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Guy's and St Thomas' NHS Foundation Trust
Kings College Hospital NHS Foundation Trust
Lewisham and Greenwich NHS Trust
 
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 Formulary Chapter 12: Ear, nose and oropharynx - Full Chapter
Notes:

Where a formulary entry does not detail a medicine’s indications for use, the medicine can be assumed to be approved for all licensed indications.

Formulary approved "off-label" use is detailed separately.

 Details...
12.03  Expand sub section  Drugs acting on the oropharynx
12.03.01  Expand sub section  Drugs for oral ulceration and inflammation
Benzydamine hydrochloride 0.15% spray (Difflam®)
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Formulary  
   
Benzydamine oral rinse 0.15%
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Formulary  
   
Cetalkonium & choline salicylate gel (Bonjela®)
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Formulary  
   
Hydrocortisone buccal tablets
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Formulary  
Link  MHRA Dec 18: Hydrocortisone muco-adhesive buccal tablets: should not be used off-label for adrenal insufficiency in children due to serious risks
   
Betamethasone soluble tabs 500 micrograms (oral ulceration and inflammation)
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Formulary

Approved off-label use:

Oral ulceration and inflammation

  • Dose = 1 tablet dissolved in water used as a mouthwash up to four times a day.  To be spat out.  Not to be swallowed.
  • Refer to APC information sheet on off-label medicines in the Oral Medicine Clinic for further information (link below at end of section)
 
   
Prednisolone tablets (oral ulceration and inflammation - off-label [mouthwash])
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Formulary
Amber 2

Approved off-label indication:

Oral ulceration and inflammation

  • Dose = 5mg, crushed and dispersed in 10mL of water and used as a mouthwash up to four times a day.  To be spat out.  Not to be swallowed.
  • Oral medicine clinic initiation only
  • Refer to APC information sheet on off-label medicines in the Oral Medicine Clinic for further information (link below at end of section)
 
   
Budesonide 0.5 mg nebules (oral ulceration and inflammation - off-label [mouthwash])
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Formulary
Red

Approved off-label indication:

Oral ulceration and inflammation (temporary formulary addition owing to fluticasone nasule shortage)

  • Dose = one nebule diluted in 10mL of water and used as a mouthwash up to four times a day.  To be spat out.  Not to be swallowed.
  • Oral medicine clinic initiation only
  • Refer to APC information sheet on off-label medicines in the Oral Medicine Clinic for further information (link below at end of section)
 
   
Fluticasone 400 microgram nasules (oral ulceration and inflammation - off-label [mouthwash])
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Formulary
Amber 2

Approved off-label indication:

Oral ulceration and inflammation

  • Dose = one nasule diluted in 10mL of water and used as a mouthwash up to four times a day.  To be spat out.  Not to be swallowed.
  • Oral medicine clinic initiation only
  • Refer to APC information sheet on off-label medicines in the Oral Medicine Clinic for further information (link below at end of section)
 
   
Mometasone nasal spray (oral ulceration and inflammation - off-label [oral use])
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Formulary
Amber 2

Approved off-label indication:

Oral ulceration and inflammation

  • Dose = one or two sprays to the lesion up to three times a day
  • Oral medicine clinic initiation only
  • Refer to APC information sheet on off-label medicines in the Oral Medicine Clinic for further information (link below at end of section)
 
   
Beclomethasone 50 or 100 microgram aerosol inhaler (oral ulceration and inflammation - off-label [oral use])
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Formulary
Amber 2

Approved off-label indication:

Oral ulceration and inflammation

  • Dose = spray one or two puffs to the lesion up to three times a day
  • Oral medicine clinic initiation only
  • Refer to APC information sheet on off-label medicines in the Oral Medicine Clinic for further information (link below at end of section)
 
   
Fluticasone 50 or 125 microgram aerosol inhaler (oral ulceration and inflammation - off-label [oral use])
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Formulary
Amber 2

Approved off-label indication:

Oral ulceration and inflammation

  • Dose = spray one or two puffs to the lesion up to three times a day
  • Oral medicine clinic initiation only
  • Refer to APC information sheet on off-label medicines in the Oral Medicine Clinic for further information (link below at end of section)
 
   
Betamethasone valerate 0.1% ointment (oral ulceration and inflammation - off-label [oral use - mixed with orabase])
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Formulary
Amber 2

Approved off-label indication:

Oral ulceration and inflammation

  • Dose = pea sized volume mixed with an equal amount of orabase ointment (using a clean plastic measure and cotton bud for each dose) and applied to the lesion once daily
  • Oral medicine clinic initiation only
  • Refer to APC information sheet on off-label medicines in the Oral Medicine Clinic for further information (link below at end of section)
 
