RISEDRONATE 35 MG 12 TAB
Generic: risedronate sodium
RISEDRONATE 35 MG 12 TAB
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Identification
risedronate sodium
risedronate sodium
Sun Pharmaceutical Industries, Inc.
HUMAN PRESCRIPTION DRUG
Administration
TABLET, FILM COATED
ORAL
ANDA090886
Active Ingredients
| Ingredient | Strength |
|---|---|
| RISEDRONATE SODIUM HEMI-PENTAHYDRATE | 35 mg/1 |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
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Drug Resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Risedronate sodium is a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Treatment and prevention of glucocorticoid-induced osteoporosis ( 1.3 ) Treatment of Paget's disease ( 1.4 ) 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. ( 1.5 ) 1.1 Postmenopausal Osteoporosis Risedronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [ see Clinical Studies ( 14.1 , 14.2 ) ]. 1.2 Osteoporosis in Men Risedronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis. 1.3 Glucocorticoid-Induced Osteoporosis Risedronate sodium tablets are indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D. 1.4 Paget's Disease Risedronate sodium tablets are indicated for treatment of Paget's disease of bone in men and women. 1.5 Important Limitations of Use The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Treatment of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week, 75 mg two consecutive days each month, 150 mg once-a-month ( 2.1 ) Prevention of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week ( 2.2 ) Men with Osteoporosis: 35 mg once-a-week ( 2.3 ) Glucocorticoid-Induced Osteoporosis: 5 mg daily ( 2.4 ) Paget's Disease: 30 mg daily for 2 months ( 2.5 ) 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 ( 2 ) Take supplemental calcium and vitamin D if dietary intake is inadequate ( 2.7 ) 2.1 Treatment of Postmenopausal Osteoporosis [see Indications and Usage (1.1)] The recommended regimen is: one 5 mg tablet orally, taken daily or one 35 mg tablet orally, taken once-a-week or one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month or one 150 mg tablet orally, taken once-a-month 2.2 Prevention of Postmenopausal Osteoporosis [see Indications and Usage (1.1)] The recommended regimen is: one 5 mg tablet orally, taken daily or one 35 mg tablet orally, taken once-a-week or alternatively, one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month may be considered or alternatively, one 150 mg tablet orally, taken once-a-month may be considered 2.3 Treatment to Increase Bone Mass in Men with Osteoporosis [see Indications and Usage (1.2)] The recommended regimen is: one 35 mg tablet orally, taken once-a-week 2.4 Treatment and Prevention of Glucocorticoid-Induced Osteoporosis [see Indications and Usage (1.3)] The recommended regimen is: one 5 mg tablet orally, taken daily 2.5 Treatment of Paget's Disease [see Indications and Usage (1.4)] The recommended treatment regimen is 30 mg orally once daily for 2 months. Retreatment may be considered (following post-treatment observation of at least 2 months) if relapse occurs, or if treatment fails to normalize serum alkaline phosphatase. For retreatment, the dose and duration of therapy are the same as for initial treatment. No data are available on more than 1 course of retreatment. 2.6 Important Administration Instructions Instruct patients to do the following: Take risedronate sodium tablets at least 30 minutes before the first food or drink of the day other than water, and before taking any oral medication or supplementation, including calcium, antacids, or vitamins to maximize absorption and clinical benefit, [see Drug Interactions (7.1) ] . Avoid the use of water with supplements, including mineral water, because they may have a higher concentration of calcium. Swallow risedronate sodium tablets whole with a full glass of plain water (6 to 8 ounces). Avoid lying down for 30 minutes after taking the medication [see Warnings and Precautions (5.1) ] . Do not chew or suck the tablet because of a potential for oropharyngeal ulceration. Do not eat or drink anything except plain water, or take other medications for at least 30 minutes after taking risedronate sodium tablets. 