Prescribing Information
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*Indication
Cuvposa is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g. cerebral palsy).
Important Safety Information
- Contraindicated in conditions that preclude anticholinergic therapy (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis)
- Contraindicated in patients taking solid oral dosage forms of potassium chloride. The passage of potassium chloride tablets through the GI tract may be arrested or delayed with coadministration of Cuvposa
- Constipation or intestinal pseudo-obstruction: Constipation is a common dose-limiting adverse reaction and may lead to discontinuation of Cuvposa. May present as abdominal distention, pain, nausea, or vomiting. Assess patients for constipation, particularly within 4-5 days of initial dosing or after a dose increase.
- Incomplete mechanical intestinal obstruction: Diarrhea may be an early symptom, especially in patients with ileostomy or colostomy. If obstruction is suspected, discontinue Cuvposa.
- Avoid high ambient temperatures. Heat prostration (fever and heat stroke due to decreased sweating) can occur with use of anticholinergic drugs such as Cuvposa.
- Cuvposa may cause drowsiness or blurred vision, do not engage in age-appropriate activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking Cuvposa.
- Use Cuvposa with caution in patients with conditions that are exacerbated by anticholinergic drug effects including:
- Autonomic neuropathy, renal disease, ulcerative colitis—large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or aggravate toxic megacolon, a serious complication of the disease; hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, tachycardia, and hypertension; hiatal hernia associated with reflux esophagitis
- Glycopyrrolate reduces GI transit time which may result in altered release of certain drugs when formulated in delayed or controlled-release forms. Cuvposa can increase serum levels of atenolol, metformin and digoxin (slow dissolution tablets; consider other dosage forms of digoxin). Dose reductions of atenolol or metformin may be needed.
- Cuvposa may decrease serum levels of haloperidol or levodopa. Consider dose increase of levodopa and monitor haloperidol patients for worsening of schizophrenic symptoms and development of tardive dyskinesia
- The anticholinergic effects of Cuvposa may be increased with concomitant administration of amantadine; Cuvposa dose reduction should be considered.
- Use with caution in patients with renal impairment.
- The most common adverse reactions (incidence ≥30%) are dry mouth (40%), vomiting (40%), constipation (35%), flushing (30%), and nasal congestion (30%).
*Cuvposa is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem
drooling (e.g. cerebral palsy)
Cuvposa™ (glycopyrrolate oral solution) has been classified by the FDA as an "Orphan Drug" that was developed to treat a rare condition (chronic severe drooling). Clinical studies of orphan drugs do not typically contain high numbers of study subjects.1
Please see Full Prescribing Information.
Reference: 1. Villarreal MA. Orphan Drug Act: Background and Proposed Legislation in the 107th Congress. CRS Report for Congress: Library of Congress.
2001; Order Code RS2097:1-6.
Cuvposa™ is a trademark of Shionogi Inc. © 2011 Shionogi Inc. Florham Park, NJ. All rights reserved. CUV11-WWW-001-00
