Important Safety Information

Contraindications:

• Patients at risk for anticholinergic toxicity due to various underlying medical conditions.
• Hypersensitivity to glycopyrrolate or the inactive ingredients.

Warnings and Precautions:

• Precipitation of acute glaucoma:  May increase intraocular pressure; if symptoms occur, discontinue use, and promptly seek medical care.
• Partial or complete mechanical intestinal obstruction: Diarrhea may be an early symptom, especially in patients with ileostomy or colostomy. If obstruction is suspected, discontinue use and evaluate the patient for obstruction.
• GI adverse reactions due to decreased GI motility: Delayed gastric emptying, constipation, and intestinal pseudo-obstruction may occur and precipitate or aggravate paralytic ileus and toxic megacolon; not recommended for use with anticholinergics or other medications that decrease GI peristalsis.
• Cognitive and visual adverse reactions: May impair mental and/or physical function. Inform patients not to operate motor vehicles or perform other hazardous tasks until reasonably certain they are not adversely affected; discontinue use if signs or symptoms develop.
• Heat prostration at high environmental temperatures: Heat prostration resulting in fever and heat stroke can occur, especially in geriatric patients. Avoid exposure to hot or very warm environmental temperatures.
• Other conditions exacerbated by anticholinergic adverse reactions:  Use is not recommended in patients with autonomic neuropathy, hyperthyroidism, cardiac disease, hiatal hernia, etc.
• Increased risk of anticholinergic adverse reactions in geriatric patients  Complications include urinary retention, bowel obstruction, heat prostration, arrythmias, delirium, and falls or fractures. Not recommended in geriatric patients and may be contraindicated in some patients with underlying medical conditions.

Adverse reactions include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention.

Drug Interactions:

• Other anticholinergic drugs: Concomitant use is not recommended.
• Drugs with altered absorption due to decreased GI motility: Concomitant use is not recommended.
• GI toxicity with solid oral dosage forms of potassium chloride: Concomitant use is not recommended.

Use in Specific Populations:

• Renal impairment. Monitor patients with renal impairment; if anticholinergic adverse reactions occur, discontinue use.

INDICATION
Dartisla ODT is an anticholinergic indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.

Please click here to see the Full Prescribing Information for Dartisla ODT.