ACTONEL- risedronate sodium tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RISEDRONATE SODIUM (UNII: OFG5EXG60L) (risedronic acid - UNII:KM2Z91756Z)

Available from:

Warner Chilcott Pharmaceuticals Inc.

INN (International Name):

RISEDRONATE SODIUM

Composition:

RISEDRONATE SODIUM 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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) ]. ACTONEL is indicated for treatment to increase bone mass in men with 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. ACTONEL is indicated for treatment of Paget’s disease of bone in men and women. - Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see Warnings and Precautions (5.1) ] - Inability to stand or sit upright for at least 30 minutes [see Dosage

Product summary:

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].

Authorization status:

New Drug Application

Summary of Product characteristics

ACTONEL- RISEDRONATE SODIUM TABLET, FILM COATED
WARNER CHILCOTT PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACTONEL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ACTONEL.
ACTONEL (RISEDRONATE SODIUM) TABLETS
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Contraindications (4)
12/2009
Warnings and Precautions (5.1, 5.3)
12/2009
INDICATIONS AND USAGE
ACTONEL is a bisphosphonate indicated for:
Treatment and prevention of postmenopausal osteoporosis (1.1),
Treatment to increase bone mass in men with osteoporosis (1.2),
Treatment and prevention of glucocorticoid-induced osteoporosis (1.3),
Treatment of Paget’s disease (1.4).
DOSAGE AND ADMINISTRATION
Must be taken with plain water (6 to 8 oz) at least 30 minutes before
the first food or drink of the day; do not lie down for 30
minutes (2)
Treatment of Osteoporosis in Postmenopausal Women: 5 mg daily, 35 mg
once a week, 75 mg taken on two consecutive
days each month, or 150 mg once a month (2.1)
Prevention of Osteoporosis in Postmenopausal Women: 5 mg daily, or 35
mg once a week (2.2)
Men with Osteoporosis: 35 mg once a week (2.3)
Treatment and Prevention of Glucocorticoid-Induced Osteoporosis: 5 mg
daily (2.4)
Paget’s Disease: 30 mg daily for 2 months (2.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 5, 30, 35, 75, and 150 mg (3)
CONTRAINDICATIONS
Abnormalities of the esophagus which delay esophageal emptying such as
stricture or achalasia (4, 5.1)
Inability to stand or sit upright for at least 30 minutes (4, 5.1)
Hypocalcemia (4, 5.2)
Known hypersensitivity to any component of this product (4, 6.2)
WARNINGS AND PRECAUTIONS
Severe irritation of the upper gastrointestinal (GI) mucosa can occur.
Dosing instructions should be followed and
caution should be used in patients with active upper GI disease.
Discontinue use if new or worsening symptoms occur
(5.1).
Hypocalcemia may worsen and must be corrected prior to use (5.2).
Osteonecrosis of the jaw has been reported r