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3.0 Respiratory

3.0 Respiratory


3.1.1 Adrenoceptor agonists Selective beta2-agonists

 For the relief of acute asthma, to be taken when required. 
 GREEN      Salbutamol 
                   metered dose inhaler (MDI) 100micrograms/inhalation
                   breath-actuated inhaler 100 microgram/inhalation (Airomir Autohaler®)  
                   breath actuated dry powder  inhaler 100mcg/inhalation (Salbutamol Easyhaler®)
                   breath actuated dry powder inhaler 200mcg/inhalation (Salbutamol Easyhaler®)
                   dry powder inhaler 200 microgram/blister (Ventolin Accuhaler®)  
                   nebuliser solution 2.5mg/2.5ml, 5mg/2.5mL
                   syrup 2mg/5mL
 RED           Salbutamol 
                   injection 500 microgram/mL
                   solution for intravenous infusion 5mg/5mL
 GREEN      Terbutaline 
                   dry powder inhaler 500 microgram/inhalation (Bricanyl Turbohaler®)  
                   nebules 5mg/2mL          
 Longer acting beta 2  - agonists
 Use regularly in addition to inhaled corticosteroids and inhaled bronchodilators for improved control as described in 
 Step 3 of BTS guidelines. Comparative costs for longer acting beta2 - adrenoceptor stimulants are indicated.
Formoterol should only be used in accordance with national and local guidance on the management of asthma or 
COPD. In asthma it should not be used as monotherapy, but be used alongside inhaled corticosteroids as per
MHRA advice.
Formoterol metered dose inhaler (MDI) presented as the brand Easyhaler® is the first line long acting beta-2 agonist of
choice within East Lancashire.
GREEN       Formoterol
                    dry powder for inhaler 12 microgram/inhalation (Easyhaler Formoterol ®)
GREEN       Formoterol
                    dry powder inhaler 6 microgram/metered inhalation (Oxis Turbohaler®)  
                    dry powder inhaler 12 microgram/metered inhalation (Oxis Turbohaler®) 
Second line option
GREEN       Salmeterol  
                   metered dose inhaler (MDI) 25 microgram/inhalation (Serevent®)
                   dry powder inhaler 50 microgram/blister (Serevent Accuhaler®) 
Third line option for patients with moderate COPD who are having difficulties with either compliance or the inhaler
GREEN      Indacaterol   
                   dry powder hard capsule 150, 300 microgram (Onbrez Breezhaler®
                   Note minimum inspiratory flow rate required 50L/min  

Beclomethasone dipropionate/formoterol fumarate dihydrate/glycopyrronium bromide [Trimbow®]
             For maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of 
             a long-acting beta-2 agonist plus a medium dose of inhaled corticosteroid, and who had one or more 
             exacerbations (flare-ups) in the past year.
AMBER  Beclomethasone dipropionate/formoterol fumarate dihydrate/glycopyrronium bromide 87/5/9 pMDI
3.1.2 Antimuscarinic bronchodilator

