ALENDRONATE SODIUM tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

ALENDRONATE SODIUM (UNII: 2UY4M2U3RA) (ALENDRONIC ACID - UNII:X1J18R4W8P)

제공처:

Unit Dose Services

INN (국제 이름):

ALENDRONATE SODIUM

구성:

ALENDRONIC ACID 70 mg

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ALENDRONATE SODIUM - ALENDRONATE SODIUM TABLET
UNIT DOSE SERVICES
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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
RECENT MAJOR CHANGES
Warnings and Precautions ( ) 02/2015 5.4
INDICATIONS AND USAGE
Alendronate sodium is a bisphosphonate indicated for:
Treatment and prevention of osteoporosis in postmenopausal women ( , )
1.11.2
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 once weekly. ( , ) 2.12.3
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.
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, 35 mg and 70 mg ( ) 3
CONTRAINDICATIONS
Abnormalities of the esophagus which delay emptying such as stricture
or achalasia ( , ) 45.1
Inability to stand/sit upright for at least 30 minutes ( , , ) 2.645.1
Hypocalcemia ( , ) 45.2
Hypersensitivity to any component of this product ( , ) 46.2
WARNINGS AND PRECAUTIONS
can occur. Instruct patients to follow dosing instructions.
Discontinue if new or worsening symptoms oc