FDA Approves New Orally Disintegrating Dosage Form of Glycopyrrolate

By Jessica Pyhtila, PharmD, BCGP, BCPS

The FDA recently approved Dartisla ODT, an orally disintegrating tablet form of the antimuscarinic agent glycopyrrolate. Originally approved in 1961, glycopyrrolate is currently available in tablet and solution forms for oral use. In addition, an inhaled version of glycopyrrolate is available to help treat COPD. The oral form of the drug is used for a variety of conditions including sialorrhea and peptic ulcer disease. The newly-approved orally disintegrating tablet is specifically approved as an adjunctive treatment for peptic ulcer disease.

The Dartisla ODT formulation of glycopyrrolate is available as 1.7 mg orally disintegrating tablets. Patients who are currently receiving a 2 mg dose of other forms of glycopyrrolate may be directly converted to Dartisla ODT. However, patients initiating or being maintained on lower doses of glycopyrrolate should not be started on Dartisla ODT.

The agent should be given two or three times daily, to a maximum total daily dose of 6.8 mg. The patient should be educated to place the tablet on the top of their tongue. They should then allow the tablet to disintegrate and swallow it without water. In addition, the drug should be given one hour before or two hours after eating.

Common adverse effects of Dartisla ODT are consistent with anticholinergic effects of other antimuscarinic agents. These include flushing, decreased sweating, blurred vision, drowsiness, dry mouth, vomiting, constipation, tachycardia, and urinary retention.

The drug should be avoided if other anticholinergic medications are used. Patients at high risk of anticholinergic effects, like the elderly and those with renal impairment, should be closely monitored. In addition, due to the potential for decreased gastrointestinal motility on glycopyrrolate, concomitant medications whose absorption is altered due to decreased motility should be avoided. This includes solid oral dosage forms of potassium chloride, due to the risk of gastrointestinal toxicity.

References:

Food and Drug Administration. “Dartisla ODT.” December 2021. Retrieved from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215019s000lbl.pdf