Active Ingredient: Risedronic acid
To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months), systemic corticosteroid treatment at doses ≥7.5mg/day prednisone or equivalent.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 5 milligrams risedronic acid, once daily.
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.
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 tablets 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 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 sodium on an individual patient basis, particularly after 5 or more years of use.
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