Indicated for:

Postmenopausal Osteoporosis:

• Indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures.

The optimal duration of use has not been determined. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use.

Reports of severe bone, joint, or muscle pain.

Risedronate sodium should be taken immediately following breakfast and not under fasting conditions because of a higher risk of abdominal pain if taken before breakfast when fasting. Swallow Risedronate sodium whole while in an upright position and with at least 4 ounces of plain water to facilitate delivery to the stomach. Avoid lying down for 30 minutes after taking the medication.

Risedronate sodium, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Risedronate sodium is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers).

Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. In some cases, these have been severe and required hospitalization.

Risedronate sodium is 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

Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.

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 risedronate. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (for example, tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (for example, chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (for example, periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures). The risk of ONJ may increase with duration of exposure to bisphosphonates.

Atypical, low-energy, or low trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are traverse or short oblique in orientation without evidence of comminution.

Atypical femur fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs.

Atelvia is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min) because of lack of clinical experience.

Hypocalcemia has been reported in patients taking Risedronate sodium. Treat hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Risedronate sodium therapy.

Concomitant administration of Atelvia and H2 blockers or PPIs is not recommended.

Drugs that raise stomach pH (for example, PPIs or H2 blockers) may cause faster drug release from enteric coated (delayed-release) drug products such as Risedronate sodium. Co-administration of Risedronate sodium with the PPI, esomeprazole, increased risedronate bioavailability. The maximum plasma concentration (Cmax) and the area under the plasma concentration (AUC) were increased by 60 percent and 22 percent, respectively.

Risedronate sodium contains the same active ingredient found in Actonel. A patient being treated with Actonel should not receive Risedronate sodium.

Atelvia contains the same active ingredient found in Actonel®. A patient being treated with Actonel should not receive Atelvia.

Calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations interfere with the absorption of Risedronate sodium and should not be taken together.

There are no adequate and well-controlled studies of Risedronate sodium in pregnant women. Animal studies: decreased neonate survival and incomplete ossification and unossified sternebrae.

It is not known whether Risedronate sodium is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Risedronate sodium, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

• Use in patients under the age of 18. GoToSource

• Use in male patients. GoToSource 

• Prevention of bone loss due to chronic immunosuppressive treatment and secondary hyperparathyroidism in renal transplant patients. GoToSource 

• Sensorineural hearing loss. GoToSource 

• Prevention of hip fracture in women with parkinson’s disease. GoToSource 

• Low bone mineral density in patients with crohn’s disease. GoToSource 

• Postpoliomyelitis syndrome. GoToSource

Atypical femoral fractures. GoToSource 

Osteonecrosis of the jaw (severe bone disease that affects the jaw). GoToSource 

Bilateral pedicle fracture. GoToSource 

Acute arthritis. GoToSource 

Barrett’s esophagus (abnormal cell changes in lower esophagus). GoToSource 

Ocular inflammation. GoToSource 

Esophageal cancer. GoToSource

Lawsuits filed for esophageal cancer.