Dexmethylphenidate (Oral)

Dexmethylphenidate is also known under US brand Focalin and Focalin XR. It is used in the treatment of ADHD.

Overview

Dexmethylphenidate is a drug used to treat attention deficit hyperactivity disorder. It belongs a group of medications known as central nervous system (CNS) stimulants.

This drug works by increasing attention and decreasing restlessness in patients who are hyperactive, are easily distracted or cannot concentrate. It's used as part of a total treatment program that also includes educational, social and psychological therapy.

This medication is only available via prescription from your doctor. Prescriptions cannot be refilled. You must obtain a new prescription from your doctor each time you need this medication. This product is available in the dosage form of tablet and capsule for extended release.

Condition(s) treated?

  • Attention Deficit Disorder with Hyperactivity

Type of medicine?

  • Tablet

Side Effects

Along with its intended effects, the consumption of dexmethylphenidate can produce unwanted side effects. Not all these side effects may appear at once, however, if they do appear, you may need medical attention.

Inform a healthcare professional or your doctor immediately if you suffer from any of the following side effects whilst taking dexmethylphenidate

Less common side effects

  • Fast, pounding, or irregular heartbeat

Rare side effects

  • Blurred vision

Incidence not known

  • Convulsions

Some side effects of dexmethylphenidate that may occur usually don't require medical attention. You usually find these side effects begin to disappear once your body begins to adjust to the medication. If they are bothering your daily life, you should contact your local pharmacist or healthcare professional for advice on how to reduce or prevent these side effects.

More common side effects

  • Sour or acid stomach

Less common side effects

  • Twitching

Remember you can report all side effects to the FDA on 1-800-FDA-1088.

Dosage

The final dosage of any medication will depend on a number of factors. This includes your age, weight, and height. What medications you are currently taking, the severity of your condition and your response to the first treatment. Never change your dose without consultation and advice from your doctor.

Typical Adult Dose for Attention Deficit Disorder

Patients new to methylphenidate

Immediate Release: Begin with an initial dose of 2.5 mg taken orally two times a day, at least four hours apart.

Maintenance dose: The dose can be adjusted in increments of 2.5 to 5 mg at weekly intervals.

Maximum dose: 10 mg taken orally two times a day (20 mg/day)

Extended Release: Begin with an initial dose of 10mg taken orally once a day in the morning time.

Initial dose: 10 mg orally once a day in the morning

Maintenance dose: If required, the dose can be adjusted in increments of 10 mg at weekly intervals.

Maximum dose: a maximum dose of 40 mg should be taken orally once a day in the morning time.

Patients currently using methylphenidate

Immediate Release: An initial dose should be taken orally in half the total daily dose of racemic methylphenidate twice a day.

Maximum dose: a maximum of 10 mg taken orally twice a day (20 mg/day)

Extended Release: Once a day in the morning, an initial dose of half the total daily dose of racemic methylphenidate should be taken orally

Maximum dose: a maximum of 40 mg taken orally once a day in the morning time.

  • All doses should be individualized according to the responses and needs of the patient.

Typical Pediatric Dose for Attention Deficit Disorder

Patients new to methylphenidate (above the age of 6)

Immediate Release: An initial dose of 2.5 mg given orally twice a day, at least four hours apart

Maintenance dose: The dose may be adjusted if necessary in increments of 2.5 - 5 mg at weekly intervals.

Maximum dose: A maximum dose of 10 mg should be given twice a day orally (20 mg/day)

Extended Release:

Initial dose: An initial dose of 5 mg taken orally once a day in the morning

Maintenance dose: A dose can be adjusted if necessary in increments of 5 mg at weekly intervals.

Maximum dose: a maximum dose of 30 mg taken orally once a day in the morning time.

Patients currently using methylphenidate (aged 6 or older)

Immediate Release: An initial dose of half the total daily dose of racemic methylphenidate taken orally twice a day

Maximum dose: a maximum of 10 mg taken orally twice a day (20 mg/day)

Extended Release: An initial dose of half the total daily dose of racemic methylphenidate taken once a day orally in the morning time

Maximum dose: a maximum of 30 mg taken orally once a day in the morning time.

Doses should be individualized according to the responses and needs of the patient.

This drug should be used as part of a comprehensive treatment program that should include other measures (education, psychological and social) such as other therapies and counseling.

Missed dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, you should skip the missed dose and revert back to your regular dosing schedule. Under no circumstances should you double dose.

Interactions

Interactions between drugs can cause some unwanted side effects and reduce the effectiveness of either drug. To limit these interactions, it's important you give your doctor or a healthcare professional a full list of all the current medications you are taking. This list should include all prescription and non-prescription drugs, all vitamins and herbal remedies. You should also inform them of any medical conditions you currently suffer from and any medical conditions that family members suffer from.

