Generic Name and Formulations:
Risedronate (as sodium) 35mg; delayed-release tabs.
Indications for ATELVIA:
Treatment of postmenopausal osteoporosis.
Limitations Of use:
Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3–5yrs.
Swallow whole; take in the AM with a full glass (4oz) plain (not mineral) water immediately after breakfast; take in upright position; do not lie down for at least 30min afterwards. 35mg once weekly.
Esophagus abnormalities which delay esophageal emptying (eg, stricture, achalasia). Inability to stand or sit upright for at least 30min. Hypocalcemia.
Active upper GI disease; discontinue and reevaluate if signs/symptoms of esophageal reaction occur. Severe renal impairment (CrCl <30mL/min): not recommended. Correct preexisting hypocalcemia, other mineral or bone disturbances before starting. Ensure adequate Vit. D and calcium intake. Risk of osteonecrosis of the jaw; consider discontinuing therapy during invasive dental procedures (eg, tooth extraction, implants, surgery). History of bisphosphonate exposure: evaluate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Reevaluate periodically. Pregnancy (Cat.C). Nursing mothers: not recommended.
Concomitant H2-blockers, PPIs, or other risedronate-containing products (eg, Actonel): not recommended. Calcium or magnesium-based supplements, antacids, laxatives, or iron preparations reduce absorption (separate dosing). Caution with aspirin, NSAIDs, other GI irritants. May interfere with bone-imaging agents.
Diarrhea, influenza, arthralgia, back pain, abdominal pain; atypical femur fractures, esophageal reactions, hypocalcemia; rare: jaw osteonecrosis, hypersensitivity (eg, angioedema, Stevens-Johnson), eye inflammation.