البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
RISEDRONATE SODIUM (UNII: OFG5EXG60L) (RISEDRONIC ACID - UNII:KM2Z91756Z)
Physicians Total Care, Inc.
RISEDRONATE SODIUM
RISEDRONATE SODIUM 5 mg
ORAL
PRESCRIPTION DRUG
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
ACTONEL is available as follows: 5 mg film-coated, oval, yellow tablets with RSN on 1 face and 5 mg on the other. 35 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other. 150 mg film-coated, oval, blue tablets with RSN on 1 face and 150 mg on the other. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
New Drug Application
ACTONEL - RISEDRONATE SODIUM TABLET, FILM COATED PHYSICIANS TOTAL CARE, 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 rarely (5 اقرأ الوثيقة كاملة