General Information

Concerta is an extended release formulation of methylphenidate HCL, is a central nervous system (CNS) stimulant.

Concerta is specifically approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65.

Concerta is supplied as tablets for oral administration. Concerta should be taken once daily in the morning and swallowed whole with the aid of liquids. Concerta should not be chewed or crushed. Concerta may be taken with or without food.

• For children and adolescents new to methylphenidate, the recommended starting dosage is 18 mg once daily. Dosage may be increased by 18 mg/day at weekly intervals and should not exceed 54 mg/day in children and 72 mg/day in adolescents.
• For adult patients new to methylphenidate, the recommended starting dose is 18 or 36 mg/day. Dosage may be increased by 18 mg/day at weekly intervals and should not exceed 72 mg/day for adults.
• For patients currently using methylphenidate, dosing is based on current dose regimen and clinical judgment

Mechanism of Action

Concerta uses osmotic pressure to deliver methylphenidate HCl at a controlled rate. The system, which resembles a conventional tablet in appearance, consists of an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat.

The mode of methylphenidate HCl's therapeutic action in ADHD is not known. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. Methylphenidate is a racemic mixture comprised of the d- and l-isomers. The d-isomer is more pharmacologically active than the l-isomer. 

Side Effects

Reported side effects of Concerta include (but are not limited to) the following:

• Headache
• Stomach pain
• Sleeplessness
• Decreased appetite

Other side effects seen with methylphenidate include nausea, vomiting, dizziness, nervousness, tics, allergic reaction, increased blood pressure, and psychosis (abnormal thinking or hallucinations).

Concerta is contraindicated in patients with marked anxiety or agitation, glaucoma, or tics. It is also contraindicated during any treatment with monoamine oxidase inhibitors.

Clinical Trial Results

Concerta was demonstrated to be effective in the treatment of ADHD in three double-blind, active and placebo-controlled studies in 416 children 6 to 12 years-old. The studies compared Concerta given qd, methylphenidate given tid over 12 hours, and placebo treatment in two single-center, three-week crossover studies and in a multicenter, four-week parallel-group comparison. The primary comparison of interest in all three trials was Concerta versus placebo.

Symptoms of ADHD were evaluated by community school teachers using the Inattention/Overactivity with Aggression (IOWA) Conners scale. Statistically significant reduction in the Inattention/Overactivity subscale versus placebo was shown consistently across all three controlled studies for Concerta qd.