In This Article

    Concerta

    Quick Overview

    Over 6 million children between the ages of 6 and 17 in the United States have been diagnosed with Attention Deficit Hyperactivity Disorder, or as it’s more commonly known ADHD, with a 42 percent increase between 2009 and 2017. It’s a chronic condition that continues well into adulthood and typically requires a combination of medication and therapy to treat.

    Those who have the disorder tend to be restless and unable to sit still, with little ability to focus without the help of medications. This is where Concerta comes into play.

    It can help alleviate the symptoms so children and adults alike can focus and exhibit more control over their movements. This leads to better success in school and at work, in achieving tasks and eliminating impulsive actions.

    What Is Concerta?

    Concerta is a central nervous system (CNS) stimulant that’s designed to help treat specific conditions of the brain related to impulse, movement and control. It’s commonly used to treat ADD, ADHD and may also be prescribed for narcolepsy if the doctor sees it as a viable option.

    Concerta comes in extended-release tablets that are yellow, gray, white or brownish-red in color, depending on the dosage, with the world alza and then the dosage imprinted on the top. The tablets come in 18, 27, 36 or 54-mg strengths so doctors can prescribe different doses for different patients.

    Other Names for Concerta Include

    Concerta contains methylphenidate and may be filled as a generic brand under this name. It’s not to be confused with Adderall or Ritalin, though Ritalin contains the same active ingredient as Concerta.

    What Does Concerta Treat and Who Is It For?

    Concerta is specially formulated to treat ADHD. Brain development and activity differ in children and adults who suffer from this chronic condition.

    Those who are diagnosed with ADHD tend to exhibit the inability to sit still and maintain self-control, and the condition is normally diagnosed in early childhood. It’s not curable, but Concerta helps manage the symptoms to help improve focus and behavior.

    People who have ADHD classically display most of the same behaviors which may include, but are not limited to:

    • Easily distracted
    • Inability to sit still
    • Fidgeting and squirming
    • Impulsive
    • Excessive talking
    • Lack of attention to details
    • Poor listening skills
    • Forgetful

    In order to be diagnosed with ADHD, a person has to exhibit these symptoms among others, for a period of at least six months. There are no diagnostic tests, so it’s merely an observation of behavior that leads to the doctor making the determination.

    Concerta is prescribed when traditional measures, such as therapy, fail to correct the issue.

    Some patients may take Concerta for narcolepsy, which is a disorder in which a person falls asleep due to overwhelming drowsiness. As a stimulant, it may help relieve the symptoms, but like ADHD, narcolepsy is incurable.

    Patient Types

    The main patients that Concerta is prescribed for are children and adolescents who have been diagnosed with ADHD. However, adults up to the age of 65 may take the medication as well.

    The dosage is different depending on the age of the patient and the efficacy of the

    What Are the Ingredients In Concerta?

    There are several ingredients that make up the extended-release tablets, but only one main ingredient: methylphenidate. This is what’s responsible for increasing dopamine and stimulating the areas of the brain to relax the symptoms of ADHD and increase focus.

    The other inactive ingredients help make up the tablet itself and include:

    • Butylated hydroxytoluene
    • Carnauba wax
    • Cellulose acetate
    • Hypromellose
    • Lactose
    • Phosphoric acid
    • Poloxamer
    • Polyethylene glycol
    • Polyethylene oxides
    • Povidone
    • Propylene glycol
    • Sodium chloride
    • Stearic acid
    • Succinic acid
    • Synthetic iron oxides
    • Titanium dioxide
    • Triacetin

    Common Concerta Side Effects

    There are a few side effects that come along with taking Concerta, though not all patients who take the medication will experience them. Common side effects include, but are not limited to:

    • Insomnia
    • Decreased appetite
    • Anxiety
    • Nausea
    • Dry mouth
    • Increased heart rate

    These tend to subside as your body acclimates to the medication. Talk to your physician to see if there are ways to reduce them or eliminate them altogether.

    The less common side effects, which warrant a call to your physician include, chest or joint pain, skin reactions such as a rash or hives, and fever.

    Rare side effects include bloody or tarry stool, blurred or changed vision, muscle cramps, unexplained bruising or bleeding, changes in the skin to include flaking, swelling and scaling, and seizures or tics.

    If you experience any of the rare side effects, it’s a good idea to call your physician immediately or visit the local emergency room to make sure you’re not having an allergic reaction to the medicine or one of its components.

    Concerta Dosage

    The dosage of Concerta depends on the amount that works effectively for each patient, as it can differ. Some patients do well with just 18 mg per day while others have to take more to reach the desired level of effectiveness.

    The higher dosages range from 36 to 72 mg per day, with 54 mg being the highest dose recommended for adolescents and 72 mg being the limit for adult patients.

    Most patients start with the minimum dose of 18 mg to help get used to the medication and its potential side effects, though some adults may start at 36 mg. If the dose proves to be too little, doctors will increase it on a specific schedule.

