Generic name: clonidine hydrochloride
Dosage form: tablet, extended release
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KAPVAY is an extended-release tablet formulation of clonidine hydrochloride. While it is dosed twice a day, the same as the immediate-release clonidine formulation, it is not to be used interchangeably with the immediate-release formulation.
2.1 General Dosing Information
KAPVAY is an extended-release tablet and, therefore, must be swallowed whole and never crushed, cut or chewed. KAPVAY may be taken with or without food.
Due to the lack of controlled clinical trial data and differing pharmacokinetic profiles, substitution of KAPVAY for other clonidine products on a mg-per-mg basis is not recommended.
2.2 Dose Selection
The dose of KAPVAY, administered either as monotherapy or as adjunctive therapy to a psychostimulant, should be individualized according to the therapeutic needs and response of the patient. Dosing should be initiated with one 0.1 mg tablet at bedtime, and the daily dosage should be adjusted in increments of 0.1 mg/day at weekly intervals until the desired response is achieved. Doses should be taken twice a day, with either an equal or higher split dosage being given at bedtime (see Table 1).
|Total Daily Dose||Morning Dose||Bedtime Dose|
|0.1 mg/day||0.1 mg|
|0.2 mg/day||0.1 mg||0.1 mg|
|0.3 mg/day||0.1 mg||0.2 mg|
|0.4 mg/day||0.2 mg||0.2 mg|
Doses of KAPVAY higher than 0.4 mg/day (0.2 mg twice daily) were not evaluated in clinical trials for ADHD and are not recommended.
When KAPVAY is being added-on to a psychostimulant, the dose of the psychostimulant can be adjusted depending on the patient's response to KAPVAY.
2.3 Maintenance Treatment
The effectiveness of KAPVAY for longer-term use (more than 5 weeks) has not been systematically evaluated in controlled trials. Therefore the physician electing to use KAPVAY for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.