Concerta: ADHD Medication

What is Concerta?

Concerta (Generic Name: methylphenidate HCl ER) is an extended release delivery system central nervous system stimulant ADHD medication that is primarily used to treat attention deficit hyperactivity disorder (ADHD or ADD) in children ages 6-12, adolescents, and adults up to age 65. Concerta may improve focus for people with inattentive ADHD, and decrease impulsivity and hyperactive behavior — hallmark ADHD symptoms for many patients.

Concerta contains methylphenidate, the same active ingredient as ADHD medications such as Ritalin, Daytrana, and Aptensio XR. According to the FDA, Concerta is a federally controlled substance (“Schedule II Stimulant”) because it can be abused or lead to dependence. It has not been studied by the FDA in children under the age of 6 and so use in younger children is considered “off label.”  Nonetheless, it has been extensively studied in government-funded studies in children down to 3 years of age and has been shown to be both effective and safe in preschool children.

Concerta is known for its proprietary delivery system, OROS, (osmotically controlled release oral-delivery system), which allows medication to be released periodically as it travels through the body.

When Concerta is taken, a shell on the outside of the capsule dissolves, releasing 22% of the total dose of the medication. Three inner compartments then release at different intervals as the chambers absorb fluid from the intestine; this results in extended medication release. The release, however, is not consistent. Concerta was the first “backloaded” delivery system (other backloaded systems are Metadate CD and Biphentin), which was designed to produce constantly increasing blood levels of methylphenidate over a period of about 10 hours followed by a rapid decline in blood level once the hard caplet has released all that it is going to release. One-sixth of the dose is never released so that an 18 mg caplet of Concerta really delivers just 15 mg and a 36 mg caplet just releases 30 mg, and so on. Even after 20 years on the market there is a disagreement among clinicians about whether a steady release delivery system or a backloaded, ever-increasing dose is better.

Concerta is available in both branded and generic versions. This causes a great deal of confusion because there are currently six different formulations that are designated methylphenidate ER and that come in the same odd dosage strengths of 18, 27, 36, and 54 mg caplets but only one of these is the authentic “branded generic” that is identical to the brand name Concerta. The other five products are quite inferior, and the FDA recently succeeded in downgrading two of these product’s quality ratings.

The marketer of the acceptable branded generic changes almost every year, usually in January. Consumers should ask their pharmacist which product they’re dispensing and should not accept substitutes for the authentic branded generic. The acceptable generics will be in the shape of a small barrel, have a dimple at one end where the medication is pumped out of the hard-shell caplet, and should still bear the name of the brand name manufacturer called ALZA. Any other products are likely to be highly inconsistent in their release of medication and, short in duration, but cheaper so that they will be preferred by pharmacy benefits managers. For further, regularly updated information, see the website www.adhdrollercoaster.org.

Concerta can also be used to treat narcolepsy.

Concerta vs. Adderall

Concerta and Adderall are both central nervous system stimulant drugs. They alleviate ADHD symptoms by activating the areas of the brain responsible for paying attention and focusing. Concerta is the brand name for the delivery system of the generic drug methylphenidate. Adderall is the brand name for a delivery system of the generic drug amphetamine.

While Concerta is only available as an extended-release capsule, Adderall is available in immediate release and extended release forms. While the Concerta capsule relies on a push compartments to release medication over an extended period of time, the extended release version of Adderall holds tiny beads. Half the beads work right away; the others are released slowly into the body after about four hours.

What Is the Best Dosage for Concerta?

The optimal dosage of Concerta varies by patient. Concerta capsules are available in 18mg, 27mg, 36mg, and 54mg dosages. The time-release formulation is designed to maintain an ever-increasing blood level of medication in your body throughout the day. FDA guidance suggests a maximum 54mg daily dose for children and adolescents, and 72mg daily for adults.

The OROS delivery system is a very hard cellulose caplet that must remain intact because it contains two different concentrations of methylphenidate and a gel that pushes the medication out of a small hole at one end of the caplet. Cutting or crushing that caplet would cause all of the medication to be released at once. Capsules should be swallowed whole with water or other liquids. If your child is unable to swallow the pill, your doctor may recommend another medication. The empty caplet does not dissolve but instead passes through the digestive tract and out of the body without being digested.

As with all medications, follow your Concerta prescription instructions exactly. Concerta is taken orally, with or without food, once daily, typically taken first thing in the morning; it should be taken at the same time each day for the best results.

Some patients report developing a tolerance to Concerta, though no data supports this phenomenon. If you notice that your dosage is no longer controlling your symptoms, talk to your doctor to plan a course of action. Never adjust your dose without consulting your clinician first.

During treatment, your doctor should check vital statistics including blood, heart, and blood pressure; or evaluate height and weight.

What Side Effects Are Associated with Concerta?

