ALENDRONATE SODIUM solution

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

ANI Pharmaceuticals, Inc.

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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. Alendronatesodiumiscontraindicatedinpatientswiththefollowing conditions: - Abnormalities of the esophagus

Огляд продуктів:

Alendronate Sodium Oral Solution, 70 mg/75 mL is supplied as a clear, colorless to pale pink solution with a raspberry flavor, free from visible particulate matter. NDC 70954-264-10 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.

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

ALENDRONATE SODIUM - ALENDRONATE SODIUM SOLUTION
ANI Pharmaceuticals, Inc.
----------
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
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 takeonce 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.
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
doct

Характеристики продукта

ALENDRONATE SODIUM - ALENDRONATE SODIUM SOLUTION
ANI PHARMACEUTICALS, 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:
(1)
Treatment of osteoporosis in postmenopausal women (1.1)
Treatment to increase bone mass in men with osteoporosis (1.3)
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) (1)
DOSAGE AND ADMINISTRATION
Treatment of osteoporosis in postmenopausal women and in men: 70 mg
(oral solution) once weekly.
(2.1, 2.3)
Instruct patients to: (2.6)
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.
DOSAGE FORMS AND STRENGTHS
Oral Solution: 70 mg (3) (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 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)
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 corrected prior to use. (5.2)
_Severe Bone, Joint, Muscle Pain_ may occur. Discontinue use if severe
symptoms develop. (5.3)
_Osteonecrosis of the Jaw_ has been reported. (5.4)
_Atypical Femur Fractures_ have been reported. Patients with new thigh
or groin pain should be evaluated
to rule out an incomp