INDICATIONS AND USAGE
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) ].
Osteoporosis in Men
ACTONEL is indicated for treatment to increase bone mass in men with osteoporosis.
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.
Paget's Disease
ACTONEL is indicated for treatment of Paget's disease of bone in men and women.
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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.
Treatment of Postmenopausal Osteoporosis
[ see Indications and Usage (1.1) ]
The recommended regimen is:
- one 5 mg tablet orally, taken daily
one 35 mg tablet orally, taken once a week
one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month
one 150 mg tablet orally, taken once a month
Prevention of Postmenopausal Osteoporosis
[ see Indications and Usage (1.1) ]
The recommended regimen is:
- one 5 mg tablet orally, taken daily
one 35 mg tablet orally, taken once a week
alternatively, one 75 mg tablet orally, taken on two consecutive days for a total of two tablets each month may be considered
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 (1.2) ]
The recommended regimen is:
- one 35 mg tablet orally, taken once a week
Treatment and Prevention of Glucocorticoid-Induced Osteoporosis
[ see Indications and Usage (1.3) ]
The recommended regimen is:
- one 5 mg tablet orally, taken daily
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.
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.
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HOW SUPPLIED/STORAGE AND HANDLING
ACTONEL is available as follows:
5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other.
NDC 0149-0471-01 bottle of 30
NDC 0149-0471-03 bottle of 2000
30 mg film-coated, oval, white tablets with RSN on 1 face and 30 mg on the other.
NDC 0149-0470-01 bottle of 30
35 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other.
NDC 0149-0472-01 dose pack of 4
NDC 0149-0472-04 dose pack of 12
75 mg film-coated, oval, pink tablets with RSN on 1 face and 75 mg on the other.
NDC 0149-0477-01 dose pack of 2
150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other.
NDC 0149-0478-01 dose pack of 1
NDC 0149-0478-03 dose pack of 3
Store at controlled room temperature 20° to 25°C (68° to 77°F) [ See USP].
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