Prescribing and switching between modified-release methylphenidate

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).

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

Initiating treatment

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.

Reviewing treatment

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. Consider stopping ADHD medicines or reducing their dose on a case-by-case basis in consultation with a specialist.

Stopping or reducing dose

Consider stopping methylphenidate or reducing its dose in patients 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.

Products and their equivalence

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
• Atenza XL tablets
• Concerta XL tablets
• Delmosart tablets
• Equasym XL capsules
• Focusim XL capsules
• Matoride XL tablets
• Medikinet XL capsules
• Meflynate XL capsules
• Metyrol XL capsules
• Ritalin XL capsules
• Xaggitin XL tablets
• Xenidate XL tablets

Addepta XL is licensed but not yet launched in the UK.

Choosing a formulation

Several considerations may impact the choice of formulation.

Benefits of MR products

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 patients

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

Best practice guidance is to prescribe methylphenidate MR products by brand.

Different methylphenidate MR products contain differing IR and MR components. Since they are not always equivalent, they should normally be prescribed by brand; or using the generic medicine name, and the name of the manufacturer.

Switching between brands

There may be occasions when switching between brands is necessary (for example, due to national or local supply disruption). Given the differences in the ratios of IR and MR components different products, the MHRA advises caution if switching between MR methylphenidate products as it can alter symptom management.

Revert back to the usual branded product as soon as possible.

Involve patients

Product choice should be made on a case-by-case basis with specialist input and by involving the patient in the decision to switch where necessary. Provide relevant counselling (for example, any changes in the timing of doses and food) and advise patients to report any changes to their symptoms or side effects. 

Reassure the patient that the alternative products belong to the same clinically equivalent group as their usual medicine and the dose has not changed.

Actions during supply disruption

When switches are necessary due to supply disruption, prescribers and pharmacists should:

• consider bioequivalence as outlined below
• prescribe generically to enable switching between bioequivalent MR products where possible to do so
• avoid mixing between different brands to achieve the required daily dose
• individualise treatment using IR products where bioequivalent MR products are not available
• discuss with patients and provide reassurance that any switching will be temporary and based on clinically equivalent products
• revert to their normal brand prescribing practice during periods in which supply is unaffected

Equivalent MR tablets

The following MR methylphenidate tablets are considered bioequivalent to one another. Generic prescribing could be undertaken and products switched between using the same dose and quantity were that to be necessary:

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

Equivalent MR capsules

The following MR methylphenidate capsules are considered bioequivalent to one another. Generic prescribing could be undertaken and products switched between using the same dose and quantity were that to be necessary:

• Focusim XL capsules
• Metyrol XL capsules
• Meflynate XL capsules
• Ritalin XL capsules

Note, however, that whilst switches from or to Medikinet XL capsules are also possible, these should be undertaken with particular care since this product is not completely bioequivalent with the other four.

Do not switch Equasym XL capsules

No other MR products are bioequivalent to Equasym XL capsules and these should not be switched to or prescribed generically.

IR preparations

An individualised approach would be required were a switch to IR preparations to be necessary. Equivalence between a number of MR products and IR products is as follows:

• Equasym XL 10mg once daily is equivalent to a total daily dose of 10mg IR methylphenidate
• Concerta XL 18mg once daily is equivalent to a total daily dose of 15mg IR methylphenidate
• Medikinet XL 10mg once daily is equivalent to a total daily dose of 10mg IR methylphenidate
• Metyrol XL 10mg once daily is equivalent to a total daily dose of 10mg IR methylphenidate

If a switch from MR to IR products becomes necessary, consider seeking advice or referring back to the specialist who initiated treatment. Additional clinical assessment will be required to ensure tolerability and efficacy. Prescribers should also be aware that there is an increased risk of misuse and diversion with IR products.

Pharmacokinetic profiles

Methylphenidate MR products include an IR component and a MR component allowing a two-phase release of methylphenidate. MR products vary in the proportion of each component they contain.

Table 1 – table comparing MR methylphenidate products’ constituents and release profiles

Acknowledgements

We are grateful to Mental Health Colleagues at NHS England for their help in creating this page. In particular:

• Peter Pratt, NHSE National Speciality Advisor for Mental Health Pharmacy
• Professor Prathiba Chitsabesan (FRCPsych), National Clinical Director for Children and Young People’s Mental Health

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