For relieving bronchoconstriction in COPD as an alternative to beta2 -agonists. Ipratropium is a short acting muscarinic 
antagonist whilst Tiotropium is long acting. Tiotropium is an option at step 2 of the local guidelines in those 
patients with persistant exacebations/breathlesness.
GREEN      Ipratropium bromide 
                  metered dose inhaler (MDI) 20micrograms/inhalation
                  nebuliser solution 250micrograms/mL
GREEN      Tiotropium inhaler (Braltus®  Zonda inhaler)  
                   (Braltus 10 microgram per delivered dose inhalation powder, hard capsule) 
Add on maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive 
pulmonary disease (COPD)
Note:  Ipratropium should be discontinued when tiotropium is introduced. 
GREEN     Tiotropium Spiriva® Respimat 
N.B. Braltus is the preferred Tiotropium product.The Tiotropium Respimat is restricted for use in COPD patients to those who
have poor manual dexterity and difficulty using the Handihaler®  
Add on maintenance bronchodilator treatment in adult patients with Asthma who meet all of the following criteria:
          >     persistent airflow limitation demonstrated by an FEV¹ <80% predicted and a ratio of FEV¹/FVC  <70% and
          >     currently treated with the maintenance combination of inhaled corticosteroids (>800 micrograms 
                 budesonide/day or equivalent*) and long acting ß² agonists and 
          >     experienced one or more severe exacerbations in the previous year. 
Second line ONLY where Tiotropium is not appropriate, not tolerated or there is difficulty using the device. 
Glycopyrronium bromide inhaler is available in a new device which requires lower inspiratory rate and enables visual
GREEN      Glycopyrronium bromide, inhaler (Seebri Breezhaler®)  
3rd line ONLY where Tiotropium is not tolerated or there is difficulty using the device.  
GREEN       Aclidinium bromide, inhalation powder (Eklira Genuair®) 
3rd line option when Tiotropium is not tolerated or the device cannot be used effectively
Long acting Antimuscarinic bronchodilators in combination with Long-Acting Beta² agonists (LAMA/LABA) 
GREEN     Tiotropium  and  olodaterol
                  (Spiolto® Respimat 2.5 microgram/2.5 microgram, inhalation solution) 
Spiolto® Respimat is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with 
chronic obstructive pulmonary disease (COPD).
GREEN    Glycopyrronium bromide 85mcg/Indacterol maleate 43mcg inhalation powder capsules device.
                (Ultibro®Breezhaler dry powder inhaler)
 GREEN    Aclidinium  and fomoterol
                  (Duaklir® Genuair 340 micrograms /12 micrograms inhalation powder)
Duaklir Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with
 chronic obstructive pulmonary disease (COPD).
Triple combination inhaler (ICS + LAMA +LABA)
Trimbow® inhaler  - link to guideline 
First line use in Patient Group D, where patient requires Triple Therapy (LAMA+LABA+ICS) (single combination inhaler, 
dose 2 puffs bd).
(Use reserved for patients who have failed to achieve or maintain an adequate response to an appropriate course of 
dual therapy)
GREEN   Beclomethasone 87mcg, formoterol fumarate 5mcg, glycopyrronium bromide 9mcg 
               (Trimbow®pMDI)   (dose = 2 puffs twice daily)

3.1.3 Theophylline

Used for reversible airways obstruction. Narrow margin between therapeutic and toxic dose. Prescribe oral 
preparations by brand name.

GREEN      Theophylline (Uniphyllin®) tablets m/r 200mg, 300mg, 400 mg      

Other preparations 
AMBER     Aminophylline tablets 225mg, 350mg
RED           Aminophylline injection 25mg/ml, 10mL ampoule 
RED           Caffeine citrate oral solution 50mg/5mL (unlicensed)  
RED           Caffeine citrate intravenous injection 10mg/2mL (NICU only) (unlicensed) 
Note: caffeine 10mg = caffeine citrate 20mg.
To avoid confusion these preparations must always be prescribed as CAFFEINE CITRATE.

3.1.4 Compound bronchodilator preparations 

In COPD, salbutamol alone should be used first line 
GREEN     Combivent® nebuliser solution - (ipratropium 500 microgram & salbutamol 2.5mg/ 2.5ml vial)

3.1.5 Peak flow meters, inhaler devices and nebulisers

Patients who require a spacer device for the first time with Allen & Hanbury inhalers (e.g. Ventolin® and Serevent® brands) should
be prescribed a Volumatic spacer device.  Aerochamber® is an alternative for other inhalers brands as it is less bulky and fits all 
If you are prescribing any spacer device to a patient for the first time, these patients should be monitored frequently in the normal
way for the emergence of or worsening of symptoms of disease or adverse effects. Any patients who are switched to a different 
device should be regarded in the same way as new patients, and the same careful monitoring is required.
For inhaled ß2 agonist bronchodilators the most frequent signs of toxicity are headache, tremor and palpitations; for inhaled 
corticosteroids the most serious concern from over exposure is adrenal suppression and particularly when high doses are 
administered to children and adolescents.
GREEN      Nebuchamber®  
GREEN      Volumatic®  
GREEN      AeroChamber Plus®  
GREEN      Pari Vortex®
GREEN      Space Chamber Plus®
GREEN      Compact Space Chamber Plus®
GREEN      AeroChamber® Plus Flow-Vu anti-static device

The preferred formulary choice of inhalers containing steroids for managing asthma and COPD with suitable conversion options from a less desirable to a preferred inhaler can be found here. Further information is below.


For asthma prophylaxis, must be used regularly. Clenil Modulite® or Qvar® are most economical when lower doses are required and should be used first line.  See 'CFC-Free Beclometasone Inhalers' below.    

