HIGHLIGHTS OF PRESCRIBING INFORMATION ...

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ACTONEL safely and effectively. See full prescribing information for ACTONEL.

ACTONEL? (risedronate sodium) tablets Initial U.S. Approval: 1998

----------------------------RECENT MAJOR CHANGES--------------------------

Warnings and Precautions (5.3)

7/2009

----------------------------INDICATIONS AND USAGE--------------------------ACTONEL 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).

-----------------------WARNINGS AND PRECAUTIONS-----------------------? Upper gastrointestinal irritation may occur. Dosing instructions should be followed. Discontinue use if new or worsening symptoms occur (5.1). ? Hypocalcemia may worsen and must be corrected prior to use (5.2). ? Osteonecrosis of the jaw has been reported rarely (5.3). ? Severe bone, joint, or muscle pain may occur. Consider discontinuing use if severe symptoms develop (5.4, 6.2). ? Before initiating treatment in patients with glucocorticoid-induced

osteoporosis, sex steroid hormonal status of both men and women

should be ascertained and appropriate replacement considered (5.6).

? Bisphosphonates may interfere with bone-imaging agents (5.7).

------------------------------ADVERSE REACTIONS------------------------------Most common adverse reactions reported in >10% of patients treated with ACTONEL and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia (6.1).

----------------------DOSAGE AND ADMINISTRATION----------------------Must be taken with plain water (6 to 8 oz) at least 30 minutes before the first food or drink of the day; do not lie down for 30 minutes (2)

Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions), and eye inflammation (iritis, uveitis) have been reported rarely (6.2).

Treatment of Osteoporosis in Postmenopausal Women: 5 mg daily, 35 mg

To report SUSPECTED ADVERSE REACTIONS, contact Procter &

once a week, 75 mg taken on two consecutive days each month, or 150 mg

Gamble Pharmaceuticals, Inc. at 1-800-836-0658 or FDA at 1-800-FDA

once a month (2.1)

1088 or medwatch.

Prevention of Osteoporosis in Postmenopausal Women: 5 mg daily, or 35 mg once a week (2.2) Men with Osteoporosis: 35 mg once a week (2.3) Treatment and Prevention of Glucocorticoid-Induced Osteoporosis: 5 mg daily

------------------------------DRUG INTERACTIONS------------------------------Calcium, antacids, or oral medications containing divalent cations interfere with the absorption of ACTONEL (7.1).

(2.4)

-----------------------USE IN SPECIFIC POPULATIONS------------------------

Paget's Disease: 30 mg daily for 2 months (2.5)

ACTONEL is not recommended for use in patients with severe renal

---------------------DOSAGE FORMS AND STRENGTHS---------------------Tablets: 5, 30, 35, 75, and 150 mg (3)

impairment (creatinine clearance ................
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