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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

hould not be used in patients with known hypersensitivity to clonidine.

KAPVAY™ can cause dose-related decreases in blood pressure and heart rate, use caution in treating patients who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration.  Use with caution in patients treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope.

Somnolence/sedation were commonly reported adverse reactions in clinical studies with KAPVAY™.  Potential for additive sedative effects with central nervous system (CNS) depressant drugs, advise patients to avoid use with alcohol. Caution patients against operating heavy equipment or driving until they know how they respond to KAPVAY™.

Patients should be instructed not to discontinue KAPVAY™ therapy without consulting their physician due to the potential risk of withdrawal effects.  KAPVAY™ should be discontinued slowly in decrements of no more than 0.1 mg every 3 to 7 days.

In patients who have developed localized contact sensitization or other allergic reaction to clonidine in a transdermal system, substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash, urticaria, or angioedema.

Use cautiously in patients with vascular disease, cardiac conduction disease, or chronic renal failure:  Monitor carefully and uptitrate slowly.

Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs.

Use caution when KAPVAY™ is administered concomitantly with antihypertensive drugs, due to the additive pharmacodynamics effects (e.g. hypotension, syncope).

KAPVAY™ should not be used during pregnancy unless clearly needed.  Since clonidine hydrochloride is
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