Risks associated with high dose inhaled corticosteroid (ICS)

The risk of systemic adverse effects from ICS is dose related. For adults, low to moderate doses represent little or no risk but, high-dose therapy has been directly linked to adverse effects such as skin thinning, bruising, osteoporosis, diabetes and adrenal suppression. Patients on high dose ICS should be reviewed regularly and provided with a steroid card.

Approximately 85% of patients with asthma can be controlled on doses ≤800 micrograms/day of ICS.


Patients with COPD and with an FEV 1  of less than or equal to 50% of predicted, and having two or more exacerbations per year (requiring antibiotic or oral corticosteroid) should be offered prophylactic treatment with inhaled corticosteroid as a combination with long acting therapy, and review at 8 weeks.

CFC-Free Beclometasone Inhalers

These two CFC-free products (QVAR® and Clenil Modulite®), both containing the active substance beclometasone dipropionate are NOT equipotent and this could have safety implications.  When the prescriber wishes a patient to have a CFC-free formulation of beclometasone dipropionate that intention should be made clear by prescribing the product by brand name.  Pharmacists receiving a generic prescription for a beclometasone dipropionate pMDI must establish which of the two available branded products should be dispensed.

1. Clenil Modulite® (Trinity-Chiesi Pharmaceuticals Limited) should be prescribed at the same dose as the CFC-containing beclometasone dipropionate pMDIs.

2. Qvar® (Ivax Pharmaceuticals Limited) has a 2 to 2.5 fold greater potency than the CFC-containing beclometasone dipropionate pMDIs and therefore should be prescribed at a lower dose than the CFC-containing beclometasone dipropionate pMDIs. Further information is available in the Summary of Product Characteristics.

3. Clenil Modulite® is authorised for use in children; Qvar® is not authorised for use in children (12 years of age and younger).

4. For all inhaled corticosteroids and in line with accepted clinical practice, when control of asthma is achieved the dose of the inhaled corticosteroid should be titrated to the lowest dose at which effective control of asthma is maintained.

All NEW patients requiring a beclometasone inhaler, should be initiated on a CFC-free brand, either QVAR® or Clenil Modulite®.  The choice of brand used should be based on the dose required, the licensed indications, cost and cost effectiveness and the inhaler types available. 

GREEN       Clenil Modulite® (beclometasone CFC-Free) metered dose inhaler (MDI) 
                   (able to use with a Volumatic® device)     
                   50 microgram/inhalation,   
                   100 microgram/inhalation 
                   200 microgram/inhalation
                   250 microgram/inhalation 

GREEN       Qvar® (beclometasone CFC-Free) metered dose inhaler (MDI)  
                   (able to use with an Aerochamber® device). Metered dose inhaler (MDI) & Autohalers available   
                   50 microgram/inhalation     
                   100 microgram/inhalation    
GREEN       Qvar® Easi-Breathe  (beclomethasone CFC free) breath actuated aerosol inhalation
                   50mcg/metered inhalation  
                   100mcg/metered inhalation    

Other Steroid Inhalers

When considering doses, beclometasone dipropionate (Clenil® brand) and budesonide are equipotent and fluticasone is twice as potent. 

GREEN      Budesonide (Pulmicort®)  dry powder inhaler

                  100 microgram/inhalation (Pulmicort Turbohaler 100®)   
                  200 microgram/inhalation (Pulmicort Turbohaler 200®)
                  400 microgram/inhalation (Pulmicort Turbohaler 400®)

GREEN      Fluticasone (only recommended when high dose therapy is required).    

             Metered dose inhaler
             Dry powder inhaler
                   50microgram/inhalation (Flixotide 50 Accuhaler®)
                   100microgram/inhalation (Flixotide 100 Accuhaler®)   
                   250microgram/inhalation (Flixotide 250 Accuhaler®)

Compound preparations containing corticosteroids

If patients remain symptomatic on monotherapy, their treatment should be intensified by combining therapies from different drug classes. Combination of long-acting beta2-agonist plus inhaled steroid is a treatment option. The clinical effectiveness of combined treatments can be assessed by improvements in symptoms, activities of daily living, exercise capacity and lung function. Combination treatment should be discontinued if there is no benefit after 4 weeks.  

DuoResp®, Spiromax®, Fobumix Easyhaler® and Symbicort® Tubohaler containin budesonide/formoterol.

There are 2 strengths of DuoResp® Spiromax and Fobumix Easyhaler®160/4.5, and   320/9 ,These are equivalent to Symbicort 200/6 and Symbicort 400/12 respectively.

