Concerta

• Janssen Pharmaceuticals, Inc.

Serious side effects have been reported with Concerta. See “Concerta Precautions” section.

Concerta may cause serious side effects, including:

• seizures, mainly in patients with a history of seizures
• slowing of growth (weight and height)
• eyesight changes or blurred vision

The most common side effects of Concerta include:

• poor appetite
• nausea
• vomiting
• stomach pain
• weight loss
• tics
• trouble sleeping
• mood swings
• dizziness

This is not a complete list of Concerta side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The following have been reported with use of Concerta and other stimulant medicines.

• Heart-related problems:
  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting Concerta.

Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with Concerta.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Concerta.

• Mental (psychiatric) problems:
  • All Patients
    • new or worse behavior and thought problems
    • new or worse bipolar illness
    • new or worse aggressive behavior or hostility
  • Children and Teenagers
  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Concerta, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

Do not take Concerta if you or your child:

• are very anxious, tense, or agitated
• have an eye problem called glaucoma
• have tics or Tourette’s syndrome, or a family history of Tourette's syndrome. Tics are hard to control repeated movements or sounds.
• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
• are allergic to anything in Concerta dosage forms

Concerta should not be used in children less than 6 years old because it has not been studied in this age group.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Concerta will harm your unborn baby.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Concerta falls into category C. There are no adequate animal or human studies; or studies in animals have shown a harmful and undesired effect on the unborn baby, yet there are no adequate and well-controlled studies in pregnant women.

This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Concerta is excreted in human breast milk or if it will harm your nursing baby.

Concerta is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Concerta in a safe place to prevent misuse and abuse. Selling or giving away Concerta may harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Drug Dependence

Concerta should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Ask your doctor before using a stomach acid medicine (including Alka-Seltzer or sodium bicarbonate). Some of these medicines can change the way your body absorbs methylphenidate, and may increase side effects.

Many drugs can interact with methylphenidate. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

Methylphenidate is used to treat attention deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Methylphenidate is also used to treat narcolepsy. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep.

Methylphenidate works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

This medicine is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methylphenidate in children. Safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies on the relationship of age to the effects of methylphenidate have not been performed in the geriatric population.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Brofaromine
• Clorgyline
• Furazolidone
• Iproniazid
• Isocarboxazid
• Lazabemide
• Linezolid
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Toloxatone
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion
• Donepezil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Drug abuse or dependence, history of—Use with caution. Dependence may be more likely to develop.

• Bipolar disorder (manic-depressive illness), history of or
• Depression, history of or
• Hypertension (high blood pressure) or
• Priapism (painful or prolonged erection of the penis) or
• Psychosis (mental illness), history of or
• Raynaud disease or
• Seizures, history of or
• Tachycardia (rapid heart rate)—Use with caution. May make these conditions worse.

• Coronary artery disease or
• Heart attack, recent or
• Heart disease (eg, cardiomyopathy) or
• Heart failure or
• Heart rhythm problems (eg, ventricular arrhythmia), history of or
• Hyperthyroidism (overactive thyroid) or
• Stroke, history of—Use with caution. May make side effects become worse.

• Phenylketonuria—The chewable tablet contains aspartame, which can make this condition worse.

Controlled Substance

Methylphenidate is a Schedule II controlled substance under the Controlled Substances Act.

Abuse

As noted in the Box Warning, Concerta® should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse.

In two placebo-controlled human abuse potential studies, single oral doses of Concerta® were compared to single oral doses of immediate-release methylphenidate (IR MPH) and placebo in subjects with a history of recreational stimulant use to assess relative abuse potential. For the purpose of this assessment, the response for each of the subjective measures was defined as the maximum effect within the first 8 hours after dose administration.

In one study (n=40), both Concerta® (108 mg) and 60 mg IR MPH compared to placebo produced statistically significantly greater responses on the five subjective measures suggestive of abuse potential. In comparisons between the two active treatments, however, Concerta® (108 mg) produced variable responses on positive subjective measures that were either statistically indistinguishable from (Abuse Potential, Drug Liking, Amphetamine, and Morphine Benzedrine Group [Euphoria]) or statistically less than (Stimulation – Euphoria) responses produced by 60 mg IR MPH.

