FOSAMAX- 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:

Merck Sharp & Dohme Corp.

INN (International Name):

ALENDRONATE SODIUM

Composition:

ALENDRONIC ACID 70 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

FOSAMAX® is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, FOSAMAX increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies (14.1).] FOSAMAX is indicated for the prevention of postmenopausal osteoporosis [see Clinical Studies (14.2)]. FOSAMAX is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3)] . FOSAMAX is 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)]. FOSAMAX is 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 alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for f

Product summary:

How Supplied No. 3814 — FOSAMAX Tablets, 70 mg, are white, oval, uncoated tablets with code 31 on one side and an outline of a bone image on the other: Storage FOSAMAX Tablets: Store in a well-closed container at room temperature, 15-30°C (59-86°F).

Authorization status:

New Drug Application

Patient Information leaflet

Merck Sharp & Dohme Corp.
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MEDICATION GUIDE
FOSAMAX® (FOSS-ah-max)
(alendronate sodium)
Tablets
Read the Medication Guide that comes with FOSAMAX® 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 FOSAMAX.
What is the most important information I should know about FOSAMAX?
FOSAMAX 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 FOSAMAX 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 FOSAMAX exactly as prescribed to help
lower your chance of
getting esophagus problems. (See the section "How should I take
FOSAMAX?")
•
Stop taking FOSAMAX 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).
FOSAMAX may lower the calcium levels in your blood. If you have low
blood calcium before you
start taking FOSAMAX, it may get worse during treatment. Your low
blood calcium must be
treated before you take FOSAMAX. 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, or around your mouth
Your doctor may prescribe calcium and vitamin D to help prevent low
calcium levels in your blood,
while you take FOSAMAX. Take calcium and vitamin D as your doctor
tells you to.
3.
Bone, joint, or musc

Summary of Product characteristics

FOSAMAX- ALENDRONATE SODIUM TABLET
MERCK SHARP & DOHME CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FOSAMAX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FOSAMAX.
FOSAMAX (ALENDRONATE SODIUM) TABLETS, FOR ORAL USE
FOSAMAX (ALENDRONATE SODIUM) ORAL SOLUTION
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
FOSAMAX 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 or oral solution) 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.
Swallow oral solution followed by at least 2 ounces of water.
Not lie down for at least 30 minutes after taking FOSAMAX and until
after food.
DOSAGE FORMS AND STRENGTHS
Tablets: 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)
Do not administer FOSAMAX oral solution to patients at increased risk
of aspiration. (4)
Hypocalcemia (4, 5.2)
Hypersensitivity to any component of this product (4, 6.2)
WARNINGS AND PRECAUTIONS
_Upper Gastrointestinal Adverse Reactions_ can occur. Instruct
p