Concerta
methylphenidate hydrochloride
Pharmacologic class: Piperidine derivative
Therapeutic class: CNS stimulant
Controlled substance schedule II
Pregnancy risk category C
FDA Box Warning
• Give cautiously to patients with history of drug dependence or alcoholism. Chronic abuse can cause marked tolerance and psychological dependence with abnormal behavior. Frank psychotic episodes may occur, especially with parenteral abuse. Supervise carefully during withdrawal from abusive use, as severe depression may occur. Withdrawal after prolonged therapeutic use may unmask symptoms of underlying disorder, possibly requiring follow-up.
Action
Increases release of norepinephrine, which stimulates impulse transmission in respiratory system and CNS. Net effect is increased mental alertness.
Availability
Capsules (extended-release): 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg
Solution (oral): 5 mg/5 ml, 10 mg/10 ml
Tablets (chewable): 2.5 mg, 5 mg, 10 mg
Tablets (extended-release): 10 mg, 18 mg, 20 mg, 27 mg, 36 mg, 54 mg
Tablets (prompt-release): 5 mg, 10 mg, 20 mg
Tablets (sustained-release): 20 mg
Transdermal patch: 10 mg/9 hours, 15 mg/9 hours, 20 mg/9 hours, 30 mg/9 hours
Indications and dosages
➣ Adjunctive treatment of attention deficit hyperactivity disorder (ADHD)
Adults: 5 to 20 mg P.O. (prompt-release tablets) two to three times daily. Or, 20 to 30 mg (oral solution) P.O. daily. Once maintenance dosage is determined, may switch to extended-release.
Children older than age 6: Initially, 5 mg P.O. (prompt-release tablets or oral solution) before breakfast and lunch; increase by 5 to 10 mg at weekly intervals, not to exceed 60 mg/day. Once maintenance dosage is determined, may switch to extended-release.
If previous methylphenidate dosage was 10 mg b.i.d. or 20 mg sustained-release, give Ritalin LA 20 mg P.O. once daily. If previous dosage was 15 mg b.i.d., give Ritalin LA 30 mg P.O. once daily. If previous dosage was 20 mg b.i.d. or 40 mg sustained-release, give Ritalin LA 40 mg P.O. once daily. If previous dosage was 30 mg b.i.d. or 60 mg sustained-release, give Ritalin LA 60 mg P.O. once daily.
In all patients, Ritalin-SR or Metadate ER may be prescribed instead of prompt-release tablets when 8-hour dosage of those forms corresponds to titrated 8-hour dosage of prompt-release tablets.
Concerta-
Adults: If new to methylphenidate, initially 18 or 36 mg/day. Increase dosage by 18 mg/day at weekly intervals, not to exceed 72 mg/day. For patients currently using methylphenidate, dosing is based on current dosage regimen and clinical judgment.
Children ages 6 and older who haven't used methylphenidate previously: Initially, 18 mg P.O. once daily in morning; may be titrated weekly up to 54 mg/day
Children ages 6 and older using other methylphenidate forms: 18 mg P.O. once daily in morning if previous dosage was 5 mg two to three times daily, or 20 mg P.O. daily (sustained-release); 36 mg once daily in morning if previous dosage was 10 mg two to three times daily or 40 mg daily (sustained-release); or 54 mg once daily in morning if previous dosage was 15 mg two to three times daily or 60 mg once daily (sustained-release)
Metadate CD-
Children ages 6 and older: Initially, 20 mg once daily; may adjust in weekly increments of 10 to 20 mg, to a maximum of 60 mg/day taken in morning
➣ Adjunctive treatment of attention deficit hyperactivity disorder (ADHD)
Daytrana-
Children ages 6 and older: Apply patch to hip area 2 hours before effect is needed; remove 9 hours after application; titrate dosages as needed.
➣ Narcolepsy
Adults: 10 mg P.O. (Ritalin, Ritalin SR, or Metadate ER) two to three times daily, 30 to 45 minutes before a meal. Some patients may require up to 60 mg daily.
Off-label uses
• Depression in ill, elderly patients (such as those with cerebrovascular accident)
• To enhance analgesia and sedation in patients receiving opioids
Contraindications
• Hypersensitivity to drug or its components, including sucrose (Metadate CD)
• Glaucoma
• Motor tics, Tourette syndrome (or family history of syndrome)
• Marked anxiety, tension, agitation
• Severe hypertension, angina, arrhythmias, heart failure, recent myocardial infarction, hyperthyroidism, thyrotoxicosis
• Concurrent use of halogenated anesthetics
• MAO inhibitor use within past 14 days
Precautions
Use cautiously in:
• hypertension, seizure disorders
• psychosis
• suicidal or homicidal tendencies
• slow growth (children)
• elderly or debilitated patients
• pregnant or breastfeeding patients
• children younger than age 6.