2.7 Recommendations for Calcium and Vitamin D Supplementation Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate; and to take calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations at a different time of the day as they interfere with the absorption of risedronate sodium. 2.8 Administration Instructions for Missed Doses Instruct patients about missing risedronate sodium tablets doses as follows: If a dose of risedronate sodium tablets 35 mg once-a-week is missed: Take 1 tablet on the morning after they remember and return to taking 1 tablet once-a-week, as originally scheduled on their chosen day. Do not take 2 tablets on the same day. If one or both tablets of risedronate sodium 75 mg on two consecutive days per month are missed, and the next month’s scheduled doses are more than 7 days away: If both tablets are missed, take one risedronate sodium 75 mg tablet in the morning after the day it is remembered and then the other tablet on the next consecutive morning. If only one risedronate sodium 75 mg tablet is missed, take the missed tablet in the morning after the day it is remembered Return to taking their risedronate sodium 75 mg tablet on two consecutive days per month as originally scheduled. Do not take more than two 75 mg tablets within 7 days. If one or both tablets of risedronate sodium 75 mg on two consecutive days per month are missed, and the next month's scheduled doses are within 7 days: Wait until their next month’s scheduled doses and then continue taking risedronate sodium tablets 75 mg on two consecutive days per month as originally scheduled. If the dose of risedronate sodium tablet 150 mg once-a-month is missed, and the next month’s scheduled dose is more than 7 days away: Take the missed tablet in the morning after the day it is remembered and then return to taking their risedronate sodium tablet 150 mg once-a-month as originally scheduled. Do not take more than one 150 mg tablet within 7 days. If the dose of risedronate sodium tablet 150 mg once-a-month is missed, and the next month's scheduled dose is within 7 days: Wait until their next month’s scheduled dose and then continue taking risedronate sodium tablet 150 mg once-a-month as originally scheduled.
Adverse Reactions
6 ADVERSE REACTIONS 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 (6.1) Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis, uveitis) have been reported rarely (6.2) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following clinically significant adverse drug reactions are described elsewhere in the labeling: Drug Products with the Same Active Ingredient [see Warnings and Precautions (5.1) ] Upper Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.2) ] Mineral Metabolism [see Warnings and Precautions (5.3) ] Jaw Osteonecrosis [see Warnings and Precautions (5.4) ] Musculoskeletal Pain [see Warnings and Precautions (5.5) ] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions (5.6) ] Renal Impairment [see Warnings and Precautions (5.7) ] Glucocorticoid-Induced Osteoporosis [see Warnings and Precautions (5.8) ] Laboratory Test Interactions [see Warnings and Precautions (5.9) ] 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Treatment of Postmenopausal Osteoporosis Daily Dosing The safety of risedronate sodium 5 mg once daily in the treatment of postmenopausal osteoporosis was assessed in four randomized, double-blind, placebo-controlled multinational trials of 3,232 women aged 38 to 85 years with postmenopausal osteoporosis. The duration of the trials was up to three years, with 1,619 patients exposed to placebo and 1,613 patients exposed to risedronate sodium 5 mg. Patients with preexisting gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors, and H 2 antagonists were included in these clinical trials. All women received 1,000 mg of elemental calcium plus vitamin D supplementation up to 500 international units per day if their 25-hydroxyvitamin D 3 level was below normal at baseline. The incidence of all-cause mortality was 2% in the placebo group and 1.7% in the risedronate sodium 5 mg daily group. The incidence of serious adverse events was 24.6% in the placebo group and 27.2% in the risedronate sodium 5 mg group. The percentage of