   
Clobetasol propionate 0.05% ointment (oral ulceration and inflammation - off-label [oral use - mixed with orabase])
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Formulary
Amber 2

Approved off-label indication:

Oral ulceration and inflammation

  • Dose = pea sized volume mixed with an equal amount of orabase ointment (using a clean plastic measure and cotton bud for each dose) and applied to the lesion once daily
  • Oral medicine clinic initiation only
  • Refer to APC information sheet on off-label medicines in the Oral Medicine Clinic for further information (link below at end of section)
 
   
Doxycyline 100 mg soluble tablets (oral ulceration and inflammation - off-label [mouthwash])
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Formulary
Amber 2

Approved off-label indication:

Oral ulceration and inflammation

  • Dose = 100mg, dispersed in 10mL of water and used as a mouthwash up to four times a day.  To be spat out.  Not to be swallowed.
  • Oral medicine clinic initiation only
  • Usual course length = 2 weeks, though for severe recalcitrant disease up to 6-8 weeks may be required
  • Refer to APC information sheet on off-label medicines in the Oral Medicine Clinic for further information (link below at end of section)
 
   
Tacrolimus 0.1% and 0.03% ointment (orofacial granulomatosis - off-label [oral use])
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Formulary
Amber 2

Approved off-label indication:

Orofacial granulomatosis

  • Apply a thin layer to the lesions once daily at bedtime
  • Usual course length 6-8 weeks
  • Oral medicine clinic initiation only
  • Refer to APC information sheet on off-label medicines in the Oral Medicine Clinic for further information (link below at end of section)
 
   
Colchicine tablets (oral ulceration and inflammation - off-label)
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Formulary
Amber 2

Approved off-label indication:

Oral ulceration and inflammation

  • Dose = 0.5 mg to 1.5 mg total daily dose
  • Oral medicine clinic initiation only
 
   
Thalidomide caps (intractable oral ulcers - off-label)
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Formulary
Red

Approved off-label indication:

Intractable recurrent oral ulcers

  • Oral Medicine use only
  • Restricted to third line use where topical steroids and colchicine have been ineffective
 
   
Carbenoxolone sodium 1% mouthwash granules  (Bioplex®)
Formulary  
   
Lidocaine 5% ointment
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Formulary  
   
Orabase® protective paste
Formulary Contains:
  • Carmellose sodium 16.7%
  • Pectin 16.7%
  • Gelatin 16.7% 
  •    
    Orahesive® powder
    Formulary Contains equal parts of:
  • Carmellose sodium
  • Pectin
  • Gelatine 
  •    
    Betnovate® (betamethasone valerate 0.05%) ointment 50% in Orabase® (oral ulceration and inflammation)
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    Unlicensed Drug Unlicensed
    Red

    Approved for use in oral ulceration and inflammation

    • Dose = apply to the lesion once daily
    • Oral medicine clinic prescribing only
    • Restricted to use in patients unable to follow the administration instructions for use of separate supplies of steroid and orabase ointments
     
       
    Dermovate® (clobetasol propionate 0.05%) ointment 50% in Orabase® (oral ulceration and inflammation)
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    Unlicensed Drug Unlicensed
    Red

    Approved for use in oral ulceration and inflammation

    • Dose = apply to the lesion once daily
    • Oral medicine clinic prescribing only
    • Restricted to use in patients unable to follow the administration instructions for use of separate supplies of steroid and orabase ointments
     
       
    Ledermix dental paste
    Unlicensed Drug Unlicensed Antiflammatory agent used following dental procedures  
       
    Oxetacaine and antacid suspension
    Unlicensed Drug Unlicensed

    Mucositis pain after radiation therapy only

    Use in accordance with the GSTFT guidelines for the management of radiation induced acute effects in the head and neck region

    To be used as a mouthwash and then swallowed.

     
       
    Sodium chloride mouthwash 0.9%
    Unlicensed Drug Unlicensed

    Mucositis pain after radiation therapy only

    Use in accordance with the GSTFT guidelines for the management of radiation induced acute effects in the head and neck region

    To be used as a mouthwash and then swallowed.

