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Home » Drug Information » FDA Approved Drugs » 2000
Medical Areas: Psychiatry/Psychology | Family Medicine

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Concerta

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Alza
Approval Status: Approved August 2000
Treatment Area: For the treatment of Attention Deficit Hyperactivity Disorder

General Information

Concerta is a central nervous system (CNS) stimulant approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Its active ingredient is methylphenidate, and it is available as an extended-release tablet in four tablet strengths (18mg, 27mg, 36mg or 54mg of methylphenidate HCL). Each tablet is designed to have a 12-hour duration of effect.

ADHD has three characteristic symptoms: inattention, hyperactivity, and impulsiveness. Some patients display more symptoms of hyperactivity and impulsiveness, while others may display more symptoms of inattentiveness. Methylphenidate has been used to treat ADHD for more than 30 years, and helps increase attention and decrease impulsiveness and hyperactivity in ADHD patients.

Clinical 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. (from FDA Label)

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.

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. (from FDA Label)

Additional Information

For additional information, please visit the web site of Children and Adults with Attention-Deficit/Hyperactivity Disorder. This national, non-profit organization offers fact sheets and other sources of information on ADHD.