Increased muscle tone (spasticity and dystonia)

Initially 5mg 3 times a day, gradually increased; maintenance up to 60mg daily in divided doses, review treatment if no benefit within 6 weeks of achieving maximum dose; maximum 100mg per day.

Initially 2mg daily, then increased in steps of 2mg daily in divided doses, increased at intervals of at least 3-4 days and adjust according to response; usual dose up to 24mg daily in 3-4 divided doses; maximum 36mg per day.

2-15mg daily in divided doses, increased if necessary in spastic conditions to max 60mg daily.

Initially 25mg daily, then increased to up to 100mg 4 times a day, dose increased at weekly intervals; usual dose 75mg 3 times a day.

Sativex is restricted to use as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to baclofen, tizanidine or dantrolene and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.

See product literature.

Prescribing Notes:

Serious side-effects can occur following abrupt withdrawal of baclofen; therapy should be discontinued by gradual dose reduction over at least 1-2 weeks (longer if symptoms occur).

History Notes

22/02/2023

Addition of Dronabinol + Cannabidiol: Sativex (SMC2473), ERFC Nov 23.

27/10/2022

East Region Formulary content agreed.

Dose as per specialist.

Delivered via implanted intrathecal pump system.

Dose as per specialist.

Prescribing Notes:

Serious side-effects can occur following abrupt withdrawal of baclofen; therapy should be discontinued by gradual dose reduction over at least 1-2 weeks (longer if symptoms occur).
Botulinum toxin can be used for focal spasticity or dystonia where increased muscle tone is impacting function, position or causing pain. Different commercial preparations are available with different dosing units which are not interchangeable. Care should be taken in calculating dosing for different preparations.
Intrathecal Baclofen should be considered where excessive sedation with enteral treatments is encountered. Therapeutic trial of intrathecal Baclofen can be delivered via lumbar puncture with pre- and post- dosing assessment.

History Notes

09/11/2023

East Region Formulary content agreed.

Dose as per specialist.

Delivered via implanted intrathecal pump system.

Dose as per specialist.

Prescribing Notes:

Benzodiazepines can be useful in spasticity and dystonia management. These different forms of increased tone often co-exist in patients with cerebral palsy.
Serious side-effects can occur following abrupt withdrawal of baclofen; therapy should be discontinued by gradual dose reduction over at least 1-2 weeks (longer if symptoms occur).
Chloral hydrate use is limited to short term use for insomnia. However, it can be very useful in difficult dystonia particularly associated with sleep difficulties where other interventions have not been useful. It should be used at as low a dose for as short a time as possible. Use should be under the supervision of a named paediatric neurologist, community paediatrician or palliative care doctor. Please see joint Neonatal and Paediatric Pharmacy Group (NPPG) Chloral Hydrate position statement.
Trihexyphenidyl dose should be increased slowly to minimise side effects. Caution when using glycopyrrolate concurrently.
Trial of co-careldopa can be considered with clinical suspicion of Segawa’s syndrome.

History Notes

27/05/2024

Removal of Cloral Betaine tablets as product discontinued.

09/11/2023

East Region Formulary content agreed.

Dose as per specialist and BNFc.

Prescribing Notes:

Sialanar 320micrograms/ml is equivalent to glycopyrronium 400micrograms/ml.
MHRA has issued advice (July 2023) Hyoscine hydrobromide patches (Scopoderm 1.5mg Patch or Scopoderm TTS Patch): risk of anticholinergic side effects, including hyperthermia.

History Notes

09/11/2023

East Region Formulary content agreed.