ALENDRONATE SODIUM tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Unit Dose Services

INN (Nama Antarabangsa):

ALENDRONATE SODIUM

Komposisi:

ALENDRONIC ACID 35 mg

Jenis preskripsi:

PRESCRIPTION DRUG

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

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 (5.4) 2/2015
INDICATIONS AND USAGE
Alendronate sodium tablets are a bisphosphonate indicated for:
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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
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DOSAGE FORMS AND STRENGTHS
5 mg, 10 mg, 35 mg, 40 mg and 70 mg tablets (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (greater than or equal to 3%) are
abdominal pain, acid regurgitation, constipation,
diarrhea, dyspepsia, musculoskeletal pain, nausea. (6.1)
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 stricture
or achalasia (4, 5.1