ALENDRONATE SODIUM tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Alendronate Sodium (UNII: 2UY4M2U3RA) (Alendronic Acid - UNII:X1J18R4W8P)

Dostupno od:

Jubilant Cadista Pharmaceuticals Inc.

INN (International ime):

Alendronate Sodium

Sastav:

Alendronic Acid 35 mg

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

ALENDRONATE SODIUM - ALENDRONATE SODIUM TABLET
JUBILANT CADISTA PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
ALENDRONATE SODIUM TABLETS, USP
RX ONLY
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) 02/2015
INDICATIONS AND USAGE
Alendronate Sodium is a bisphosphonate indicated for:
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)
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 (tablet or oral solution) 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 6-8 ounces plain water at least 30 minutes
before the first food, drink, or medication of
the day.
Swallow oral solution followed by at least 2 ounces of water.
Not lie down for at least 30 minutes after taking Alendronate Sodium
Tablets and until after food.
DOSAGE FORMS AND STRENGTHS
Tablets: 35 mg and 70 mg (3)
CONTRAINDICATIONS
Abnormalities of the esophagus which delay emptying such as stricture
or achalasia (4, 5.1)
Inability to stand/sit upright for at least 30 minutes (2.6, 4, 5.1)
Do not administer Alendronate Sodium oral solution to patients at
increased risk of aspiration. (4)
Hypocalcem