methylphenidate hydrochloride(redirected from Apo-Methylphenidate)
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.
Increases release of norepinephrine, which stimulates impulse transmission in respiratory system and CNS. Net effect is increased mental alertness.
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.
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)
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)
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.
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.
• Depression in ill, elderly patients (such as those with cerebrovascular accident)
• To enhance analgesia and sedation in patients receiving opioids
• Hypersensitivity to drug or its components, including sucrose (Metadate CD)
• 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
Use cautiously in:
• hypertension, seizure disorders
• suicidal or homicidal tendencies
• slow growth (children)
• elderly or debilitated patients
• pregnant or breastfeeding patients
• children younger than age 6.
☞ 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.
☞ 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.
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
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
• 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.
• 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.