Although equivalent the inhaler devices are significantly different. Resultantly it is important to specify theinhaler by brand when prescribing in order to ensure patients receive a device they are familiar with.

GREEN     DuoResp® Spiromax 160/4.5 
                 equivalent to Formoterol 6micrograms/inhalation + budesonide 200micrograms/inhalation  
                 (dose= 1-2 puffs twice daily, max 4 puffs twice daily) 
GREEN     DuoResp® Spiromax 320/9        
                 equivalent to Formoterol 12micrograms/inhalation + budesonide 400micrograms/inhalation    
                 (dose= 1 puff twice daily, max 2 puffs twice daily) 
GREEN     Symbicort Turbohaler® 100/6,200/6  Formoterol 6micrograms/inhalation + budesonide
                  (dose= 1-2 puffs twice daily, max 4 puffs twice daily) 

GREEN     Symbicort Turbohaler® 400/12 (Formoterol 12micrograms/inhalation + budesonide 400) 

                  (dose= 1puff twice daily, max 2 puffs twice daily)           

GREEN    Fobumix Easyhaler® 160/4.5 (equivalent to Budesonide 200micrograms + Formoterol 6 mcg/inhalation
                (dose = 2 puffs twice daily, max 4 puffs twice daily)
GREEN    Fobumix Easyhaler® 320/9 (equivalent to Budesonide 400micrograms + Formoterol 12 micrograms/inhalation)

                 (dose = 1 puffs twice daily, max 2 puffs twice daily) Dose for COPD is 1 puff twice a day

GREEN    Trelegy Ellipta® (Umeclidinium+Vilanterol+Fluticasone)
                (dose = 1 puff daily)
AMBER  Anoro Ellipta® Umeclidinium bromide 65micrograms + Vilanterol 22micrograms/dose dry powder inhaler
               (dose = 1 inhalation daily) [specialist initiation]

2nd line treatment in asthma pathway, secondary care initiation only
AMBER    Relvar Ellipta® 92 micrograms/22 micrograms/dose  [Futicasone with vilanterol] dry powder inhaler
                 Relvar Ellipta® 184 micrograms/22 micrograms/dose  [Futicasone with vilanterol] dry powder inhaler
                  [dose = 1 puff daily]
Trimbow® inhaler  - link to guideline
First line use in Patient Group D, where patient requires Triple Therapy (LAMA+LABA+ICS)
(single combination inhaler, dose 2 puffs bd)
GREEN   Beclomethasone 87mcg, formoterol fumarate 5mcg,  
                glycopyrronium bromide 9mcg   (Trimbow®pMDI)
                (dose = 2 puffs twice daily)

Note: Of the Symbicort® range, both the 200/6 and 400/12 strengths are licensed for use in COPD as are the DuoResp Spiromax.

 Symbicort® SMART, DuoResp Spiromax maintenance and reliever therapy and Fostair® MARTregime for asthma

 Symbicort® and DuoResp Spiromax inhalers contain the inhaled steroid budesonide and the long action beta-2 agonist formoterol whilst Fostair contains ultra fine beclomethasone and formoterol. Although long acting formoterol has a quick onset of action allowing it to be used to relieve symptoms when required..The use of Symbicort® 100/6 or 200/6 used as a rescue medication instead of a short acting beta-2 agonist such as salbutamol in addition to its regular use as a controller therapy has been shown to be an effective treatment regimen. In line with updated BTS Guidance, Symbicort® SMART regimen for use in asthma in adults is approved within the following restrictions:

  • In selected adult patients at step 3 of the BTS/NICE guidelines who are poorly controlled, or in selected adult patients at step 2 (above beclometasone 400micrograms/day who are poorly controlled),
  • Patients taking rescue Symbicort® once a day or more should have their treatment reviewed,
  • Careful patient selection and education of patients about the specific issues around this management strategy is required.

 Only the 100/6 and 200/6 strengths should be used as part of this regimen. The 400/12 strength of Symbicort® should not be used in this way.

DuoResp Spiromax maintenance and reliever therapy- Only the 160/4.5microgram strength should be used as part of this regimen.

Patients take a daily maintenance dose of DuoResp Spiromax and in addition take DuoResp Spiromax as needed in response to symptoms. Patients should be advised to always have DuoResp Spiromax available for rescue use. DuoResp Spiromax maintenance and reliever therapy should especially be considered for patients with:

• inadequate asthma control and in frequent need of a reliever inhaler.

• asthma exacerbations in the past requiring medical intervention.

