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Shionogi Inc. Announces Commercial Availability of KAPVAY™ (clonidine hydrochloride) Extended-Release Tablets for the Treatment of ADHD
Date:1/10/2011

excreted in human milk, caution should be exercised when KAPVAY™ is administered to a nursing woman.

Caution is warranted in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers and beta-blockers) due to a potential for additive effects such as bradycardia and AV block.

Clonidine, the active ingredient in KAPVAY™, is also approved as an antihypertensive.  Do not use KAPVAY™ in patients concomitantly taking other clonidine-containing products, (e.g. Catapres®, JENLOGA, etc.).

Common adverse reactions (incidence at least 5% and twice the rate of placebo) include:

Somnolence, fatigue, upper respiratory tract infection, irritability, throat pain, insomnia, nightmares, emotional disorder, constipation, nasal congestion, increased body temperature, dry mouth, and ear pain.

To report SUSPECTED ADVERSE REACTIONS, contact Shionogi Pharma, Inc. at 1-800-849-9707 ext. 1454 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For full prescribing information, please visit www.KAPVAY.com.  

About ADHD

ADHD is a neurobehavioral disorder that most often occurs in childhood and may continue into adolescence and adulthood. There are three subtypes of ADHD: predominantly hyperactive-impulsive, predominantly inattentive, and combined hyperactive-impulsive and inattentive, with the latter being the most common. ADHD symptoms fall under three main categories: inattention, hyperactivity and impulsivity, which can include behaviors such as trouble focusing, frequent daydreaming, excessive talking, fidgeting/squirming, chronic impatience and difficulty waiting their turn, depending on the category.

The cause of ADHD is not yet known. However, research has shown potential links to genetic and environmental fac
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SOURCE Shionogi Inc.
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