Generic name: glycopyrrolate 1mg in 5mL
Dosage form: oral liquid
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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)].
|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|