Generic Name and Formulations:
Guanfacine (as HCl) 1mg, 2mg, 3mg, 4mg; ext-rel tabs.

Company:
Shire US, Inc.
Indications for INTUNIV:
Attention deficit hyperactivity disorder (ADHD), as monotherapy or as an adjunct to stimulant medications.

Adult:
≥18yrs: not established.

Children:
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; usual range: 1–4mg once daily. Doses >4mg/day: not studied. Mono- and adjunctive therapy: improvements seen at doses of 0.05–0.08mg/kg once daily; doses up to 0.12mg/kg once daily may provide additional benefit. Reeva luate periodically. Withdraw gradually (by 1mg every 3–7 days).

Contraindications:
Concomitant use with other forms of guanfacine.

Warnings/Precautions:
Do not substitute with other forms of guanfacine on a mg-mg basis. Concomitant antihypertensives, other risks for hypotension, syncope, bradycardia, cardiovascular disease. Monitor heart rate, BP. Dehydration. Elevated temperature. Renal or hepatic impairment. Pregnancy (Cat.B). Nursing mothers.

Interactions:
Avoid with alcohol. May be potentiated by CYP3A4/5 inhibitors (eg, ketoconazole). May be antagonized by CYP3A4 inducers (eg, rifampin). May potentiate valproic acid. Additive effects with other antihypertensives, CNS depressants (eg, benzodiazepines, antipsychotics, barbiturates).

Pharmacological Class:
Central alpha-2A agonist.

Adverse Reactions:
Somnolence, sedation, fatigue, nausea, lethargy, hypotension, insomnia, dizziness, abdominal pain, dry mouth, constipation; bradycardia.

Generic Availability:
YES

How Supplied:
Tabs—100