Recommended doses:

Adults (18 years and older): The recommended maintenance dose is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening. For some patients a maintenance dose of 2 inhalations twice daily may be appropriate. Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion.

A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period. Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice. They should be reassessed and their maintenance therapy should be reconsidered.

Fostair® may also be used as maintenance and reliever therapy (MART) It  is currently recommended as an option for the management of asthma in adults in line with BTS guidance. This product is not licensed for use in children or adolescents under the age of 18 years.

(Fostair 100/6 MDI 1 puff twice a day plus extra puffs as required max 8 puffs daily)

Again careful patient selection and education about the specific issues around this management strategy is required.

GREEN       Beclometasone + formoterol 100micrograms/6micrograms per inhalation  
                   (metered dose inhaler (Fostair® 100/6)
                    (dose= 1-2 puffs twice daily, max 4 puffs daily unless being used as MART therapy discussed above)
GREEN      Beclometasone + formoterol 200micrograms/6micrograms per inhalation     
                   (metered dose inhaler (Fostair® 200/6) 
                   (dose= 2 puffs twice daily)

Please note Fostair
 requires storage in a fridge prior to dispensing, and has an expiry of 5 months after dispensing to the patient (who should then keep the inhaler at room temperature). Note it contains a small amount of alcohol in the formulation.

Trimbow® inhaler  - link to guideline
First line use in Patient Group D, where patient requires Triple Therapy (LAMA+LABA+ICS)
(single combination inhaler, dose 2 puffs bd)
GREEN   Beclomethasone 87mcg, formoterol fumarate 5mcg,  
                glycopyrronium bromide 9mcg   (Trimbow®pMDI)
                (dose = 2 puffs twice daily)

Fluticasone/Salmeterol inhalers

These are currently not included in the ELMMB Asthma and COPD guidelines for adults over 18 years of age.
There are more than one product containing the combination of fluticasone/salmeterol.
These are AirFlusal®, Fospiro , Sirdupla® and Seretide.  Whilst these products are clinically equivalent, the 
devices differ. In order to prevent confusion to patients such combination inhalers should be prescribed by brand.
When Fostair®  or Duoresp®  are not suitable or the patient wishes to remain on Fluticasone then AirFlusal® is the preferred product of choice. 

For 12-18 year olds at Step 3 of the asthma guidelines who cannot use Symbicort Turbohaler, Fostair or Sirdupla are not licensed. The alternative choice therefore is Seretide 50 MDI 2 puffs BD at Step 3a and Seretide 125 2 puffs BD at Step 3b.

GREEN           Salmeterol 25micrograms/inhalation + fluticasone 
                       (dose=2 puffs twice daily)  
                       (AirFluSal® 25/125mcg MDI/ 25/250mcg MDI - preferred choice)
(Sirdupla® inhaler or Seretide Evohaler® 125, 250 Seretide Evohaler® 50) 
 GREEN          Salmeterol 50micrograms/blister + fluticasone
                       (dose=1 blister twice daily)     
                        Dry powder inhaler  AirFluSal®Forspiro (preferred choice) 
                                                            Seretide Accuhaler® 100, 250, 500)       

Please note the difference in dosing between:
                       >   Metered dose inhalers (2 puffs twice daily) and
                       >   Accuhalers® (One blister twice daily).

NOTE: Of the Seretide® range, only the 
Seretide® Accuhaler 500
is licensed for use in COPD.

            Neither the Seretide® Evohaler nor the Accuhaler® strengths are licensed for use in COPD. 

3.3.2 Leukotriene receptor antagonists and omalizumab

The leukotriene receptor antagonists block the effects of the cysteinyl leukotrienes in the airways. They are relatively expensive agents and BTS guidelines recommend their addition to therapy only at Step 3 for both adults and children.

GREEN        Montelukast
                     tablets 10mg                    (for patients over 15 years of age)  
                     chewable tablets 5mg    (for patients 6 to14 years of age) 
                     granules 4mg                   (for patients 6 months to 5 years of age) 

Omalizumab  - NICE TA278  (review of NICE TA133 and TA201)

Omalizumab should be initiated and prescribed only by a specialist in the treatment of asthma, and used strictly within its licensed indications.  Omalizumab is licensed as add-on therapy to improve control of asthma control in adults and adolescents 12 years and over and children aged 6 to 11 years with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1<80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled β2-agonist. Treatment should only be considered for patients with convincing IgE mediated asthma.

