Methylphenidate

Methylphenidate is a prescription medication used to treat attention-deficit hyperactivity disorder (ADHD).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Methylphenidate 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 methylphenidate.

Your doctor will decide whether methylphenidate can be taken with other medicines.

Especially tell your doctor if you or your child takes:

• anti-depression medicines including MAOIs
• seizure medicines
• blood thinner medicines
• blood pressure medicines
• cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking methylphenidate without talking to your doctor first.

Methylphenidate may be habit-forming, and this medicine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Do not use methylphenidate if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Methylphenidate may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems--chest pain, feeling light-headed or short of breath; signs of psychosis--paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems--unexplained wounds on your fingers or toes.

Avoid drinking alcohol, especially if you take extended-release methylphenidate. Alcohol may cause the medicine to be released into the bloodstream too fast.

Methylphenidate may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

• Methylphenidate HCl
• Methylphenidate Hydrochloride
• NWP09

Depression (terminal illness, palliative care)

Data from a randomized, placebo-controlled study of hospice patients [Kerr 2012], a double-blind, randomized, placebo-controlled crossover trial in older adult patients who were medically ill [Wallace 1995], and a phase II open-label study in patients with advanced cancer [Homsi 2001] supports the use of methylphenidate in the treatment of depression in medically ill older adult patients with terminal illness and/or receiving palliative care. Clinical experience as a systematic review also suggests the utility of methylphenidate in the treatment of this condition [Hardy 2009]. Additional trials may be necessary to further define the role of methylphenidate in the treatment of this condition.

Fatigue, cancer related (adults)

Data from a randomized, placebo-controlled study of hospice patients support the use methylphenidate in the management of cancer-related fatigue in adults with advanced disease [Kerr 2012]. Additional data may be necessary to further define the role of methylphenidate in this condition.

Based on the American Society of Clinical Oncology (ASCO) guidelines for screening, assessment, and management of fatigue in adult survivors of cancer, methylphenidate may be used to manage severe cancer-related fatigue in adult patients with advanced disease or in patients receiving active cancer treatment.

Major depressive disorder (antidepressant augmentation; geriatric patients)

Data from a limited number of patients studied suggest that methylphenidate augmentation of antidepressants may be beneficial for the treatment of major depressive disorder in geriatric patients and that it may accelerate treatment response [Lavretsky 2015], [ Lavrestky 2006]. Additional data may be necessary to further define the role of methylphenidate in this condition.

May interfere with urine detection of amphetamines/methamphetamines (false-positive).

Periodic CBC, differential, and platelet counts with prolonged use; blood pressure, heart rate; signs and symptoms of depression, aggression, hostility, suicidal behavior/ideation; growth rate in children; signs of central nervous system stimulation; signs of peripheral vasculopathy (eg, digital changes)

Transdermal: Signs of worsening erythema, blistering or edema which does not improve within 48 hours of patch removal, or spreads beyond patch site.

When used for the treatment of ADHD, thoroughly evaluate for cardiovascular risk. Monitor heart rate, blood pressure, and consider obtaining ECG prior to initiation (Vetter 2008).

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Take methylphenidate exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Methylphenidate may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

To prevent sleep problems, take this medicine in the morning.

Some brands of methylphenidate should be taken at least 30 minutes before a meal. Extended-release methylphenidate can be taken with or without food. Follow the directions on your medicine label

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

To make swallowing easier, you may open the capsule and sprinkle the medicine into a spoonful of pudding or applesauce. Swallow right away without chewing. Do not save the mixture for later use.

The chewable tablet must be chewed before you swallow it.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

To take the orally disintegrating tablet (Cotempla XR-ODT):

• Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.

• Use dry hands to remove the tablet and place it in your mouth.

• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

While using methylphenidate, your doctor will need to check your progress at regular visits. Tell any doctor who treats you that you are using this medicine.

If you need surgery, tell the surgeon ahead of time that you are using methylphenidate. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

Keep track of your medicine. Methylphenidate is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Commonly reported side effects of methylphenidate include: insomnia, nausea, headache, vomiting, decreased appetite, and xerostomia. Other side effects include: anxiety, tics, hyperhidrosis, and irritability. See below for a comprehensive list of adverse effects.

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

• Time to peak concentrations of methylphenidate following immediate-release formulations is approximately 1.9 hours.
• Extended-release tablets or capsules have a two-phase release system. Initial peak concentrations are reached within an hour following administration, and another peak is seen approximately three hours later.
• Some relief from the symptoms of ADHD may be noticed within one to two hours of dosing; however, it may take up to two weeks for the full effects of methylphenidate to develop.

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