Actonel

ACTONEL — risedronate sodium tablet, film coated
Physicians Total Care, Inc.

1 INDICATIONS AND USAGE

1.1 Postmenopausal Osteoporosis

ACTONEL is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ACTONEL reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see Clinical Studies (14.1, 14.2)].

1.2 Osteoporosis in Men

ACTONEL is indicated for treatment to increase bone mass in men with osteoporosis.

1.3 Glucocorticoid-Induced Osteoporosis

ACTONEL 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.

1.4 Paget’s Disease

ACTONEL is indicated for treatment of Paget’s disease of bone in men and women.

2 DOSAGE AND ADMINISTRATION

ACTONEL 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 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 (5.1) ].

Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate [see Warnings and Precautions (5.2) ]. Calcium supplements and calcium-, aluminum-, and magnesium-containing medications may interfere with the absorption of ACTONEL and should be taken at a different time of the day. ACTONEL 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.

2.1 Treatment of Postmenopausal Osteoporosis

[see Indications and Usage (1.1) ]

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

2.2 Prevention of Postmenopausal Osteoporosis

[see Indications and Usage (1.1) ]

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

2.3 Treatment to Increase Bone Mass in Men with Osteoporosis

[see Indications and Usage (1.2) ]

The recommended regimen is:

  • one 35 mg tablet orally, taken once a week

2.4 Treatment and Prevention of Glucocorticoid-Induced Osteoporosis

[see Indications and Usage (1.3) ]

The recommended regimen is:

  • one 5 mg tablet orally, taken daily

2.5 Treatment of Paget’s Disease

[see Indications and Usage (1.4) ]

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.

3 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.

4 CONTRAINDICATIONS

  • 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 and Precautions (5.2) ]
  • Known hypersensitivity to any component of this product [see Adverse Reactions (6.2) ]

5 WARNINGS AND PRECAUTIONS

5.1 Upper Gastrointestinal Adverse Reactions

ACTONEL, 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 the underlying disease, caution should be used when ACTONEL is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers) [see Contraindications (4), Adverse Reactions (6.1), Information for Patients (17.1)].

Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. In some cases, these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue ACTONEL and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.

The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (6-8 oz) of water, and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient [see Dosage and Administration (2) ]. In patients who cannot comply with dosing instructions due to mental disability, therapy with ACTONEL should be used under appropriate supervision.

There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials.

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