ALENDRONATE SODIUM tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Avera McKennan Hospital

INN (mednarodno ime):

ALENDRONATE SODIUM

Sestava:

ALENDRONIC ACID 5 mg

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

ALENDRONATE SODIUM- ALENDRONATE SODIUM TABLET
AVERA MCKENNAN HOSPITAL
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions (5.4) 2/2015
INDICATIONS AND USAGE
Alendronate Sodium Tablets USP 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
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