Generic name: CLONIDINE HYDROCHLORIDE 0.1mg
Dosage form: tablet, extended release
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2.1 General Dosing Information
KAPVAY is an extended-release tablet to be taken orally with or without food. Swallow tablets whole. Do not crush, chew, or break tablets because this will increase the rate of clonidine release.
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 [see Clinical Pharmacology (12.3)].
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.
When discontinuing KAPVAY, the total daily dose should be tapered in decrements of no more than 0.1 mg every 3 to 7 days to avoid rebound hypertension [see Warnings and Precautions (5.3)].