Generic Name: dexmethylphenidate

Brand Names: Focalin, Focalin XR

Drug Class: Stimulants; ADHD Agents

What is dexmethylphenidate, and what is it used for?

Dexmethylphenidate is a medication used to treat attention deficit hyperactivity disorder (ADHD) in adults and children 6 years and older.

Dexmethylphenidate is the active molecule derived from methylphenidate, a central nervous system (CNS) stimulant. The mechanism of action of dexmethylphenidate in ADHD is not clear, but it is believed to work by increasing the levels of certain chemical messengers (neurotransmitters) in the brain that nerves use to communicate.

Dexmethylphenidate increases the concentration of dopamine and norepinephrine by blocking their reabsorption (reuptake) after the completion of neurotransmission, a natural process in the brain. Dopamine and norepinephrine have multiple functions that include the regulation of movement, attention, memory, motivation and pleasure. Increase in the levels of these neurotransmitters is believed to improve concentration and reduce hyperactive and impulsive behaviors associated with ADHD.

Stimulants including dexmethylphenidate have a high risk for misuse, abuse and dependence. Chronic abuse can lead to psychosis, discontinuation can cause withdrawal symptoms, and overdose can have serious consequences.

Warnings

• Do not use dexmethylphenidate in patients with the following conditions:
  • Hypersensitivity to methylphenidate or any of the components of the dexmethylphenidate formulation, can cause severe reactions
  • Significant anxiety, tension and agitation, the drug may aggravate these symptoms
  • Glaucoma, an eye condition with high intraocular pressure that causes progressive damage to the optic nerve
  • Motor tics, or a family history or diagnosis of Tourette’s syndrome
• Do not use dexmethylphenidate concurrently or within 14 days following the administration of monoamine oxidase inhibitors (MAOI), an antidepressant drug, can lead to a hypertensive crisis.
• Concurrent use with drugs that increase serotonin levels, including selective serotonin reuptake inhibitors (SSRIs), MAOIs and others can lead to serotonin syndrome, a potentially life-threatening reaction.
• Dexmethylphenidate has a high potential for abuse and dependence. Chronic abuse can lead to psychotic behavior and withdrawal symptoms upon discontinuation. Following are some points for caution:
  • The drug should be used as part of a comprehensive therapy for ADHD
  • Patient should be assessed for risk of abuse before prescribing and monitored for signs of abuse while on therapy
  • Should be used with caution in patients with a history of drug dependence or alcoholism
  • Patient should be evaluated for treatment need every 6 weeks
  • The drug should be discontinued if there is no improvement after one month
  • Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up
• Do not use dexmethylphenidate in patients with structural cardiac abnormalities or other serious heart conditions. Stroke, heart attack (myocardial infarction), and sudden death have been reported with even recommended doses.
• Stimulants can cause a modest increase in heart rate and blood pressure. Monitor all patients for larger increases.
• Evaluate patient’s cardiovascular status before initiating stimulant treatment. Use with caution in patients with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia and monitor closely.
• Evaluate cardiovascular status promptly in patients who develop symptoms such as exertional chest pain, unexplained fainting, or other symptoms suggestive of cardiac disease during stimulant treatment.
• Dexmethylphenidate can exacerbate symptoms in patients with pre-existing psychotic disorders. Use with caution.
• Use with caution in ADHD patients with comorbid bipolar disorder, stimulants may induce mixed and manic episodes in such patients.
• Consider discontinuing dexmethylphenidate if patients without a history of psychotic disorders develop psychotic or manic symptoms.
• Monitor children and adolescents for development or worsening of aggressive behavior or hostility.
• Dexmethylphenidate may lower seizure threshold. Monitor the patient and discontinue if seizure occurs.
• Stimulants may cause blurry vision or difficulty focusing (accommodation disorder).
• Periodic complete blood count (CBC), differential, and platelet counts are advised during prolonged therapy.
• Dexmethylphenidate may suppress growth in young children, monitor growth in children 7 to 10 years of age and interrupt treatment, if required.
• Dexmethylphenidate is associated with peripheral vascular diseases such as Raynaud’s phenomenon.
• Dexmethylphenidate may exacerbate phonic and motor tics in Tourette syndrome.
• Dexmethylphenidate may rarely cause prolonged and painful erection (priapism), sometimes requiring surgical intervention.
• Do not use dexmethylphenidate for depression or fatigue.
• Abrupt discontinuation following high doses or prolonged periods may result in symptoms of withdrawal including severe depression. Discontinue gradually.

What are the side effects of dexmethylphenidate?