patients who withdrew from the study due to adverse events was 15.6% in the placebo group and 14.8% in the risedronate sodium 5 mg group. The most common adverse reactions reported in greater than 10 percent of subjects were: back pain, arthralgia, abdominal pain and dyspepsia. Table 1 lists adverse events from the Phase 3 postmenopausal osteoporosis trials reported in greater than or equal to 5% of patients. Adverse events are shown without attribution of causality. Table 1 Adverse Events Occurring at a Frequency greater than or equal to 5% in Either Treatment Group Combined Phase 3 Postmenopausal Osteoporosis Treatment Trials Body System Placebo N = 1,619 5 mg Risedronate Sodium N = 1,613 % % Body as a Whole Infection 29.9 31.1 Back Pain 26.1 28 Accidental Injury 16.8 16.9 Pain 14 14.1 Abdominal Pain 9.9 12.2 Flu Syndrome 11.6 10.5 Headache 10.8 9.9 Asthenia 4.5 5.4 Neck Pain 4.7 5.4 Chest Pain 5.1 5 Allergic Reaction 5.9 3.8 Cardiovascular System Hypertension 9.8 10.5 Digestive System Constipation 12.6 12.9 Diarrhea 10 10.8 Dyspepsia 10.6 10.8 Nausea 11.2 10.5 Metabolic & Nutritional Disorders Peripheral Edema 8.8 7.7 Musculoskeletal System Arthralgia 22.1 23.7 Arthritis 10.1 9.6 Traumatic Bone Fracture 12.3 9.3 Joint Disorder 5.3 7 Myalgia 6.2 6.7 Bone Pain 4.8 5.3 Nervous System Dizziness 5.7 7.1 Depression 6.1 6.8 Insomnia 4.6 5 Respiratory System Bronchitis 10.4 10 Sinusitis 9.1 8.7 Rhinitis 5.1 6.2 Pharyngitis 5 6 Increased Cough 6.3 5.9 Skin and Appendages Rash 7.1 7.9 Special Senses Cataract 5.7 6.5 Urogenital System Urinary Tract Infection 10.4 11.1 Gastrointestinal Adverse Events: The incidence of adverse events in the placebo and risedronate sodium 5 mg daily groups were: abdominal pain (9.9% versus 12.2%), diarrhea (10% versus 10.8%), dyspepsia (10.6% versus 10.8%), and gastritis (2.3% versus 2.7%). Duodenitis and glossitis have been reported uncommonly in the risedronate sodium 5 mg daily group (0.1% to 1%). In patients with active upper gastrointestinal disease at baseline, the incidence of upper gastrointestinal adverse events was similar between the placebo and risedronate sodium 5 mg daily groups. Musculoskeletal Adverse Events: The incidence of adverse events in the placebo and risedronate sodium 5 mg daily groups were: back pain (26.1% versus 28%), arthralgia (22.1% versus 23.7%), myalgia (6.2% versus 6.7%), and bone pain (4.8% versus 5.3%). Laboratory Test Findings : Throughout the Phase 3 studies, transient decreases from baseline in serum calcium (less than 1%) and serum phosphate (less than 3%) and compensatory increases in serum PTH levels (less than 30%) were observed within 6 months in patients in osteoporosis clinical trials treated with risedronate sodium 5 mg once daily. There were no significant differences in serum calcium, phosphate, or PTH levels between placebo and risedronate sodium 5 mg once daily at 3 years. Serum calcium levels below 8 mg/dL were observed in 18 patients, 9 (0.5%) in each treatment arm (placebo and risedronate sodium 5 mg once daily). Serum phosphorus levels below 2 mg/dL were observed in 14 patients, 3 (0.2%) treated with placebo and 11 (0.6%) treated with risedronate sodium 5 mg once daily. There have been rare reports (less than 0.1%) of abnormal liver function tests. Endoscopic Findings : In the risedronate sodium clinical trials, endoscopic evaluation was encouraged in any patient with moderate-to-severe gastrointestinal complaints, while maintaining the blind. Endoscopies were performed on equal numbers of patients between the placebo and treated groups [75 (14.5%) placebo; 75 (11.9%) risedronate sodium]. Clinically important findings (perforations, ulcers, or bleeding) among this symptomatic population were similar between groups (51% placebo; 39% risedronate sodium). Once-a-Week Dosing The safety of risedronate sodium 35 mg once-a-week in the treatment of postmenopausal osteoporosis was assessed in a 1-year, double-blind, multicenter study comparing risedronate sodium 5 mg daily and risedronate sodium 35 mg once-a-week in postmenopausal women aged 50 to 95 years. The duration of the trials was one year, with 480 patients exposed to risedronate sodium 5 mg daily and 485 exposed to risedronate sodium 35 mg once-a-week. Patients