS (70 mg/5600 IU) once weekly. The appropriate dosage of FOSAMAX PLUS must be determined by the physician based on the patient's vitamin D requirement.
All patients must receive supplemental calcium and/or vitamin D, if intake is inadequate (see Precautions).
The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of FOSAMAX PLUS on an individual patient basis.
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]). FOSAMAX/FOSAMAX PLUS is not recommended for patients with more severe renal insufficiency (creatinine clearance < 0.58 mL/s [< 35 mL/min]) due to lack of experience.
Missed Dose: Patients should be instructed that if they miss a dose of FOSAMAX/FOSAMAX PLUS, they should take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.
Administration: Fosamax: FOSAMAX 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 FOSAMAX (see INTERACTIONS). Waiting less than 30 minutes will lessen the effect of FOSAMAX by decreasing its absorption into the body.
FOSAMAX should only be taken upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, a FOSAMAX tablet should be swallowed with a full glass of water (200-250 mL). To facilitate gastric emptying, FOSAMAX oral solution should be followed by at least 60 mL (a quarter of a cup) of water. Patients should not lie down for at least 30 minutes and until after their first food of the day. FOSAMAX 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 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 to FOSAMAX there are known or theoretical safety concerns related to FOSAMAX in patients who previously received any other antiosteoporotic therapy.
Fosamax Plus: FOSAMAX PLUS 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 FOSAMAX PLUS (see Interactions). Waiting less than 30 minutes will lessen the effect of FOSAMAX PLUS by decreasing its absorption into the body.
To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, FOSAMAX PLUS should only be swallowed upon arising for the day with a full glass of water (200-250 mL) and patients should not lie down for at least 30 minutes and until after their first food of the day. FOSAMAX PLUS 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 Precautions).
All patients must receive supplemental calcium and/or vitamin D, if intake is inadequate. Physicians should consider the vitamin D intake from vitamins and dietary supplements. Patients at increased risk for vitamin D insufficiency (e.g. over the age of 70 years, home bound, or chronically ill) should receive FOSAMAX PLUS (70 mg/5600 IU) and may also need additional vitamin D supplementation. For patients fifty years and over, the recommended dose is at least 800 IU per day.
Although no specific studies have been conducted on the effects of switching patients on another therapy for osteoporosis to FOSAMAX PLUS, there are no known or theoretical safety concerns related to FOSAMAX PLUS in patients who previously received any other antiosteoporotic therapy.
