CUVPOSA Oral solution Ref.[10794] Active ingredients: Glycopyrronium

Source: FDA, National Drug Code (US)  Revision Year: 2020 

1. Indications and Usage

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).

2. Dosage and Administration

CUVPOSA must be measured and administered with an accurate measuring device [see Patient Counseling Information (17)].

Initiate dosing at 0.02 mg/kg orally three times daily and titrate in increments of 0.02 mg/kg every 5-7 days based on therapeutic response and adverse reactions. The maximum recommended dosage is 0.1 mg/kg three times daily not to exceed 1.5-3 mg per dose based upon weight. For greater detail, see Table 1.

During the four-week titration period, dosing can be increased with the recommended dose titration schedule while ensuring that the anticholinergic adverse events are tolerable. Prior to each increase in dose, review the tolerability of the current dose level with the patient’s caregiver.

CUVPOSA should be dosed at least one hour before or two hours after meals.

The presence of high fat food reduces the oral bioavailability of CUVPOSA if taken shortly after a meal [see Clinical Pharmacology (12.3)].

Table 1. Recommended Dose Titration Schedule (each dose to be given three times daily):

Weight Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4 Dose Level 5
kg lbs (~0.02 mg/kg) (~0.04 mg/kg) (~0.06 mg/kg) (~0.08 mg/kg) (~0.1 mg/kg)
13-17 27-38 0.3 mg 1.5 mL 0.6 mg 3 mL 0.9 mg 4.5 mL 1.2 mg 6 mL 1.5 mg 7.5 mL
18-22 39-49 0.4 mg 2 mL 0.8 mL 4 mL 1.2 mg 6 mL 1.6 mg 8 mL 2.0 mg 10 mL
23-27 50-60 0.5 mg 2.5 mL 1.0 mg 5 mL 1.5 mg 7.5 mL 2.0 mg 10 mL 2.5 mg 12.5 mL
28-32 61-71 0.6 mg 3 mL 1.2 mg 6 mL 1.8 mg 9 mL 2.4 mg 12 mL 3.0 mg 15 mL
33-37 72-82 0.7 mg 3.5 mL 1.4 mg 7 mL 2.1 mg 10.5 mL 2.8 mg 14 mL 3.0 mg 15 mL
38-42 83-93 0.8 mg 4 mL 1.6 mg 8 mL 2.4 mg 12 mL 3.0 mg 15 mL 3.0 mg 15 mL
43-47 94-104 0.9 mg 4.5 mL 1.8 mg 9 mL 2.7 mg 13.5 mL 3.0 mg 15 mL 3.0 mg 15 mL
≥48 ≥105 1.0 mg 5 mL 2.0 mg 10 mL 3.0 mg 15 mL 3.0 mg 15 mL 3.0 mg 15 mL

10. Overdosage

Because glycopyrrolate is a quaternary amine which does not easily cross the blood-brain barrier, symptoms of glycopyrrolate overdosage are generally more peripheral in nature rather than central compared to other anticholinergic agents. In case of accidental overdose, therapy may include:

  • Maintain an open airway, providing ventilation as necessary.
  • Managing any acute conditions such as hyperthermia, coma and or seizures as applicable, and managing any jerky myoclonic movements or choreoathetosis which may lead to rhabdomyolysis in some cases of anticholinergic overdosage.
  • Administering a quaternary ammonium anticholinesterase such as neostigmine to help alleviate-peripheral anticholinergic effects such as anticholinergic induced ileus.
  • Administering activated charcoal orally as appropriate.

16.2. Storage and Handling

Store at room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

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