"The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis."...
SKELID (tiludronate) is indicated for treatment of Paget's disease of bone (osteitis deformans).
Treatment is indicated in patients with Paget's disease of bone (1) who have a level of serum alkaline phosphatase (SAP) at least twice the upper limit of normal, or (2) who are symptomatic, or (3) who are at risk for future complications of their disease.
DOSAGE AND ADMINISTRATION
A single 400-mg daily oral dose of SKELID (tiludronate) , taken with 6 to 8 ounces of plain water only, should be administered for a period of 3 months. Beverages other than plain water (including mineral water), food (see below), and some medications (see PRECAUTIONS: DRUG INTERACTIONS) are likely to reduce the absorption of SKELID (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
Patients should not lie down for at least 30 minutes after taking this medication. In patients who cannot comply with dosing instructions due to mental or physical disability, therapy with SKELID (tiludronate) should be used under appropriate supervision (See WARNINGS).
SKELID (tiludronate) should not be taken within 2 hours of food.
Calcium or mineral supplements should be taken at least 2 hours before or two hours after SKELID (tiludronate) . Aluminum- or magnesium-containing antacids, if needed, should be taken at least two hours after taking SKELID (tiludronate) .
SKELID (tiludronate) should not be taken within 2 hours of indomethacin.
Following therapy, allow an interval of 3 months to assess response. Specific data regarding retreatment are limited, although results from uncontrolled studies indicate favorable biochemical improvement similar to initial SKELID (tiludronate) treatment.
SKELID (tiludronate) is supplied as white to practically white, biconvex round tablets containing 240 mg tiludronate disodium, which is the molar equivalent of 200 mg tiludronic acid. SKELID (tiludronate) tablets are engraved with “S.W” on one side and “200” on the other side and packaged in foil strips in cartons of 56 tablets per carton (0024-1800-16).
SKELID (tiludronate) should be stored at 25° C (77° F); excursions permitted to 15° C to 30° C (59° F to 86° F) [see USP Controlled Room Temperature]. Tablets should not be removed from the foil strips until they are to be used.
sanofi-aventis U.S. LLC Bridgewater, NJ 08807, Country of origin: France. Revised March 2010This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/14/2010
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