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risedronate sodium 150 mg tab generic actonel

Out of Stock Manufacturer APOTEX CORP 60505309702
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Uses

Risedronate sodium is used in the prevention and treatment of osteoporosis in postmenopausal women and in the prevention and treatment of corticosteroid-induced osteoporosis in men and women. Risedronate also is used for the treatment of Paget's disease of bone (osteitis deformans). Risedronate sodium copackaged with calcium carbonate is used for the prevention and treatment of osteoporosis in postmenopausal women.

All patients with osteoporosis or who were at risk for development of osteoporosis in clinical trials of risedronate received concomitant therapy with calcium. Patients with osteoporosis or Paget's disease of bone who are receiving risedronate should receive supplemental calcium and vitamin D if their daily dietary intake is inadequate.

Osteoporosis

Prevention in Postmenopausal Women

Risedronate is used for the prevention of osteoporosis in postmenopausal women. Risk factors include premature ovarian failure, a family history of osteoporosis, a small, slim body frame, cigarette smoking, drinking excessive amounts of alcohol, low dietary calcium intake, a sedentary lifestyle, and Caucasian or Asian race. For additional information on osteoporosis,

In a double-blind, placebo-controlled study in early postmenopausal women (42-63 years of age), risedronate sodium administration (5 mg daily for 2 years) was associated with an increase in bone mineral density (BMD) in the lumbar spine, femoral neck, and trochanter bone compared with placebo. In another study, increases in BMD in the femoral neck and midshaft radius were observed in postmenopausal women (37-82 years of age) with osteopenia who received risedronate sodium (5 mg daily for 1 year) and conjugated estrogens (0.625 mg daily) compared with those who received conjugated estrogens without risedronate. Bone histology studies in postmenopausal women treated with risedronate sodium 5 mg daily plus estrogen indicate that the bone formed had normal lamellar structure and mineralization.

Efficacy of risedronate 35 mg once weekly for the prevention of osteoporosis was evaluated in a randomized, double-blind, placebo-controlled study in 278 postmenopausal women. All women received daily supplementation with vitamin D (400 units) and calcium (1 g). After 1 year of treatment, risedronate substantially increased BMD at the lumbar spine, total proximal femur, femoral neck, and trochanter compared with placebo (least-square mean increase in BMD of 2.9, 1.5, 1.2, and 1.8%, respectively).

Treatment in Postmenopausal Women

Risedronate is used in the treatment of osteoporosis in postmenopausal women. In placebo-controlled studies in postmenopausal women with osteoporosis, therapy with risedronate sodium 5 mg daily for 2-3 years substantially increased BMD in the lumbar spine, femoral neck, and femoral trochanter and maintained BMD at the midshaft radius while patients treated with placebo lost BMD at all sites. Bone histology studies in postmenopausal women with osteoporosis treated with risedronate sodium 5 mg daily indicate that bone formed during treatment with the drug is of normal quality. Risedronate therapy reduced the incidence of vertebral and nonvertebral (e.g., wrist, humerus, hip, pelvis, leg) fractures among postmenopausal women with osteoporosis who had previously sustained vertebral fractures.

In a 1-year controlled study in postmenopausal women with osteoporosis, risedronate sodium 35 or 50 mg once weekly produced increases in lumbar spine and hip BMD similar to those observed with a dosage of 5 mg daily.

In 2 double-blind trials, risedronate sodium in a monthly dosage of 150 mg was found to be noninferior to a regimen of 5 mg daily in increasing BMD. Risedronate was administered as a single 150-mg tablet once a month in one of the studies and as a 75-mg tablet on 2 consecutive days each month in the other study. In both studies, the mean change in BMD for the lumbar spine and other skeletal sites was similar between the monthly and daily dosing regimens.

Treatment in Men

Risedronate is used for the treatment of osteoporosis in men to increase bone mass. Efficacy and safety of the drug for this use is based principally on results of a double-blind, placebo-controlled study in men 36-84 years of age (mean age: 60.6 years) with osteoporosis (defined as a femoral neck BMD of at least 2 standard deviations below the normal adult mean and a lumbar spine BMD of at least 1 standard deviation below the normal adult mean, or a femoral neck BMD of at least 1 standard deviation below the normal adult mean and a lumbar spine BMD of at least 2.5 standard deviations below the normal adult mean). All patients received supplemental calcium (1 g daily) and vitamin D (400-500 units daily). Treatment with risedronate 35 mg once weekly substantially increased BMD in the lumbar spine, femoral neck, trochanter, and total hip compared with placebo (mean treatment differences of 4.5, 1.1, 2.2, and 1.5%, respectively). Increases in BMD were apparent as early as 6 months (the earliest time point tested) after initiation of risedronate therapy. Few vertebral and nonvertebral fractures were reported in this study, and no difference in fracture rates was observed between the treatment groups.

