ALENDRONATE- 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:

Virtus Pharmaceuticals

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 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 indicat

Product summary:

How Supplied Alendronate sodium tablets USP, 35 mg (alendronate), are modified oval, white to off-white tablets; one side debossed 'AP207', the other side blank. NDC 60723-207-31 blister packs of 4 with child resistant package. NDC 60723-207-32 unit-of-use packages of 12 with child resistant package. NDC 60723-207-33 unit dose packages of 20. This package not intended for household use. For institutional use only. Alendronate sodium tablets USP, 70 mg (alendronate), are modified oval, white to off-white tablets; one side debossed 'AP205', the other side blank. NDC 60723-205-31 blister packs of 4 with child resistant package. NDC 60723-205-32 unit-of-use packages of 12 with child resistant package. NDC 60723-205-33 unit dose packages of 20. This package not intended for household use. For institutional use only. Storage Store in a well-closed container at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Virtus Pharmaceuticals
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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
•
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.
•
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, or around your mouth
Your doctor may

Summary of Product characteristics

ALENDRONATE- ALENDRONATE SODIUM TABLET
VIRTUS PHARMACEUTICALS
----------
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
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 6-8 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.
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 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_