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December 20, 2021December 17, 2022 – Dartisla ODT (glycopyrrolate) orally disintegrating tablets have been approved for use as an adjunct to treatment for peptic ulcer in adults to reduce the symptoms of peptic ulcer.
- Dartisla ODT is the first and only orally disintegrating tablet form of glycopyrrolate, its active pharmaceutical ingredient (API). The API has been FDA approved for more than 20 years.
- Recommended dosing is one 1.7mg tablet taken two or three times daily (up to a maximum daily
dosage of 6.8mg) at least one hour before or two hours after having food. The tablet should be
placed on top of the tongue, allowed to disintegrate, and swallowed without water.
- Under the recommended dosing, patients should be prescribed the lowest effective dosage of glycopyrrolate to control symptoms. Patients should be switched from Dartisla ODT to another oral dosage form of glycopyrrolate if symptoms can be controlled at a dose less than 1.7mg.
- Edenbridge Pharmaceuticals, the manufacturer, has launched Dartisla ODT at a wholesale acquisition cost (WAC) of $166.67 per 30 tablets.