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Shionogi Announces Commercial Availability of CUVPOSA™ (Glycopyrrolate) Oral Solution for Pediatric Chronic Severe Drooling Associated With Neurologic Conditions
Date:4/7/2011

y lead to discontinuation of CUVPOSA™. CUVPOSA™ may present abdominal distention, pain, nausea, or vomiting. It is important for physicians to assess patients for constipation, particularly within four to five days of initial dosing or after a dose increase. Diarrhea associated with CUVPOSA™ may be an early symptom of incomplete mechanical intestinal obstruction especially in patients with ileostomy or colostomy. If obstruction is suspected, discontinue CUVPOSA™.

Avoid patient exposure to high ambient temperatures.  Heat prostration (fever and heat stroke due to decreased sweating) can occur with use of anticholinergic drugs such as CUVPOSA™.

Patients should not engage in age-appropriate activities requiring mental alertness such as operating a motor vehicle or other machinery or perform hazardous work, as CUVPOSA™ may cause drowsiness or blurred vision.

Use CUVPOSA™ with caution in patients with conditions that are exacerbated by anticholinergic drug effects including:

  • Autonomic neuropathy, renal disease and 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, hypertension, and 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 i
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SOURCE Shionogi Inc.
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