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Alendronate (Alendronate Sodium) - Indications and Dosage

 
 



INDICATIONS AND USAGE


Alendronate sodium tablets are indicated for: 
 

  • Treatment and prevention of osteoporosis in postmenopausal women 
      For the treatment of osteoporosis, alendronate sodium tablets increases 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 example, at least 1 standard deviation below the mean for healthy young adult women); thin body build; Caucasian or Asian race; and family history of osteoporosis. The presence of such risk factors may be important when considering the use of alendronate sodium tablets for prevention of osteoporosis.
 
  • Treatment to increase bone mass in men with osteoporosis.
  • 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 PRECAUTIONS, Glucocorticoid-induced osteoporosis). Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
  • Treatment of Paget's disease of bone in men and women
      Treatment is indicated in patients with Paget's disease of bone having 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.

DOSAGE AND ADMINISTRATION


Alendronate sodium tablets must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only (see PRECAUTIONS, Information for Patients). Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate sodium tablets (see PRECAUTIONS, Drug Interactions). Waiting less than 30 minutes, or taking alendronate sodium tablets with food, beverages (other than plain water) or other medications will lessen the effect of alendronate sodium tablets by decreasing its absorption into the body.
 
Alendronate sodium tablets should only be taken upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, an alendronate sodium tablet should be swallowed with a full glass of water (6 to 8 oz). Patients should not lie down for at least 30 minutes and until after their first food of the day. Alendronate sodium tablets should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences (see WARNINGS, PRECAUTIONS, Information for Patients).
 
Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate (see PRECAUTIONS, General).
 
No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). Alendronate sodium tablets are not recommended for patients with more severe renal insufficiency (creatinine clearance <35 mL/min) due to lack of experience.

Treatment of osteoporosis in postmenopausal women (see  INDICATIONS AND USAGE)

 
The recommended dosage is:
 

  • one 70 mg tablet once weekly

                              or

  • one 10 mg tablet once daily

Treatment to increase bone mass in men with osteoporosis


The recommended dosage is:  
 

  • one 70 mg tablet once weekly 

                              or

  • one 10 mg tablet once daily


Prevention of osteoporosis in postmenopausal women (see  INDICATIONS AND USAGE)
 
The recommended dosage is:  
 
  • one 35 mg tablet once weekly 

                              or

  • one 5 mg tablet once daily

The safety of treatment and prevention of osteoporosis with alendronate sodium tablets has been studied for up to 7 years.
 
Treatment of glucocorticoid-induced osteoporosis in men and women
 
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.

Paget's disease of bone in men and women
 
The recommended treatment regimen is 40 mg once a day for six months.

Retreatment of Paget's disease
 
In clinical studies in which patients were followed every six months, relapses during the 12 months following therapy occurred in 9% (3 out of 32) of patients who responded to treatment with alendronate sodium. Specific retreatment data are not available, although responses to alendronate sodium were similar in patients who had received prior bisphosphonate therapy and those who had not. Retreatment with alendronate sodium may be considered, following a six-month post-treatment evaluation period in patients who have relapsed, based on increases in serum alkaline phosphatase, which should be measured periodically. Retreatment may also be considered in those who failed to normalize their serum alkaline phosphatase.

HOW SUPPLIED


Alendronate Sodium Tablets USP, 10 mg  are white to off-white, circular, biconvex, uncoated tablets debossed with "F’ on one side and "18" on the other side. 
 
                  Bottles of 30                                      NDC 65862-327-30
                  Bottles of 100                                    NDC 65862-327-01
                  Bottles of 1000                                  NDC 65862-327-99  
                  10 x 10 Unit-dose Tablets                  NDC 65862-327-10

Alendronate Sodium Tablets USP, 35 mg
are white to off-white, oval shaped, biconvex, uncoated tablets debossed with "F" on one side and "19" on the other side.
 
                  Unit-of-use blister package of 4          NDC 65862-328-04
                  Unit-of-use blister package of 12        NDC 65862-328-08  
                  10 x 10 Unit-dose Tablets                  NDC 65862-328-10
 
Alendronate Sodium Tablets USP, 70 mg  are white to off-white, oval shaped, biconvex, uncoated tablets debossed with ‘F" on one side and "21" on the other side.
 
                 Unit-of-use blister package of 4           NDC 65862-329-04
                 Unit-of-use blister package of 12         NDC 65862-329-08
                 10 x 10 Unit-dose Tablets                   NDC 65862-329-10
 
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
 
Store in a well-closed container.
 
Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
 
Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 072, India
 
Revised: 12/2008

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