ALENDRONATE- alendronate sodium tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

A-S Medication Solutions

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 Page

製品概要:

Product: 50090-3593 NDC: 50090-3593-0 4 TABLET in a BLISTER PACK / 1 in a CARTON

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

ALENDRONATE- ALENDRONATE SODIUM TABLET
A-S Medication Solutions
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MEDICATION GUIDE
ALENDRONATE SODIUM TABLETS, USP
Read the Medication Guide that comes with Alendronate Sodium Tablets
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.
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 in your fingers, toes

製品の特徴

ALENDRONATE- ALENDRONATE SODIUM TABLET
A-S MEDICATION SOLUTIONS
----------
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, USP.
ALENDRONATE SODIUM TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions, Osteonecrosis of the Jaw (5.4)
3/2015
INDICATIONS AND USAGE
Alendronate sodium is 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
Tablets: 5 mg, 10 mg, 35 mg and 70 mg (3)
CONTRAINDICATIONS
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (≥3%) are abdominal pain, acid
regurgitation, constipation, diarrhea, dyspepsia,
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 6-8 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
tablet and until after food.
Abnormalities of the esophagus which delay emptying such as stricture
or achalasia (4, 5.1)
Inability to stand/sit upright for at l