Corticosteroid-induced Osteoporosis

Risedronate sodium is used for the prevention and treatment of corticosteroid-induced osteoporosis. The manufacturer recommends use of risedronate for the treatment of corticosteroid-induced osteoporosis in men and women who are either initiating or continuing systemic corticosteroid therapy for chronic disease in a daily dosage equivalent to at least 7.5 mg of prednisone.

The American College of Rheumatology (ACR) currently recommends use of a bisphosphonate (i.e., alendronate, risedronate, or zoledronic acid) in conjunction with lifestyle modification and calcium and vitamin D supplementation for the prevention and treatment of corticosteroid-induced osteoporosis in select postmenopausal women and men 50 years of age or older who are initiating or currently receiving corticosteroid therapy. ACR recommendations are based on a risk-stratification approach in which a patient's clinical risk level for developing a fracture is determined, guided in part by the FRAX risk assessment tool (which employs variables such as gender, age, race/ethnicity, and femoral neck density) and the patient's preexisting or anticipated corticosteroid dosage. ACR states that because of limited data, use of bisphosphonates for prevention or treatment of corticosteroid-induced osteoporosis in premenopausal women and men younger than 50 years of age can be recommended only in those who have a history of fragility fracture. For additional details on the use of bisphosphonates for prevention and treatment of corticosteroid-induced osteoporosis, .

Bisphosphonate therapy has resulted in significant increases in BMD (most consistently in the lumbar spine) in patients with a variety of corticosteroid-treated conditions, most commonly rheumatoid arthritis or polymyalgia rheumatica, and such beneficial effects generally occurred irrespective of patient age, gender, or female menopausal status. For additional information on the minimization of risk of corticosteroid-induced bone loss, .

Prevention

Risedronate is used in the prevention of corticosteroid-induced osteoporosis in men and women initiating therapy with corticosteroids in a daily dosage equivalent to at least 5 mg of prednisone.

In a placebo-controlled, double-blind, randomized study, risedronate sodium 5 mg daily for 1 year prevented bone loss in men and women with a variety of underlying diseases (e.g., rheumatoid arthritis, temporal arteritis, polymyalgia rheumatica, systemic lupus erythematosus, asthma) who had initiated corticosteroid therapy within 3 months of study entry and had normal mean lumbar spine BMD. BMD was maintained or increased in patients receiving risedronate while patients receiving placebo experienced decreases in BMD at the lumbar spine, femoral neck, and trochanter. In patients who underwent bone biopsies at the end of the study, bone histology was normal in patients receiving risedronate and corticosteroids.

Treatment

Risedronate is used in the treatment of corticosteroid-induced osteoporosis in men and women receiving corticosteroids in a daily dosage equivalent to at least 5 mg of prednisone.

In patients with corticosteroid-induced osteopenia or osteoporosis who had been receiving corticosteroids for at least 6 months before study entry, therapy with risedronate sodium (5 mg daily for 1 year) was associated with a 2.7 or 1.9% increase in BMD at the lumbar spine or femoral neck, respectively, compared with placebo. A dosage of 2.5 daily of risedronate sodium was not substantially more effective than placebo in this study. When both risedronate dosage groups were combined, risedronate therapy also was associated with a decreased incidence of vertebral fractures relative to placebo.

Paget's Disease of Bone

Risedronate is used in the treatment of Paget's disease of bone (osteitis deformans).

