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|June 01, 2015 8:31 a.m.|
|Teva Announces Exclusive Launch of Generic Actonel® Tablets in the United States|
Risedronate sodium tablets, USP are the second approved product to treat osteoporosis in Teva’s generic portfolio. Approximately 54 million Americans have low bone mass and osteoporosis, a condition that causes the bones to become weak and brittle. Anyone can develop osteoporosis but studies suggest it is most common in older women and patients taking specific medications. As a leading global pharmaceutical company, Teva is committed to care in women’s health and bringing to market high-quality, accessible generic medicines for doctors, pharmacists, and most importantly, patients.
Actonel® (risedronate sodium) Tablets marketed by
About Risedronate Sodium Tablets, USP
Risedronate Sodium Tablets, USP are indicated for: treatment and prevention of postmenopausal osteoporosis; treatment to increase bone mass in men with osteoporosis; treatment and prevention of glucocorticoid-induced osteoporosis; and 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.
Important Safety Information
Risedronate sodium tablets, USP are contraindicated in patients with: 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; or known hypersensitivity to any component of this product. Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Patients being treated with risedronate sodium delayed-release tablets (Atelvia®) should not receive risedronate sodium tablets, since both drugs contain the same active ingredient.
Risedronate may cause local irritation of the upper gastrointestinal mucosa. Patients with known esophageal diseases, gastritis, duodenitis or ulcers should be carefully evaluated for possible irritant effects and a potential for worsening of the underlying disease. Esophageal adverse experiences, some severe and requiring hospitalization, have been reported. Patients should be instructed to discontinue risedronate and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.
Other serious adverse reactions associated with the use of risedronate or other bisphosphonates include: hypocalcemia; osteonecrosis of the jaw; severe and occasionally incapacitating bone, joint, and/or muscle pain; and atypical, low-energy, or low trauma fractures of the femoral shaft and femur.
The most common adverse reactions reported in greater than 10% of patients treated with risedronate 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.
Please see accompanying Full Prescribing Information.
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