Common side effects of dexmethylphenidate include:

• Headache
• Insomnia
• Restlessness
• Anxiety
• Dizziness
• Irritability
• Reduced appetite
• Loss of appetite (anorexia)
• Abdominal pain
• Dry mouth (xerostomia)
• Indigestion (dyspepsia)
• Nausea
• Vomiting
• Throat pain
• Nasal congestion
• Fever

Less common side effects of dexmethylphenidate include:

• Depression
• Mood swings (emotional lability)
• Itching (pruritus)
• Rare side effects of dexmethylphenidate include:
• Hypersensitivity reactions
• Swelling in the tissue below the skin and mucous membranes (angioedema)
• Severe allergic reactions (anaphylaxis)
• Drowsiness
• Breakdown of muscle tissue (rhabdomyolysis)
• Movement disorder (dyskinesia)
• Tourette syndrome, a nervous system disorder that causes tics
• Peripheral vascular disease
• Raynaud’s phenomenon, a condition with reduced blood flow to extremities due to cold or stress
• Toxic psychosis
• Abnormal liver function
• Elevation of liver enzymes
• Severe liver injury
• Growth suppression in pediatric patients
• Prolonged and painful erection (priapism)
• Serotonin syndrome in combination with serotonergic drugs

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

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What are the dosages of dexmethylphenidate?

Tablet

• 2.5 mg
• 5 mg
• 10 mg

Capsule, extended-release

• 5 mg
• 10 mg
• 15 mg
• 20 mg
• 25 mg
• 30 mg
• 35 mg
• 40 mg

Attention Deficit Hyperactivity Disorder

Adult:

Focalin

• Initial: 2.5 orally twice daily; may increase in 2.5- to 5-mg increments every week if warranted
• Not to exceed 20 mg/day

Focalin XR

• Not taking Focalin or methylphenidate: 10 mg orally every day initially; may increase in 10-mg increments every week if warranted; not to exceed 20 mg/day
• Switch from Focalin: Administer the same total daily dose as Focalin but administer every day
• Switch from methylphenidate: Initiate with half total daily dose of methylphenidate and administer every day; not to exceed 40 mg/day

Dosing Modifications

• Hepatic impairment: Safety and efficacy not established
• Renal impairment: Not studied; expected to have minimal effects on kinetics of dexmethylphenidate considering its extensive metabolism to inactive compounds

Pediatric:

Children below 6 years

• Safety and efficacy not established

Children 6 years and above (Focalin)

• Initial: 2.5 orally twice daily; may increase in 2.5- to 5-mg increments every week if warranted
• Not to exceed 20 mg/day

Children 6 years and above (Focalin XR)

• Not taking Focalin or methylphenidate: 5 mg orally every day initially; may increase in 5-mg increments every week if warranted; not to exceed 30 mg/day
• Switch from Focalin: Administer the same total daily dose as Focalin but administer every day
• Switch from methylphenidate: Initiate with half total daily dose of methylphenidate and administer every day; not to exceed 30 mg/day

The abbreviated term ADHD denotes the condition commonly known as:
See Answer

Addiction/overdose

• Dexmethylphenidate has a high potential for abuse and dependence that can result in overdose.
• Overdose overstimulates the central nervous system (CNS) and can cause a multitude of symptoms including agitation, confusion, hallucinations, vomiting, headache, high temperature, tremors, convulsions progressing to coma, and serious cardiovascular conditions such as high blood pressure, high heart rate and irregular heart rhythm.
• Treatment for dexmethylphenidate overdose is symptomatic and supportive therapy, with respiratory support, intravenous fluids and other intensive care measures, as needed. Undigested drug from the gastrointestinal tract may be eliminated with gastric lavage and administration of activated charcoal and purgative.

What drugs interact with dexmethylphenidate?

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of dexmethylphenidate include:
  • iobenguane I 123
  • isocarboxazid
  • linezolid
  • phenelzine
  • procarbazine
  • rasagiline
  • safinamide
  • selegiline
  • selegiline transdermal
  • tranylcypromine
• Dexmethylphenidate has serious interactions with at least 30 different drugs.
• Dexmethylphenidate has moderate interactions with at least 176 different drugs.
• Dexmethylphenidate has mild interactions with at least 69 different drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

Pregnancy and breastfeeding

• There are no adequate and well-controlled studies of dexmethylphenidate use in pregnant women, however, animal reproductive studies indicate it can cause fetal harm. Use during pregnancy only if maternal benefits outweigh potential risks to the fetus.
• It is not known if dexmethylphenidate is excreted in breast milk, however, many drugs are present in breast milk. Use with caution in nursing mothers.

What else should I know about dexmethylphenidate?

• Dexmethylphenidate is a Schedule II controlled substance, diversion of Schedule II products is subject to criminal penalty.
• Take dexmethylphenidate exactly as prescribed, do not take larger or more frequent doses.
• Dexmethylphenidate has a high risk for addiction and dependency, and can lead to overdose, exercise caution.
• In case of overdose, immediately seek medical help or contact Poison Control.
• Store dexmethylphenidate safely out of reach of children.