Six months after initiation of therapy in a clinical study in men and women with moderate to severe Paget's disease of bone (serum alkaline phosphatase concentrations at least twice the upper limit of normal), normalization of serum alkaline phosphatase concentrations occurred in 77% of patients receiving risedronate sodium (30 mg daily for 2 months) and in 11% of those receiving etidronate disodium (400 mg daily for 6 months). At month 18 (16 and 12 months after discontinuance of risedronate and etidronate, respectively), 53% of those who had received risedronate remained in biochemical remission, compared with 14% of those treated with etidronate. Risedronate has been effective in a limited number of patients with refractory Paget's disease who had not responded to prior therapy with etidronate or calcitonin. Bone biopsies of non-Pagetic bone in patients with Paget's disease of bone treated with risedronate did not reveal evidence of osteomalacia, impairment of bone remodeling, or an appreciable decline in bone turnover.

Dosage and Administration

Administration

Risedronate sodium and risedronate sodium copackaged with calcium carbonate are administered orally. To facilitate absorption, the drug should be taken with a full glass (180-240 mL) of plain water at least 30 minutes before the first food or beverage of the day. Vitamins with mineral supplements or antacids that contain metals such as calcium, aluminum, or magnesium may affect absorption of risedronate and should be avoided for 30 minutes before risedronate is administered. Such supplements should be taken at a different time of the day than when risedronate is taken. Because of the potential for oropharyngeal irritation, patients should be instructed not to suck or chew risedronate tablets. Patients should be instructed to avoid lying down for at least 30 minutes following administration of risedronate to facilitate delivery of the drug to the stomach and minimize potential esophageal irritation.

Dosage

Hypocalcemia and other disturbances of bone and mineral metabolism must be corrected before risedronate therapy is initiated, and patients with osteoporosis or Paget's disease of bone should receive supplemental calcium and vitamin D if their dietary intake is inadequate.

Osteoporosis

For treatment of osteoporosis in postmenopausal women, the usual dosage of risedronate sodium is 5 mg once daily, 35 mg once weekly, or 150 mg monthly (given as a 150-mg tablet once monthly or a 75-mg tablet on 2 consecutive days per month).

For the prevention of osteoporosis in postmenopausal women, the usual dosage of risedronate sodium is 5 mg once daily or 35 mg once weekly. Alternatively, a dosage of 150 mg once monthly (given as a 150-mg tablet or as a 75-mg tablet on 2 consecutive days) may be considered.

For the treatment of osteoporosis in men, the recommended dosage of risedronate sodium is 35 mg once weekly.

If a weekly 35-mg dose of risedronate sodium is missed, the missed dose should be taken the next morning after the day it is remembered, followed by resumption of the regular weekly schedule on the originally chosen day. Patients should not take 2 risedronate sodium 35-mg tablets on the same day.

If a monthly 150-mg dose of risedronate sodium is missed and the next scheduled dose is more than 7 days away, patients should take the missed dose the next morning after it is remembered and resume the regular schedule. If the next scheduled dose is within 7 days, patients should wait until the next month's scheduled dose and resume their regular dosing schedule at that time; more than one 150-mg tablet should not be taken within the same week.

If one or both doses are missed in patients receiving the consecutive-day dosing schedule (i.e., risedronate sodium 75 mg on 2 consecutive days per month) and the next month's scheduled dose is more than 7 days away, patients should be instructed as follows: if both 75-mg doses are missed, one dose should be taken the next morning after it is remembered followed by the second dose the next consecutive morning; if only one 75-mg dose is missed, the missed dose should be taken the next morning after it is remembered. The regular dosing schedule should then be resumed; more than two 75-mg tablets should not be taken within the same week. If one or both doses are missed in patients receiving the consecutive-day dosing schedule and the next month's scheduled doses are within 7 days, patients should wait until the time of the next month's scheduled dose and resume their regular dosing schedule at that time.

For the treatment and prevention of osteoporosis in postmenopausal women, the usual dosage of risedronate sodium (copackaged with calcium carbonate) is 35 mg once a week (orange tablet) in a 4-week cyclic regimen. Risedronate sodium usually is administered on day 1 of each 7-day treatment cycle, followed by 6 days (days 2-7) of calcium carbonate (blue tablet) at a dosage of 1250 mg daily. Each blister package of risedronate sodium copackaged with calcium carbonate contains enough tablets of each drug for four 7-day treatment cycles.