The use of this medication with any of the following drugs isn't recommended. Your doctor may avoid treating you with this medicine or change some of the other medications you are taking.

  • Clorgyline

There are over 401 drugs that interact with dexmethylphenidate. Some of these are listed below. You should let your doctor know if you are taking any of the following drugs.

  • Acetaminophen / phenylephrine
  • Salicylate
  • Chlorthalidone / clonidine
  • Pyrilamine
  • Pheniramine / phenylpropanolamine / phenyltoloxamine / -

Other interactions

If you suffer from other medical conditions, this can affect the use of this medication. Ensure you inform your doctor if you have any other medical conditions present, especially:

  • Agitation

Warnings

Use in pediatric population

Studies performed to date have not indicated any pediatric-specific problems that could limit the effectiveness of dexmethylphenidate in children. However, efficacy and safety have not been established in children younger than six years old.

Use in geriatric population

Studies on the relationship of age to the effects of this drug have not been conducted in the geriatric population. Therefore efficacy and safety have not been established.

Pregnancy and breastfeeding

This drug is under FDA pregnancy category C. Taking this medication whilst pregnant can cause low birth weight, premature birth or withdrawal symptoms in the newborn baby. Let your doctor know if you are pregnant or intend to become pregnant.

It's unknown whether this drug can pass into breast milk or if it could harm a nursing infant. Let your doctor or a healthcare professional know if you are currently breastfeeding or intend on breastfeeding.

Allergies

Let your doctor know if you have ever had any allergic reactions to this medication or any other medications. You should also inform them if you have allergic reactions to animals, foods, preservatives dyes etc.

Don't take this drug alongside a monoamine oxidase (MAO) inhibitor. Do not start taking this medication during the two weeks after you stop an MAO inhibitor. If you don't wait two weeks or take them together, you may develop agitation, confusion headaches, restlessness, or intestinal and stomach symptoms, a sudden high body temperature, severe convulsions or an extremely high blood pressure.

The use of dexmethylphenidate can cause serious blood vessel or heart problems. This can be more likely to occur in patients who have a family history of heart disease. Speak with your doctor right away if you have trouble breathing, pain, or fainting whilst taking this medication.

This medication can cause some people to have vision changes or to become dizzy, drowsy or less alert than they usually are. Ensure you know how you react to this medication before you use machinery, drive or do anything else that could cause danger if you are not alert or feel dizzy.

Let your doctor know immediately if you or your family notice any unusual changes in your behavior, such as an increase in hostility, aggression, agitation, irritability, or suicidal behavior or thinking. Also let them know if you or your child have unusual thoughts or hallucinations, especially if they are new or worsening.

If you have been using this medication for a long period of time and you think you may have physically or mentally dependent, then speak with your doctor or a healthcare professional. Some signs of dependence may be:

  • A strong need or desire to continue taking the medication.

This medication may cause Raynaud phenomenon. This is a problem with blood circulation in the toes or fingers. Let your doctor know if you have pain or tingling, paleness, a cold feeling or skin color changes in the toes or fingers, especially when exposed to the cold. Call your doctor immediately if you have unexplained ulcers or sores on your toes or fingers.

This drug can sometimes cause addiction. The risk may be higher if you have a substance use disorder (such as an addiction to alcohol or drugs). Take this medicine exactly as it's been prescribed to you to help decrease the risk of addiction.

Don't take other medications unless they have been discussed with your doctor.

If you take this medication late in the day, it can cause insomnia.

Take this medicine regularly to enjoy the benefit from it. If you need help to remember, try taking it at the same time every day.

Storage

This medication should be stored in a closed container at room temperature. It needs to be kept away from moisture, heat, and light. Do not allow this medication to freeze.

Always keep this medicine out of the reach of children.

Don't keep medicine that is no longer needed or is out of date. Speak with a pharmacist or healthcare professional about how you should dispose of this medication.

Summary

When used correctly, dexmethylphenidate is successful in the treatment of ADHD. When you are prescribed this medication, it should come with a Medication Guide. You should read carefully and follow the instructions. Speak with your doctor if you've got any concerns or questions and request a Medication Guide if you have not received one. This drug can be taken with or without food. Do not crush, divide or chew this tablet. If you believe this medication is not working properly after you have taken it for a prescribed period of time, you should refer back to your doctor. Don't increase the dose without consultation with a healthcare professional. Due to a large number of interactions possible with this drug, it's important you let your doctor know about all drugs you are currently and have taken. Let your doctor know if you are pregnant or breastfeeding. This drug should not be used in children under the age of six years old.