Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
ALENDRONATE SODIUM (UNII: 2UY4M2U3RA) (ALENDRONIC ACID - UNII:X1J18R4W8P)
MedVantx, Inc.
ALENDRONATE SODIUM
ALENDRONIC ACID 70 mg
ORAL
PRESCRIPTION DRUG
Alendronate Sodium Tablets USP are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, Alendronate Sodium Tablets USP increase 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 Paget's di
Alendronate Sodium Tablets USP, for oral administration, are available as: 5 mg – white to off-white, round, flat-faced beveled-edge, unscored tablet debossed with “93” on one side and “5140” on the other side, in bottles of 30 and 100. 10 mg – white to off-white, round, convex, unscored tablet debossed with “93” on one side and “5141” on the other side, in bottles of 30 and 100. 35 mg – white to off-white, pillow-shaped, convex, unscored tablet debossed with “93” on one side and “5172” on the other side, in unit-of-use blister packages of 4 and 12 (3 x 4). 40 mg – white to off-white, oval, convex, unscored tablet debossed with “93” on one side and “5142” on the other side, in bottles of 30. 70 mg – white to off-white, pillow-shaped, convex, unscored tablet debossed with “93” on one side and “5171” on the other side, in unit-of-use blister packages of 4 and 12 (3 x 4). Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL OTHER MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
ALENDRONATE SODIUM- ALENDRONATE SODIUM TABLET MedVantx, Inc. ---------- MEDICATION GUIDE ALENDRONATE (a-LEN-droe-nate) SODIUM TABLETS USP Read the Medication Guide that comes with alendronate sodium tablets before you start taking them 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. What is the most important information I should know about alendronate sodium tablets? Alendronate sodium tablets 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 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 exactly as prescribed to help lower your chance of getting esophagus problems. (See the section “How should I take alendronate sodium tablets?”) • Stop taking alendronate sodium tablets 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 may lower the calcium levels in your blood. If you have low blood calcium before you start taking alendronate sodium tablets, it may get worse during treatment. Your low blood calcium must be treated before you take alendronate sodium tablets. 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: • Spasms, twitches, or cramps in your muscles • Numbness or tingling i Przeczytaj cały dokument
ALENDRONATE SODIUM- ALENDRONATE SODIUM TABLET MEDVANTX, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ALENDRONATE SODIUM TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALENDRONATE SODIUM TABLETS USP. ALENDRONATE SODIUM TABLETS USP FOR ORAL USE INITIAL U.S. APPROVAL: 1995 RECENT MAJOR CHANGES Indications and Usage (1.6) 04/2013 Dosage and Administration (2) 06/2012 Warnings and Precautions (5.4) 04/2013 INDICATIONS AND USAGE Alendronate Sodium Tablets USP are a bisphosphonate indicated for: • • • • 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 • • • • • DOSAGE FORMS AND STRENGTHS 5 mg, 10 mg, 35 mg, 40 mg and 70 mg tablets (3) CONTRAINDICATIONS • • • • WARNINGS AND PRECAUTIONS • • • • • ADVERSE REACTIONS Most common adverse reactions (greater than or equal to 3%) are abdominal pain, acid regurgitation, constipation, 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) 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) Swallow tablets whole with 6 to 8 ounces plain water at least 30 minutes before the first food, drink, or medication of the day. Not lie down for at least 30 minutes after taking alendronate sodium tablets and until after food. Abnormalities of the esophagus which delay emptying such as stric Przeczytaj cały dokument