ALENDRONATE SODIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

ALENDRONATE SODIUM

Composition:

ALENDRONIC ACID 35 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alendronate sodium tablets, USP are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium tablets, USP increase bone mass and reduce the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies ( 14.1).] Alendronate sodium tablets, USP are indicated for the prevention of postmenopausal osteoporosis [see Clinical Studies ( 14.2)] Alendronate sodium tablets, USP are indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies ( 14.3)]. Alendronate sodium tablets, USP are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see Clinical Studies ( 14.4)]. Alendronate sodium table

Product summary:

How Supplied 35 mg Tablets Alendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side. NDC 68071-3171-4 Carton of 4 Storage Store at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ALENDRONATE SODIUM- ALENDRONATE SODIUM TABLET
NuCare Pharmaceuticals, Inc.
----------
17. MEDICATION GUIDE
See FDA-approved patient labeling (Medication Guide).
Instruct patients to read the Medication Guide before starting therapy
with alendronate sodium and to
reread it each time the prescription is renewed.
17.1 OSTEOPOROSIS RECOMMENDATIONS, INCLUDING CALCIUM AND
VITAMIN D SUPPLEMENTATION
Instruct patients to take supplemental calcium and vitamin D, if daily
dietary intake is inadequate.
Weight-bearing exercise should be considered along with the
modification of certain behavioral factors,
such as cigarette smoking and/or excessive alcohol consumption, if
these factors exist.
17.2 DOSING INSTRUCTIONS
Instruct patients that the expected benefits of alendronate sodium may
only be obtained when it is taken
with plain water the first thing upon arising for the day at least 30
minutes before the first food, beverage,
or medication of the day. Even dosing with orange juice or coffee has
been shown to markedly reduce the
absorption of alendronate sodium [see Clinical Pharmacology ( 12.3)] .
Instruct patients not to chew or suck on the tablet because of a
potential for oropharyngeal ulceration.
Instruct patients to swallow each tablet of alendronate sodium with a
full glass of water (6-8 ounces) to
facilitate delivery to the stomach and thus reduce the potential for
esophageal irritation.
Instruct patients not to lie down for at least 30 minutes and until
after their first food of the day.
Instruct patients not to take alendronate sodium at bedtime or before
arising for the day. Patients should
be informed that failure to follow these instructions may increase
their risk of esophageal problems.
Instruct patients that if they develop symptoms of esophageal disease
(such as difficulty or pain upon
swallowing, retrosternal pain or new or worsening heartburn) they
should stop taking alendronate sodium
and consult their physician.
If patients miss a dose of once weekly alendronate sodium, instruct
patients to take one dose

Summary of Product characteristics

ALENDRONATE SODIUM- ALENDRONATE SODIUM TABLET
NUCARE PHARMACEUTICALS, INC.
----------
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:
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) 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)
o Swallow tablets whole with 6-8 ounces plain water at least 30
minutes before the first food, drink, or medication of the
day.
o 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, 35mg, 40 mg and 70 mg ( 3)
CONTRAINDICATIONS
Abnormalities of the esophagus which delay esophageal emptying such as
stricture or achalasia _[see Warnings and_
_Precautions ( 4, 5.1)]_
Inability to stand/sit upright for at least 30 minutes ( 2.6, 4, 5.1)
Hypocalcemia ( 4, 5.2)
Hypersensitivity to any component of this product ( 4, 6.2)
WARNINGS AND PRECAUTIONS
_Upper Gastrointestinal Adverse Reactions_ can oc