The FDA has approved orally disintegrating glycopyrrolate tablets (Dartisla ODT; Edenbridge Pharmaceuticals) to reduce ulcer symptoms as an adjunct to treatment for peptic ulcer disease in adults.
The FDA has approved orally disintegrating glycopyrrolate tablets (Dartisla ODT; Edenbridge Pharmaceuticals) to reduce ulcer symptoms as an adjunct to treatment for peptic ulcer disease in adults. The approval includes the limitation that Dartisla ODT is not indicated as monotherapy for the treatment of gastric ulcers, as its effectiveness in healing gastric ulcers has not been established.1
Pharmacology and pharmacokinetics
Dartisla ODT is an anticholinergic that inhibits the action of acetylcholine on the parietal cells in the stomach and reduces the acidity and volume of gastric secretion. The median time to maximum plasma concentration is 3 hours and it shows a mean plasma elimination half-life of 2.8 hours.1
Dosage and Administration
Patients taking 2 mg of another oral tablet dosage form of glycopyrrolate may be switched to Dartisla ODT. Dartisla ODT is not recommended for patients starting or on maintenance treatment with a lower dose of another oral glycopyrrolate product. The recommended dose of Dartisla ODT is 1.7 mg, 2 or 3 times daily, with a maximum daily dose of 6.8 mg. The tablet should be placed on the tongue, disintegrate and swallow without water. Each dose should be taken at least 1 hour before or 2 hours after eating. The lowest effective dose should be used to control symptoms and patients who can be titrated to a lower dose should be switched to an alternative oral tablet dosage form of glycopyrrolate.1
Dartisla ODT is a 505(b)(2) branded product. The FDA initially approved glycopyrrolate in 1961, and Dartisla ODT is the drug’s first orally disintegrating tablet formulation. Dartisla ODT uses a patented delivery technology, resulting in a freeze-dried tablet that dissolves almost instantly in the mouth without water.1.2
Contraindications, Warnings and Precautions
The use of Dartisla ODT is contraindicated in patients with hypersensitivity to glycopyrrolate or any of its inactive ingredients. The drug is also contraindicated in patients at risk of anticholinergic toxicity due to underlying medical conditions, such as active inflammatory or infectious colitis, which can lead to toxic megacolon; bleeding gastrointestinal (GI) ulcer, GI motility disorders, glaucoma, history of or current toxic megacolon, mechanical obstructive diseases of the gastrointestinal tract, myasthenia gravis, or obstructive uropathies, including prostatic hypertrophy.
Glycopyrrolate may cause increased intraocular pressure in patients with glaucoma and may reduce the effects of antiglaucoma medications. Dartisla ODT may aggravate the mechanical obstruction of the bowel. Constipation, delayed gastric emptying and intestinal pseudo-obstruction may occur and exacerbate or precipitate paralytic ileus and toxic megacolon. Glycopyrrolate may cause blurred vision and drowsiness, which may impair mental and/or physical abilities.
Patients should avoid hazardous tasks, such as driving a car or operating machinery, until they are reasonably sure they will not experience any ill effects. In very hot environments, heat exhaustion can occur, resulting in fever and heat stroke, especially in elderly patients. Dartisla ODT should not be used in patients with conditions exacerbated by anticholinergic side effects, such as autonomic neuropathy, heart disease, hiatal hernia, and hyperthyroidism. Due to an increased risk of anticholinergic side effects, Dartisla ODT is not recommended for use in elderly patients and may be contraindicated in some elderly patients with underlying medical conditions. Patients with renal impairment should be monitored for anticholinergic adverse reactions and Dartisla ODT should be discontinued if anticholinergic adverse reactions occur. Dartisla ODT should not be used concomitantly with agents showing altered absorption when gastrointestinal motility is impaired. Patients should avoid concomitant use of other anticholinergics or solid oral dosage forms of potassium chloride. Side effects include blurred vision, constipation, decreased sweating, drowsiness, dry mouth, flushing, tachycardia, urinary retention, and vomiting.1
About the author
Monica Holmberg, PharmD, BCPSis a pharmacist in Phoenix, Arizona, and Pharmacy Times® contributor.
1. Dartisla. Prescribing information. Edenbridge pharmaceutical products; 2021. Accessed May 10, 2022. https://dartislahcp.com/documents/DARTISLA-ODT-Prescribe-Information.pdf
2. Edenbridge Pharmaceuticals Announces US FDA Approval of Dartisla ODT (Glycopyrrolate) Orally Disintegrating Tablets. news item. Edenbridge Pharmaceuticals. December 17, 2021. Accessed May 20, 2022. https://www.businesswire.com/news/home/20211217005400/en