with preexisting gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors, and H 2 antagonists were included in these clinical trials. All women received 1,000 mg of elemental calcium plus vitamin D supplementation up to 500 international units per day if their 25-hydroxyvitamin D 3 level was below normal at baseline. The incidence of all-cause mortality was 0.4% in the risedronate sodium 5 mg daily group and 1% in the risedronate sodium 35 mg once-a-week group. The incidence of serious adverse events was 7.1% in the risedronate sodium 5 mg daily group and 8.2% in the risedronate sodium 35 mg once-a-week group. The percentage of patients who withdrew from the study due to adverse events was 11.9% in the risedronate sodium 5 mg daily group and 11.5% in the risedronate sodium 35 mg once-a-week group. The overall safety and tolerability profiles of the two dosing regimens were similar. Gastrointestinal Adverse Events : The incidence of gastrointestinal adverse events was similar between the risedronate sodium 5 mg daily group and the risedronate sodium 35 mg once-a-week group: dyspepsia (6.9% versus 7.6%), diarrhea (6.3% versus 4.9%), and abdominal pain (7.3% versus 7.6%). Musculoskeletal Adverse Events: Arthralgia was reported in 11.5% of patients in the risedronate sodium 5 mg daily group and 14.2% of patients in the risedronate sodium 35 mg once-a-week group. Myalgia was reported by 4.6% of patients in the risedronate sodium 5 mg daily group and 6.2% of patients in the risedronate sodium 35 mg once-a-week group. Laboratory Test Findings : The mean percent changes from baseline at 12 months were similar between the risedronate sodium 5 mg daily and risedronate sodium 35 mg once-a-week groups, respectively, for serum calcium (0.4% versus 0.7%), phosphate (-3.8% versus -2.6%) and PTH (6.4% versus 4.2%). Monthly Dosing Two Consecutive Days per Month The safety of risedronate sodium 75 mg administered on two consecutive days per month for the treatment of postmenopausal osteoporosis was assessed in a double-blind, multicenter study in postmenopausal women aged 50 to 86 years. The duration of the trial was two years; 613 patients were exposed to risedronate sodium 5 mg daily and 616 were exposed to risedronate sodium 75 mg two consecutive days per month. Patients with preexisting gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors, and H 2 antagonists were included in this clinical trial. All women received 1,000 mg of elemental calcium plus 400 to 800 international units of vitamin D supplementation per day. The incidence of all-cause mortality was 1% for the risedronate sodium 5 mg daily group and 0.5% for the risedronate sodium 75 mg two consecutive days per month group. The incidence of serious adverse events was 10.8% in the risedronate sodium 5 mg daily group and 14.4% in the risedronate sodium 75 mg two consecutive days per month group. The percentage of patients who withdrew from treatment due to adverse events was 14.2% in the risedronate sodium 5 mg daily group and 13% in the risedronate sodium 75 mg two consecutive days per month group. The overall safety and tolerability profiles of the two dosing regimens were similar. Acute Phase Reactions : Symptoms consistent with acute phase reaction have been reported with bisphosphonate use. The overall incidence of acute phase reaction was 3.6% of patients on risedronate sodium 5 mg daily and 7.6% of patients on risedronate sodium 75 mg two consecutive days per month. These incidence rates are based on reporting of any of 33 acute phase reaction-like symptoms within 5 days of the first dose. Fever or influenza-like illness with onset within the same period were reported by 0% of patients on risedronate sodium 5 mg daily and 0.6% of patients on risedronate sodium 75 mg two consecutive days per month. Gastrointestinal Adverse Events : The risedronate sodium 75 mg two consecutive days per month group resulted in a higher incidence of discontinuation due to vomiting (1% versus 0.2%) and diarrhea (1% versus 0.3%) compared to the risedronate sodium 5 mg daily group. Most of these events occurred within a few days of dosing. Ocular Adverse Events : None of the patients treated with risedronate sodium 75 mg two consecutive