Only patients with an IgE level of >30 – 700 IU/ml, and body weight of >20 – 150kg are eligible for treatment.  The dose is determined from the baseline IgE level, see the SPC for details.  It is given subcutaneously, at 2-4 weekly intervals, and response to treatment is measured at 16 weeks.  Only patients who have shown an adequate response to treatment will continue therapy.   

The manufacturer in the USA has been asked by the FDA to add a boxed warning stating that there is a possibility of a patient developing anaphylaxis after any dose, even if there was no reaction to the first dose. In addition, anaphylaxis after administration of the drug may be delayed for up to 24 hours after the dose is given.

Therefore, health care professionals should:

  • be prepared to manage life-threatening anaphylaxis following administration of the drug
  • observe patients foe at least two hours after an injection
Patients should:

be offered and know how to initiate emergency self-treatment for anaphylaxis (Where this is prescribed & patients should know how and when to administer an adrenaline/epinephrine autojector (Epipen®) with their first prescription.

Anaphylaxis was reported in clinical trials at a frequency of approximately one in a thousand patients (0.1%); usually these reactions occurred within 2 hours of an injection. However the agency has received new reports of delayed anaphylaxis (within 2 to 24 hours or even longer) after treatment.

Please note that for children under the age of 6 omalizumab has a BLACK traffic light.

RED           Omalizumab injection 150mg – Risk of anaphylaxis (up to 24hrs after dose) see advice above

Mepolizumab  -NICE TA431

 Mepolizumab, as an add-on to optimised standard therapy, is recommended as an option for treating severe refractory eosinophilic asthma in adults only if:

          >   the blood eosinophil count is 300 cells/microlite or more in the previous 12 months AND
          >   the person has agreed to and followed the optimised standard treatment  plan and
                      >   has had 4 or more asthma exacerbations needing systemic corticosteroids in the previous 12 months or
                      >   has had continuous oral corticosteroids of at least the equivalent of prednisolone 5mg per day over the                             previous 6 months AND
          >   the company provides the drug with the discount agreed in the patient access scheme.
At 12 months of treatment:
         >   stop mepoliizumab if the asthma has not responded adequately or
         >   continue treatment if the asthma has responded adequately and assess response each year.

An adequate response is defined as:
        >   at least 50% fewer asthma exacerbations needing systemic corticosteroids in those people with 4 or more                          exacerbations in the previous 12 months or
        >   a clinically significant reduction in continuous oral corticosteroid use while maintaining or improving asthma                      control.
For further guidance see NICE TA431

RED          Mepolizumab 100mg powder for solution for injection

Reslizumab - NICE TA479

 1. Reslizumab, as an add-on therapy, is recommended as an option for the treatment of
     severe eosinophilic asthma that is inadequately controlled in adults despite 
     maintenance therapy with high-dose inhaled corticosteroids plus another drug, only if:
        >       the blood eosinophil count has been recorded as 400 cells per microlitre or more
        >       the person has had 3 or more severe asthma exacerbations needing systemic
                 corticosteroids in the past 12 months and
        >       the company provides reslizumab with the discount agreed in the patient access 
 1.2.  At 12 months:
        >      stop reslizumab if the asthma has not responded adequately or
        >      continue reslizumab if the asthma has responded adequately  and assess
                response each year.
       An adequate response is defined as:
        >      a clinically meaningful reduction in the number of severe exacerbations needing 
                systemic corticosteroids or
        >     a clinically significant reduction in continuous oral cortiscosteroid use while
               maintaining or improving asthma control.
 RED     Reslizumab 
              100mg/10ml concentration for solution for infusion (Cinqaero®)
                                                                                                    (NHS England Commissioned)
Benralizumab - NICE TA565 - updated September 2019
Benralizumab, as and add-on therapy, is recommended as an option for treating severe eosinophilic asthma that is 
inadequately controlled in adults despite maintenance therapy with high-dose inhaled corticosteroids and long-acting beta-agonists, only if:

          >     and person has agreed to and followed the optimised standard treatment plan and
          >     and blood eosinophil count has been recorded as 300 cells per microlitre or more and the person has had 
                 4 or more exacerbations needing systemic corticosteroids in the previous 12 months, or has had continuous 
                 oral corticosteroids of at least the equivalent of prednisolone 5 mg per day over the previous 6 months (that 
                 is, the person is eligible for mepolizumab) or
          >     the  blood eosinophil count has been recorded as 400 cells per microlitre or more with 3 or more 
                 exacerbations needing systemic corticosteroids in the past 12 months (that is, the person is eligible for 
Benralizumab is recommended only if the company provides it according to the commercial arrangement.
RED     Benralizumab 
             30mg/1mL solution for injection pre-filled syringes (Fasenra▼)

