ALENDRONATE SODIUM tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Physicians Total Care, Inc.

INN (الاسم الدولي):

ALENDRONATE SODIUM

تركيب:

ALENDRONIC ACID 10 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Alendronate sodium tablets are indicated for: - Treatment and prevention of osteoporosis in postmenopausal women For the treatment of osteoporosis, alendronate sodium tablets increase bone mass and reduce the incidence of fractures, including those of the hip and spine (vertebral compression fractures). Osteoporosis may be confirmed by the finding of low bone mass (for example, at least 2 standard deviations below the premenopausal mean) or by the presence or history of osteoporotic fracture (see CLINICAL PHARMACOLOGY , Pharmacodynamics ). For the prevention of osteoporosis, alendronate sodium tablets may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of future fracture. Bone loss is particularly rapid in postmenopausal women younger than age 60. Risk factors often associated with the development of postmenopausal osteoporosis include early menopause; moderately low bone mass (for examp

ملخص المنتج:

Alendronate sodium tablets USP, for oral administration, are available as: 10 mg – white to off-white, round, convex, unscored tablet debossed with “93” on one side and “5141” on the other side, 35 mg – white to off-white, pillow-shaped, convex, unscored tablet debossed with “93” on one side and “5172” on the other side, in unit-of-use blister package of 4        NDC 54868-5860-0 In unit-of-use blister packages of 12    NDC 54868-5860-1 70 mg – white to off-white, pillow-shaped, convex, unscored tablet debossed with “93” on one side and “5171” on the other side, in unit-of-use blister package of 4        NDC 54868-5861-0 in unit-of-use blister packages of 12      NDC 54868-5861-1 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. J 1/2011 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma     74146

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

Physicians Total Care, Inc.
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MEDICATION GUIDE
ALENDRONATE SODIUM TABLETS USP
Rx only
Read the Medication Guide that comes with alendronate sodium tablets
before you start taking them 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, or around your mouth

خصائص المنتج

ALENDRONATE SODIUM - ALENDRONATE SODIUM TABLET
PHYSICIANS TOTAL CARE, INC.
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ALENDRONATE SODIUM TABLETS USP
5140
5141
5172
5142
5171
RX ONLY
DESCRIPTION
Alendronate sodium is a bisphosphonate that acts as a specific
inhibitor of osteoclast-mediated bone
resorption. Bisphosphonates are synthetic analogs of pyrophosphate
that bind to the hydroxyapatite
found in bone.
Alendronate sodium is chemically described as
(4-amino-1-hydroxybutylidene) bisphosphonic acid
monosodium salt trihydrate.
The structural formula is:
C H NNaO P •3H O M.W. 325.12
Alendronate sodium is a white, crystalline, nonhygroscopic powder. It
is soluble in water, very slightly
soluble in alcohol, and practically insoluble in chloroform.
Each tablet, for oral administration contains 6.53, 13.05, 45.68,
52.21 or 91.37 mg of alendronate
monosodium salt trihydrate, which is the molar equivalent of 5, 10,
35, 40 and 70 mg, respectively, of
free acid, and the following inactive ingredients: croscarmellose
sodium, magnesium stearate, and
microcrystalline cellulose.
Alendronate sodium tablets USP meet USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Animal studies have indicated the following mode of action. At the
cellular level, alendronate shows
preferential localization to sites of bone resorption, specifically
under osteoclasts. The osteoclasts
4
12
7
2
2
adhere normally to the bone surface but lack the ruffled border that
is indicative of active resorption.
Alendronate does not interfere with osteoclast recruitment or
attachment, but it does inhibit osteoclast
activity. Studies in mice on the localization of radioactive [
H]alendronate in bone showed about 10
fold higher uptake on osteoclast surfaces than on osteoblast surfaces.
Bones examined 6 and 49 days
after [ H]alendronate administration in rats and mice, respectively,
showed that normal bone was formed
on top of the alendronate, which was incorporated inside the matrix.
While incorporated in bone matrix,
alendronate is not pharmacologically active. Thus, alendrona