The manufacturer states that when a woman misses a weekly dose of risedronate sodium (orange tablet), the missed dose should not be taken later on the same day; it should be taken the next morning, followed by resumption of the regular weekly schedule on the originally chosen day. The usual calcium carbonate tablet (blue tablet) should be taken with food later in the same day that the missed risedronate sodium tablet is taken. Women should not take risedronate sodium and calcium carbonate at the same time. If a woman misses a calcium carbonate tablet (days 2-7) and remembers it later the same day, the calcium carbonate should be taken with food. If 1 day of calcium carbonate therapy is missed, 2 tablets of calcium carbonate may be taken the next day at separate times of the day with food. Women should not take more than 2 tablets of calcium carbonate on the same day unless directed by their clinician.

The optimal duration of bisphosphonate treatment for osteoporosis has not been established. Safety and efficacy of risedronate for the treatment of osteoporosis are based on clinical data supporting fracture reduction over 3 years of therapy. Some evidence suggests that bisphosphonate therapy for more than 3 years (median 7 years in one analysis of available data) in patients with osteoporosis may be associated with an increased risk of atypical fracture of the femur.(See Atypical Fracture of the Femur under Warnings/Precautions: Warnings, in Cautions.) All patients receiving a bisphosphonate should have periodic evaluations to determine the need for continued therapy with the drug.

Corticosteroid-induced Osteoporosis

For the prevention or treatment of corticosteroid-induced osteoporosis, the usual adult dosage of risedronate sodium is 5 mg daily. Although the manufacturer states that the safety and efficacy of risedronate when given for periods exceeding 1 year in the prevention or treatment of corticosteroid-induced osteoporosis have not been established, the American College of Rheumatology (ACR) recommends that therapy to prevent or treat corticosteroid-induced osteoporosis be continued as long as the patient continues to receive corticosteroid therapy.

Paget's Disease

For the treatment of Paget's disease of bone, the usual dosage of risedronate sodium in adults is 30 mg administered once daily for 2 months. After a post-treatment observation period of at least 2 months, a second course of risedronate sodium at the same dosage should be considered if there is evidence of recurrence of the disease process or if the initial treatment fails to normalize serum alkaline phosphatase concentrations. No data are available on the safety and efficacy of more than one course of retreatment with risedronate sodium for Paget's disease.

Special Populations

Risedronate should not be used in patients with severe renal impairment (creatinine clearance less than 30 mL/minute). Adjustments in risedronate sodium dosage are not necessary in patients with mild-to-moderate renal impairment (a creatinine clearance of 30 mL/minute or greater), geriatric patients, or in patients with hepatic impairment.

Cautions

Contraindications

Hypocalcemia, known hypersensitivity to risedronate or any ingredient in the formulation, inability to stand or sit upright for at least 30 minutes, or abnormalities of the esophagus that delay esophageal emptying (e.g., stricture, achalasia).

Warnings/Precautions

GI Effects

Since severe adverse esophageal effects including esophagitis, esophageal ulcers, and/or erosions (occasionally with bleeding and rarely followed by esophageal stricture or perforation) have been reported in patients receiving oral bisphosphonates, clinicians should be alert to any sign or symptom associated with such adverse effects. Patients should be instructed to discontinue risedronate and contact a clinician if dysphagia, odynophagia, retrosternal pain, or new or worsening heartburn occurs. Since the incidence of severe adverse esophageal effects is greater in patients who do not drink a full (180-240 mL) glass of water when taking the drug and in those who do not avoid lying down for at least 30 minutes following administration of risedronate or who continue to take the drug after experiencing symptoms suggestive of esophageal irritation, patients should be instructed carefully about proper administration of the drug and should be given a copy of the patient instructions provided by the manufacturer. Risedronate should be used with caution in patients with active upper GI disease (e.g., Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, ulcers) or a history of such problems.

Gastric or duodenal ulcers, including some that were severe and with complications, have been reported in patients receiving oral bisphosphonates during postmarketing experience, although no increased risk was observed in controlled clinical trials.