Administration
See Be aware that Metadate CD contains sucrose. Don't give to patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency.
• Don't give Metadate CD on day of surgery.
• Don't crush extended-release tablets or extended-release trilayer core tablets (Concerta).
• Have patient swallow extended-release capsules (Metadate CD, Ritalin LA) intact; or, if desired, sprinkle entire contents onto small amount (1 tbsp) of applesauce immediately before administration. (However, don't sprinkle Ritalin LA onto warm applesauce because its release properties may be affected.) Give water after patient swallows dose.
• Don't give extended-release tablets to initiate therapy or for daily use until dosage has been titrated using conventional tablets.
• Apply patch immediately after opening pouch to a clean, dry hip area and alternate hips daily.
See Don't give within 14 days of MAO inhibitor use.
• To help prevent insomnia, give last daily dose of conventional tablets several hours before bedtime.
• Discontinue drug periodically in children who have responded to therapy, to assess patient's condition. After withdrawal, improvement may be temporary or permanent.
• Be aware that therapy shouldn't continue indefinitely.
Adverse reactions
CNS: restlessness, tremor, dizziness, headache, irritability, hyperactivity, insomnia, akathisia, dyskinesia, reversible ischemic neurologic deficit, toxic psychosis
CV: hypertension, hypotension, palpitations, tachycardia, Raynaud's phenomenon, sudden death (patients with structural cardiac abnormalities or other serious heart problems)
EENT: blurred vision
GI: nausea, vomiting, diarrhea, constipation, cramps, dry mouth, anorexia
Skin: rash, contact sensitization
Other: metallic taste, fever, suppression of weight gain (in children), hypersensitivity reactions, physical or psychological drug dependence, drug tolerance, peripheral coldness
Interactions
Drug-drug. Anticonvulsants, phenylbutazone, selective serotonin reuptake inhibitors, tricyclic antidepressants, warfarin: inhibited metabolism and increased effects of these drugs
Guanethidine: antagonism of hypotensive effect
Halogenated anesthetics: sudden blood pressure increase
MAO inhibitors, vasopressors: hypertensive crisis
Drug-food. Caffeine-containing foods and beverages (such as coffee, cola, chocolate): increased CNS stimulation
Drug-herbs. Ephedra (ma huang), caffeine-containing herbs (such as cola nut, guarana, maté): increased CNS stimulation
Drug-behaviors. Alcohol use: additive hypotension
Patient monitoring
• Monitor patient periodically for drug tolerance and psychological dependence.
• Watch for adverse effects. Know that these usually can be controlled by adjusting schedule or dosage.
• Monitor for contact sensitization (erythema accompanied by edema, papules, vesicles) that does not significantly improve within 48 hours or spreads beyond the patch site. Discontinue drug if this occurs.
• Stay alert for tachycardia, abdominal pain, insomnia, anorexia, and weight loss (more common in children).
• Consider periodic hematologic and liver function tests, especially during prolonged therapy.
• Monitor blood pressure, especially in patients with history of hypertension.
• Evaluate child's weight and growth patterns.
• Assess child for tics, which may develop in 15% to 30% of children using drug.
Patient teaching
• Inform patient or parent that last daily dose should be taken several hours before bedtime to avoid insomnia.
• Make sure patient or parent understands how drug should be taken.
• Tell patient taking Concerta not to be concerned if tablet-like substance appears in stool.
• Teach caregiver how to use patch and to make sure that skin is clean, dry, and free of cuts or irritation.
• Tell caregiver not to allow child to use heat sources, such as heating pads or electric blankets, while wearing the patch.
• Instruct caregiver to report redness accompanied by swelling or solid bumps or blisters on the skin that do not significantly improve within 48 hours or spread beyond the patch site.
• Tell caregiver to replace the patch if it falls off, but total wear time for the day should remain 9 hours.
• Advise patient or parent to report insomnia, palpitations, vomiting, fever, or rash.
• Caution patient or parent that continual use may lead to psychological or physical dependence.
