Alendronate Sandoz is intended for oral use only. The recommended dosage is one 70 mg tablet once weekly.
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 alendronate on an individual patient basis, particularly after 5 or more years of use.
To permit adequate absorption of alendronic acid: Alendronate Sandoz 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 Sandoz (see Interactions).
To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse experiences (see Precautions): Alendronate should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml or 7 fl.oz.).
Patients should only swallow alendronate 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 alendronate.
Alendronate should not be taken at bedtime or before arising for the day.
Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate (see Precautions).
Use in the elderly: In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronate. Therefore no dose adjustment is necessary for the elderly.
Use in renal impairment: No dose adjustment is necessary for patients with GFR greater than 35 ml/min. Alendronate is not recommended for patients with renal impairment where GFR is less than 35 ml/min, due to lack of experience.
Use in impaired hepatic function: No dose adjustment is necessary.
Paediatric patients: Alendronate sodium is not recommended for use in children under the age of 18 years due to insufficient data on safety and efficacy in conditions associated with paediatric osteoporosis (also see PHARMACOLOGY: Pharmacodynamics under Actions).
Alendronate Sandoz 70 mg has not been investigated in the treatment of glucocorticoid-induced osteoporosis.
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