Concerta (methylphenidate hydrochloride) extended-release tablets belong to a class of stimulant drugs used to treat attention deficit-hyperactivity disorder (ADHD) in children aged 6 and older, adolescents and adults.
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, manufactures the drug approved, which was approved by the U.S. Food and Drug Administration (FDA) in 2000.
J&J obtained Concerta in a 2001 acquisition of Alza Corporation.
In 2011, the FDA required a black box warning to be included in drug labeling for Concerta advising patients of the high risk of drug dependence associated with the ADHD medication and warning that chronic abuse of Concerta could lead to psychological dependence, varying levels of abnormal behavior and psychotic episodes.
Concerta has been linked to other serious side effects as well, including cardiovascular events (including cardiac arrest and stroke), seizures, tics, gastrointestinal obstruction, long-term growth impairment and decreased white blood-cell counts.
In 2013, the FDA released a safety communication warning of prolonged and sometimes painful erections in males (a condition known as priapism) that can cause permanent damage to the penis in individuals who do not seek immediate medical treatment.
Concerta (methylphenidate hydrochloride) is used to treat attention deficit-hyperactivity disorder (ADHD). ADHD is a brain disorder marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with a person’s ability to function or develop, as defined by the National Institutes of Health (NIH).
Concerta’s effectiveness in treating this condition was demonstrated in four randomized, double-blind, placebo-controlled studies in children and adolescents who met the criteria for a diagnosis of ADHD, according to FDA clinical trial data. Three controlled trials involved children aged 6 to 12 and one controlled trial was conducted with adolescents aged 13 to 17.
Attention Deficit-Hyperactivity Disorder (ADHD)
ADHD is characterized by three key behaviors. These behaviors include the following signs and symptoms of the condition affecting the patient’s brain:
- Inattention (lack of focus or persistence; wandering off task)
- Hyperactivity (extreme restlessness; excessive fidgeting and/or talking)
- Impulsivity (hasty decision-making without regard for high potential for harm; inability to delay gratification)
Some people with ADHD exhibit symptoms from all three behavioral categories, while others may only have problems associated with one. However, the presence of these behavioral signs and symptoms alone does not result in a diagnosis of ADHD. These characteristics must also cause a person significant impairment in social, academic or occupational functioning in at least two or more settings, such as school, work or home, and they must have been apparent before the age of 7.
At least six symptoms of inattention or hyperactivity/impulsivity must persist for at least six months to meet the criteria for a diagnosis. Patients can also meet the criteria for a combined type ADHD if symptoms of both inattention and hyperactivity/impulsivity are present.
There is no single diagnostic test to adequately diagnosis the condition. Therefore, a patient’s health care provider will use medical, psychological, educational and social resources, and rule out other mental disorders, to determine a definitive diagnosis.
There is no cure for ADHD, but available treatments, such as Concerta, can help reduce symptoms and improve functioning. Other than medication, treatment can include psychotherapy, education or training, and a combination of all therapies.
How Does Concerta Work?
Concerta is a stimulant of the central nervous system (CNS) (made up of the nerves in the brain and the spinal cord). The CNS takes in information through the senses, processes the information and reacts accordingly, guiding movement, registering (feeling) sensations throughout the body and controlling thought processes.
Although the medication is a stimulant, it works to improve thinking and attention by increasing the brain chemicals dopamine and norepinephrine, both essential components in a person’s cognitive functioning. Dopamine is associated with pleasure, movement and attention, while norepinephrine is produced naturally to mobilize the brain and the body for action. It is thereby responsible for arousal and alertness, promoting vigilance, enhancing formation and retrieval of memory, focusing attention, and fight-or-flight responses during stressful or dangerous situations.
These symptoms may include:
- Muscle twitching
- Excessive sweating
- Faster than normal heart beat at rest or increased heart rate
If it is suspected that a patient has overdosed on Concerta, treatment will consist of protecting the patient against self-injury and providing a calm environment.
It may also be necessary to empty the contents of the stomach by pumping (also known as gastric irrigation), or activated charcoal along with psychological relief may be administered.
Other measures may be used as appropriate for external cooling, maintenance of adequate circulation and breathing, or other remedies suggested by poison control for the management of methylphenidate overdose.
