ALENDRONATE SODIUM solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Alendronate Sodium (UNII: 2UY4M2U3RA) (Alendronic acid - UNII:X1J18R4W8P)

Available from:

TAGI Pharma, Inc.

INN (International Name):

Alendronate Sodium

Composition:

Alendronic acid 70 mg in 75 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Alendronate sodium is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate 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 is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies ( 14.3) ] . The optimal duration of use has not been determined. The safety and effectiveness of alendronate for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically. Alendronate sodium is contraindicated in patients with the following conditions: Risk Summary: Availabl

Product summary:

Alendronate Sodium Oral Solution 70 mg oral solution is supplied as a clear, colorless to pale pink solution with a raspberry flavor. NDC 51224-301-10 unit-of-use cartons of 4 single-dose bottles containing 75 mL each Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not freeze.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ALENDRONATE SODIUM- ALENDRONATE SODIUM SOLUTION
TAGI Pharma, Inc.
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MEDICATION GUIDE
ONCE WEEKLY
Alendronate Sodium Oral Solution
(a len’ droe nate soe’ dee um)
Rx only
Read the Medication Guide that comes with Alendronate Sodium Oral
Solution 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 Oral Solution.
What is the most important information I should know about Alendronate
Sodium Oral Solution?
Alendronate Sodium Oral Solution 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 Oral Solution 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 Oral Solution exactly
as prescribed to help lower
your chance of getting esophagus problems. (See the section "How
should I take once weekly
Alendronate Sodium Oral Solution sodium oral solution?")
•
Stop taking Alendronate Sodium Oral Solution 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 Oral Solution may lower the calcium levels in your
blood. If you have low blood
calcium before you start taking Alendronate Sodium Oral Solution, it
may get worse during treatment.
Your low blood calcium must be treated before you take Alendronate
Sodium Oral Solution. Most people
with low blood calcium levels do not have symptoms, but some people
may have symptoms. Call your
doctor

Summary of Product characteristics

ALENDRONATE SODIUM- ALENDRONATE SODIUM SOLUTION
TAGI PHARMA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ALENDRONATE SODIUM ORAL SOLUTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ALENDRONATE SODIUM ORAL SOLUTION.
ALENDRONATE SODIUM ORAL SOLUTION, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Alendronate Sodium Oral Solution 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
Oral Solution: 70 mg (3)
CONTRAINDICATIONS
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
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ADVERSE REACTIONS
Most common adverse reactions (greater than or equal to 3%) are
abdominal pain, acid regurgitation, constipation,
diarrhea, dyspepsia, musculoskeletal pain, nausea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward
Pharmaceuticals Corp. at 1-800-962-8364 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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•
USE IN SPECIFIC POPULATIONS
Treatment of osteoporosis in postmenopausal women (1.1)
Treatment to increase bone mass in men with osteoporosis (1.3)
Treatment of osteoporosis in postmenopausal women and in men: 70 mg
(oral solution) once weekly. (2.1, 2.3)
Instruct patients to: (2.6)
o
o
Swallow oral solution followed by at least 2 ounces of water.
Not lie down for at least 30 minutes after taking alendronate sodium
oral solution 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 least 30 minutes (2.6, 4, 5.1)
Do not administer Alendronate Sodium Oral Solution to patients at
increased risk of aspiration (4)
Hypocalcemia (4, 5.2)
Hypersensitivity to any component of this product (4, 6.2)
_Upper Gastrointestinal Adverse Reactions_ can occur. Instruct
patien