Risedronate Sodium
Generic Name: risedronate sodium
Brand Names:
Risedronate Sodium
11 DESCRIPTION Risedronate sodium tablets, USP are pyridinyl bisphosphonates that inhibit osteoclast-mediated bone resorption and modulate bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 35, 75, or 150 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate. The empirical formula for risedronate sodium hemi-pentahydrate is C 7 H 10 NO 7 P 2 Na •2.5 H 2 O.
Overview
11 DESCRIPTION Risedronate sodium tablets, USP are pyridinyl bisphosphonates that inhibit osteoclast-mediated bone resorption and modulate bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 35, 75, or 150 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate. The empirical formula for risedronate sodium hemi-pentahydrate is C 7 H 10 NO 7 P 2 Na •2.5 H 2 O.
Uses
1 INDICATIONS AND USAGE Risedronate sodium tablets, USP are 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, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Dosage
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...
Side Effects
6 ADVERSE REACTIONS 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 )] Most common adverse reactions reported in greater than...
Interactions
7 DRUG 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 ( 7.1 ) 7.1 Calcium Supplements/Antacids Co-administration of risedronate sodium tablets and calcium, antacids, or oral medications containing divalent cations will interfere with the absorption of risedronate sodium tablets.
Warnings
5 WARNINGS AND PRECAUTIONS Products Containing Same Active Ingredient : Patients receiving Atelvia should not be treated with risedronate sodium tablets ( 5.1 ) Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue use if new or worsening symptoms occur ( 5.2 ) Hypocalcemia may worsen and must be corrected prior to use ( 5.3 ) Osteonecrosis of the Jaw has been reported ( 5.4 ) Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop ( 5.5 , 6.2 ) Atypical Fractures Including Femoral Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture. 4 CONTRAINDICATIONS Risedronate sodium tablets are contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see Warnings and Precautions ( 5.1 )] Inability to stand or sit upright for at least 30 minutes [see Dosage and Administration ( 2 ), Warnings and Precautions ( 5.1 )] Hypocalcemia [see Warnings...
Pregnancy
8.1 Pregnancy Risk Summary Available data on the use of risedronate sodium tablets in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. Discontinue risedronate sodium tablets when pregnancy is recognized. In animal reproduction studies, daily oral administration of risedronate to pregnant rats during organogenesis decreased neonatal survival and body weight at doses approximately 5 and 26 times, respectively, the highest recommended human daily dose of 30 mg (based on body surface area, mg/m 2 ).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Risedronate Sodium Tablets, USP are available as follows: 35 mg film-coated, round, orange biconvex tablet, engraved ‘APO’ on one side, ‘RIS’ over ‘35’ on the other side NDC 60505-3165-0 dose pack of 4 NDC 60505-3165-2 dose pack of 12 75 mg film-coated, round, dark pink biconvex tablet, engraved ‘APO’ on one side, ‘RIS’ over ‘75’ on the other side NDC 60505-309...
Frequently Asked Questions
What is Risedronate Sodium used for?▼
1 INDICATIONS AND USAGE Risedronate sodium tablets, USP are 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, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women.
What are the side effects of Risedronate Sodium?▼
6 ADVERSE REACTIONS 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 )] Most common adverse reactions reported in greater than...
Can I take Risedronate Sodium during pregnancy?▼
8.1 Pregnancy Risk Summary Available data on the use of risedronate sodium tablets in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. Discontinue risedronate sodium tablets when pregnancy is recognized. In animal reproduction studies, daily oral administration of risedronate to pregnant rats during organogenesis decreased neonatal survival and body weight at doses approximately 5 and 26 times, respectively, the highest recommended human daily dose of 30 mg (based on body surface area, mg/m 2 ).
What are the important warnings for Risedronate Sodium?▼
5 WARNINGS AND PRECAUTIONS Products Containing Same Active Ingredient : Patients receiving Atelvia should not be treated with risedronate sodium tablets ( 5.1 ) Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue use if new or worsening symptoms occur ( 5.2 ) Hypocalcemia may worsen and must be corrected prior to use ( 5.3 ) Osteonecrosis of the Jaw has been reported ( 5.4 ) Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop ( 5.5 , 6.2 ) Atypical Fractures Including Femoral Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture. 4 CONTRAINDICATIONS Risedronate sodium tablets are contraindicated in patients with the following conditions: Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see Warnings and Precautions ( 5.1 )] Inability to stand or sit upright for at least 30 minutes [see Dosage and Administration ( 2 ), Warnings and Precautions ( 5.1 )] Hypocalcemia [see Warnings...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.