Warner Chilcott Pharmaceuticals Inc.

Warner Chilcott Pharmaceuticals Inc. Drugs

• Actonel
  

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  Actonel

  

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  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.

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