The recommended dose is one 70 mg effervescent tablet once weekly.
Patients should be instructed that if they miss a dose of Alendronate sodium (Buffered Binosto) 70 mg, they should take one effervescent tablet on the morning after they remember.
They should not take two effervescent tablets on the same day but should return to taking one effervescent 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 Alendronate sodium (Buffered Binosto) on an individual patient basis, particularly after 5 or more years of use.
Paediatric population: 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 (see Pharmacology: Pharmacodynamics under Actions).
Use in the elderly: In clinical studies there was no age related difference in the efficacy or safety profiles of alendronate. Therefore no dosage adjustment is necessary for the elderly.
Use in renal impairment: No dosage 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.
Method of administration: To permit adequate absorption of alendronate: Alendronate sodium (Buffered Binosto) 70 mg 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 (see Interactions).
To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse experiences (see Precautions): Alendronate sodium (Buffered Binosto) 70 mg should only be taken upon arising for the day dissolved in half a glass of plain water (not less than 120 ml or 4.2 fl.oz.). Dissolving the tablet in water yields a buffered solution of pH 4.8-5.4. The buffered solution should be drunk, once the fizzing has subsided and the effervescent tablet has completely dissolved to give a clear, to slightly cloudy, buffered solution, followed by at least 30 ml (one sixth of a glass) of plain water. Additional plain water may be taken.
Patients should not swallow the undissolved effervescent tablet, should not chew the effervescent tablet or allow the effervescent tablet to dissolve in their mouths because of the risk for oropharyngeal irritation (see Precautions and Adverse Reactions).
If the tablet does not dissolve completely, the buffered solution may be stirred until it is clear to slightly cloudy.
Patients should not lie down until after their first food of the day, which should be at least 30 minutes after drinking the oral solution.
Patients should not lie down for at least 30 minutes after drinking the oral solution.
Alendronate sodium (Buffered Binosto) 70 mg should not be taken at bedtime or before arising for the day.
Alendronate sodium (Buffered Binosto) 70 mg can be given to patients who are unable or unwilling to swallow tablets.
Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate (see Precautions).
Alendronate sodium (Buffered Binosto) 70 mg has not been investigated in the treatment of glucocorticoid-induced osteoporosis.