Indications
Bondrova® is indicated for the:
l Treatment of osteoporosis in women (specially postmenopausal)
l Prevention of osteoporosis in women (specially postmenopausal)
l Prevention and treatment of osteoporosis in men
Dose
The recommended dose of Bondrova® for the treatment and prevention of osteoporosis is one 150 mg tablet once-a-month.
Special dosage instructions
Patients with Hepatic Impairment
No dose adjustment is necessary.
Patients with Renal Impairment
No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal to or greater than 30mL/min.
Geriatric Patients
No dose adjustment is necessary in the elderly.
Administration
l The tablet should preferably be taken on the same date each month.
l To maximize absorption and clinical benefit, Bondrova® should be taken at
least 60 minutes before the first food or drink or any oral medication or
supplementation (including calcium).
l To facilitate delivery to the stomach and reduce the potential for esophageal
irritation, Bondrova® should be swallowed whole with a full glass of plain water.
l The tablet should not be chewed or sucked.
l Patients should not lie down for 60 minutes after taking Bondrova®. However,
patients can sit down, walk, exercise or do the regular activities.
l If the once-monthly dose is missed and the patient’s next scheduled Bondrova®
day is more than 7 days away, the patient should be instructed to take one
Bondrova® 150mg tablet in the morning following the date that it is
remembered. Then the patient should return to the original schedule.
l If the next scheduled dose is within 7 days, patients should wait until the next
dose and then continue taking one tablet once-a-month as originally
scheduled. Two 150 mg tablets should not be taken within the same week.
Adverse reactions
In a one-year study in patients with osteoporosis treated with ibandronate
150mg once monthly, the majority of adverse drug reactions observed, were mild
to moderate in intensity, and most cases did not lead to cessation of therapy.
Common adverse reactions include dyspepsia, nausea, diarrhoea, constipation,
abdominal pain, myalgia, headache, mild flu-like symptoms, dizziness, skin rash.
Contraindications
Bondrova® is contraindicated in patients with
l Known hypersensitivity to ibandronic acid or to any of its excipients.
l Uncorrected hypocalcemia.
l Inability to stand or sit upright for at least 60 minutes.
Warnings
Bondrova® may cause upper gastrointestinal disorders such as dysphagia, esophagitis. So patient should comply with the dosing instructions.
Precautions
l Adequate intake of calcium and vitamin D is important in all patients. l Patients should also pay particular attention to and be able to comply with the dosing instructions to minimize the risk of gastrointestinal side effects.
Drug interactions
It is likely that products containing calcium and other multivalent cations (such as aluminium, magnesium, iron) including milk, food, and antacids are likely to interfere with absorption of ibandronate. Therefore, patients must wait 60 minutes after taking Bondrova® before taking other oral medications.
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