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4 X 70 mg
This drug must be taken at least one-half hour before the first food, beverage, or medication of theday with plain water only. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of it. Waiting less than 30 minutes, or taking FOSALAN with food, beverages (other than plain water) or other medications will lessen the effect of FOSALAN by decreasing its absorption into the body. This drug should only be taken upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, it should be swallowed with a full glass of water (180-240 mL). Patients should not lie down for at least 30 minutes and until after their first food of
the day. It 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.
Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate. No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal
insufficiency (creatinine clearance 35 to 60 mL/min). FOSALAN is not recommended for patients with more severe renal insufficiency (creatinine clearance <35 mL/min) due to lack of experience.
Treatment of osteoporosis in postmenopausal women.The recommended dosage is: one 70 mg tablet once weekly or one 10 mg tablet once daily.
Treatment of Osteoporosis in men: The recommended dosage is: one 70 mg tablet once weekly or one 10 mg tablet once daily.
The safety of treatment and prevention of osteoporosis with FOSALAN has been studied for up to 7 years. Prevention and treatment of glucocorticoid-induced osteoporosis in postmenopausal women not receiving estrogen The recommended dosage for postmenopausal women not receiving estrogen is one 10 mg tablet once daily.
Once Weekly 70 mg: Treatment of Osteoporosis in Postmenopausal Women (see Dosage and Administration) Indicated for the treatment of osteoporosis in postmenopausal women to prevent fractures, including those of the hip and spine (vertebral compression fractures). Treatment to increase bone mass in men with osteoporosis.Contra-Indications Hypersensitivity to any component of this product, abnormality of the esophagus which delay esophageal emptying, such as stricture or achalasia, inability to stand or sit for at least 30 minutes, hypocalcemia. Patients with renal insufficiency.
FOSALAN 10 mg: Treatment of Osteoporosis in Postmenopausal Women (see Dosage and Administration): It is indicated for the treatment of osteoporosis in postmenopausal women to prevent fractures, including those of the hip and spine (vertebral compression fractures). For the treatment of osteoporosis in men. Prevention and Treatment of Glucocorticoid-Induced Osteoporosis in Postmenopausal Women Not Receiving Estrogen (see Dosage and Administration): This drug is indicated for the prevention and treatment of glucocorticoid-induced osteoporosis in postmenopausal women not receiving estrogen. The safety and effectiveness for the treatment of osteoporosis are based on clinical data of four years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.
Abnormalities of the esophagus which delay esophageal emptying, such as stricture or achalasia. Inability to stand or sit upright for at least 30 minutes, Hypersensitivity to any component of this product. Hypocalcemia.
General: Causes of osteoporosis other than estrogen deficiency, aging, and glucocorticoid use should be considered. Hypocalcemia must be corrected before initiating therapy with FOSALAN. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. In patients with these conditions, serum calcium and symptoms of
hypocalcemia should be monitored during therapy with it. Presumably due to the effects of FOSALAN on increasing bone mineral, small, asymptomatic decreases in serum calcium and phosphate may occur, especially in patients receiving glucocorticoids, in whom calcium absorption may be decreased. Ensuring adequate calcium and vitamin D intake is especially important in patients receiving glucocorticoids.
Musculoskeletal Pain: In post marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates that are approved for the prevention and treatment of osteoporosis. This category of drugs includes FOSALAN (alendronate). Most of the patients were postmenopausal women. The time to onset of symptoms varied from one day to several months after starting the drug. Discontinue use if severe symptoms develop. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate. In placebo-controlled clinical studies of FOSALAN, the percentages of patients with these symptoms
were similar in the FOSALAN and placebo groups.
Dental: Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including FOSALAN. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids), poor oral hygiene, and co-morbid disorders (e.g., periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures). For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit/risk assessment.
For full details see prescribing information.
Clinical Studies: In clinical studies of up to five years in duration adverse experiences associated with it usually were mild, and generally did not require discontinuation of therapy. This drug has been evaluated for safety in approximately 8000 postmenopausal women in clinical studies.
Treatment of osteoporosis: Postmenopausal women: In two identically designed, three-year, placebo-controlled, double-blind, multicenter studies (United States and Multinational; n=994), discontinuation of therapy due to any clinical adverse experience occurred in 4.1% of 196 patients treated with FOSALAN 10 mg/day and 6.0% of 397 patients treated with placebo. In the Fracture Intervention Trial (n=6459), discontinuation of therapy due to any clinical adverse experience occurred in 9.1% of 3236 patients treated with FOSALAN 5 mg/day for 2 years and 10 mg/day for either one or two additional years and 10.1% of 3223 patients treated with placebo. Discontinuations due to upper gastrointestinal adverse experiences were: FOSALAN, 3.2%; placebo,
2.7%. In these study populations, 49-54% had a history of gastrointestinal disorders at baseline and 54-89% used nonsteroidal anti-inflammatory drugs or aspirin at some time during the studies.
For full details see prescribing information.
Calcium supplements, antacids, NSAID’s, aspirin.