About methylphenidate

Methylphenidate is a central nervous stimulant available in the UK as a schedule 2 controlled drug. It is licensed for treating attention deficit hyperactivity disorder (ADHD).

National guidance

NICE recommends methylphenidate as the first-line pharmacological treatment for ADHD in children aged 5 years and over and adolescents. In adults, lisdexamfetamine or methylphenidate are first-line pharmacological options.

An ADHD specialist (healthcare professional with training and expertise in diagnosis and managing ADHD) should start all medicines for ADHD. Shared care arrangements should be in place to facilitate ongoing prescribing and monitoring in primary care.

Review regularly

If symptoms fail to improve despite 6 weeks of methylphenidate at a maximum tolerated dose, consider alternative treatments.

Annual review

Review ADHD medicines at least once a year and discuss the need for continuation. Consideration can be given to stopping ADHD medicines or reducing the dose, on a case-by-case basis. Some people may experience a sustained improvement in condition even when methylphenidate is temporarily or permanently stopped. This is because symptom profile and impairment may change over time.

Stopping or reducing dose

Consider stopping or reducing methylphenidate dose in people with severe side effects or paradoxical symptom aggravation.

If temporarily or permanently stopping methylphenidate, it is possible to stop without tapering, but monitor for withdrawal symptoms. If restarting methylphenidate after short breaks (up to 2 weeks), it is possible to recommence at the same dose if appropriate. Seek specialist advice for dosing after longer breaks. 

Temporary treatment breaks

On specialist advice, temporary treatment breaks (for example, at the weekend or during school holidays) can be considered for those stable on treatment. This may be beneficial if there are concerns regarding growth, appetite or insomnia.

UK licensed products

Methylphenidate is available as immediate-release (IR) and modified-release (MR) oral solid dosage forms.

The following methylphenidate MR products are licensed and can be prescribed in the UK:

• Affenid XL tablets
• Concerta XL tablets
• Delmosart tablets
• Equasym XL capsules
• Matoride XL tablets
• Medikinet XL capsules
• Meflynate XL capsules
• Metyrol XL capsules
• Xaggitin XL tablets
• Xenidate XL tablets

Note that Ritalin XL is licensed but is no longer marketed in the UK. Addepta XL is licensed but not yet launched in the UK.

Formulation choice

Methylphenidate MR products may be preferred over IR products as they offer:

• convenience
• improved adherence
• reduced stigma related to taking medicine at school or workplace
• reduced issues with storing and administering controlled drugs in a school or workplace setting
• reduced risk of misuse and diversion
• improved control of symptoms in some people

IR preparations may be suitable if more flexible dosing regimens are needed, or during initial titration to determine correct dosing levels.

Consider product choice on an individual basis depending on the person’s needs and treatment priority.

Prescribe by brand

Methylphenidate MR products include an IR component and a MR component allowing a two-phase release of methylphenidate. Proportions of IR and MR methylphenidate differs between brands; different products may not therefore have the same clinical effect. To avoid confusion, prescribe methylphenidate MR products by brand. Alternatively, prescribe using the generic medicine name and name of the manufacturer.

Supporting system response to the ADHD medicine shortage contains advice on generic prescribing during the current supply disruption.

Switching between brands

There may be occasions when switching between brands is necessary (for example, due to a manufacturing shortage or symptom control). The MHRA advises caution if switching between MR methylphenidate products as it can alter symptom management at different times of the day. This is due to differences in available strengths, ratios of IR to MR methylphenidate, and pharmacokinetics.

Product choice should be made on a case-by-case basis with specialist input. Communicate with the person about any requirement to switch brands and involve the person in the decision where possible. Provide relevant counselling (for example, change in requirements to timing doses around food). Advise people to report any changes to their symptoms or side effects after switching. Review the person post switch.

Comparison of pharmacokinetic profiles

The composition of IR and MR components of methylphenidate vary between products. The table below may help to compare the MR methylphenidate products.

*Manufacturers have not provided exact IR/MR ratio but confirms bioequivalent to the reference product.

Bioequivalents

A bioequivalent medicine contains the same active ingredient as the reference (originator) product and is expected to have the same therapeutic effect. Bioequivalent products are available for the reference products Concerta XL and Ritalin XL. Marketing authorisations for bioequivalent products are granted on the basis of meeting a satisfactory criteria of equivalent release profile for the reference products. Excipients may vary between bioequivalent products.

Specialist advice may be needed to support switching between IR and MR methylphenidate.

Concerta XL tablets

The following MR methylphenidate products are bioequivalent to Concerta XL tablets and should be considered if needing to switch:

• Affenid XL tablets
• Delmosart tablets
• Matoride XL tablets
• Xaggitin XL tablets
• Xenidate XL tablets

Switching between IR and MR

Concerta XL 18mg once daily is equivalent to a total daily dose of 15mg IR methylphenidate.

Equasym XL capsules

There are no products bioequivalent to Equasym XL. Seek specialist advice if switching is required.

Switching between IR and MR

Equasym XL 10mg once daily is equivalent to a total daily dose of 10mg IR methylphenidate.

Medikinet XL capsules

There is no bioequivalent product for Medikinet XL, however other products with similar IR/MR ratio are available for example, Metyrol XL.

Switching between IR and MR

Medikinet XL 10mg once daily is equivalent to a total daily dose of 10mg IR methylphenidate.

Metyrol XL capsules

Meflynate XL is newly available and can be considered bioequivalent to Metyrol XL. If there is a need to switch, consider use of Meflynate XL.

Other products with similar IR/MR ratio are available for example, Medikinet XL.

Switching between IR and MR

Metyrol XL 10mg once daily is equivalent to a total daily dose of 10mg IR methylphenidate.

Clinical implications

The different MR methylphenidate products allow prescribers to choose a product to suit a person’s needs. Consider the preference of the person (or carer or guardian) where appropriate.

Release profile

Onset of action is similar across all MR methylphenidate products, however the timing of the second peak related to the MR component and duration of action differs. The extent of peaks is related to the ratio of IR and MR components.

Being aware of the different release profiles can help target symptom management. For example, consider a product with a longer duration of action for people with evening symptoms or consider a product with a higher component of IR methylphenidate in people with insomnia.

Side effects

Side effects of MR methylphenidate products can impact the person and subsequent treatment choice. Common side effects include growth retardation during prolonged use in children, decreased appetite, insomnia, changes in blood pressure and heart rate. Ongoing monitoring in primary care is outlined in shared care arrangements.

Food requirements for dosing

Food can affect absorption of some brands of methylphenidate. Check the individual summary of product characteristics (SPCs) for guidance. Counsel people starting treatment or if switching products.

Swallowing and alternative administration

Consider if the person can swallow solid dosage forms. All MR methylphenidate capsules are licensed to be opened and contents sprinkled onto soft food (for example, apple sauce or yoghurt) to aid administration. This makes them particularly suitable for people with swallowing difficulties.

Licensing

The licensed indications can vary between products. Refer to the individual SPCs for guidance.

Monitoring after treatment change

Monitoring arrangements following dose adjustments should be agreed as part of shared care arrangements. Ensure the person is monitored for symptom control and side effects before and after switching products.

Undispensed prescriptions

Local services or prescribers should implement a system to manage prescriptions that have not been dispensed against. This is to reduce the risk of diversion, misuse or overdose (intentional or unintentional). For example, prescribers should always request the return of any undispensed prescriptions before issuing a new prescription for an alternative product.

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