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).
DOSAGE AND ADMINISTRATION
CUVPOSA must be measured and administered with an accurate measuring device [see PATIENT INFORMATION].
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].
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||12 mg||6 mL||15 mg||7.5 mL|
|18-22||39-49||0.4 mg||2 mL||0.8 mL||4 mL||12 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||15 mg||7.5 mL||2.0 mg||10 mL||2.5 mg||12.5 mL|
|28-32||61-71||0.6 mg||3 mL||12 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|
Dosage Forms And Strengths
CUVPOSA is available as a 1mg/5 mL clear, cherry-flavored solution for oral administration in 16 ounce bottles.
Storage And Handling
NDC 0259-0501-16; 1 mg/5mL clear, cherry-flavored solution; 16 oz. bottle.
Store at room temperature 20° -25°C (68° -77°F); excursions permitted to 15° -30°C (59° -86°F) [See USP Controlled Room Temperature].
Manufactured by: Mikart, Inc. Atlanta, GA 30318, Manufactured for: Merz North America, Inc. Raleigh, NC 27615. Revised: May 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/24/2017
Additional Cuvposa Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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