Formulary Chapter 16: Paediatrics - Full Chapter
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Notes: |
*** WORK WILL BE TAKING PLACE ON THIS CHAPTER w/c 24/01/21***
PLEASE NOTE: THIS CHAPTER IS STILL UNDER CONSTRUCTION
Where medicines are included in the BSWformulary (for any indication) and are in the BNF for Children (BNF-C), they can be prescribed for a licensed indication within the manufactrer's recommendations using any formulation.
Where medicines are not included and therefore non-formulary (despite being in the BNF-C) they must be approved for use by the local Formulary team by submitting a Non-Formulary Medicine Request Form or an IFR application for individual patient requests where exceptionality can be shown.
Paediatric drugs are frequently used outside of the SPC since many manufacturers fail to conduct the relevant trials needed to secure licensed use in paediatrics. Prescribers take full responsibility for prescribing products outside the license. However all prescribing should be carried out in the best interest of the child irrespective of license status.
Traffic Light Status Information for Paediatric Chapter
Red Traffic Light
Amber with Shared Care Agreement (SCA)
- In BNF-C within indication and dose range
- Unlicensed or Off label use of drug (as per BNF-C definition Guidance on prescribing: BNFC and marketing authorisation)
- Require specialist initiation and stabilisation. Ongoing division of responsibility for drug and disease monitoring between specialist and GP detailed in SCA
Amber No Shared Care Agreement (SCA) needed
- In BNF-C within indication and dose range
- Considered suitable for GP prescribing following specialist initiation or recommendation.
Green Traffic Light
- In BNF-C within indication and dose range
- Considered suitable for initiation in both primary and secondary care.
Useful resources
RCPCH and NPPG joint position statement -using standardised strengths of unlicensed liquid medicines
RCPCH and NPPG joint position statement - choosing an oral liquid medicine for children
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Details... |
16.04 |
Central Nervous System (paediatric) |
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Melatonin
(Circadin MR 2mg®)
(Oral)
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First Choice

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- 2mg MR
- Melatonin MR 2mg tablets are licensed for use in adults over 55 years. Use in children is an 'off label' use.
- Melatonin guidance due Q1 2021.
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Methylphenidate
(Concerta® XL, Xaggitin XL, Medikinet XL, Equasym® XL)
(Modified release tablets and capsules)
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First Choice

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- Xaggitin® XL Modified release tablet 18mg, 27mg, 36mg, 54mg - First line for new patients as the most cost-effective formulary choice locally
- Concerta® XL Modified release tablet 18mg, 27mg, 36mg,54mg: existing patients only.
- Equasym® XL Modified release capsule 10mg, 20mg, 30mg
- Prescribe by brand Modified release brands provide different release profiles of methylphenidate and switching brands should only be considered following specialist advice.
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BSW SCA For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents
NICE NG87 Attention deficit hyperactivity disorder: diagnosis and management Sept 2019
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Methylphenidate
(Immediate release tablets)
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First Choice

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BSW SCA For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents
NICE NG87 Attention deficit hyperactivity disorder: diagnosis and management Sept 2019
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Lisdexamfetamine
(Elvanse®)
(Capsules)
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Second Choice

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- 20mg, 30mg, 40mg, 50mg, 60mg and 70mg
- Once daily dosing
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BSW SCA For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents
NICE NG87 Attention deficit hyperactivity disorder: diagnosis and management Sept 2019
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Melatonin 5mg/5ml
(Oral solution or suspension (alcohol free))
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Second Choice

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- Melatonin 5mg/5ml oral solution or suspension (alcohol free)
Unlicensed only in line with melatonin policy see here - link to add - 22/02/2020
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Atomoxetine
(Oral)
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Third Choice

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- 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg capsules
- 4mg/1ml oral solution
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BSW SCA For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents
NICE NG87 Attention deficit hyperactivity disorder: diagnosis and management Sept 2019
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Dexamfetamine Sulphate
(Tablets)
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Third Choice

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- 5mg
- Only for those whose ADHD symptoms are responding to lisdexamfetamine but who cannot tolerate the longer effect profile.
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BSW SCA For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents
NICE NG87 Attention deficit hyperactivity disorder: diagnosis and management Sept 2019
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Hyoscine hydrobromide
(Scopoderm®)
(Topical patch)
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Formulary

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- 1.5mg patch
- Unlicensed indication
- Only licensed from 10 years for travel sickness.
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Levetiracetam
(Tablets and oral solution)
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Formulary

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- 250mg, 500mg, 750mg and 1g (category 3 MHRA)
- Oral solution SF 100mg/ml
- Granules in sachets 250mg, 500mg and 1000mg Desitrend (second line use only)
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Levetiracetam
(Intravenous infusion)
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Formulary

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Midazolam Maleate Oromucosal
(Epistatus®)
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Formulary

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- Epistatus® Oromucosal solution prefilled single syringe 10mg/1ml (licensed in adolescents from 10 years to less than 18 years)
unlicensed Epistatus® Oromucosal solution 10mg/ml prefilled syringes: 2.5mg/0.25ml, 5mg/0.5ml, 7.5mg/0.75ml. Individually wrapped in a pack of 4.
- Do not prescribe Oromucosal solution 10mg/ml multidose 5ml bottle. In primary care, all patients should use the pre-filled syringe format as this is what the specialist primary care nursing team can provide training on for carers/schools/nurseries/after-school clubs etc.
- Prescribe by BRAND (NB Buccolam brand is a different salt, STRENGTH and volume)
- See Shared Care Guidelines: Use of Oromucosal Midazolam as an intervention for prolonged seizures and prevention od Status Epilepticus
 Swindon only - when used for sedation and pre-med in theatres
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Pizotifen
(Tablets)
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Formulary

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- 500microgram tablet
- 1.5mg tablet
- Pizotifen is only included for prophylaxis of migraine in paediatrics. See Chapter 4.7.4.2 for BSWformulary choices for migraine in adults.
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Medicines for Children PIL - Pizotifen to prevent migraine headaches
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Sodium Valproate
(Various formulations)
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Formulary

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- Crushable tablets 100mg
- E/C tablets 200mg, 500mg
- M/R tablets 200mg, 300mg, 500mg
- M/R capsules 150mg, 300mg
- LiquidSF 200mg/5ml
COVID-19 MHRA have issued guidance - Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)
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Valproate use by women and girls
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Sodium Valproate
(Intravenous injection)
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Formulary

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COVID-19 MHRA have issued guidance - Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)
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Valproate use by women and girls
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Trihexyphenidyl
(Tablets and oral solution)
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Formulary

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- 2mg and 5mg tablets
- 5mg/5ml (200ml)
- Not licensed for this indication and 'Not Recommended' for children in the SPC but is listed in the BNF-C
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Guanfacine
(Intuniv®)
(Tablets)
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Formulary

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- Use as per NICE NG87
- Offer guanfacine to children aged 5 years and over and young people if:
- they cannot tolerate methylphenidate or lisdexamfetamine or
- their symptoms have not responded to separate 6-week trials of lisdexamfetamine and methylphenidate, having considered alternative preparations and adequate doses.
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NICE NG87 Attention deficit hyperactivity disorder: diagnosis and management Sept 2019
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Sulthiame
(Unlicensed product)
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Unlicensed

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RUH ONLY - as adjunctive therapy in pharmaco-resistant paediatric epilepsy where other AEDs have failed at optimal doses.
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Key |
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Cytotoxic Drug
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Controlled Drug
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High Cost Medicine
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Cancer Drugs Fund
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NHS England |
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Homecare |
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CCG |
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High Cost Drug Approval System |
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Traffic Light Status Information
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