• Instruct patient to avoid driving and other hazardous tasks until drug effects are known.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, foods, herbs, and behaviors mentioned above.
methylphenidate (oral)
(meth-ill-fen-i-date) methylphenidate,Biphentin
(trade name),Concerta
(trade name),Metadate CD
(trade name),Metadate ER
(trade name),Methylin
(trade name),Methylin ER
(trade name),Quillivant XR
(trade name),Ritalin
(trade name),Ritalin LA
(trade name),Ritalin SR
(trade name)methylphenidate (transdermal)
,Daytrana
(trade name)Classification
Therapeutic: central nervous system stimulantsIndications
Action
Therapeutic effects
Pharmacokinetics
Time/action profile (CNS stimulation)
| ROUTE | ONSET | PEAK | DURATION |
|---|---|---|---|
| PO | unknown | 1–3 hr | 4–6 hr |
| PO-ER | unknown | 4–7 hr | 3–12 hr† |
| Transdermal | unknown | unknown | 12 hr |
Contraindications/Precautions
Adverse Reactions/Side Effects
Central nervous system
- hyperactivity (most frequent)
- insomnia (most frequent)
- restlessness (most frequent)
- tremor (most frequent)
- behavioral disturbances
- dizziness
- hallucinations
- headache
- irritability
- mania
- thought disorder
Ear, Eye, Nose, Throat
- blurred vision
- teeth grinding
Cardiovascular
- sudden death (life-threatening)
- hypertension (most frequent)
- palpitations (most frequent)
- tachycardia (most frequent)
- hypotension
- peripheral vasculopathy
Gastrointestinal
- anorexia (most frequent)
- constipation
- cramps
- diarrhea
- dry mouth
- metallic taste
- nausea
- vomiting
Dermatologic
- contact sensitization (erythema, edema, papules, vesicles) (transdermal)
- erythema
- rashes
Metabolic
- growth suppression
- weight loss (may occur with prolonged use)
Neurologic
- akathisia
- dyskinesia
- tics
Miscellaneous
- anaphylaxis (life-threatening)
- angioedema (life-threatening)
- fever
- physical dependence
- psychological dependence
- tolerance
Interactions
Drug-Drug interaction
↑ sympathomimetic effects with other adrenergics, including vasoconstrictors, decongestants, and halogenated anesthetics.Use with MAO inhibitors or vasopressors may result in hypertensive crisis (concurrent use or use within 14 days of MAO inhibitors is contraindicated).Metabolism of warfarin, phenytoin, phenobarbital, primidone, phenylbutazone, selective serotonin reuptake inhibitors, and tricyclicantidepressants may be ↓ and effects ↑.Avoid concurrent use with pimozide (may mask cause of tics).May ↓ the effectiveness of antihypertensives.Alcohol may ↑ rate of release of drug from some methylphenidate formulations (Metadate CD, Ritalin LA)Use with caffeine-containing herbs (guarana, tea, coffee) ↑ stimulant effect.St. John's wort may ↑ serious side effects (concurrent use is NOT recommended).Excessive use of caffeine-containing foods or beverages (coffee, cola, tea) may cause ↑ CNS stimulation.Route/Dosage
Availability (generic available)
Nursing implications
Nursing assessment
- Monitor BP, pulse, and respiration before administering and periodically during therapy. Obtain a history (including assessment of family history of sudden death or ventricular arrhythmia), physical exam to assess for cardiac disease, and further evaluation (ECG and echocardiogram), if indicated. If exertional chest pain, unexplained syncope, or other cardiac symptoms occur, evaluate promptly.
- Monitor closely for behavior change.
- Monitor for signs and symptoms of peripheral vasculopathy (numbness and burning in fingers, digital changes). May require reduction in dose or discontinuation.
- Pediatric: Monitor growth, both height and weight, in children on long-term therapy.
- May produce a false sense of euphoria and well-being. Provide frequent rest periods and observe patient for rebound depression after the effects of the medication have worn off.
- Methylphenidate has a high abuse potential; may lead to tolerance and psychological dependence.
- ADHD: Assess children for attention span, impulse control, and interactions with others. Therapy may be interrupted at intervals to determine whether symptoms are sufficient to continue therapy.
- Narcolepsy: Observe and document frequency of episodes.
- Transdermal: Assess skin for signs of contact sensitization (erythema with edema, papules, or vesicles that does not improve within 48 hr or spreads beyond patch site) during therapy. May lead to systemic sensitization to other forms of methylphenidate (flare-up of previous dermatitis or prior positive patch-test sites, generalized skin eruptions, headache, fever, malaise, arthralgia, diarrhea, vomiting). If contact sensitization develops and oral methylphenidate is instituted, monitor closely.