days per month reported ocular inflammation such as uveitis, scleritis, or iritis; 1 patient treated with risedronate sodium 5 mg daily reported uveitis. Laboratory Test Findings : When risedronate sodium 5 mg daily and risedronate sodium 75 mg two consecutive days per month were compared in postmenopausal women with osteoporosis, the mean percent changes from baseline at 24 months were 0.2% and 0.8% for serum calcium, -1.9% and -1.3% for phosphate, and -10.4% and -17.2% for PTH, respectively. Compared to the risedronate sodium 5 mg daily group, risedronate sodium 75 mg two consecutive days per month resulted in a slightly higher incidence of hypocalcemia at the end of the first month of treatment (4.5% versus 3%). Thereafter, the incidence of hypocalcemia with these regimens was similar at approximately 2%. Once-a-Month The safety of risedronate sodium 150 mg administered once-a-month for the treatment of postmenopausal osteoporosis was assessed in a double-blind, multicenter study in postmenopausal women aged 50 to 88 years. The duration of the trial was one year, with 642 patients exposed to risedronate sodium 5 mg daily and 650 exposed to risedronate sodium 150 mg once-a-month. Patients with preexisting gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors, and H 2 antagonists were included in this clinical trial. All women received 1,000 mg of elemental calcium plus up to 1,000 international units of vitamin D supplementation per day. The incidence of all-cause mortality was 0.5% for the risedronate sodium 5 mg daily group and 0% for the risedronate sodium 150 mg once-a-month group. The incidence of serious adverse events was 4.2% in the risedronate sodium 5 mg daily group and 6.2% in the risedronate sodium 150 mg once-a-month group. The percentage of patients who withdrew from treatment due to adverse events was 9.5% in the risedronate sodium 5 mg daily group and 8.6% in the risedronate sodium 150 mg once-a-month group. The overall safety and tolerability profiles of the two dosing regimens were similar. Acute Phase Reactions : Symptoms consistent with acute phase reaction have been reported with bisphosphonate use. The overall incidence of acute phase reaction was 1.1% in the risedronate sodium 5 mg daily group and 5.2% in the risedronate sodium 150 mg once-a-month group. These incidence rates are based on reporting of any of 33 acute phase reaction-like symptoms within 3 days of the first dose and for a duration of 7 days or less. Fever or influenza-like illness with onset within the same period were reported by 0.2% of patients on risedronate sodium 5 mg daily and 1.4% of patients on risedronate sodium 150 mg once-a-month. Gastrointestinal Adverse Events : A greater percentage of patients experienced diarrhea with risedronate sodium 150 mg once-a-month compared to 5 mg daily (8.2% versus 4.7%, respectively). The risedronate sodium 150 mg once-a-month group resulted in a higher incidence of discontinuation due to abdominal pain upper (2.5% versus 1.4%) and diarrhea (0.8% versus 0%) compared to the risedronate sodium 5 mg daily regimen. All of these events occurred within a few days of the first dose. The incidence of vomiting that led to discontinuation was the same in both groups (0.3% versus 0.3%). Ocular Adverse Events : None of the patients treated with risedronate sodium 150 mg once-a-month reported ocular inflammation such as uveitis, scleritis, or iritis; 2 patients treated with risedronate sodium 5 mg daily reported iritis. Laboratory Test Findings : When risedronate sodium 5 mg daily and risedronate sodium 150 mg once-a-month were compared in postmenopausal women with osteoporosis, the mean percent changes from baseline at 12 months were 0.1% and 0.3% for serum calcium, -2.3% and -2.3% for phosphate, and 8.3% and 4.8% for PTH, respectively. Compared to the risedronate sodium 5 mg daily regimen, risedronate sodium 150 mg once-a-month resulted in a slightly higher incidence of hypocalcemia at the end of the first month of treatment (0.2% versus 2.2%). Thereafter, the incidence of hypocalcemia with these regimens was similar at approximately 2%. Prevention of Postmenopausal Osteoporosis Daily Dosing The safety of risedronate sodium 5 mg daily in the prevention