    Concerta does offer a 27 mg strength dosage for doctors to prescribe if 18 mg is too little and 36 mg too high.

    Warnings: Before You Take Concerta, Talk to Your Healthcare Provider If:

    Like all medications, there are certain situations where taking Concerta may do more harm than good. If the patient has been diagnosed with or has a family history of specific diseases or conditions, taking Concerta can prove to be problematic with either exacerbated symptoms or potentially fatal outcomes.

    Those with cardiac disease and hypertension should avoid the medication, if possible. Concerta should also not be combined with specific medications, as discussed in more detail below.

    If you’re pregnant or trying to become pregnant, taking Concerta may not be a good idea. Talk to your doctor about the potential risks involved to both the pregnancy and the baby.

    How Should You Take Concerta?

    Concerta is meant to be taken whole with liquid at the start of the day. It is not meant to be chewed, crushed or otherwise divided. Whether you take one, two or three tablets of the medication, they’re all taken at the same time.

    If a child is unable to swallow the tablet whole, the doctor may have to prescribe methylphenidate in a different form. The capsule contains the dose in powder form and the shell is not digested by the body.

    How Much Concerta Can You Take in One Day?

    The maximum dosage of Concerta depends on the age of the person taking it. Children between the ages of 6 and 12 shouldn’t take more than 54 mg per day.

    Children 13 to 17, and adults 18 and over can take up to 72 mg per day, depending on the dosage the doctor prescribes.

    Concerta Addiction Risks

    Concerta comes with an addiction risk, like many other prescription drugs. It is considered a schedule II controlled narcotic substance and therefore usage may be monitored to prevent abuse.

    As a stimulant, it increases the dopamine levels in the brain which can lead to the feeling of exhilaration or being high. For this reason, many teens and adults abuse the drug in search of the feeling that it brings, even though they have no symptoms to treat.

    If you’ve had problems with alcohol or other drugs in the past, it’s worth mentioning to your physician to see if there are any other options for treating your symptoms to prevent Concerta abuse.

    Overdosing on Concerta

    It is possible to overdose on Concerta, especially if the patient takes more than the prescribed dosage. If you suspect an overdose, visit the emergency room right away and let the doctors on staff know the situation. Common signs of a Concerta overdose include, but are not limited to:

    • Dizziness or faintness
    • Confusion
    • Restlessness or nervousness
    • Muscle pain and/or twitching
    • Agitation
    • Diarrhea
    • Dilated pupils
    • Dark urine
    • Anxiety

    Doctors will likely pump the patient’s stomach and monitor cardiovascular activity while administering fluids intravenously.

    Concerta Interactions: What Should You Avoid Taking With Concerta?

    There is a long list of medications that interact with Concerta and therefore, should be avoided. A total of 24 drugs cause major interactions, meaning the risk far outweighs the benefit, while 382 others cause moderate interaction which means they should only be used in special circumstances and under careful watch.

    Some medications that cause major interactions include:

    • Iopamidol, a contrast dye that’s injected when you have imaging done
    • MAOI inhibitors used to treat depression and anxiety
    • Methylene Blue used to treat low blood oxygen
    • Pimozide, a medication used to calm motor and vocal tics caused by disorders such as Tourette Syndrome
    • Safinamide, used in the treatment of Parkinson’s

    If you’re on any of these drugs, it’s important to speak with your doctor and figure out another treatment method. There are different drugs that may not interact with these medications.

    Concerta and Alcohol

    In addition to medications, Concerta can interact very badly with alcohol, so it’s important to avoid drinking liquor and foods that contain alcohol.

    The combination can cause excess drowsiness, depression and even bring on seizures. It also poses a higher risk of experiencing side effects and can cause the drug to be released too quickly into the bloodstream.

    Concerta and Other Diseases/Conditions

    Believe it or not, a medication can interact badly with another condition or disease, and the same is true for Concerta. Your doctor will do a thorough medical history for you or your child to ascertain the risks the medication proposes.

    CNS drugs should never be taken by those who have cardiac disease or hypertension as they can cause an increase in blood pressure which can be fatal in some instances. It’s also not recommended for patients who also have liver disease as it may not be metabolized properly or those with glaucoma as it can increase ocular pressure.

    Make sure you’re completely honest in your medical history and mention if there’s a family history of any of the above, even if you or your child haven’t been diagnosed with any of the conditions.

    When you first your prescription filled, it’s important to read over the pamphlet that comes with it as it goes into detail about the side effects and warnings associated with the Concerta narcotic. It’s also important to read the insert every time you fill the script because you don’t know when new and vital information may be added.

    Concerta Withdrawal Symptoms

    It’s important to wean off of Concerta under the care of a physician. Immediately cutting off the dose can lead to withdrawal symptoms. A person withdrawing from Concerta may find themselves craving the drug and looking for ways to get their hands on it, legally or otherwise.

