Generic Name and Formulations:
Guanfacine (as HCl) 1mg, 2mg, 3mg, 4mg; ext-rel tabs.
Shire US, Inc.
Indications for INTUNIV:
Attention deficit hyperactivity disorder (ADHD), as monotherapy or as an adjunct to stimulant medications.
≥18yrs: not established.
Swallow whole with water, milk, or other liquid. Do not give with high-fat meals. <6yrs: not established. 6–17yrs: Initially 1mg once daily; adjust in increments of no more than 1mg/week; target range: 0.05–0.12mg/kg/day (1–7mg/day). Doses >4mg/day: not evaluated in children (6–12yrs); doses >7mg/day: not evaluated in adolescents (13–17yrs). Reevaluate periodically. Withdraw gradually (by 1mg every 3–7 days). Dose adjustment with concomitant strong and moderate CYP3A4 inhibitors or inducers: see full labeling.
Concomitant use with other forms of guanfacine.
Do not substitute with other forms of guanfacine on a mg-mg basis. Concomitant antihypertensives, other risks for hypotension, syncope, bradycardia, heart block, cardiovascular or cerebrovascular disease. Monitor heart rate, BP. Dehydration. Elevated temperature. Cardiac conduction abnormalities. Avoid abrupt discontinuation to minimize risk of rebound hypertension. Renal or hepatic impairment. Pregnancy (Cat.B). Nursing mothers.
Avoid with alcohol. May be potentiated by strong and moderate CYP3A4 inhibitors (eg, ketoconazole, fluconazole). May be antagonized by strong and moderate CYP3A4 inducers (eg, carbamazepine, rifampin, efavirenz). Additive effects with other antihypertensives, CNS depressants (eg, benzodiazepines, antipsychotics, barbiturates). May worsen sinus node dysfunction and AV block when concomitant other sympatholytic drugs; monitor.
Central alpha-2A agonist.
Somnolence, sedation, fatigue, nausea, lethargy, hypotension, insomnia, dizziness, abdominal pain, dry mouth, vomiting, irritability, constipation; bradycardia, hypertensive encephalopathy.