In another study (n=49), both doses of Concerta® (54 mg and 108 mg) and both doses of IR MPH (50 mg and 90 mg) produced statistically significantly greater responses compared to placebo on the two primary scales used in the study (Drug Liking, Euphoria). When doses of Concerta® (54 mg and 108 mg) were compared to IR MPH (50 mg and 90 mg), respectively, Concerta® produced statistically significantly lower subjective responses on these two scales than IR MPH. Concerta® (108 mg) produced responses that were statistically indistinguishable from the responses on these two scales produced by IR MPH (50 mg). Differences in subjective responses to the respective doses should be considered in the context that only 22% of the total amount of methylphenidate in Concerta® tablets is available for immediate release from the drug overcoat [see System Components and Performance (11.1)].

Although these findings reveal a relatively lower response to Concerta® on subjective measures suggestive of abuse potential compared to IR MPH at roughly equivalent total MPH doses, the relevance of these findings to the abuse potential of Concerta® in the community is unknown.

Dependence

As noted in the Box Warning, careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

Concerta® was demonstrated to be effective in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in 4 randomized, double-blind, placebo-controlled studies in children and adolescents and 2 double-blind placebo-controlled studies in adults who met the Diagnostic and Statistical Manual 4th edition (DSM-IV) criteria for ADHD.

Children

Three double-blind, active- and placebo-controlled studies were conducted in 416 children aged 6 to 12 years. The controlled studies compared Concerta® given once daily (18, 36, or 54 mg), methylphenidate given three times daily over 12 hours (15, 30, or 45 mg total daily dose), and placebo in two single-center, 3-week crossover studies (Studies 1 and 2) and in a multicenter, 4-week, parallel-group comparison (Study 3). The primary comparison of interest in all three trials was Concerta® versus placebo.

Symptoms of ADHD were evaluated by community schoolteachers 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®. The scores for Concerta® and placebo for the three studies are presented in Figure 2.

In Studies 1 and 2, symptoms of ADHD were evaluated by laboratory schoolteachers using the SKAMP1 laboratory school rating scale. The combined results from these two studies demonstrated statistically significant improvements in attention and behavior in patients treated with Concerta® versus placebo that were maintained through 12 hours after dosing. Figure 3 presents the laboratory schoolteacher SKAMP ratings for Concerta® and placebo.

Adolescents

In a randomized, double-blind, multicenter, placebo-controlled trial (Study 4) involving 177 patients, Concerta® was demonstrated to be effective in the treatment of ADHD in adolescents aged 13 to 18 years at doses up to 72 mg/day (1.4 mg/kg/day). Of 220 patients who entered an open 4-week titration phase, 177 were titrated to an individualized dose (maximum of 72 mg/day) based on meeting specific improvement criteria on the ADHD Rating Scale and the Global Assessment of Effectiveness with acceptable tolerability. Patients who met these criteria were then randomized to receive either their individualized dose of Concerta® (18 – 72 mg/day, n=87) or placebo (n=90) during a two-week double-blind phase. At the end of this phase, mean scores for the investigator rating on the ADHD Rating Scale demonstrated that Concerta® was statistically significantly superior to placebo.

Adults

Two double-blind, placebo-controlled studies were conducted in 627 adults aged 18 to 65 years. The controlled studies compared Concerta® administered once daily and placebo in a multicenter, parallel-group, 7-week dose-titration study (Study 5) (36 to 108 mg/day) and in a multicenter, parallel-group, 5-week, fixed-dose study (Study 6) (18, 36, and 72 mg/day).

Study 5 demonstrated the effectiveness of Concerta® in the treatment of ADHD in adults aged 18 to 65 years at doses from 36 mg/day to 108 mg/day based on the change from baseline to final study visit on the Adult ADHD Investigator Rating Scale (AISRS). Of 226 patients who entered the 7-week trial, 110 were randomized to Concerta® and 116 were randomized to placebo. Treatment was initiated at 36 mg/day and patients continued with incremental increases of 18 mg/day (36 to 108 mg/day) based on meeting specific improvement criteria with acceptable tolerability. At the final study visit, mean change scores (LS Mean, SEM) for the investigator rating on the AISRS demonstrated that Concerta® was statistically significantly superior to placebo.

Study 6 was a multicenter, double-blind, randomized, placebo-controlled, parallel-group, dose-response study (5-week duration) with 3 fixed-dose groups (18, 36, and 72 mg). Patients were randomized to receive Concerta® administered at doses of 18 mg (n=101), 36 mg (n=102), 72 mg/day (n=102), or placebo (n=96). All three doses of Concerta® were statistically significantly more effective than placebo in improving CAARS (Conners' Adult ADHD Rating Scale) total scores at double-blind end point in adult subjects with ADHD.