    Anxiety and depression are also symptoms of withdrawal, which is one of the main reasons why doctors caution against going cold turkey. Extreme fatigue is not out of the question either because the patient is losing the stimulation to the central nervous system that Concerta provides.

    Concerta Efficacy: What Does Concerta Do for Your Symptoms?

    One of the major symptoms of ADHD is the lack of ability to focus, and with the Concerta narcotic, patients experience improved focus. It does this by gradually increasing the dopamine and norepinephrine levels in the patient’s brain.

    What Are Norepinephrine and Dopamine?

    Norepinephrine is a hormone in the body which works as a neurotransmitter. It’s a stimulant where dopamine is related to a person’s pleasure and movement as well as their attention span which is where it comes into play with Concerta.

    The end result of these two increased neurotransmitters is a more honed-in sense of focus that makes it easier to pay attention and maintain control, reducing or potentially eliminating impulses altogether.

    It’s important to note that sometimes the body will build up a tolerance to Concerta doses and it may need to be increased. Other times, the drug loses its efficacy, and a new treatment method is required.

    This especially happens if the patient reaches the maximum suggested dosage and does not experience significant relief from the symptoms.

    Concerta and Pregnancy

    If you’re pregnant or considering getting pregnant while you’re on Concerta, it’s a good idea to talk to your doctor about how it can affect your pregnancy.

    According to studies carried out over a span of 10 years and involving 4.3 million pregnancies in the United States and Nordic regions, researchers have determined that there is an increased risk of cardiac malformations in fetuses of women who take methylphenidate while pregnant. The same risk was not present for amphetamines.

    Infants exposed to the drug right before birth may experience withdrawal symptoms that may require monitoring in the hospital.

    In addition, Concerta is passed through breast milk, so women choosing to nurse should speak with their doctors about the potential risk of the drug’s effect on nursing infants.

    Men who take Concerta or other methylphenidates do not have to worry about the presence of the stimulant in their semen posing a risk to the pregnancy, it’s only the continued exposure through the mother’s bloodstream that increases the risk of heart defects.

    Clinical Trials

    Clinical studies were carried out to test the efficacy of Concerta for children, adolescents, and adults, each age group in a different study.

    Three studies involved 416 children whose ages ranged between 6 and 12. The first study involved giving Concerta once a day, the second administered methylphenidate three times a day, while the third and final study involved a placebo.

    The symptoms were evaluated by school teachers using the IOWA, or Inattention/Overactivity with Aggression Conners scale. Those who took Concerta treatments had better results over a period of 12 hours than those who took the placebo.

    The study with adolescents evaluated the effect on 177 patients who were either given Concerta in an individualized dose according to their diagnostic results, or a placebo. The study took place for two weeks with investigators rating the results according to the ADHD Rating scale.

    At the end of the study, it was determined that Concerta was far more effective than the placebo, proving it to be therapeutically acceptable for treatment in children and adolescents.

    Adults between 18 and 65 also participated in two clinical studies, over a 5- and 7-week period, depending on their placement. Both studies were effective in showing that Concerta treatments were superior to the placebo, thus proving its efficacy in adults.

    Concerta Manufacturers

    Concerta itself is manufactured by Janssen Pharmaceuticals, Inc. This company also does the marketing of the drug and distribution to pharmacies and physicians.

    There are three generic brands and they are manufactured by Mallinckrodt as well as UCB/Kremers Urban. The third is manufactured by Janssen and marketed under the name of Actavis.

    It’s an identical copy of the Concerta drug, just marketed as an authorized generic brand to offer customers a cheaper option when filling their prescription.

    FDA Approval Status of Concerta

    Concerta is currently listed as approved on the FDA website. Its approval okays this ADHD medication for use in children ages 6 and up. It was approved by the FDA in 2000 for the treatment of ADHD based on results of studies presented to the agency that the drug indeed helped relieve the symptoms of the disorder.

    Concerta’s generic brands were approved in 2012 and 2013, though they were plagued by issues regarding equivalence. Approximately 200 reports came in between 2013 and 2014 that called the medication’s effectiveness into question.

    This prompted the FDA to reduce their therapeutically equivalent, or TE status, from AB to BX. BX drugs still maintain their approval status, but they are not automatically substituted as a generic for the brand name at the pharmacy.

    Related Drugs or Medications

    Concerta is related to other methylphenidate stimulants, including Ritalin which is also prescribed to patients who have ADD or ADHD. Similar prescriptions include those that also treat the same conditions and fall under the ADHD medication umbrella:

    • Adderall
    • Dexedrine
    • Evekeo
    • Quillivant XR
    • Strattera

    Not all of these medications contain methylphenidate, but they are options for treating ADHD and are prescribed regularly as part of a treatment plan for the condition. Some contain amphetamines and a combination of other drugs to effectively treat those who react badly or cannot take methylphenidate.