Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
ALENDRONATE SODIUM (UNII: 2UY4M2U3RA) (ALENDRONIC ACID - UNII:X1J18R4W8P)
EXELAN PHARMACEUTICALS INC.
ORAL
PRESCRIPTION DRUG
Alendronate sodium tablets, USP are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium tablets, USP increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies (14.1).] Alendronate sodium tablets, USP are indicated for the prevention of postmenopausal osteoporosis [see Clinical Studies (14.2)]. Alendronate sodium tablets, USP are indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3)]. Alendronate sodium tablets, USP are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see Clinical Studies (14.4)]. Alendronate sodium tablets, USP are indicated for the treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Page
How Supplied 35 mg Tablets Alendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side. NDC 76282-681-45 Unit-of-use blister package of 4 NDC 76282-681-46 Unit-of-use blister package of 12 (3 X 4) 70 mg Tablets Alendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side. NDC 76282-682-45 Unit-of-use blister package of 4 NDC 76282-682-46 Unit-of-use blister package of 12 (3 X 4) Storage Store at 20°C to 25°C (68°F to77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
ALENDRONATE SODIUM- ALENDRONATE SODIUM TABLET EXELAN PHARMACEUTICALS INC. ---------- MEDICATION GUIDE Alendronate Sodium Tablets, USP (a len' droe nate soe' dee um) Read the Medication Guide that comes with alendronate sodium tablets, USP before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about alendronate sodium tablets, USP. What is the most important information I should know about alendronate sodium tablets, USP? Alendronate sodium tablets, USP can cause serious side effects including: 1. Esophagus problems 2. Low calcium levels in your blood (hypocalcemia) 3. Bone, joint, or muscle pain 4. Severe jaw bone problems (osteonecrosis) 5. Unusual thigh bone fractures 1. Esophagus problems. Some people who take alendronate sodium tablets, USP may develop problems in the esophagus (the tube that connects the mouth and the stomach). These problems include irritation, inflammation, or ulcers of the esophagus which may sometimes bleed. • It is important that you take alendronate sodium tablets, USP exactly as prescribed to help lower your chance of getting esophagus problems. (See the section "How should I take alendronate sodium tablets, USP?") • Stop taking alendronate sodium tablets, USP and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow. 2. Low calcium levels in your blood (hypocalcemia). Alendronate sodium tablets, USP may lower the calcium levels in your blood. If you have low blood calcium before you start taking alendronate sodium tablets, USP, it may get worse during treatment. Your low blood calcium must be treated before you take alendronate sodium tablets, USP. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as Прочитајте комплетан документ
ALENDRONATE SODIUM- ALENDRONATE SODIUM TABLET EXELAN PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ALENDRONATE SODIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL:1995 INDICATIONS AND USAGE Alendronate sodium is a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2) Treatment to increase bone mass in men with osteoporosis (1.3) Treatment of glucocorticoid-induced osteoporosis (1.4) Treatment of Paget's disease of bone (1.5) Limitations of use: Optimal duration of use has not been determined. For patients at low- risk for fracture, consider drug discontinuation after 3 to 5 years of use. (1.6) DOSAGE AND ADMINISTRATION Treatment of osteoporosis in postmenopausal women and in men: 10 mg daily or 70 mg (tablet) once weekly. (2.1, 2.3) Prevention of osteoporosis in postmenopausal women: 5 mg daily or 35 mg once weekly. (2.2) Glucocorticoid-induced osteoporosis: 5 mg daily; or 10 mg daily in postmenopausal women not receiving estrogen. (2.4) Paget's disease: 40 mg daily for six months. (2.5) Instruct patients to: (2.6) o Swallow tablets whole with 6-8 ounces plain water at least 30 minutes before the first food, drink, or medication of the day. o Not lie down for at least 30 minutes after taking alendronate sodium tablets and until after food. DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, 10 mg, 35 mg, 40 mg and 70 mg (3) CONTRAINDICATIONS Abnormalities of the esophagus which delay emptying such as stricture or achalasia _(4, 5.1)_ Inability to stand/sit upright for at least 30 minutes (2.6, 4, 5.1) Hypocalcemia (4, 5.2) Hypersensitivity to any component of this product (4, 6.2) WARNINGS AND PRECAUTIONS _Upper Gastrointestinal Adverse Reactions_ can occur. Instruct patients to follow dosing instructions. Discontinue if new or worsening symptoms occur. (5.1) _Hypocalcem Прочитајте комплетан документ