of postmenopausal osteoporosis was assessed in two randomized, double-blind, placebo-controlled trials. In one study of postmenopausal women aged 37 to 82 years without osteoporosis, the use of estrogen replacement therapy in both placebo- and risedronate sodium-treated patients was included. The duration of the trial was one year, with 259 exposed to placebo and 261 patients exposed to risedronate sodium 5 mg. The second study included postmenopausal women aged 44 to 63 years without osteoporosis. The duration of the trial was one year, with 125 exposed to placebo and 129 patients exposed to risedronate sodium 5 mg. All women received 1,000 mg of elemental calcium per day. In the trial with estrogen replacement therapy, the incidence of all-cause mortality was 1.5% for the placebo group and 0.4% for the risedronate sodium 5 mg group. The incidence of serious adverse events was 8.9% in the placebo group and 5.4% in the risedronate sodium 5 mg group. The percentage of patients who withdrew from treatment due to adverse events was 18.9% in the placebo group and 10.3% in the risedronate sodium 5 mg group. Constipation was reported by 1.9% of the placebo group and 6.5% of risedronate sodium 5 mg group. In the second trial, the incidence of all-cause mortality was 0% for both groups. The incidence of serious adverse events was 17.6% in the placebo group and 9.3% in the risedronate sodium 5 mg group. The percentage of patients who withdrew from treatment due to adverse events was 6.4% in the placebo group and 5.4% in the risedronate sodium 5 mg group. Nausea was reported by 6.4% of patients in the placebo group and 13.2% of patients in the risedronate sodium 5 mg group. Once-a-Week Dosing There were no deaths in a 1-year, double-blind, placebo-controlled study of risedronate sodium 35 mg once-a-week for prevention of bone loss in 278 postmenopausal women without osteoporosis. More treated subjects on risedronate sodium reported arthralgia (placebo 7.8%; risedronate sodium 13.9%), myalgia (placebo 2.1%; risedronate sodium 5.1%), and nausea (placebo 4.3%; risedronate sodium 7.3%) than subjects on placebo. Treatment to Increase Bone Mass in Men with Osteoporosis In a 2-year, double-blind, multicenter study, 284 men with osteoporosis were treated with placebo (N = 93) or risedronate sodium 35 mg once-a-week (N = 191). The overall safety and tolerability profile of risedronate sodium in men with osteoporosis was similar to the adverse events reported in the risedronate sodium postmenopausal osteoporosis clinical trials, with the addition of benign prostatic hyperplasia (placebo 3%; risedronate sodium 35 mg 5%), nephrolithiasis (placebo 0%; risedronate sodium 35 mg 3%), and arrhythmia (placebo 0%; risedronate sodium 35 mg 2%). Treatment and Prevention of Glucocorticoid-Induced Osteoporosis The safety of risedronate sodium 5 mg daily in the treatment and prevention of glucocorticoid-induced osteoporosis was assessed in two randomized, double-blind, placebo-controlled multinational trials of 344 patients [male (123) and female (221)] aged 18 to 85 years who had recently initiated oral glucocorticoid therapy (less than or equal to 3 months, prevention study) or were on long-term oral glucocorticoid therapy (greater than or equal to 6 months, treatment study). The duration of the trials was one year, with 170 patients exposed to placebo and 174 patients exposed to risedronate sodium 5 mg daily. Patients in one study received 1,000 mg elemental calcium plus 400 international units of vitamin D supplementation per day; patients in the other study received 500 mg calcium supplementation per day. The incidence of all-cause mortality was 2.9% in the placebo group and 1.1% in the risedronate sodium 5 mg daily group. The incidence of serious adverse events was 33.5% in the placebo group and 30.5% in the risedronate sodium 5 mg daily group. The percentage of patients who withdrew from the study due to adverse events was 8.8% in the placebo group and 7.5% in the risedronate sodium 5 mg daily group. Back pain was reported in 8.8% of patients in the placebo group and 17.8% of patients in the risedronate sodium 5 mg daily group. Arthralgia was reported in 14.7% of patients in the placebo group and 