Osteoporosis

Active Ingredient: Alendronic acid

Indication for Alendronic acid

Population group: only adults (18 years old or older)

Alendronic acid is indicated for the treatment of:

  • osteoporosis in post-menopausal women to prevent fractures
  • osteoporosis in men to prevent fractures
  • glucocorticoid-induced osteoporosis and prevention of bone loss in post-menopausal women considered at risk of developing the disease

For this indication, competent medicine agencies globally authorize below treatments:

70 mg once weekly

Route of admnistration

Oral

Defined daily dose

70 - 70 mg

Dosage regimen

From 70 To 70 mg once every 7 day(s)

Detailed description

The recommended dosage is one 70 mg tablet once weekly.

Patients should be instructed that if they miss a dose of alendronic acid, they should take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.

The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of ‘alendronic acid’ on an individualpatient basis, particularly after 5 or more years of use.

Dosage considerations

To permit adequate absorption of alendronate:

Alendronic acid must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with plain water only. Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate.

To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse experiences:

  • Alendronic acid should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml).
  • Patients should only swallow alendronic acid whole. Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
  • Patients should not lie down for at least 30 minutes after taking alendronic acid and until after the first food of the day.
  • Alendronic acid should not be taken at bedtime or before arising for the day.

10 mg once a day

Route of admnistration

Oral

Defined daily dose

10 - 10 mg

Dosage regimen

From 10 To 10 mg once every day

Detailed description

The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of alendronic acid on an individual patient basis, particularly after 5 or more years of use.

Treatment of osteoporosis in post-menopausal women: The recommended dosage is 10 mg once a day.

Treatment of osteoporosis in men: The recommended dosage is 10 mg once a day.

Treatment and prevention of glucocorticoid-induced osteoporosis: For post-menopausal women not receiving hormone replacement therapy (HRT) with an oestrogen, the recommended dosage is 10 mg once a day.

To permit adequate absorption of alendronic acid: alendronic acid must be taken at least 30 minutes before the first food, beverage, or medication of the day with plain water only. Other beverages (including mineral water), food and some medications are likely to reduce the absorption of alendronic acid.

Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.

Dosage considerations

  • Alendronic acid should only be swallowed upon arising for the day with a full glass of water (not less than 200 mls or 7 fl.oz.).
  • Patients should only swallow alendronic acid whole. Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
  • Patients should not lie down until after their first food of the day which should be at least 30 minutes after taking the tablet.
  • Patients should not lie down for at least 30 minutes after taking alendronic acid.
  • Alendronic acid should not be taken at bedtime or before arising for the day.

Active ingredient

Alendronic acid

Alendronic acid is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation. The bone formed during treatment with alendronic acid is of normal quality.

Read more about Alendronic acid

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