|Manufacturer:||Merck & Co., Inc.|
In addition to FOSAMAX, your doctor may suggest one or more of the following lifestyle changes:Stop smoking.
Smoking may increase your chance of getting osteoporosis.Reduce the use of alcohol.
Too much alcohol may increase the risk of osteoporosis and injuries that can cause fractures.Exercise regularly.
Like muscles, bones need exercise to stay strong and healthy.
Exercise must be safe to prevent injuries, including fractures.
Talk with your doctor before you begin any exercise program.Eat a balanced diet.
Having enough calcium in your diet is important.Your doctor can advise you whether you need to change your diet or take any dietary supplements, such as calcium or vitamin D.Rx OnlyMERCK & CO., INC.Whitehouse Station, NJ 08889, USAIssued February 20089636808
FOSAMAX is indicated for:Treatment and prevention of osteoporosis in postmenopausal womenFor the treatment of osteoporosis, FOSAMAX increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures).
Osteoporosis may be confirmed by the finding of low bone mass (for example, at least 2 standard deviations below the premenopausal mean) or by the presence or history of osteoporotic fracture.
(See CLINICAL PHARMACOLOGY, Pharmacodynamics.)For the prevention of osteoporosis, FOSAMAX may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of future fracture.Bone loss is particularly rapid in postmenopausal women younger than age 60.
Risk factors often associated with the development of postmenopausal osteoporosis include early menopause; moderately low bone mass (for example, at least 1 standard deviation below the mean for healthy young adult women); thin body build; Caucasian or Asian race; and family history of osteoporosis.
The presence of such risk factors may be important when considering the use of FOSAMAX for prevention of osteoporosis.Treatment to increase bone mass in men with osteoporosisTreatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density (see PRECAUTIONS, Glucocorticoid-induced osteoporosis).Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.Treatment of Paget's disease of bone in men and womenTreatment is indicated in patients with Paget's disease of bone having alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.
FOSAMAX, 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 or perforation, have been reported in patients receiving treatment with FOSAMAX.
In some cases these have been severe and required hospitalization.
Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue FOSAMAX 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 FOSAMAX and/or who fail to swallow it with the recommended amount of water, and/or who continue to take FOSAMAX after developing symptoms suggestive of esophageal irritation.
Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient (see DOSAGE AND ADMINISTRATION).In patients who cannot comply with dosing instructions due to mental disability, therapy with FOSAMAX should be used under appropriate supervision.Because of possible irritant effects of FOSAMAX on the upper gastrointestinal mucosa and a potential for worsening of the underlying disease, caution should be used when FOSAMAX is given to patients with active upper gastrointestinal problems (such as dysphagia, esophageal diseases, gastritis, duodenitis, or ulcers).There have been post-marketing reports of gastric and duodenal ulcers, some severe and with complications, although no increased risk was observed in controlled clinical trials.