Although data are conflicting, there is some evidence suggesting a possible association between use of oral bisphosphonates and an increased risk of esophageal cancer. During the period of postmarketing surveillance from October 1995 (initial marketing of alendronate) through mid-May 2008, the US Food and Drug Administration (FDA) received reports of esophageal cancer in 23 patients in the US receiving alendronate (as the suspect drug in 21 cases and the concomitant drug in 2 cases); 8 deaths were reported. An additional 31 cases of esophageal cancer were reported at the time in patients in Europe and Japan who had received an oral bisphosphonate, including alendronate, risedronate, ibandronate, and etidronate. In a large case-control study in a cohort of patients from the UK General Practice Research Database, risk of esophageal cancer was increased by 30% in patients who had at least one prescription issued for an oral bisphosphonate (alendronate, etidronate, or risedronate) compared with those not receiving such prescriptions; the risk was approximately doubled among patients who had 10 or more prescriptions issued for an oral bisphosphonate or who had an estimated duration of bisphosphonate use (calculated as the time between the first and last prescription issued during the observation period) of more than 3 years. However, another retrospective cohort study that used the same database found no evidence of an increased risk of esophageal cancer in patients receiving oral bisphosphonates. Other observational studies, including a study in patients receiving long-term alendronate therapy and a cohort study of Danish patients with fractures, have shown either no risk or a reduced risk of esophageal cancer following use of oral bisphosphonates. Because of conflicting findings and limitations of currently available data, additional study is needed to determine the association, if any, between oral bisphosphonate use and esophageal cancer. FDA states that benefits of oral bisphosphonates in reducing the risk of serious fractures continue to outweigh their potential risks in patients with osteoporosis and that it is important to consider that esophageal cancer is rare, especially in women. FDA also states that there is insufficient information at this time to recommend routine endoscopic screening in asymptomatic patients receiving oral bisphosphonates. Avoidance of oral bisphosphonates in patients with Barrett's esophagus, a known precursor to esophageal adenocarcinoma, has been recommended.

Osteonecrosis of the Jaw

Osteonecrosis and osteomyelitis of the jaw have been reported in patients, principally in those with cancer, who have received bisphosphonates. Most instances of osteonecrosis of the jaw have been observed during IV bisphosphonate therapy, but some patients have experienced this adverse effect during oral bisphosphonate therapy, including risedronate. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), cancer, concomitant therapies (e.g., chemotherapy, corticosteroids), poor oral hygiene, and comorbid disorders (e.g., periodontal and/or other preexisting dental disease, anemia, coagulopathy, infection, ill-fitting dentures). Discontinuance of bisphosphonate treatment may reduce the risk for osteonecrosis of the jaw in patients requiring invasive dental procedures. Clinical judgment of the treating clinician and/or oral surgeon should guide the management of each patient based on individual benefit/risk assessment. Patients who develop osteonecrosis of the jaw while receiving bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat osteonecrosis of the jaw may exacerbate the condition. Discontinuance of bisphosphonate therapy should be considered based on assessment of benefits and risks in individual patients.

Atypical Fracture of the Femur

Atypical, low-energy, or low-trauma femoral fractures have been reported in bisphosphonate-treated patients. These fractures can occur anywhere in the femoral shaft from the subtrochanteric region of the hip (i.e., below the lesser trochanter) to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Such fractures generally have occurred with use of bisphosphonate therapy for more than 3 years (median 7 years in one analysis of available data). The magnitude of this risk is unclear, although such fractures appear to be rare; in addition, causality has not been established since atypical fractures also have occurred in patients not receiving bisphosphonates. Most cases of atypical femoral fractures with bisphosphonate therapy have been reported in individuals receiving treatment for osteoporosis. Such fractures most commonly occur in individuals with minimal or no trauma. Most individuals have reported prodromal symptoms presenting as dull, aching thigh pain for weeks to months prior to the occurrence of an atypical fracture. Bilateral involvement (i.e., a fracture in the contralateral limb) and evidence of delayed healing of the fracture also may be present. Concomitant use of glucocorticoid, estrogen, and proton-pump inhibitor therapy may increase the risk of an atypical fracture.

Individuals with a history of bisphosphonate exposure presenting with new thigh or groin pain should be evaluated for possible atypical femoral fracture; an assessment of the contralateral limb also should be performed to rule out possible bilateral involvement (i.e., presence of radiographic change or fracture). Interruption of bisphosphonate therapy should be considered in individuals presenting with symptoms suggestive of a possible femoral fracture following completion of a comprehensive risk-benefit assessment performed on an individualized basis. Bisphosphonate therapy should be discontinued if a femoral shaft fracture is confirmed.

