Generic Actonel

What it is used for

1 INDICATIONS AND USAGE Risedronate sodium delayed-release tablets are bisphosphonate in a delayed-release formulation and is indicated for treatment of postmenopausal osteoporosis (1.1) 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 (1.2). 1.1 Postmenopausal Osteoporosis Risedronate sodium delayed-release tablets are 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 [ see Clinical Studies (14.1) ]. 1.2 Important Limitations of Use The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium delayed-release tablets for the treatment of osteoporosis are based on clinical data of one year 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 disc

How it is taken

2 DOSAGE AND ADMINISTRATION One 35 mg delayed-release tablet once-a-week (2.1) Instruct patients to: • Take risedronate sodium delayed-release tablets in the morning immediately following breakfast with at least 4 ounces of plain water (2.2) • Avoid lying down for 30 minutes after taking risedronate sodium delayed-release tablets (2.2) • Take supplemental calcium and vitamin D if dietary intake is inadequate (2.3) 2.1 Treatment of Postmenopausal Osteoporosis [ see Indications and Usage (1.1) ] The recommended regimen is: • one 35 mg delayed-release tablet orally, taken once-a-week [see Indications and Usage (1.1)] 2.2 Important Administration Instructions Instruct patients to do the following: • Take risedronate sodium delayed-release tablets in the morning immediately following breakfast. Risedronate sodium delayed-release tablets 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 delayed-release tablets 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

Warnings

5 WARNINGS AND PRECAUTIONS • Products Containing Same Active Ingredient : Patients receiving Actonel should not be treated with risedronate sodium delayed-release 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 Femur Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture (5.6) 5.1 Drug Products with the Same Active Ingredient Risedronate sodium delayed-release tablets contain the same active ingredient found in Actonel ® . A patient being treated with Actonel should not receive risedronate sodium delayed-release tablets. 5.2 Upper Gastrointestinal Adverse Reactions 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 t

Source: openFDA / DailyMed. Provided for information only — always follow the directions given by your own prescriber.