NDC 50458-588-01
100 tablets

Concerta®
(methylphenidate HCl)
CII

Extended-release tablets

27 mg

Each tablet contains 27 mg
methylphenidate hydrochloride
in a controlled-release formulation.

Rx only

Please see the Medication Guide
provided by your pharmacist.

Janssen

NDC 50458-586-01
100 tablets

Concerta®
(methylphenidate HCl)
CII

Extended-release tablets

36 mg

Each tablet contains 36 mg
methylphenidate hydrochloride
in a controlled-release formulation.

Rx only

Please see the Medication Guide
provided by your pharmacist.

Janssen

Concerta (methylphenidate) is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Concerta extended-release tablets are used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy.

Concerta may also be used for purposes not listed in this medication guide.

Usual Dose for Narcolepsy and Attention Deficit Disorder:
Initial: (Methylphenidate - naive patients) 18 mg once daily in the morning before breakfast.
For patients already receiving methylphenidate:
If switching from immediate release tablets 5 mg 2 or 3 times a day: 18 mg once daily.
If switching from immediate release tablets 10 mg 2 or 3 times a day: 36 mg once daily.
If switching from immediate release tablets 15 mg 2 or 3 times a day: 54 mg once daily.
If switching from immediate release tablets 20 mg 2 or 3 times a day: 72 mg once daily.

Applies to methylphenidate: oral capsule extended release, oral powder for reconstitution extended release, oral solution, oral tablet, oral tablet chewable, oral tablet chewable extended release, oral tablet disintegrating extended release, oral tablet extended release, transdermal film extended release

General

In children, the following adverse reactions may occur more frequently: loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia.[Ref]

Other

Very common (10% or more): Infections and infestations (45.2%)
Common (1% to 10%): Lethargy, ear infection, pyrexia, fatigue, ear and labyrinth disorders, reproductive system and breast disorders, growth retardation (reduced weight and height gain), thirst, asthenia, influenza, erectile dysfunction, injury/poisoning/procedural complications
Uncommon (0.1% to 1%): Chest pain
Rare (less than 0.1%): Gynecomastia
Frequency not reported: Increased erection, prolonged erection, chest discomfort, hyperpyrexia, abuse and dependence
Postmarketing reports: Priapism[Ref]

Psychiatric

Very common (10% or more): Psychiatric disorders (27.9%), insomnia (13.3%), irritability (11%)
Common (1% to 10%): Anxiety, restlessness, sleep disorder, agitation, affect lability, aggression, depression, depressed mood, abnormal behavior, bruxism, confusional state, initial insomnia, decreased libido, nervousness, emotional poverty, tension, panic attack
Uncommon (0.1% to 1%): Psychotic disorders, hallucinations (auditory, visual, tactile), anger, suicidal ideation, altered mood, mood swings, tearfulness, tics, worsening of pre-existing tics or Tourette's syndrome, hypervigilance
Rare (less than 0.1%): Mania, disorientation, libido disorder
Very rare (less than 0.01%): Suicidal attempt/completed suicide, transient depressed mood, abnormal thinking, apathy, repetitive behaviors, over-focusing
Frequency not reported: Delusions, thought disturbances, confessional state, logorrhea[Ref]

Metabolic

Very common (10% or more): Decreased appetite (27.1%), metabolism and nutrition disorders (11.5%)
Common (1% to 10%): Anorexia, decreased weight[Ref]

Gastrointestinal

Very common (10% or more): Gastrointestinal disorders (23.5%), dry mouth (21.5%), nausea (12.2%), vomiting (10.2%)
Common (1% to 10%): Abdominal pain (upper and general), diarrhea, dyspepsia, toothache, stomach discomfort
Uncommon (0.1% to 1%): Constipation[Ref]

Nervous system

Very common (10% or more): Nervous system disorders (23.5%), headache (23.2%)
Common (1% to 10%): Dizziness, dyskinesia, tremor, drowsiness, feeling jittery, psychomotor hyperactivity, somnolence, vertigo, paresthesia, motion sickness, tension headache
Uncommon (0.1% to 1%): Sedation, tremor
Very rare (less than 0.01%): Convulsions, choreoathetoid movements, reversible ischemic neurological deficit, cerebrovascular disorders (vasculitis, cerebral hemorrhages, cerebrovascular accidents, cerebral arteritis, cerebral occlusion), neuroleptic malignant syndrome (NMS)
Frequency not reported: Grand mal convulsions, migraine, sedation[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (19.1%), respiratory/thoracic/mediastinal disorders (10.6%)
Common (1% to 10%): Upper respiratory tract infection, cough, oropharyngeal/pharyngolaryngeal pain, sinusitis, dyspnea[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal and connective tissue disorders (14.4%),
Common (1% to 10%): Joint sprain, arthralgia
Uncommon (0.1% to 1%): Myalgia, muscle twitching, muscle tightness, muscle spasms
Very rare (less than 0.01%): Muscle cramps
Frequency not reported: Rhabdomyolysis[Ref]