Concerta is an extended-release (ER) drug, meaning it releases its active ingredient, methylphenidate hydrochloride, at a steady, controlled rate throughout the day.
Concerta is taken in a tablet form. The tablet is administered whole by mouth once a day in the morning. It is important that the pill is not chewed, divided or crushed.
The stimulant drug is indicated to be used as an important part of a total treatment plan that can include psychological, educational and social measures.
The effectiveness of Concerta used long-term (more than four to seven weeks) has not been systematically evaluated in controlled trials, according to the FDA. The agency recommends that doctors opting to prescribe the medication for longer periods of time should periodically re-evaluate the long-term usefulness of the drug. This should include trials of medications as well to assess the patient’s functioning and possible sustained improvement when the drug is temporarily or permanently discontinued.
Concerta (methylphenidate hydrochloride) extended-release tablets are supplied in four dosage strengths. Each tablet is a different color with its number of milligrams imprinted on the pill.
|18 mg tablets||Yellow and labeled “alza 18”|
|27 mg tablets||Gray and labeled “alza 27”|
|36 mg tablets||White and labeled “alza 36”|
|54 mg tablets||Brownish-red and labeled “alza 54”|
The recommended starting dose for patients who are not currently taking methylphenidate or other stimulants is 18 milligrams taken once a day for children and adolescents and 18 or 36 milligrams taken once a day for adults. Dosages should not exceed 54 milligrams a day for children aged 6 to 12, and 72 milligrams a day for adolescents aged 13 to 17 and adults aged 18 to 65.
Doses may be increased in 18-milligram increments at weekly intervals for patients who are not seeing desired therapeutic results at a lower dose. A 27-milligram dosage strength is available to doctors to prescribe between the 18 and 36 milligram dosages.
When patients are already taking methylphenidate two or three times a day at doses of 10 to 60 milligrams, dosing recommendations are based on current dosing regimens and clinical judgment. The conversion dosage should not exceed 72 milligrams a day.
|Previous Methylphenidate Daily Dose||Recommended Concerta Starting Dose|
|5 mg methylphenidate two or three times a day||18 mg once a day in the morning|
|10 mg methylphenidate two or three times a day||36 mg once a day in the morning|
|15 mg methylphenidate two or three times a day||54 mg once a day in the morning|
|20 mg methylphenidate two or three times a day||72 mg once a day in the morning|
Overdosage of Concerta
It is possible to overdose on Concerta, or take too large of a dose, resulting in adverse reactions. Signs and symptoms of overdosage involve those that result in overstimulation of the central and sympathetic nervous systems.
Concerta Dependence and Abuse
Concerta is classified as a Schedule II controlled substance by federal regulation. This class of drugs is considered dangerous, according to the Drug Enforcement Administration (DEA). Medications categorized as Schedule II substances have a high potential for abuse, potentially leading to severe psychological and physical dependence.
When stimulants such as Concerta are abused, they can result in harm to the individual misusing the medication. Stimulants can be abused for a number of reasons, including weight loss, performance enhancement and euphoria.
Stimulants like Concerta can mimic the effects of methamphetamine when taken in doses or administered in ways other than prescribed.
The National Institute of Health (NIH) warns that when stimulants like Concerta are taken in doses and administered in ways other than those prescribed, the medications can increase brain dopamine levels in a rapid and intense manner, similar to the effects experienced by individuals abusing other prescription drugs, such as methamphetamine. When these dopamine levels are increased in this way, normal communication between brain cells is disrupted, creating a euphoric effect and increasing the potential for addiction.
Withdrawal symptoms may occur when a person stops taking the drug.
These symptoms can include fatigue, depression and irregular sleep patterns. When crushed or injected, insoluble (unable to be dissolved) fillers in the tablets can block small blood vessels leading to heightened cardiovascular risks, such as stroke.
Other dangers associated with the abuse of Concerta can include malnutrition (due to decreased appetite), and feelings of hostility and paranoia.
Concerta carries a black box warning advising of the risks of drug dependence associated with it. It’s label instructs caution be given when administered to people with a history of alcoholism or drug dependence.
Concerta’s drug label includes a boxed warning (also known as a black box warning), the FDA’s most serious type of warning, advising patients and health care providers of the risks of drug dependence associated with the ADHD medication. The label warns that Concerta should be “given cautiously” to individuals with a history of drug dependence or alcoholism.