     
       
    12.03.02  Expand sub section  Oropharyngeal anti-infective drugs
    12.03.02  Expand sub section  Oropharyngeal Fungal infections
    Miconazole oral gel
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    Formulary  
    Link  MHRA Sep 17: Miconazole (Daktarin): over-the-counter oral gel contraindicated in patients taking warfarin
       
    Nystatin oral suspension 100 000 units/mL
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    Formulary  
       
    12.03.02  Expand sub section  Oropharyngeal Viral infections to top
    12.03.03  Expand sub section  Lozenges and sprays
    Dequacaine® lozenges
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    Formulary Contains:
  • Benzocaine
  • Dequalinium  
  •    
    12.03.04  Expand sub section  Mouthwashes, gargles, and dentifrices
    Chlorhexidine gluconate mouthwash 0.2%
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    Formulary  
       
    Hydrogen peroxide mouth wash BP
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    Formulary Strengths avaialble:
  • 3% (10 volume)
  • 6% (20 volume) 
  •    
    Sodium chloride mouthwash, compound BP
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    Formulary Contains:
  • Sodium bicarbonate 1%
  • Sodium choride 1.5% 
  •    
    Thymol Mouthwash Solution-tablets
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    Formulary  
       
    OM1 antimicrobial soution
    Unlicensed Drug Unlicensed
    Red

    To be used under the supervision of a Consultant in Oral Microbiology or Oral Medicine only

    Treatment of the following conditions where coliforms and other microorganism counts are high and the patient is symptomatic:

    • Exfoliative cheilitis chronic mucocutaneous candidiasis (CMCC)
    • Oral infections caused by Gram negative rods e.g. E. coli & proteus spp.

    PIL available on GTi

     
       
    12.03.05  Expand sub section  Treatment of dry mouth
    Minocycline periodontal gel
    Unlicensed Drug Unlicensed Gum disease  
       
    Tetracycline capsules 250mg (unlicensed product for aphthae ulcers)
    Unlicensed Drug Unlicensed

    Aphthae ulcers Mix contents of one capsule in 10 ml of warm water and use as a mouthwash four times a day

     
       
    12.03.05  Expand sub section  Local Treatment
    Artificial saliva spray
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    Formulary The brand in use at each site will depend on local contracts. Contact the pharmacy department for information if required.
  • Glandosane spray
  • Xerotin spray
  • Saliveze spray
  • AS Saliva Orthana  
  •    
    Biotene Oralbalance® saliva replacement gel
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    Formulary

     
       
    Oralieve® moisturising mouth gel
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    Formulary

     
       
    BioXtra® gel
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    Formulary

    For Oncology and Palliative Care use only

     
       
    Gelclair® oral rinse gel
    Restricted Drug Restricted

    For Oncology and Palliative Care use only

    Also available as part of oral mucosa management in  Stevens–Johnson syndrome/toxic epidermal necrolysis as per 2016 BAD guidance

     
       
    12.03.05  Expand sub section  Systemic treatment to top
    Pilocarpine eye drops 4% (dry mouth - off-label)
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    Restricted Drug Restricted
    Red

    Approved off-label indication:

    • For symptoms of dry mouth in patients with Sjögren's syndrome or following irradiation for head and neck cancer (alternative when there are supply issues with pilocarpine tabs) Given orally.

    Starting dose = 3 drops of 4% (6mg) three times a day

     
       
    Pilocarpine tabs
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    Restricted Drug Restricted For symptoms of dry mouth and dry eyes in patients with Sjögren's syndrome 
       
     ....
    Key
    note Notes
    Section Title Section Title (top level)
    Section Title Section Title (sub level)
    First Choice Item First Choice item
    Non Formulary Item Non Formulary section
    Restricted Drug
    Restricted Drug
    Unlicensed Drug
    Unlicensed
    Track Changes
    Display tracking information
    click to search medicines.org.uk
    Link to adult BNF
    click to search medicines.org.uk
    Link to SPCs
    SMC
    Scottish Medicines Consortium
    Cytotoxic Drug
    Cytotoxic Drug
    CD
    Controlled Drug
    High Cost Medicine
    High Cost Medicine
    Cancer Drugs Fund
    Cancer Drugs Fund
    NHSE
    NHS England
    Homecare
    Homecare
    CCG
    CCG

    Traffic Light Status Information

    Status Description

    Red

    Specialist or hospital prescribing only. The responsibility for prescribing, monitoring, dose adjustment and review should remain with the specialist or hospital. In very exceptional circumstances a specialist may discuss individual patient need for a RED drug to be prescribed by a GP and the GP should consider informing the Medicines Management team before a decision is made to prescribe for individual patients.   

    Amber 1

    Treatment can be initiated in primary care after a recommendation from an appropriate specialist  

    Amber 2

    Specialist initiation followed by maintenance prescribing in primary care  

    Amber 3

    Specialist initiation with ongoing monitoring required. After dose stabilisation GPs can be requested to take over prescribing responsibilities using the approved APC shared care documentation  

    Green

    Specialist and non-specialist initiation  

    Grey

    Not recommended for prescribing  

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