24.7% of patients in the risedronate sodium 5 mg daily group. Treatment of Paget's Disease Risedronate sodium has been studied in 392 patients with Paget's disease of bone. As in trials of risedronate sodium for other indications, the adverse experiences reported in the Paget's disease trials have generally been mild or moderate, have not required discontinuation of treatment, and have not appeared to be related to patient age, gender, or race. The safety of risedronate sodium was assessed in a randomized, double-blind, active-controlled study of 122 patients aged 34 to 85 years. The duration of the trial was 540 days, with 61 patients exposed to risedronate sodium and 61 patients exposed to etidronate disodium. The adverse event profile was similar for risedronate sodium and etidronate disodium: 6.6% (4/61) of patients treated with risedronate sodium 30 mg daily for 2 months discontinued treatment due to adverse events, compared to 8.2% (5/61) of patients treated with etidronate disodium 400 mg daily for 6 months. Table 2 lists adverse events reported in greater than or equal to 5% of risedronate sodium-treated patients in Phase 3 Paget's disease trials. Adverse events shown are considered to be possibly or probably causally related in at least one patient. Table 2 Adverse Events Reported in greater than or equal to 5% of Risedronate Sodium-Treated Patients Considered to be possibly or probably causally related in at least one patient. in Phase 3 Paget's Disease Trials Body System 30 mg/day x 2 months Risedronate Sodium % (N = 61) 400 mg/day x 6 months Etidronate Disodium % (N = 61) Body as a Whole Flu Syndrome 9.8 1.6 Chest Pain 6.6 3.3 Gastrointestinal Diarrhea 19.7 14.8 Abdominal Pain 11.5 8.2 Nausea 9.8 9.8 Constipation 6.6 8.2 Metabolic and Nutritional Disorders Peripheral Edema 8.2 6.6 Musculoskeletal Arthralgia 32.8 29.5 Nervous Headache 18 16.4 Dizziness 6.6 4.9 Skin and Appendages Rash 11.5 8.2 Gastrointestinal Adverse Events: During the first year of the study (treatment and nontreatment follow-up), the proportion of patients who reported upper gastrointestinal adverse events was similar between the treatment groups; no patients reported severe upper gastrointestinal adverse events. The incidence of diarrhea was 19.7% in the risedronate sodium group and 14.8% in the etidronate disodium group; none were serious or resulted in withdrawal. Ocular Adverse Events : Three patients who received risedronate sodium 30 mg daily experienced acute iritis in 1 supportive study. All 3 patients recovered from their events; however, in 1 of these patients, the event recurred during risedronate sodium treatment and again during treatment with pamidronate. All patients were effectively treated with topical steroids. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of risedronate sodium or bisphosphonate products. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity Reactions Hypersensitivity and skin reactions have been reported, including angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis. Gastrointestinal Adverse Events Events involving upper gastrointestinal irritation, such as esophagitis and esophageal or gastric ulcers, have been reported [ see Warnings and Precautions (5.1) ]. Musculoskeletal Bone, joint, or muscle pain, described as severe or incapacitating, have been reported rarely [ see Warnings and Precautions (5.4) ]; low-energy femoral shaft and subtrochanteric fractures, and atypical fractures of other bones, [see Warnings and Precautions (5.6)] . Eye Inflammation Reactions of eye inflammation including iritis and uveitis have been reported rarely. Jaw Osteonecrosis Osteonecrosis of the jaw has been reported rarely [ see Warnings and Precautions (5.3) ]. Pulmonary Asthma exacerbations
Information for Patients