Local

Very common (10% or more): Administration site and general disorders (12.9%)
Postmarketing reports: Patch application site reactions[Ref]

Cardiovascular

Common (1% to 10%): Palpitations, tachycardia, cardiac disorders, vascular disorders, arrhythmias, hypertension, hot flush, changes in blood pressure and heart rate (usually an increase)
Uncommon (0.1% to 1%): Cardiac murmur
Rare (less than 0.1%): Angina pectoris
Very rare (less than 0.01%): Cardiac arrest, myocardial infarction, peripheral coldness, Raynaud's phenomenon, sudden cardiac death
Frequency not reported: Supraventricular tachycardia, bradycardia, ventricular extrasystoles, extrasystoles[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus, urticaria, fever, scalp hair loss/alopecia, dermatitis, excoriation hyperhidrosis, skin and subcutaneous tissue disorders
Uncommon (0.1% to 1%): Angioneurotic edema, bullous conditions, exfoliative conditions
Rare (less than 0.1%): Macular rash, erythema
Very rare (less than 0.01%): Thrombocytopenic purpura, exfoliative dermatitis, erythema multiforme, fixed drug eruption[Ref]

Immunologic

Common (1% to 10%): Immune systems disorders[Ref]

Ocular

Common (1% to 10%): Eye disorders, eye pain
Uncommon (0.1% to 1%): Diplopia, blurred vision
Rare (less than 0.1%): Visual accommodation difficulties, mydriasis, visual disturbance
Frequency not reported: Dry eye
Postmarketing reports: Visual impairment[Ref]

Genitourinary

Uncommon (0.1% to 1%): Hematuria, pollakiuria[Ref]

Hepatic

Uncommon (0.1% to 1%): Hepatic enzyme elevations
Very rare (less than 0.01%): Abnormal liver function, hepatic coma, increased blood alkaline phosphatase, increased blood bilirubin
Postmarketing reports: Hepatocellular injury, acute hepatic failure[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions (angioedema, anaphylaxis, auricular swelling, exanthemas)[Ref]

Hematologic

Very rare (less than 0.01%): Leukopenia, thrombocytopenia, anemia, decreased platelet count, abnormal white blood count
Postmarketing reports: Pancytopenia[Ref]

Some side effects of Concerta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

• Used in the treatment of ADHD in adults and children older than six. Usually used in conjunction with other treatment options (such as psychotherapy, education about the disorder, and social integration advice).
• Also used to treat attention deficit disorder (ADD) and narcolepsy.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• May cause abdominal pain, anxiety, decreased appetite, dry mouth, headache, nausea, insomnia, irritability, increase blood pressure or cause excessive sweating.
• Risk of dependence particularly in people with a history of drug dependence and alcoholism. Tolerance can also develop to Concerta's effect. Psychotic episodes have also been reported particularly with overuse.
• May impair judgment or reaction skills; exercise caution before driving or operating machinery until the full effects of Concerta are known.
• Risk of depression is high when withdrawing from Concerta, particularly in those who have been overusing it.
• May aggravate pre-existing symptoms of anxiety, tension, and agitation.
• May not be suitable for people with certain heart conditions and other psychiatric disorders or who have taken certain medications (such as MAO inhibitors in the past 14 days).
• Should not be used by people with glaucoma, tics, or Tourette's syndrome, or by people who suffer from severe anxiety or who get agitated or stressed easily.
• May increase the risk of seizures and peripheral circulatory problems and cause visual problems.
• Reports indicate some temporary slowing of growth may occur when regular Concerta is given to children aged 7 through 10 years: doctors should monitor height and weight and consider treatment interruption if growth suppression is suspected.
• Rare cases of priapism (painful erections more than 4 hours in duration) have been reported.
• Caution when using in people with preexisting bowel problems (includes those with severe narrowing of the intestinal tract and gut motility disorders) as Concerta tablets maintain their shape and potentially may cause a blockage.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.