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:

Cipla USA 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 increases 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 Page

Product summary:

How Supplied 5 mg Tablets Alendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side. NDC 69097-234-02    Bottles of 30 10 mg Tablets Alendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side. NDC 69097-235-02    Bottles of 30 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 69097-223-16    Unit-of-use blister package of 4 NDC 69097-223-76    Unit-of-use blister package of 12 (3 X 4) 40 mg Tablets Alendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side. NDC 69097-236-02    Bottles of 30 70 mg Tablets Alendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side. NDC 69097-224-16    Unit-of-use blister package of 4 NDC 69097-224-76    Unit-of-use blister package of 12 (3 X 4) Storage Store at 20°C to 25°C (68°F to77°F); excursions permitted to 15°C to 30°C (59°F 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
Cipla USA Inc.
----------
MEDICATION GUIDE
Alendronate Sodium Tablets, USP
(a len' droe nate soe' dee um)
Read the Medication Guide that comes with alendronate sodium tablets,
USP before you start taking it
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, USP.
What is the most important information I should know about alendronate
sodium tablets, USP?
Alendronate sodium tablets, USP can cause serious side effects
including:
•
Esophagus problems
•
Low calcium levels in your blood (hypocalcemia)
•
Bone, joint, or muscle pain
•
Severe jaw bone problems (osteonecrosis)
•
Unusual thigh bone fractures
1. Esophagus problems.
Some people who take alendronate sodium tablets, USP 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, USP exactly
as prescribed to help lower
your chance of getting esophagus problems. (See the section "How
should I take alendronate
sodium tablets, USP?")
•
Stop taking alendronate sodium tablets, USP 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, USP may lower the calcium levels in your
blood. If you have low blood
calcium before you start taking alendronate sodium tablets, USP, it
may get worse during treatment. Your
low blood calcium must be treated before you take alendronate sodium
tablets, USP. 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:
•
Sp

Summary of Product characteristics

ALENDRONATE SODIUM- ALENDRONATE SODIUM TABLET
CIPLA USA 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
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 occur. Instruct
patients to follow dosing instructions. Discontinue if new
or worsening sympt