Most people taking Concerta do not experience any side effects. That said, the most common side effects associated with Concerta are as follows:

• decreased appetite
• dry mouth
• sleep disruption
• dizziness
• stomach ache
• increased sweating
• headache
• nausea
• weight loss
• irritability, especially if the dose is wearing off

Serious Side Effects of Concerta

• slowed growth in children
• priapism (an erection that does not subside)
• eyesight changes or blurred vision

Concerta and Heart- or Blood-Pressure Related Problems

Report to your doctor any heart-related problems or a family history of heart and blood pressure problems. Patients with structural cardiac abnormalities and other serious heart problems have experienced sudden death, stroke, heart attack, and increased blood pressure while taking Concerta but no causal relationship has ever been found. Stimulants can increase blood pressure and heart rate. Physicians should monitor these vital signs closely during treatment. Call your doctor immediately if you or your child experiences warning signs such as chest pain, shortness of breath, or fainting while taking Concerta.

Concerta and Familial Mental Health Issues

Disclose to your physician all mental health issues including any family history of suicide, bipolar disorder, tics, or depression. Patients should be evaluated for bipolar disorder, tics, and Tourette’s syndrome prior to stimulant administration. Concerta may create new or exacerbate existing behavior problems, bipolar illness, or Tourette’s syndrome. Call your doctor immediately if you or your child experiences new or worsening mental health symptoms including hallucinations or sudden suspicions.

Concerta and Circulation Problems

Discuss circulation problems with your doctor before taking Concerta, which has been known to cause numbness, coolness, or pain in fingers or toes, including Raynaud’s phenomenon. Report to your doctor any new blood-flow problems, pain, skin color changes, or sensitivities to temperature while taking Concerta.

Concerta and Substance Abuse

Stimulants like Concerta have a potential for abuse, especially among people who do not have ADHD. It is a “Schedule II Stimulant,” a designation that the Drug Enforcement Agency uses for drugs with a high potential for abuse. Other Schedule II drugs include Dexedrine, Ritalin, and cocaine. People with a history of drug abuse should use caution when trying this medication. Taking the medication exactly as prescribed can reduce potential for abuse.

The above is not a complete list of potential side effects. If you notice any health changes not listed above, discuss them with your doctor or pharmacist.

What Precautions Are Associated with Concerta?

You should take Concerta with caution if you have:

• allergy or hypersensitivity to methylphenidate HCI
• if you are taking monoamine oxidase inhibitors (MAOIs)

You should use caution taking Concerta if you have a history of:

• heart or mental problems
• untreated glaucoma
• tics or history of Tourette’s syndrome
• circulation problems
• esophagus, stomach or intestine problems

If you’re thinking of becoming pregnant, discuss the use of Concerta with your doctor. The FDA designates MPH as a Pregnancy Risk Category C, which means that no risk of birth defects, difficulty with the pregnancy, or problems with delivery or the post-partum period have been found, but these problems cannot be absolutely ruled out either. Concerta is passed through breastmilk. Although it has never been studied, the American Academy of Pediatrics recommends that mothers do not nurse while taking methylphenidate “out of an abundance of caution.”

Store Concerta in a secure place out of the reach of children, and at room temperature. Do not share your Concerta prescription with anyone, even another person with ADHD. Sharing prescription medication is illegal, and can cause harm.

The safety of Concerta for children under 6 has not been studied by the FDA and so cannot be FDA-approved for preschoolers. It has been extensively studied, however, by other governmental agencies and found to be both effective and safe down to 3 years of age.. The effects of Concerta on adults over age 65 have not been studied.

What Interactions Are Associated with Concerta?

Before taking Concerta, discuss all other active prescription medications with your doctor. Concerta can have a dangerous, possibly fatal, interaction with antidepressants including MAOIs.

Tell your doctor if you are taking blood thinners, blood pressure medication, or any medication containing a decongestant.

Share a list of all vitamin or herbal supplements, and prescription and non-prescription medications you take with the pharmacist when you fill your prescription, and let all doctors and physicians know you are taking Concerta before having any surgery or laboratory tests. The above is not a complete list of all possible drug interactions.

More Information on Concerta and Other ADHD Medications:

Free Download: The Complete Guide to ADHD Medications
A Parent’s Guide to ADHD Medications
5 Rules for Treating Children with Stimulant Medications
ADHD Specialists and Clinics Near You

Concerta Sources:

¹What Is Concerta? https://www.concerta.net/

²Label for Concerta (methylphenidate HCI) Extended-Release Tablets. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021121s038lbl.pdf

³Katzman, Martin. A Review of OROS Methylphenidate (Concerta) in the treatment of Attention Deficit/Hyperactivity Disorder. CNS Drugs (2014). https://link.springer.com/article/10.1007/s40263-014-0175-1

⁴Listen to “How To Solve The Three Biggest Challenges of ADHD Medication” with Laurie Dupar. ADDitude Magazine (2019) https://www.additudemag.com/podcast-medication-timing-dose-laurie-dupar/