3.3.3 Phophodiesterase type-4 inhibitors

NICE guidance TA461 (update to TA244)
Roflumilast, as an add-on to bronchodilator therapy, is recommended as an option for treating  severe chronic obstructive pulmonary disease in adults with chronic bronchitis, only if:

        >     the disease is severe, defines as a forced expiratory volume in 1 second FEV¹
               after a bronchodilator of less than 50% of predicted normal, and
        >     the person has ja 2 or more exacerbations in the previous 12  months despite 
               triple inhaled therapy with a long-acting muscarinic antagonist, a long-acting
               beta-2 agonist and an inhaled corticosteroid.
 Treatment with roflumilast should be started by a specialist in respiratory medicine.
AMBER       Roflumilast tablets 500mcg (Daxas®)

3.4.1 Antihistamines

Of some value in treatment of nasal allergies, urticarial rashes, pruritus, insect bites and drug allergies.  Non-sedating 
preparations are usually longer acting. 
Non-sedating antihistamines
Although drowsiness is rare, nevertheless patients should be advised that it can occur and may affect performance
of skilled tasks (e.g. driving); excess alcohol should be avoided. 
Non-sedating antihistamines should be offered first line to all patients, especially children and adolescents.
GREEN       Cetirizine [Consider OTC/Self care] 
                    tablets 10mg  
                    oral solution 5mg/5mL
GREEN       Fexofenadine
                    tablets 120mg, 180mg
GREEN       Loratadine [Consider OTC/Self care]               
                    tablets 10mg 
                    syrup 5mg/5mL
Sedating antihistamines
GREEN       Chlorphenamine (chlorpheniramine) [Consider OTC/Self care] 
                    tablets 4mg  
                    syrup 2mg/5mL
                    injection 10mg/mL   
GREEN       Hydroxyzine  
                    tablets 10mg, 25mg   
GREEN       Promethazine tablets 10mg, 25mg   [Consider OTC/Self care]                             
                   Promethazine  liquid 5mg/5mL


3.4.2 Allergen Immunotherapy

Treatment of severe persistent allergic asthma (NICE TAG278)  
 (recommended as an option by NICE in people aged 6 years and older)
RED           Omalizumab injection 150mg/mL 
For previously treated chronic spontaneous urticaria - recommended as an option by NICE TAG 339
RED           Omalizumab injection 150mg/mL

3.4.3 Allergic emergencies

In anaphylactic shock adrenaline 1 in 1000 should be give by intramuscular injection at the doses below.
NOTE:   1. When administering adrenaline in an emergency the Health Care Professional should base the dose on age.   
             2. When prescribing for a patient 'just in case' then the prescription should be  based on weight. 
                 Any child over 30kg should be prescribed  the 300mcg strength pen.
By intramuscular injection
Child under 6 years       150 micrograms (0.15 mL), repeated every 5 minutes if necessary
Child 6–12 years               300 micrograms (0.3 mL), repeated every 5 minutes if necessary
Child 12–18 years           500 micrograms (0.5 mL), repeated every 5 minutes if necessary
Adult                                     500 micrograms (0.5 mL), repeated every 5 minutes if necessary    
GREEN      Adrenaline injection 1 in 1000, 1mL     

Adrenaline pre-filled syringes

Note the expiry of Jext ® has been reduced by the manufacturers from 24 months to 18 months.

Jext® - 18 month expiry
GREEN       Adrenaline (epinephrine) (Jext®) single dose pre-loaded syringe  
                     150micrograms (for issue to patients at risk of anaphylaxis)     
                   300micrograms (body weight 30Kg and above for self administration)
                   Jext Website information for Patients includes the 'How to use' videos 
                   Jext Patient Information Leaflet - view here
                  The following link provide training materials for the Jext devices:
                  Jext® devices
                  Jext® 150 Training Video
                  Jext® 300 Training Video
GREEN       Adrenaline (epinephrine) (Emerade®) single dose pre-loaded syringe  
                   500micrograms (for issue to patients at risk of severe anaphylaxis)  
                   300micrograms ( for self administration) 
                   150micrograms (for self administration)   
 See latest MHRA Emerade® recall information here 
Adrenaline (epinephrine) (EpiPen Auto-injector®) single dose pre-loaded syringe (for issue to patients at risk of 
GREEN     Epipen 150micrograms [19 month expiry see SPC]
                   EpiPen 300micrograms [24 month expiry - see SPC]
                   EpiPen Website - information for Patients 
                   EpiPen Patient information Leaflet - view here
                   The following links provide training materials for the Epipen devices: 
                   EpiPen® devices
                   EpiPen® 0.15mg

