Risedronate sodium hemi-pentahydrate

Risedronate sodium is a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis. Treatment to increase bone mass in men with osteoporosis. Treatment and prevention of glucocorticoid-induced osteoporosis. Treatment of Paget's disease. Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use.

Risedronate sodium has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, risedronate sodium inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption (for example, lack of ruffled border). Histomorphometry in rats, dogs, and minipigs showed that risedronate sodium treatment reduces bone turnover (activation frequency, that is, the rate at which bone remodeling sites are activated) and bone resorption at remodeling sites.

Treatment of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week, 75 mg two consecutive days each month, 150 mg once-a-month. Prevention of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week. Men with Osteoporosis: 35 mg once-a-week. Glucocorticoid-Induced Osteoporosis: 5 mg daily. Paget's Disease: 30 mg daily for 2 months. Instruct patients to: Swallow tablet whole with 6 to 8 ounces of plain water, at least 30 minutes before the first food, beverage, or medication of the day Avoid lying down for 30 minutes. Take supplemental calcium and vitamin D if dietary intake is inadequate

Risedronate sodium tablets are contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia Inability to stand or sit upright for at least 30 minutes Hypocalcemia Known hypersensitivity to risedronate sodium tablets or any of its excipients. Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. Inability to stand or sit upright for at least 30 minutes. Hypocalcemia ( 4, 5. 3) Known hypersensitivity to any component of this product

Products Containing Same Active Ingredient: Patients receiving risedronate sodium delayed-release tablets should not be treated with risedronate sodium tablets. Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue use if new or worsening symptoms occur. Hypocalcemia may worsen and must be corrected prior to use. Osteonecrosis of the Jaw has been reported. Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop. Atypical Fractures Including Femoral Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture. Risk/benefit of continuing bisphosphonate therapy should be re-evaluated in these patients and interruption of bisphosphonate therapy should be considered

Most common adverse reactions reported in greater than 10% of patients treated with risedronate sodium and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia. Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis, uveitis) have been reported rarely. The following clinically significant adverse drug reactions are described elsewhere in the labeling: Drug Products with the Same Active Ingredient Upper Gastrointestinal Adverse Reactions Mineral Metabolism Jaw Osteonecrosis Musculoskeletal Pain Atypical Fractures Including Femoral Fractures Renal Impairment Glucocorticoid-Induced Osteoporosis Laboratory Test Interactions

No specific drug-drug interaction studies were performed. Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (for example, Cytochrome P450). Calcium, antacids, or oral medications containing divalent cations interfere with the absorption of risedronate sodium

Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F).