Active Ingredient: Risedronic acid
Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures.
Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Oral, 35 milligrams risedronic acid, once weekly.
Regimen B: Oral, 5 milligrams risedronic acid, once daily.
The recommended dose in adults is one 35 mg tablet orally once a week. The tablet should be taken on the same day each week.
The recommended daily dose in adults is one 5 mg tablet orally.
The absorption of risedronate sodium is affected by food, thus to ensure adequate absorption patients should take risedronate sodium:
Before breakfast: At least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day.
Patients should be instructed that if a dose is missed, one risedronate sodium 35 mg tablet should be taken on the day that the tablet is remembered. Patients should then return to taking one tablet once a week on the day the tablet is normally taken. Two tablets should not be taken on the same day.
In the particular instance that before breakfast dosing is not practical, risedronate sodium can be taken between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to ensure risedronate sodium is taken on an empty stomach:
Between meals: risedronate sodium should be taken at least 2 hours before and at least 2 hours after any food, medicinal product or drink (other than plain water).
In the evening: risedronate sodium should be taken at least 2 hours after the last food, medicinal product or drink (other than plain water) of the day. Risedronate sodium should be taken at least 30 minutes before going to bed.
If an occasional dose is missed, risedronate sodium can be taken before breakfast, between meals, or in the evening according to the instructions above.
The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach risedronate sodium is to be taken while in an upright (standing or sitting) position with a glass of plain water (≥120 ml). Patients should not lie down for 30 minutes after taking the tablet.
Supplemental calcium and vitamin D should be considered, if the dietary intake is inadequate.
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 risedronate on an individual patient basis, particularly after 5 or more years of use.
For:
Oral, 75 milligrams risedronic acid, once daily, 2 doses in total, over the duration of 1 month.
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