* Ibandrocare (Ibandronic acid) 150 mg 2 Film-Coated Scored Tablets. | ||
* Composition: Each film-coated scored tablet contains: | ||
& Ibandronate sodium monohydrate 168.75 mg (Equivalent to Ibandronic acid 150 mg). | ||
* Indications: | ||
& Treatment and prevention of postmenopausal osteoporosis: | ||
& IBANDROCARE is indicated for the treatment and prevention of osteoporosis in postmenopausal women. | ||
& IBANDROCARE increases bone mineral density (BMD) and reduces the incidence of vertebral fractures. | ||
* Dosage and mode of administration: | ||
# Dose: | ||
& The dose of IBANDROCARE is 150 mg F.C. Scored Tablet taken once monthly on the same date each month. | ||
# Dosing instructions: | ||
– To maximize absorption and clinical benefit, IBANDROCARE should be taken at least 60 minutes before the | ||
& first food or drink (other than water) of the day or before taking any oral medication or supplementation | ||
& including calcium, antacids, or vitamins. | ||
– To facilitate delivery of the stomach and thus reduce the potential for esophageal irritation (Ibandrocare tablets | ||
& should be swallowed whole with a full glass of plain water (6 to 8 oz) while the patient is standing or sitting in | ||
& an upright position. Patients should not lie down for 60 minutes after taking Ibandrocare. Patients should not eat, | ||
& drink anything except water, or take other medications for at least 60 minutes after taking Ibandrocare. Plain | ||
& water is the only drink that should be taken with Ibandrocare. 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. The Ibandrocare 150 mg tablet should be taken on the same date | ||
& each month (i.e., the patient’s Ibandrocare day). | ||
– The patient must not take two Ibandrocare 150 mg tablets within the same week. | ||
– If the once-monthly dose is missed, and the patients next scheduled Ibandrocare day is more than 7 days away, | ||
& the patient should be instructed to take IBANDROCARE 150 mg tablet in the morning following the date that it is | ||
& remembered. The patient should then return to taking one IBANDROCARE 150 mg tablet every month in the | ||
& morning of their chosen day, according to their original schedule. | ||
– If the once-monthly dose is missed, and the patient’s next scheduled IBANDROCARE day is 1 to 7 days away | ||
& the patient must wait until the subsequent month’s scheduled IBANDROCARE day to take their tablet. The patient | ||
& should then return to taking one IBANDROCARE 150 mg tablet every month in the morning of their chosen day | ||
& according to their original schedule. | ||
# Recommendations for calcium and vitamin D supplementation: | ||
& Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate. | ||
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