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CUVPOSA

Last Updated: April 21, 2011

Manufacturer:

Shionogi, Inc.

Pharmacological Class:

Anticholinergic.

Active Ingredient(s):

Glycopyrrolate 1mg/5mL; soln; cherry-flavored.

Indication(s):

To reduce chronic severe drooling in patients 3–16yrs of age with neurologic conditions associated with problem drooling (eg, cerebral palsy).

Pharmacology:

Glycopyrrolate is a competitive inhibitor of acetycholine receptors that are located on certain peripheral tissues, including salivary glands. Glycopyrrolate acts indirectly to reduce the rate of salivation by preventing the stimulation of these receptors.

Clinical Trials:

In a multicenter, randomized, double-blind, placebo-controlled, eight-week study, Cuvposa was evaluated for the control of pathologic drooling in children aged 3 to 23 years of age. The study involved 38 subjects who had cerebral palsy, mental retardation, or another neurologic condition associated with problem drooling defined as drooling in the absence of treatment so that clothing became damp on most days. Subjects were randomized to receive Cuvposa (titrated over a 4-week period to optimal response) or placebo.

Subjects were evaluated on the 9-point modified Teacher’s Drooling Scale (mTDS) defined as 1 = dry: never drools; 2 = mild: only the lips are wet, occasionally; 3 = mild: only the lips are wet, frequently; 4 = moderate: wet on the lips and chin, occasionally; 5 = moderate: wet on the lips and chin, frequently; 6 = severe: drools to the extent that clothing becomes damp, occasionally; 7 = severe: drools to the extent that clothing becomes damp, frequently; 8 = profuse: clothing, hands, tray and objects become wet, occasionally; 9 = profuse: clothing, hands, tray and objects become wet, frequently. The mTDS evaluations were recorded by parents/caregivers 3 times daily approximately two hours post-dose during pre-treatment baseline and at Weeks 2, 4, 6 and 8 of therapy. Responders were defined as subjects with at least a 3-point reduction in mean daily mTDS scores from baseline to Week 8. The percentage of responders at Week 8 was significantly higher for the Cuvposa group (75%) as compared with the placebo group (11%).

Legal Classification:

Adults:

Not applicable.

Children:

<3yrs: not recommended. Use accurate measuring device. Take on empty stomach. 3–16yrs: initially 0.02mg/kg 3 times daily; may titrate in increments of 0.02mg/kg every 5–7 days based on response and adverse reactions. Max 0.1mg/kg 3 times daily, not to exceed 1.5–3mg per dose based upon weight. See literature.

Contraindication(s):

Conditions that preclude anticholinergic therapy (eg, glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon, myasthenia gravis). Concomitant potassium chloride solid oral dosage forms (passage through GI may be arrested or delayed).

Warnings/Precautions:

Monitor for constipation esp. within 4–5 days of initial dosing or after dose increase. Discontinue if incomplete mechanical intestinal obstruction develops (diarrhea may be early symptom). Autonomic neuropathy. Renal impairment. Ulcerative colitis (esp. large doses). Hyperthyroidism. Cardiovascular disease. CHF. Arrhythmias. Tachycardia. Hypertension. Hiatal hernia associated with reflux esophagitis. Avoid high environmental temperature. Pregnancy (Cat.C). Nursing mothers.

Interaction(s):

See Contraindications. May potentiate digoxin slow dissolution oral tabs; monitor and consider using other forms (eg, elixir, caps). Additive antichlolinergic effects with amantadine; consider reducing glycopyrrolate dose. May potentiate atenolol, metformin; consider dose reduction. May antagonize haloperidol (closely monitor or avoid), levodopa (consider increasing dose).

Adverse Reaction(s):

Dry mouth, vomiting, constipation, flushing, nasal congestion; drowsiness, blurred vision, intestinal pseudo-obstruction, mechanical intestinal obstruction.