Concerta

What is Concerta?

• Concerta (methylphenidate) is a CNS stimulant used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65.

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What are the uses of this medicine?

Concerta (methylphenidate) is a central nervous system stimulant prescription medicine.

• It is used for the treatment of attention deficit and hyperactivity disorder (ADHD).
• Concerta® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
• Concerta® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

How does this medicine work?

• Methylphenidate (meth" il fen' i date) is a piperidine derivative that is structurally related to amphetamine which acts as a central nervous system (CNS) sympathomimetic stimulant, probably by causing release of norepinephrine at CNS nerve terminals promoting neurotransmission.
• Methylphenidate may also affect dopaminergic neurotransmission.
• Therapy with methylphenidate has been shown to increase cognitive abilities and improve psychological functioning and performance in children and adults with suspected attention deficit disorders.
• It has a paradoxical calming action in children with hyperactivity.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

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

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

What drug interactions can this medicine cause?

• Concerta® and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Concerta®.
• Your doctor will decide whether Concerta® can be taken with other medicines.

Especially tell your doctor if you or your child takes:

• antidepression medicines including MAOIs
• seizure medicines
• blood thinner medicines
• blood pressure medicines
• cold or allergy medicines that contain decongestants

Is this medicine FDA approved?

• Methylphenidate was initially approved for use in the United States in 1955 and its indications have been broadened to include children above the age of 6 and adolescents with attention deficit disorder.

How should this medicine be used?

Recommended dosage:

• For children and adolescents new to methylphenidate, the recommended starting dosage is 18 mg once daily. Dosage may be increased by 18 mg/day at weekly intervals and should not exceed 54 mg/day in children and 72 mg/day in adolescents.
• For adult patients new to methylphenidate, the recommended starting dose is 18 or 36 mg/day. Dosage may be increased by 18 mg/day at weekly intervals and should not exceed 72 mg/day for adults.

Administration:

• Do not chew, crush, or divide the tablets. Swallow Concerta® tablets whole with water or other liquids. Tell your doctor if you or your child cannot swallow Concerta® whole. A different medicine may need to be prescribed.
• Concerta® can be taken with or without food.
• Take Concerta® once each day in the morning. Concerta® is an extended-release tablet. It releases medication into your or your child's body throughout the day.
• The Concerta® tablet does not dissolve completely in the body after all the medicine has been released. You or your child may sometimes notice the empty tablet in a bowel movement. This is normal.
• From time to time, your doctor may stop Concerta® treatment for a while to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking Concerta®. Children should have their height and weight checked often while taking Concerta®. Concerta® treatment may be stopped if a problem is found during these check-ups.
• If you or your child takes too much Concerta® or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 18, 27, 36, and 54 mg

This medicine is available in fallowing brand namesː

• Concerta

What side effects can this medication cause?

The most common side effects of this medicine include:

• decreased appetite
• dry mouth
• trouble sleeping
• dizziness
• stomach ache
• increased sweating
• headache
• nausea
• anxiety
• weight loss
• irritability

Other serious side effects include:

• slowing of growth (height and weight) in children
• seizures, mainly in patients with a history of seizures
• eyesight changes or blurred vision
• blockage of the esophagus, stomach, small or large intestine in patients who already have a narrowing in any of these organs
• Heart-related problems
• Mental (Psychiatric) problems

What special precautions should I follow?

• Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Stimulant products generally should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems.
• Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mm Hg) and average heart rate (about 3 to 6 bpm). Monitor patients for changes in heart rate and blood pressure and use with caution in patients for whom an increase in blood pressure or heart rate would be problematic.
• Use of stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with preexisting psychiatric illness. Clinical evaluation for Bipolar Disorder is recommended prior to stimulant use. Monitor for aggressive behavior.
• Stimulants may lower the convulsive threshold. Discontinue in the presence of seizures.
• Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products, including Concerta. Immediate medical attention should be sought if signs or symptoms of painful or prolonged penile erections or priapism are observed.
• Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants.
• Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
• Published data are inadequate to determine whether chronic use of amphetamines may cause similar suppression of growth; however, it is anticipated that they likely have this effect as well. Monitor height and weight at appropriate intervals in pediatric patients.
• Because the Concerta® tablet is nondeformable and does not appreciably change in shape in the GI tract, Concerta® should not ordinarily be administered to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic, for example: esophageal motility disorders, small bowel inflammatory disease, "short gut" syndrome due to adhesions or decreased transit time, past history of peritonitis, cystic fibrosis, chronic intestinal pseudo-obstruction, or Meckel's diverticulum). Concerta® should be used only in patients who are able to swallow the tablet whole.
• Periodic CBC, differential, and platelet counts are advised during prolonged therapy.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• vomiting, agitation, muscle twitching, convulsion, grand mal convulsion, confusional state, hallucinations (auditory and/or visual), hyperhidrosis, headache, pyrexia, tachycardia, palpitations, heart rate increased, sinus arrhythmia, hypertension, rhabdomyolysis, mydriasis, and dry mouth.

Management of overdosage:

• Treatment consists of appropriate supportive measures.
• Gastric contents may be evacuated by gastric lavage as indicated.
• Before performing gastric lavage, control agitation and seizures if present and protect the airway. Other measures to detoxify the gut include administration of activated charcoal and a cathartic. Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for pyrexia.
• Efficacy of peritoneal dialysis or extracorporeal hemodialysis for Concerta® overdosage has not been established.
• The prolonged release of methylphenidate from Concerta® should be considered when treating patients with overdose.

Can this medicine be used in pregnancy?

• Pregnancy Category C
• The safety of methylphenidate for use during human pregnancy has not been established.
• There are no adequate and well-controlled studies in pregnant women.
• Concerta® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Concerta® should not be used in children under six years, since safety and efficacy in this age group have not been established.
• Long-term effects of methylphenidate in children have not been well established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: methylphenidate HCl

• Inactive Ingredients: 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, and triacetin.

Who manufactures and distributes this medicine?

Manufactured by:

• Janssen-Cilag Manufacturing, LLC
• Gurabo, Puerto Rico or
• Alza Corp.
• Vacaville, CA

Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ

What should I know about storage and disposal of this medication?

• Store Concerta® in a safe place at room temperature, 59 to 86° F (15 to 30° C). Protect from moisture.
• Keep Concerta® and all medicines out of the reach of children.

• Dailymed label info on Concerta
• FDA Concerta

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