Clonidine Extended-Release (Clonidine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications.

The efficacy of clonidine hydrochloride extended-release tablets in the treatment of ADHD is based on two controlled trials (one monotherapy and one adjunctive to stimulant medication) in children and adolescents ages 6-17 who met DSM-IV criteria for ADHD hyperactive or combined hyperactive/inattentive subtypes [see Clinical Studies]. In the adjunctive study, clonidine hydrochloride extended-release tablets were administered to patients who had been on a stable regimen of either methylphenidate or amphetamine (or their derivatives) and who had not achieved an optimal response. The effectiveness of clonidine hydrochloride extended-release tablets for longer-term use (more than 5 weeks) has not been systematically evaluated in controlled trials.

A diagnosis of ADHD implies the presence of hyperactive-impulsive and/or inattentive symptoms that cause impairment and were present before the age of 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go"; excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV^® characteristics.

Need for Comprehensive Treatment program

Clonidine hydrochloride extended-release tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Clonidine hydrochloride extended-release tablets are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational/vocational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe clonidine hydrochloride extended-release tablets will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms and on the level of functional impairment.

DOSAGE AND ADMINISTRATION

Clonidine hydrochloride extended-release tablet is dosed twice a day, the same as the immediate-release clonidine formulation. Clonidine hydrochloride extended-release tablets are not to be used interchangeably with the immediate-release formulation.

General Dosing Information

Clonidine hydrochloride extended-release tablets must be swallowed whole and never crushed, cut or chewed. Clonidine hydrochloride extended-release tablets may be taken with or without food.

Due to the lack of controlled clinical trial data and differing pharmacokinetic profiles, substitution of clonidine hydrochloride extended-release tablets for other clonidine products on a mg-per-mg basis is not recommended.

Dose Selection

The dose of clonidine hydrochloride extended-release tablets, administered either as monotherapy or as adjunctive therapy to a psychostimulant, should be individualized according to the therapeutic needs and response of the patient. Dosing should be initiated with one 0.1 mg tablet at bedtime, and the daily dosage should be adjusted in increments of 0.1 mg/day at weekly intervals until the desired response is achieved. Doses should be taken twice a day, with either an equal or higher split dosage being given at bedtime (see Table 1).

Table 1 Clonidine Hydrochloride Extended-Release Tablets Dosing Guidance

Total Daily Dose	Morning Dose	Bedtime Dose
0.1 mg/day		0.1 mg
0.2 mg/day	0.1 mg	0.1 mg
0.3 mg/day	0.1 mg	0.2 mg
0.4 mg/day	0.2 mg	0.2 mg

Doses of clonidine hydrochloride extended-release tablets higher than 0.4 mg/day were not evaluated in clinical trials for ADHD and are not recommended.

When clonidine hydrochloride extended-release tablets are being added-on to a psychostimulant, the dose of the psychostimulant can be adjusted depending on the patient's response to clonidine hydrochloride extended-release tablets.

Maintenance Treatment

The effectiveness of clonidine hydrochloride extended-release tablets for longer-term use (more than 5 weeks) has not been systematically evaluated in controlled trials. Therefore the physician electing to use clonidine hydrochloride extended-release tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Discontinuation

When discontinuing clonidine hydrochloride extended-release tablets, the total daily dose should be tapered in decrements of no more than 0.1 mg every 3 to 7 days.

DOSAGE FORMS AND STRENGTHS

Clonidine hydrochloride extended-release tablets are available in 0.1 mg strength as an extended-release formulation. The 0.1 mg tablet is round, white, non-scored, standard convex with debossing on one side. Clonidine hydrochloride extended-release tablets must be swallowed whole and never crushed, cut or chewed.