ALENDRONATE SODIUM tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Preferred Pharmaceuticals, Inc.

INN (Nome Internazionale):

ALENDRONATE SODIUM

Composizione:

ALENDRONIC ACID 70 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

ALENDRONATE SODIUM- ALENDRONATE SODIUM TABLET
PREFERRED PHARMACEUTICALS, INC.
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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 is a bisphosphonate indicated for:
1.
2.
3.
4.
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
1.
2.
3.
4.
5.
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, 35 mg and 70 mg (3)
CONTRAINDICATIONS
1.
2.
3.
4.
WARNINGS AND PRECAUTIONS
1.
2.
3.
4.
5.
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)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT APOTEX CORP., AT
1-800-706-5575 OR FDA AT 1-800-FDA-
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)
1.
2.
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
and until after food.
Abnormalities of t