It also notes that chronic abuse of the drug can lead to its tolerance and psychological dependence as well as psychotic episodes. Withdrawal following the abusive use of Concerta can result in severe depression and therefore, the label further warns that “careful supervision is required” when withdrawing chronic therapeutic use.
Side Effects of Concerta
Other than its high potential for drug dependence, Concerta and its active ingredient methylphenidate hydrochloride are linked to many side effects ranging from mild to serious. Some side effects of the ADHD drug can even cause death, including sudden death due to the use of the medication by patients with preexisting heart problems.
The most common side effect demonstrated in children and adolescents given Concerta in clinical trials was upper abdominal pain. In adults, the most common side effects reported with use of the drug included decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability and abnormal excess sweating (hyperhidrosis).
These side effects were present in a pediatric population of 2,216 children given 18 to 54 milligrams of Concerta once daily, 502 adolescents given 18 to 72 milligrams of the stimulant once a day, and 1,188 adults given 18 to 108 milligrams of Concerta at the same daily rate.
Trials were also conducted to measure adverse reactions to patients who discontinued use of the drug. Among children and adults, the most common side effects associated with stopping treatment with Concerta included anxiety, irritability, insomnia and increased blood pressure.
Other side effects reported in children taking Concerta include:
- Common cold
- Inability to sleep
- Sore throat
Adults taking Concerta have reported the following side effects:
- Faster than normal heart beat
- Spinning sensation or dizzy spells
- Blurred vision
- Upper respiratory tract infection
- Anorexia (self-starvation; excessive weight loss)
- Muscle tightness
- Involuntary and uncontrollable crying and/or laughing
Drug Interactions and Contraindications
Certain medications can interact with Concerta when patients take both drugs concurrently. These interactions can reduce the effectiveness of either drug or increase the potential for adverse reactions.
Patients taking MAO (monoamine oxidase) inhibiters (antidepressants) should not take Concerta due to the increased risk for hypertensive crises to occur. A hypertensive crisis is a severe increase in blood pressure that can lead to a stroke. This is the case even where the use of an MAOI has been discontinued if it was last taken within the preceding two weeks.
Due to possible increases in blood pressure, patients using vasopressor agents (antihypotensive medications indicated to raise low blood pressure) should exercise caution when taking Concerta.
Coumarin Anticoagulants, Antidepressants and Selective Serotonin Reuptake Inhibitors
Concerta may inhibit the metabolism (break down) of certain blood thinners, antidepressants, and antiepileptic or antiseizure drugs (also known as anticonvulsants, and sometimes used in the treatment of bipolar disorder, borderline personality disorder and neuropathic pain). Dosing of these medications may need to be lowered while taken along with Concerta. Dosages may need to be adjusted and plasma drug concentrations monitored when starting or stopping the use of Concerta.
Concerta is not advised to be used by certain individuals, meaning it is contraindicated for those patients. Children aged 6 and younger should not take Concerta because safety and effectiveness has not yet been established in this age group. Also, long-term effects of Concerta has not been well-established in children.
Use of Concerta has also not been studied in patients greater than age 65 or in women who are pregnant. Potential risks to fetuses or breastfeeding infants are unknown.
Patients who have the following conditions are advised not to take Concerta:
- Hypersensitivity (including swelling underneath the skin and anaphylaxis, a severe, potentially life-threatening allergic reaction) to methylphenidate, the active ingredient in Concerta
- Agitation, or those individuals with anxiety and tension since Concerta may aggravate symptoms
- Glaucoma (a group of eye diseases that can damage the optic nerve that carries information from the eye to the brain, potentially causing blindness)
- Tics, including motor tics or patients with a diagnosis or family history of Tourette’s syndrome (a neurological disorder that causes repeated, involuntary physical tics and vocal outbursts; the most severe of tic syndromes)
Kristin Compton is a medical writer with a background in legal studies. She has experience working in law firms as a paralegal and legal writer. She also has worked in journalism and marketing. She’s published numerous articles in a northwest Florida-based newspaper and lifestyle/entertainment magazine, as well as worked as a ghost writer on blog posts published online by a Central Florida law firm in the health law niche. As a patient herself, and an advocate, Kristin is passionate about “being a voice” for others.