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Study Data Show INTUNIV™ (guanfacine) Extended Release Tablets Co-administered With Stimulants Provided ADHD Symptom Improvement in Children and Adolescents
Date:5/21/2010

periods should periodically reevaluate its long-term usefulness for the individual patient.

INTUNIV is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).

INTUNIV should not be used in patients with a history of hypersensitivity to guanfacine or any of its inactive ingredients or by patients taking other products containing guanfacine.

Hypotension, bradycardia, and syncope were observed in clinical trials.  Use INTUNIV with caution in treating patients who have experienced hypotension, bradycardia, heart block, or syncope, or who may have a condition that predisposes them to syncope; are treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope.  Heart rate and blood pressure should be measured prior to initiation of therapy, following dose increases, and periodically while on therapy.  Advise patients to avoid becoming dehydrated or overheated.

Sedation and somnolence were commonly observed in clinical trials.  The potential for additive sedative effects with CNS depressant drugs should be considered.  Patients should be cautioned against operating heavy equipment or driving until they know how they respond to INTUNIV.  Advise patients to avoid use with alcohol.

Common adverse reactions in patients taking INTUNIV that may be dose related over the range of 1 to 4 mg/day include somnolence, sedation, abdominal pain, dizziness, hypotension/decreased blood pressure, dry mouth, and constipation.

Please see accompanying Full Prescribing Information at

SOURCE Shire plc
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