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:

NorthStar Rx LLC

INN (International Name):

ALENDRONATE SODIUM

Composition:

ALENDRONIC ACID 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alendronate sodium tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium tablets 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 are indicated for the prevention of postmenopausal osteoporosis [see Clinical Studies (14.2)] . Alendronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3)] . Alendronate sodium tablets 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 are indicated for the treatment of Paget’s disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have al

Product summary:

How Supplied Alendronate Sodium Tablets USP, 10 mg are white to off-white, circular, biconvex, uncoated tablets debossed with ‘F’ on one side and ‘18’ on the other side.                    Bottles of 30                                      NDC 16714-631-01                   Bottles of 100                                    NDC 16714-631-02                   10 x 10 Unit-dose Tablets                  NDC 16714-631-11 Alendronate Sodium Tablets USP, 35 mg are white to off-white, oval shaped, biconvex, uncoated tablets debossed with ‘F’ on one side and ‘19’ on the other side.                   Unit-of-use blister package of 4          NDC 16714-632-01                   Unit-of-use blister package of 20        NDC 16714-632-02                    10 x 10 Unit-dose Tablets                  NDC 16714-632-11 Alendronate Sodium Tablets USP, 70 mg  are white to off-white, oval shaped, biconvex, uncoated tablets debossed with ‘F’ on one side and ‘21’ on the other side.                  Unit-of-use blister package of 4           NDC 16714-633-01                  Unit-of-use blister package of 20         NDC 16714-633-02                  10 x 10 Unit-dose Tablets                   NDC 16714-633-11 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store in a well-closed container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ALENDRONATE SODIUM - ALENDRONATE SODIUM TABLET
NorthStar Rx LLC
----------
MEDICATION GUIDE
Alendronate Sodium Tablets, USP
(a len' droe nate soe' dee um)
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, they 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
•
Num

Summary of Product characteristics

ALENDRONATE SODIUM - ALENDRONATE SODIUM TABLET
NORTHSTAR RX LLC
----------
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)
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.
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg, 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)
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 symptoms occur. (5.1)
_Hypocalcemia _can worsen and must be