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INDICATIONS AND
USAGE
Postmenopausal Osteoporosis:
ACTONEL is indicated for the treatment and prevention
of osteoporosis in postmenopausal women.
Treatment of Osteoporosis:
In postmenopausal women with osteoporosis, ACTONEL
increases BMD and reduces the incidence of vertebral fractures
and a composite endpoint of nonvertebral osteoporosis-related
fractures (see CLINICAL STUDIES). Osteoporosis may be
confirmed by the presence or history of osteoporotic fracture,
or by the finding of low bone mass (for example, at least
2 SD below the premenopausal mean).
Prevention of Osteoporosis:
ACTONEL may be considered in postmenopausal women
who are at risk of developing osteoporosis and for whom
the desired clinical outcome is to maintain bone mass
and to reduce the risk of fracture.
Factors such as family history of osteoporosis, previous
fracture, smoking, BMD (at least 1 SD below the premenopausal
mean), high bone turnover, thin body frame, Caucasian
or Asian race, and early menopause are associated with
an increased risk of developing osteoporosis and fractures.
The presence of these risk factors may be important when
considering the use of ACTONEL for prevention of osteoporosis.
Glucocorticoid-Induced Osteoporosis:
ACTONEL is indicated for the prevention and treatment
of glucocorticoid-induced osteoporosis in men and women
who are either initiating or continuing systemic glucocorticoid
treatment (daily dosage equivalent to 7.5 mg or greater
of prednisone) 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 (osteitis deformans). Treatment is indicated
in patients with Paget s disease of bone (1) who have
a level of serum alkaline phosphatase at least 2 times
the upper limit of normal, or (2) who are symptomatic,
or (3) who are at risk for future complications from their
disease, to induce remission (normalization of serum alkaline
phosphatase).
DOSAGE AND ADMINISTRATION
ACTONEL should be taken once per day 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 PRECAUTIONS, General).
Patients should receive supplemental calcium and vitamin
D if dietary intake is inadequate (see PRECAUTIONS, General).
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 and Prevention of Postmenopausal Osteoporosis/Glucocorticoid-Induced
Osteoporosis (see
INDICATIONS
AND USAGE):
The recommended regimen is 5 mg orally daily.
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.
HOW SUPPLIED
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
5-mg film-coated, oval, yellow tablets with RSN on 1 face
and 5 mg on the other. 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
Store at controlled room temperature 20°-25°C
(68°-77°F) [See USP].
Sold under U.S. patent No. 5,583,122
Dist. by: Procter & Gamble Pharmaceuticals, TM Owner
Cincinnati, OH 45202 ,Marketed with: Aventis Pharmaceuticals
Inc. Kansas City, MO 64137
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