Product: Kapvay

Company: Shionogi

Pharmacologic class: Central α2-agonist

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Active ingredient: Clonidine 0.1 mg, 0.2 mg; extended-release tablets.

Indication: 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.

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 BP.

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 ADHD Rating Scale-IV total score.

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

Study 2 was an eight-week, randomized, double-blind, placebo-controlled flexible dose study in children and adolescents who had been treated with a psychostimulant for four 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 0.4 mg/day over a three-week period based on tolerability and response. The study dose was maintained for two weeks before being tapered to 0.1 mg/day for the last week of treatment. Patients given the combination of Kapvay + stimulant had improved ADHD scores compared with those on stimulant alone at the end of five weeks.

Adults: Not recommended.

Children: Age <6 years: not recommended. Swallow whole. Titrate by response. Initially 0.1 mg at bedtime for one week, then 0.1 mg b.i.d. for one week, then 0.1 mg in the morning and 0.2 mg at bedtime for one week, then 0.2 mg b.i.d. Withdraw gradually; reduce by 0.1 mg/day at three- to seven-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. Re-evaluate periodically. Pregnancy (Category C). Nursing mothers.

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

Adverse reactions: 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

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