Route of Administration: Oral.
The recommended dose of Bonviva for treatment is one 150 mg film-coated tablet once a month. The tablet should preferably be taken on the same date each month.
Bonviva should be taken 60 minutes before the first food or drink (other than water) of the day (see Interactions) or any other oral medication or supplementation (including calcium): Tablets should be swallowed whole with a full glass of plain water (180 to 240 ml) while the patient is sitting or standing in an upright position. Patients should not lie down for 60 minutes after taking Bonviva.
Plain water is the only drink that should be taken with Bonviva. Please note that some mineral waters may have a higher concentration of calcium and therefore should not be used.
Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration.
Patients should receive supplemental calcium or vitamin D if dietary intake is inadequate.
In case a once-monthly dose is missed, patients should be instructed to take one Bonviva 150 mg tablet the morning after the tablet is remembered, unless the time to the next scheduled dose is within 7 days. Patients should then return to taking their dose once a month on their originally scheduled date.
If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled. Patients should not take two 150 mg tablets within the same week.
Special Dosage Instructions: Patients with hepatic impairment: No dosage adjustment is necessary (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
Patients with renal impairment: No dosage adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is ≥30 ml/min.
Below 30 ml/min creatinine clearance, the decision to administer Bonviva should be based on an individual risk-benefit assessment (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
Elderly: No dosage adjustment is necessary.
Children: Safety and efficacy have not been established in patients less than 18 years old.