Postmenopausal Osteoporosis

Actonel (risedronate sodium) is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, Actonel (risedronate sodium) reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies].

Osteoporosis in Men

Actonel (risedronate sodium) is indicated for treatment to increase bone mass in men with osteoporosis.

Glucocorticoid-Induced Osteoporosis

Actonel (risedronate sodium) is 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 ≥ 7.5 mg prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

Paget's Disease

Actonel (risedronate sodium) is indicated for treatment of Paget's disease of bone in men and women.

Important Limitations of Use

The safety and effectiveness of Actonel (risedronate sodium) for the treatment of osteoporosis are based on clinical data of three years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.

Actonel (risedronate sodium) should be taken at least 30 minutes before the first food or drink of the day other than water.

To facilitate delivery to the stomach, Actonel (risedronate sodium) should be swallowed while the patient is in an upright position and with a full glass of plain water (6 to 8 oz). Patients should not lie down for 30 minutes after taking the medication [see WARNINGS AND PRECAUTIONS].

Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate [see WARNINGS AND PRECAUTIONS]. Calcium supplements and calcium-, aluminum-, and magnesium-containing medications may interfere with the absorption of Actonel (risedronate sodium) and should be taken at a different time of the day. Actonel (risedronate sodium) is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min). No dosage adjustment is necessary in patients with a creatinine clearance ≥ 30 mL/min or in the elderly.

Treatment of Postmenopausal Osteoporosis [see INDICATIONS AND USAGE]

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

Prevention of Postmenopausal Osteoporosis [see INDICATIONS AND USAGE]

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

Treatment to Increase Bone Mass in Men with Osteoporosis [see INDICATIONS AND USAGE]

The recommended regimen is:

• one 35 mg tablet orally, taken once a week

Treatment and Prevention of Glucocorticoid-Induced Osteoporosis [see INDICATIONS AND USAGE]

The recommended regimen is:

• one 5 mg tablet orally, taken daily

Treatment of Paget's Disease [see INDICATIONS AND USAGE]

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.

Dosage Forms And Strengths

• 5 mg film-coated, oval, yellow tablet with RSN on 1 face and 5 mg on the other.
• 30 mg film-coated, oval, white tablet with RSN on 1 face and 30 mg on the other.
• 35 mg film-coated, oval, orange tablet with RSN on 1 face and 35 mg on the other.
• 75 mg film-coated, oval, pink tablet with RSN on 1 face and 75 mg on the other.
• 150 mg film-coated, oval, blue tablet with RSN on 1 face and 150 mg on the other.

Storage And Handling

Actonel® (risedronate sodium) is available as follows:

5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.

NDC 0430-0471-15 bottle of 30

30 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.

NDC 0430-0470-15 bottle of 30

35 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.

NDC 0430-0472-03 dose pack of 4
NDC 0430-0472-07 dose pack of 12

75 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.

NDC 0430-0477-02 dose pack of 2

150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.

NDC 0430-0478-01 dose pack of 1
NDC 0430-0478-02 dose pack of 3

Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].

Manufactured by: Warner Chilcott Puerto Rico LLC, Manati, Puerto Rico 00674 or Norwich Pharmaceuticals, Inc., North Norwich, NY 13814 or Chinoin Pharmaceutical and Chemical Works Private Co. Ltd Veresegyhaz, Hungary. Marketed by: Warner Chilcott (US), LLC Rockaway, NJ 07866 1-800-521-8813. Issued January 2011

Last reviewed on RxList: 3/10/2011
This monograph has been modified to include the generic and brand name in many instances.