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide) Instruct patients to read the Medication Guide before starting therapy with risedronate sodium tablets and to re-read it each time the prescription is renewed. Instruct patients that risedronate sodium delayed-release tablets and risedronate sodium tablets contain the same active ingredient and if they are taking risedronate sodium delayed-release tablets, they should not take risedronate sodium tablets [see Warnings and Precautions ( 5.1 )] . Instruct patients to pay particular attention to the dosing instructions as clinical benefits may be compromised by failure to take the drug according to instructions. Specifically, risedronate sodium tablets should be taken at least 30 minutes before the first food or drink of the day other than water. Instruct patients to take risedronate sodium tablets while in an upright position (sitting or standing) with a full glass of plain water (6 to 8 ounces) to facilitate delivery to the stomach, and thus reduce the potential for esophageal irritation. Instruct patients not to lie down for 30 minutes after taking the medication [ see Warnings and Precautions ( 5.1 ) ]. Instruct patients not to chew or suck on the tablet because of a potential for oropharyngeal irritation. Instruct patients that if they develop symptoms of esophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or severe persistent or worsening heartburn) they should consult their physician before continuing risedronate sodium tablets. Instruct patients about missing risedronate sodium tablets doses as follows: If a dose of risedronate sodium tablet 35 mg once-a-week is missed, they should take 1 tablet on the morning after they remember and return to taking 1 tablet once-a-week, as originally scheduled on their chosen day. Patients should not take 2 tablets on the same day. If one or both tablets of risedronate sodium tablet 75 mg on two consecutive days per month are missed, and the next month's scheduled doses are more than 7 days away, the patient should be instructed as follows: If both tablets are missed, take one risedronate sodium 75 mg tablet in the morning after the day it is remembered and then the other tablet on the next consecutive morning. If only one risedronate sodium 75 mg tablet is missed, take the missed tablet in the morning after the day it is remembered. Patients should then return to taking their risedronate sodium tablets 75 mg on two consecutive days per month as originally scheduled. Patients should not take more than two 75 mg tablets within 7 days. If one or both tablets of risedronate sodium 75 mg on two consecutive days per month are missed, and the next month's scheduled doses are within 7 days, patients should wait until their next month's scheduled doses and then continue taking risedronate sodium tablet 75 mg on two consecutive days per month as originally scheduled. If the dose of risedronate sodium tablet 150 mg once-a-month is missed, and the next month's scheduled dose is more than 7 days away, the patient should be instructed to take the missed tablet in the morning after the day it is remembered. Patients should then return to taking their risedronate sodium tablets 150 mg once-a-month as originally scheduled. Patients should not take more than one 150 mg tablet within 7 days. If the dose of risedronate sodium tablet 150 mg once-a-month is missed, and the next month’s scheduled dose is within 7 days, patients should wait until their next month's scheduled dose and then continue taking risedronate sodium tablet 150 mg once-a-month as originally scheduled. Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate [ see Warnings and Precautions ( 5.3 ) ]. Weight-bearing exercise should be considered along with the modification of certain behavioral factors, such as excessive cigarette smoking, and/or alcohol consumption, if these factors exist. Instruct patients to take calcium supplements or calcium-, aluminum-, and magnesium-containing medications at a different time of the day than risedronate sodium tablets as these medications may interfere with the absorption of risedronate sodium tablets. Remind patients to give all of their healthcare providers an accurate medication history. Instruct patients to tell all of their healthcare providers that they are taking risedronate sodium tablets. Patients should be instructed that any time they have a medical problem they think may be from risedronate sodium tablets, they should talk to their doctor. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 1012, Dadra-396 193, U.T. of D & NH and Daman & Diu, India. 5269850 Revised: 02/2026
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.