Manufacturer:

Shionogi Pharma Inc.

Pharmacological Class:

Central alpha₂-agonist.

Active Ingredient(s):

Clonidine HCl 0.1mg, 0.2mg; ext-rel tabs.

Indication(s):

Attention deficit hyperactivity disorder (ADHD).

Pharmacology:

This formulation of clonidine is indicated for treating patients with ADHD, either as monotherapy or as adjunctive therapy to stimulant medications. It has not been studied in adults with ADHD.

The mechanism of action of clonidine in the treatment of ADHD is not known. In addition to its effects in ADHD, it reduces sympathetic outflow from the brain, resulting in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure.

Other forms of clonidine are used in the treatment of hypertension in adults, but these formulations should not be interchanged.

Clinical Trials:

The efficacy of Kapvay in the treatment of children and adolescents with ADHD was established in two placebo-controlled trials. For both trials, the primary efficacy analysis is the comparison between treatment groups on change scores from baseline to week 5 of the ADHDRS-IV scale total score.

Study 1 was an 8-week, randomized, double-blind fixed-dose monotherapy study in patients 6–17 years of age. Patients were randomized to Kapvay 0.2mg/day, Kapvay 0.4mg/day, or placebo. Following titration to the target dose, patients were maintained on that dose for at least 2 weeks and then tapered down to 0.1mg/day at the last week of treatment. For both doses of Kapvay, improvements in ADHD symptoms were statistically significant for the Kapvay groups compared to the placebo group.

Study 2 was an 8-week, randomized, double-blind, placebo-controlled flexible dose study in children and adolescents who had been treated with a psychostimulant for 4 weeks with an inadequate response. Patients were randomized to receive either Kapvay + stimulant (methylphenidate or amphetamine) or stimulant alone. Kapvay doses were titrated up to 0.4mg/day over a 3-week period based on tolerability and response. The study dose was maintained for 2 weeks before being tapered to 0.1mg/day for the last week of treatment. Patients given the combination of Kapvay + stimulant had improved ADHD scores compared to those on stimulant alone at the end of 5 weeks.

Legal Classification:

Rx

Adults:

Not recommended.

Children:

<6 years: not recommended. Swallow whole. Titrate by response. Initially 0.1mg at bedtime for 1 week, then 0.1mg twice daily for 1 week, then 0.1mg in the morning and 0.2mg at bedtime for 1 week, then 0.2mg twice daily. Withdraw gradually; reduce by 0.1mg/day at 3–7 day intervals. Renal dysfunction: may need reduced dose.

Warnings/Precautions:

Hypotension. Bradycardia. Heart block. Vascular disease. Conduction disturbances. Chronic renal failure. Syncope. Severe coronary insufficiency. Recent MI. Monitor pulse, BP. Maintain adequate hydration. Reevaluate periodically. Pregnancy (Cat.C). Nursing mothers.

Interaction(s):

Potentiates alcohol, other CNS depressants, antihypertensives. Hypotensive effect may be antagonized by tricyclic antidepressants. Additive AV block, bradycardia with drugs that affect cardiac conduction (eg, digitalis, calcium channel blockers, beta-blockers). Avoid other forms of clonidine. May need to adjust dose of concurrent stimulant medication.

Adverse Reaction(s):

Somnolence, fatigue, upper respiratory tract infection, irritability, sore throat, insomnia, nightmares, emotional disorder, constipation, nasal congestion, fever, dry mouth, ear pain.

How Supplied:

Tabs—60

Last Updated:

1/21/2011