October 6, 2015
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How Supplied


KAPVAY® (clonidine hydrochloride) extended-release is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies].


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].

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).

Table 1 : KAPVAY Dosing Guidance

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].

Missed Doses

If patients miss a dose of KAPVAY, they should skip that dose and take the next dose as scheduled. Do not take more than the prescribed total daily amount of KAPVAY in any 24-hour period.


Dosage Forms And Strengths

KAPVAY tablets are available in two strengths, 0.1 mg and 0.2 mg as an extended-release formulation. Both the 0.1 mg and 0.2 mg tablets are white, non-scored, standard convex with debossing on one side. The 0.1 mg tablets are round and the 0.2 mg tablets are oval. KAPVAY tablets must be swallowed whole and never crushed, cut or chewed.

Storage And Handling

KAPVAY extended-release tablets are white, non-scored, standard convex with debossing (“651” for 0.1 mg and “652” for 0.2 mg) on one side.

NDC 59212-658-60 – 0.1 mg round tablets supplied in bottles containing 60 tablets.
NDC 59212-659-60 – 0.2 mg oval tablets supplied in bottles containing 60 tablets.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Dispense in a tight container.

Manufactured for: Concordia Pharmaceuticals Inc. St. Michael, Barbados BB11005. Revised: 2015

Last reviewed on RxList: 7/1/2015
This monograph has been modified to include the generic and brand name in many instances.

How Supplied

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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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