ACTONEL with CALCIUM is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

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).

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.

ACTONEL should be taken at least 30 minutes before the first food or drink of the day other than water. Actonel should not be taken at the same time as other medications, including calcium.

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). 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.

The recommended total (diet and otherwise) daily calcium intake in postmenopausal women is 1200 mg of elemental calcium. If patients need calcium in excess of that provided by ACTONEL with CALCIUM, this should be taken with food at a separate time of day.

Patients should receive additional vitamin D if dietary intake is inadequate (see PRECAUTIONS, General). Co-administration of calcium tablets and calcium-, aluminum-, and magnesium-containing medications may interfere with the absorption of ACTONEL (see DRUG INTERACTIONS).

ACTONEL with CALCIUM 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.

ACTONEL with CALCIUM is supplied in blister packages containing a 28-day course of therapy.

Four Actonel Tablets:

35 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other

Twenty-four Calcium Carbonate Tablets, USP:

1250 mg calcium carbonate (equivalent to 500 mg elemental calcium) film-coated, oval, light blue tablets with NE 2 engraved on both faces

NDC 0149-0475-01

Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

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