A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Actonel Indications, Dosage, Storage, Stability - Risedronate
Actonel Indications, Dosage, Storage, Stability - Risedronate
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 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 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
Prevention of Postmenopausal Osteoporosis (see INDICATIONS
AND USAGE):
· The recommended regimen is
one 5-mg tablet orally, taken daily
· Alternatively, one 35-mg tablet
orally, taken once a week may be considered
Treatment and Prevention of Glucocorticoid-Induced Osteoporosis
(see INDICATIONS AND USAGE):
The recommended regimen is:
·one 5-mg tablet orally,
taken 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
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
Store at controlled room temperature 20°-25°C (68°-77°F) [See
USP].
Sold under U.S. patent No. 5,583,122; 6,096,342
and 6,165,513
Mfg. by: Procter & Gamble Pharmaceuticals
Cincinnati, OH 45202, or OSG Norwich Pharmaceuticals, Inc. North Norwich, NY
13814
Dist. by: Procter & Gamble Pharmaceuticals,
TM Owner Cincinnati, OH 45202
Marketed with: Aventis Pharmaceuticals Inc.
Kansas City, MO 64137 MARCH 2003
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