ALENDRONATE SODIUM tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

DIRECT RX

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

1.1 Treatment of Osteoporosis in Postmenopausal Women 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 reduce the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies (14.1).] 1.2 Prevention of Osteoporosis in Postmenopausal Women Alendronate sodium tablets, USP are indicated for the prevention of postmenopausal osteoporosis [see Clinical Studies (14.2)] 1.3 Treatment to Increase Bone Mass in Men with Osteoporosis Alendronate sodium tablets, USP are indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3)]. 1.4 Treatment of Glucocorticoid-Induced Osteoporosis Alendronate sodium tablets, USP are 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

Dettagli prodotto:

5 mg Tablets Alendronate Sodium Tablets USP, 5 mg are white, circular, biconvex tablets debossed with 'C234' on one side and plain on the other side. Bottles of 30 10 mg Tablets Alendronate Sodium Tablets USP, 10 mg are white, oval shaped, biconvex tablets debossed with 'C235' on one side and plain on the other side. Bottles of 30 35 mg Tablets Alendronate Sodium Tablets USP, 35 mg are white, capsule shaped, biconvex tablets debossed with 'C223' on one side and plain on the other side. Unit-of-use blister package of 4 Unit-of-use blister package of 12 (3 X 4) 40 mg Tablets Alendronate Sodium Tablets USP, 40 mg are white, circular, biconvex tablets debossed with 'C236' on one side and plain on the other side. Bottles of 30 70 mg Tablets Alendronate Sodium Tablets USP, 70 mg are white, capsule shaped, biconvex tablets debossed with 'C224' on one side and plain on the other side. Unit-of-use blister package of 4 Unit-of-use blister package of 12 (3 X 4) Storage Store at 20° to 25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

ALENDRONATE SODIUM- ALENDRONATE SODIUM TABLET
DIRECT RX
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MEDICATION GUIDE
Alendronate Sodium Tablets, USP
(a len' droe nate soe' dee um)
Read the Medication Guide that comes with alendronate sodium tablets,
USP 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, USP.
What is the most important information I should know about alendronate
sodium tablets, USP?
Alendronate sodium tablets, USP can cause serious side effects
including:
Esophagus problems
Low calcium levels in your blood (hypocalcemia)
Bone, joint, or muscle pain
Severe jaw bone problems (osteonecrosis)
Unusual thigh bone fractures
1. Esophagus problems.
Some people who take alendronate sodium tablets, USP 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, USP exactly
as prescribed to help lower your
chance of getting esophagus problems. (See the section "How should I
take alendronate sodium tablets,
USP?")
Stop taking alendronate sodium tablets, USP 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, USP may lower the calcium levels in your
blood. If you have low blood
calcium before you start taking alendronate sodium tablets, USP, it
may get worse during treatment. Your
low blood calcium must be treated before you take alendronate sodium
tablets, USP. 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 mus

Scheda tecnica

ALENDRONATE SODIUM- ALENDRONATE SODIUM TABLET
DIRECT RX
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ALENDRONATE SODIUM
1.1 Treatment of Osteoporosis in Postmenopausal Women
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 reduce the
incidence of fractures, including those of the hip and spine
(vertebral compression fractures). [See
Clinical Studies (14.1).]
1.2 Prevention of Osteoporosis in Postmenopausal Women
Alendronate sodium tablets, USP are indicated for the prevention of
postmenopausal osteoporosis [see
Clinical Studies (14.2)]
1.3 Treatment to Increase Bone Mass in Men with Osteoporosis
Alendronate sodium tablets, USP are indicated for treatment to
increase bone mass in men with
osteoporosis [see Clinical Studies (14.3)].
1.4 Treatment of Glucocorticoid-Induced Osteoporosis
Alendronate sodium tablets, USP are 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)].
1.5 Treatment of Paget's Disease of Bone
Alendronate sodium tablets, USP are 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 future
complications from their disease. [See Clinical Studies (14.5).]
1.6 Important Limitations of Use
The optimal duration of use has not been determined. The safety and
effectiveness of alendronate
sodium 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 di