"The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of "...
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.
The efficacy of KAPVAY in the treatment of ADHD is based on two controlled trials (one monotherapy and one adjunctive to stimulant medication) in children and adolescents ages 6-17 who met DSM-IV criteria for ADHD hyperactive or combined hyperactive/inattentive subtypes [see Clinical Studies]. In the adjunctive study, KAPVAY was administered to patients who had been on a stable regimen of either methylphenidate or amphetamine (or their derivatives) and who had not achieved an optimal response. The effectiveness of KAPVAY for longer-term use (more than 5 weeks) has not been systematically evaluated in controlled trials.
A diagnosis of ADHD implies the presence of hyperactive-impulsive and/or inattentive symptoms that cause impairment and were present before the age of 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV® characteristics.
Need for Comprehensive Treatment program
KAPVAY is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. KAPVAY is not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational/vocational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe KAPVAY will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms and on the level of functional impairment.
NOTE: This extended-release formulation of clonidine hydrochloride is also approved for the treatment of hypertension in adults under the trade name JENLOGA.
DOSAGE AND ADMINISTRATION
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.
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.
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.
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.
When discontinuing KAPVAY, the total daily dose should be tapered in decrements of no more than 0.1 mg every 3 to 7 days.
Dosage Form 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.
The 0.1 mg are round tablets supplied in bottles containing 60 (NDC 59630-658-60) or 180 tablets (NDC 59630-658-18).
The 0.2 mg are oval tablets supplied in bottles containing 60 (NDC 59630-659-60) or 180 tablets (NDC 59630-659-18).
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.
Issued: 1/2013. Distributed by: Shionogi Inc., Florham Park, NJ 07932
Last reviewed on RxList: 2/22/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Kapvay Information
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