INTUNIV is indicated for the treatment of ADHD in kids ages 6-17 (efficacy evaluated up to 8 weeks) Important Safety Information Patients with a history of hypersensitivity to INTUNIV, its inactive ingredients, or other products containing guanfacine should not take INTUNIV. Hypotension, bradycardia, and syncope were observed in clinical trials. Somnolence and sedation were commonly reported adverse reactions in clinical studies. Read more Important Safety Information
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Indication

  • INTUNIV is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications in children and adolescents ages 6 to 17. The effectiveness of INTUNIV for more than 8 weeks has not been systematically evaluated.

Important Safety Information

  • Patients with a history of hypersensitivity to INTUNIV, its inactive ingredients, or other products containing guanfacine should not take INTUNIV.
  • Hypotension, bradycardia, and syncope were observed in clinical trials. Decreases in blood pressure and heart rate were dose-dependent and were less pronounced over time of treatment. Heart rate and blood pressure should be measured prior to initiation of therapy, following dose increases, and periodically while on therapy. Use INTUNIV with caution in patients with a history of hypotension, heart block, bradycardia, cardiovascular disease, 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. Advise patients to avoid becoming dehydrated or overheated.
  • Somnolence and sedation were commonly reported adverse reactions in clinical studies. The potential for additive sedative effects with CNS depressant drugs should be considered. Caution patients against operating heavy equipment or driving until they know how they respond to INTUNIV. Advise patients to avoid use with alcohol.
  • The most common adverse reactions (incidence ≥5% and at least twice the rate for placebo) in the monotherapy trials with INTUNIV were somnolence, fatigue, nausea, lethargy, and hypotension, and in the adjunctive trial with INTUNIV were somnolence, fatigue, insomnia, dizziness, and abdominal pain.

Please see Full Prescribing Information.

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