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Shionogi Announces FDA Approval of KAPVAY™ - The First and Only Therapy Approved for Use with Stimulant Medication for the Treatment of ADHD
Date:10/4/2010

482; has not been studied in children with ADHD less than 6-years old.

Use KAPVAY™ with caution in patients at risk for hypotension, bradycardia and heart block. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Advise patients to avoid becoming dehydrated or overheated.

Somnolence and sedation have been observed with KAPVAY™. Consider the potential for additive sedative effects with CNS depressant drugs. 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 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.

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.

Do not use KAPVAY™ concomitantly with other products containing clonidine.

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/medwa
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SOURCE Shionogi Inc.
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