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:

MedVantx, Inc.

INN (International Name):

ALENDRONATE SODIUM

Composition:

ALENDRONIC ACID 70 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 reduces 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 Tablets USP are indicated for the treatment of Paget’s disease of bone in men and women. Treatment is indicated in patients with Paget's di

Product summary:

Alendronate Sodium Tablets USP, for oral administration, are available as: 5 mg – white to off-white, round, flat-faced beveled-edge, unscored tablet debossed with “93” on one side and “5140” on the other side, in bottles of 30 and 100. 10 mg – white to off-white, round, convex, unscored tablet debossed with “93” on one side and “5141” on the other side, in bottles of 30 and 100. 35 mg – white to off-white, pillow-shaped, convex, unscored tablet debossed with “93” on one side and “5172” on the other side, in unit-of-use blister packages of 4 and 12 (3 x 4). 40 mg – white to off-white, oval, convex, unscored tablet debossed with “93” on one side and “5142” on the other side, in bottles of 30. 70 mg – white to off-white, pillow-shaped, convex, unscored tablet debossed with “93” on one side and “5171” on the other side, in unit-of-use blister packages of 4 and 12 (3 x 4). Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL OTHER MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ALENDRONATE SODIUM- ALENDRONATE SODIUM TABLET
MedVantx, Inc.
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MEDICATION GUIDE
ALENDRONATE (a-LEN-droe-nate) SODIUM TABLETS USP
Read the Medication Guide that comes with alendronate sodium tablets
before you start taking them and
each time you get a refill. There may be new information. This
Medication Guide does not take the place
of talking with your doctor about your medical condition or treatment.
Talk to your doctor if you have
any questions about alendronate sodium tablets.
What is the most important information I should know about alendronate
sodium tablets?
Alendronate sodium tablets can cause serious side effects including:
1.
Esophagus problems
2.
Low calcium levels in your blood (hypocalcemia)
3.
Bone, joint, or muscle pain
4.
Severe jaw bone problems (osteonecrosis)
5.
Unusual thigh bone fractures
1. Esophagus problems.
Some people who take alendronate sodium tablets may develop problems
in the esophagus (the tube that
connects the mouth and the stomach). These problems include
irritation, inflammation, or ulcers of the
esophagus which may sometimes bleed.
•
It is important that you take alendronate sodium tablets exactly as
prescribed to help lower your
chance of getting esophagus problems. (See the section “How should I
take alendronate sodium
tablets?”)
•
Stop taking alendronate sodium tablets and call your doctor right away
if you get chest pain, new or
worsening heartburn, or have trouble or pain when you swallow.
2. Low calcium levels in your blood (hypocalcemia).
Alendronate sodium tablets may lower the calcium levels in your blood.
If you have low blood calcium
before you start taking alendronate sodium tablets, it may get worse
during treatment. Your low blood
calcium must be treated before you take alendronate sodium tablets.
Most people with low blood calcium
levels do not have symptoms, but some people may have symptoms. Call
your doctor right away if you
have symptoms of low blood calcium such as:
•
Spasms, twitches, or cramps in your muscles
•
Numbness or tingling i

Summary of Product characteristics

ALENDRONATE SODIUM- ALENDRONATE SODIUM TABLET
MEDVANTX, INC.
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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 USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Indications and Usage (1.6) 04/2013
Dosage and Administration (2) 06/2012
Warnings and Precautions (5.4) 04/2013
INDICATIONS AND USAGE
Alendronate Sodium Tablets USP are a bisphosphonate indicated for:
•
•
•
•
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
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
5 mg, 10 mg, 35 mg, 40 mg and 70 mg tablets (3)
CONTRAINDICATIONS
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (greater than or equal to 3%) are
abdominal pain, acid regurgitation, constipation,
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 stric