Hyperacidity, GERD, and ulcers:
Indications for: DARTISLA ODT
To reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.
Limitations of Use:
Not indicated as monotherapy for treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.
Use lowest effective dosage to control symptoms. Administer at least 1hr before or 2hrs after food. 1.7mg given two or three times daily. Max dose: 6.8mg/day. Allow tab to dissolve on the tongue; swallow without water. Patients receiving 2mg dose of another oral tab form of glycopyrrolate may switch to 1.7mg dose of Dartisla ODT. Patients on initial or maintenance treatment with a lower dosage strength of another oral glycopyrrolate product (eg, 1mg tab strength): Dartisla ODT is not recommended.
DARTISLA ODT Contraindications:
Glaucoma. Obstructive uropathies including prostatic hypertrophy. Mechanical obstructive diseases of GI tract (eg, pyloroduodenal stenosis, strictures). GI motility disorders (eg, achalasia, paralytic ileus, intestinal atony). Bleeding GI ulcer. Active inflammatory or infectious colitis that can lead to toxic megacolon. Toxic megacolon. Myasthenia gravis.
DARTISLA ODT Warnings/Precautions:
Discontinue if incomplete mechanical intestinal obstruction is suspected (diarrhea may be early symptom), symptoms of acute angle closure glaucoma, cognitive or visual impairment develop. Monitor for decreased GI motility. Conditions exacerbated by anticholinergic adverse reactions (eg, autonomic neuropathy, hyperthyroidism, cardiac disease, hiatal hernia associated with reflux esophagitis): not recommended. Avoid high environmental temperature. Renal impairment: monitor. Elderly: not recommended. Pregnancy. Nursing mothers.
DARTISLA ODT Classification:
DARTISLA ODT Interactions:
Additive anticholinergic effects with other anticholinergic drugs (eg, tricyclics, antiepileptics, type I antiarrhythmics, antispasmodics, amantadine). Concomitant with other anticholinergics or drugs that are affected by altered GI motility: not recommended. May worsen tardive dyskinesia with antipsychotics. May worsen GI mucosal injury with solid oral dosage forms of potassium chloride; avoid concomitant use.
Blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, urinary retention.
Generic Drug Availability: