Risedronate Sodium

What it is and how it works

Mechanism of Action Risedronate sodium has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, risedronate sodium inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption (for example, lack of ruffled border). Histomorphometry in rats, dogs, and minipigs showed that risedronate sodium treatment reduces bone turnover (activation frequency, that is, the rate at which bone remodeling sites are activated) and bone resorption at remodeling sites.

Indications

Risedronate sodium tablets, USP are a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis Treatment to increase bone mass in men with osteoporosis • Treatment and prevention of glucocorticoid-induced osteoporosis • 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. Postmenopausal Osteoporosis Risedronate sodium tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets, USP reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [ see Clinical Studies ( 14.1 , 14.2 ) ]. Osteoporosis in Men Risedronate sodium tablets, USP are indicated for treatment to increase bone mass in men with osteoporosis.

Dosage and administration (summary)

Treatment of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week, 75 mg two consecutive days each month, 150 mg once-a-month Prevention of Postmenopausal Osteoporosis: 5 mg daily, 35 mg once-a-week Men with Osteoporosis: 35 mg once-a-week Glucocorticoid-Induced Osteoporosis: 5 mg daily Paget's Disease: 30 mg daily for 2 months 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.

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 • Inability to stand or sit upright for at least 30 minutes • Hypocalcemia • Known hypersensitivity to risedronate sodium tablets or any of its excipients.

Warnings and precautions

Products Containing Same Active Ingredient : Patients receiving Atelvia should not be treated with risedronate sodium tablets • Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue use if new or worsening symptoms occur • Hypocalcemia may worsen and must be corrected prior to use Osteonecrosis of the Jaw has been reported Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop ( 5.5 , 6.2 ) Atypical Femur Fractures have been reported.

Pregnancy

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.

Storage and supply

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 71205-714-04 dose pack of 4 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

Source: Risedronate Sodium (Risedronate Sodium) — US FDA prescribing information, 2022-11-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.