                   EpiPen® 0.3mg

All material in this section is aimed at health care professionals, but is information currently held in the public domain, members of the  public seeking advice on medicine-related matters are advised to speak with their GP, pharmacist, nurse or contact NHS111 Service.

  Email: info.elmmb@nhs.net

Copyright© 2016 - 2020 East Lancashire Medicines Management Board. 
 All rights reserved.  Disclaimer/Terms and conditions

3.5.1 Respiratory stimulants

RED           Doxapram injection
                  20mg/ml, 5ml ampoule
                  2mg/ml in glucose 5%, 500ml bottle

3.5.2 Respiratory surfactants

RED           Poractant suspension (Curosurf®) 80mg/ml, 1.5ml & 3ml vial

Carbocisteine should be initiated by secondary care respiratory physicians for chronic cough productive of sputum as outlined in NICE guidance. Therapy should only be continued if there is symptomatic improvement e.g. reduction in frequency of cough and sputum production.

GREEN     Carbocisteine  
                  capsules 375mg
                  sachets -750mg/10ml sugar-free oral solution in sachet 
                  (2nd line choice for adults with COPD and swallowing difficulties) 
RED           Oral Solution 250mg/5ml (paediatric use only) 
RED          Dornase alfa nebuliser solution 1mg/ml
RED          Mannitol, dry powder inhalation 40mg capsules

  •  Dornase alfa is RED Traffic Light where prescribing has been initiated on or after 1st April 2013.

    Where prescribing was initiated prior to April 1st 2013 the traffic light status may remain amber until repatriation of patients has been agreed by NHS England, local commissioners and providers.

Hypertonic sodium chloride

Inhaled hypertonic saline is a widely-used and well-accepted therapy for increasing the mucilliary clearance in the lower airways in patients with cystic fibrosis. Patients especially benefit from sputum expectoration due to osmotic effects of hypertonic saline. Different doses and concentrations are used in common therapy. The DTC has supported the use of this product .The efficacy and tolerability of hypertonic saline has been demonstrated in several clinical trials.

AMBER      Resp-Ease® (Sodium chloride 7% solution for inhalation)
                   [PRESCRIBE BY BRAND]
RED            All other unlicensed products and strengths
Mucolytic  [Palliative Care, Tracheostomy]
 Breathlessness - See page 8 & 19  Consensus Approach to Managing Palliative Care Symptoms Clinical Practice Summary 
 Tracheostomy use.
 GREEN       Sodium Chloride 0.9% for nebulisation [Respi-Clear® 20 x 2.5ml, Salineb® 20 x 2.ml]
                     PRESCRIBE BY BRAND

3.11.1  Antifibrotics

RED      Pirfenidone capsules 267mg 

              For the treatment of idiopathic pulmonary fibrosis recommended as an option by NICE TA504 in adults only if:
      >     the person has a forced vital capacity (FVC) between 50% and 80% predicted
      >     the company [provides pirfenidone with the agreed discount agreed in the patient
             access scheme and
      >     treatment is stopped if there is evidence of disease progression (an absolute
              decline of 10% or more in predicted FVC within any 12-month period).
RED      Nintedanib capsules 100mg, 150mg
             For the treatment of idiopathic pulmonary fibrosis (NICE TAG379)
             recommend as an option by NICE.
 RED     Nintedanib (Ovef®)
              NICE TA747  Recommended, within its marketing authorisation,  as an option for treating chronic progressive 
                                   fibrosing interstitial lung diseases (PF‑ILD) in adults.
                                                                                                                                                         NHS England Commissioned
All material in this section is aimed at health care professionals, but is information currently held in the public domain, members of the
 public seeking advice on medicine-related matters are advised to speak with their GP, pharmacist, nurse or contact NHS111 Service
 Email: info.elmmb@nhs.net
 Copyright© 2016 -2022 East Lancashire Medicines Management Board
 All rights reserved.  Disclaimer/Terms and conditions