Musculoskeletal Pain

Severe, occasionally incapacitating bone, joint, and/or muscle pain have been reported infrequently during postmarketing experience in patients receiving bisphosphonates, including risedronate. The time to onset of symptoms varied from 1 day to years (mean onset about 3 months) after treatment initiation. Musculoskeletal pain has improved following discontinuance of the drug in most patients; however, some patients have reported slow or incomplete resolution of severe musculoskeletal pain. In some patients, musculoskeletal pain recurred upon subsequent rechallenge with the same drug or another bisphosphonate. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown. The association between bisphosphonates and severe musculoskeletal pain may be overlooked by clinicians, which may delay diagnosis, prolong pain and/or impairment, and necessitate the use of analgesics. Clinicians should evaluate whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms; temporary or permanent discontinuance of therapy should be considered in such cases.

When risedronate is given concurrently with calcium carbonate, the cautions, precautions, and contraindications associated with calcium carbonate must be considered in addition to those associated with risedronate.(See Dosage and Administration: Administration.)

Metabolic Effects

Hypocalcemia and other disturbances of bone and mineral metabolism must be corrected before risedronate therapy is initiated, and patients with osteoporosis or Paget's disease of bone should receive supplemental calcium and vitamin D if their daily dietary intake is inadequate.

Endocrine Effects

Before initiating treatment with risedronate in men and women receiving long-term corticosteroid therapy, sex hormones should be measured and replacement therapy considered, if appropriate.

Atrial Fibrillation

While data are conflicting, a possible increased risk of atrial fibrillation has been identified with use of bisphosphonates.

Specific Populations

Pregnancy

Category C.

Lactation

Risedronate is distributed into milk in rats. Discontinue nursing or drug because of potential risk in nursing infants.

Pediatric Use

Risedronate is not indicated for use in pediatric patients. Efficacy and safety of the drug in pediatric patients were evaluated in a 1-year, randomized, double-blind, placebo-controlled study in 143 pediatric patients 4 to less than 16 years of age with osteogenesis imperfecta. Although risedronate was effective in increasing lumbar spine bone mineral density (BMD) compared with placebo, therapy with the drug was not associated with a reduction in fracture risk. Adverse effects reported in the pediatric patients evaluated in this study generally were similar to those reported in adults with osteoporosis; however, an increased risk of vomiting relative to placebo was observed with risedronate.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.

Gender

Safety and efficacy of risedronate not established in men for treatment of osteoporosis unrelated to corticosteroid use. Safety and efficacy of risedronate sodium copackaged with calcium carbonate not established in men for the treatment of primary osteoporosis.

Renal Impairment

Use not recommended in patients with severe renal impairment (creatinine clearance less than 30 mL/minute). No dosage adjustments necessary in patients with mild to moderate renal impairment (creatinine clearances of at least 30 mL/minute).

Hepatic Impairment

Efficacy and safety of risedronate not evaluated in patients with hepatic impairment. Because the drug is not metabolized in the liver, the manufacturer states that dosage adjustments are not likely to be necessary in patients with hepatic impairment.

Common Adverse Effects

Adverse effects occurring in more than 5% of patients receiving daily risedronate therapy include back, chest or abdominal pain, pain (unspecified), hypertension, flu-like syndrome, peripheral edema, nausea, diarrhea, constipation, arthralgia, joint disorder,depression, headache, dizziness, myalgia, rash, cataract, pharyngitis, rhinitis, urinary tract infection, and infection (unspecified). Adverse effects occurring in more than 5% of patients receiving once-weekly risedronate include back or abdominal pain, pain (unspecified), hypertension, flu syndrome, infection (unspecified), accidental injury, overdose, nausea, constipation, dyspepsia, arthralgia, traumatic bone fracture, myalgia, headache, asthenia, and urinary tract infection.

Drug Interactions

Antacids or Mineral Supplements Containing Divalent Cations

Pharmacokinetic interaction (decreased risedronate absorption) when risedronate is used concomitantly with antacids or mineral supplements containing divalent cations (e.g., aluminum, calcium, magnesium).

Drugs Affecting Hepatic Microsomal Enzymes

Risedronate does not induce or inhibit cytochrome P-450 (CYP) isoenzymes and is not metabolized. Pharmacokinetic interaction unlikely.

Nonsteroidal Anti-inflammatory Agents (NSAIAs)

No evidence of increased adverse upper GI effects.

Histamine H2 Receptor Antagonists, Proton Pump Inhibitors

No evidence of increased adverse upper GI effects.

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