- Lab Test Considerations: Monitor CBC, differential, and platelet count periodically in patients receiving prolonged therapy.
Potential Nursing Diagnoses
Disturbed thought process (Side Effects)Implementation
- Do not confuse Metadate ER/CD (methylphenidate), or methylphenidate with methadone. Do not confuse Metadate CD with Metadate ER. Do not confuse Ritalin LA with Ritalin SR.
- Oral: Administer immediate and sustained-release tablets on an empty stomach (30–45 min before a meal). Sustained-release tablets should be swallowed whole; do not break, crush, or chew. Medate CD and Ritalin LA capsules may be opened and sprinkled on cool applesauce; entire mixture should be ingested immediately and followed by a drink of water. Do not store for future use. Concerta may be administered without regard to food, but must be taken with water, milk, or juice.
- Shake extended-release oral suspension for 10 seconds before administering. May be given with or without food.
- Transdermal: Apply patch to a clean, dry site on the hip which is not oily, damaged, or irritated; do not apply to waistline where tight clothing may rub it. Press firmly in place with palm of hand for 30 seconds to make sure of good contact with skin, especially around edges. Alternate site daily. Apply patch 2 hr before desired effect and remove 9 hr after applied; effects last several more hours. Do not apply or reapply with dressings, tape, or other adhesives. Do not cut patches.
- If difficulty in separating patch from release liner, tearing, or other damage occurs during removal from liner, discard patch and apply a new patch. Inspect release liner to ensure no adhesive containing medication has transferred to liner; if transfer has occurred, discard patch. Avoid touching adhesive during application; wash hands immediately after application.
- If patch does not fully adhere or partially detaches, remove and replace with another patch. Wear patched for a total of 9 hr, regardless of number used. Exposure to water during bathing, swimming, or showering may affect patch adherence.
- Patches may be removed earlier before decreasing dose if an unacceptable loss of appetite or insomnia occurs.
- Store patches at room temperature in a safe place to prevent abuse and misuse; do not refrigerate or freeze.
- To remove patch, peel off slowly. An oil-based product (petroleum jelly, olive oil, mineral oil) may be applied gently to facilitate removal. Upon removal, fold so that adhesive side of patch adheres to itself and flush down toilet or dispose of in an appropriate lidded container.
Patient/Family Teaching
- Instruct patient to take medication as directed. If an oral dose is missed, take the remaining doses for that day at regularly spaced intervals; do not double doses. Take the last dose before 6 pm to minimize the risk of insomnia. Instruct patient not to alter dose without consulting health care professional. Abrupt cessation of high doses may cause extreme fatigue and mental depression. Instruct parent/caregiver to read the Medication Guide prior to use and with each Rx refill; new information may be available.
- Advise patient to check weight 2–3 times weekly and report weight loss to health care professional.
- May cause dizziness or blurred vision. Caution patient to avoid driving or activities requiring alertness until response to medication is known.
- Inform patient and/or parents that shell of Concerta tablet may appear in the stool. This is no cause for concern.
- Advise patient to avoid using caffeine-containing beverages concurrently with this therapy.
- Advise patient to notify health care professional if nervousness, insomnia, palpitations, vomiting, skin rash, or fever occurs.
- Advise patient and/or parents to notify health care professional of behavioral changes.
- Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
- Inform patient that health care professional may order periodic holidays from the drug to assess progress and to decrease dependence.
- Emphasize the importance of routine follow-up exams to monitor progress.
- Transdermal: Encourage parent or caregiver to use the administration chart included in package to monitor application and removal time and disposal method.
- Caution patient to avoid exposing patch to direct external heat sources (hair dryers, heating pads, electric blankets, heated water beds, etc.). May increase rate and extent of absorption.
- Inform parent/caregiver that skin redness, itching and small bumps on the skin are common. If swelling or blistering occurs, the patch should not be worn and health care professional notified. Caution parent/caregiver not to apply hydrocortisone or other solutions, creams, ointments, or emollients prior to application.
- Advise patient referred for MRI test to discuss patch with referring health care professional and MRI facility to determine if removal of patch is necessary prior to test and for directions for replacing patch.
- Home Care Issues: Pediatric: Advise parents to notify school nurse of medication regimen.
Evaluation/Desired Outcomes
- Improved attention span and social interactions in ADHD.
- Decreased frequency of narcoleptic symptoms.