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Ibanox

Ibanox Dosage/Direction for Use

ibandronic acid

Manufacturer:

Pharmathen

Distributor:

Sandoz
Full Prescribing Info
Dosage/Direction for Use
Dosage: The recommended dose is one 150 mg film-coated tablet once a month. The tablet should preferably be taken on the same date each month.
Ibandronic acid should be taken after an overnight fast (at least 6 hours) and 1 hour before the first food or drink (other than water) of the day (see Interactions) or any other oral medicinal products or supplementation (including calcium).
In case a dose is missed, patients should be instructed to take one Ibandronic acid 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 tablets within the same week.
Patients should receive supplemental calcium and/or vitamin D if dietary intake is inadequate (see Precautions and Interactions).
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 ibandronic acid on an individual patient basis, particularly after 5 or more years of use.
Special populations: Renal impairment: Ibandronic acid is not recommended for patients with a creatinine clearance below 30 mL/min due to limited clinical experience (see Precautions and Pharmacology: Pharmacokinetics under Actions).
No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal or greater than 30 mL/min.
Hepatic impairment: No dose adjustment is required (see Pharmacology: Pharmacokinetics under Actions).
Elderly (>65 years): No dose adjustment is required (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: There is no relevant use of Ibandronic acid in children below 18 years, and ibandronate sodium was not studied in this population. (See Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions.)
Method of administration: For oral use.
Tablets should be swallowed whole with a glass of water (180 to 240 mL) while the patient is sitting or standing in an upright position. Water with a high concentration of calcium should not be used. If there is a concern regarding potentially high levels of calcium in the tap water (hard water), it is advised to use bottled water with a low mineral content.
Patients should not lie down for 1 hour after taking Ibandronic acid.
Water is the only drink that should be taken with Ibandronic acid.
Patients should not chew or suck the tablet, because of a potential for oropharyngeal ulceration.
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