3.3.2 Leukotriene receptor antagonists (LTRAs)

Patients in whom leukotriene receptor antagonists (LTRAs) may be particularly effective are those with aspirin sensitivity, a large exercise induced component to the symptoms, highly atopic eczema, and rhinitis.

Montelukast

• Tablets 10mg (£1.96)
• Chewable tablets sugar free 4mg, 5mg (£1.15 = 4mg, £1.34 = 5mg)
• Granules sachets sugar free 4mg (£6.23)

Indications and dose:

• Prophylaxis of asthma:
  
  • Child 6 months–5 years: 4mg once daily, dose to be taken in the evening.
  • Child 6–14 years: 5mg once daily, dose to be taken in the evening.
  • Adults and adolescents 15 years of age and above: 10mg once daily, dose to be taken in the evening.

Notes

1. Montelukast is not indicated for treatment of an acute deterioration of asthma and should not be used to relieve an attack of acute severe asthma. Montelukast does not necessarily allow a reduction in the existing corticosteroid treatment.
2. Montelukast may be considered if exercise induced asthma is a specific problem in a patient who is otherwise well controlled.
3. Treatment should be trialled – if no benefit seen after 4 weeks, montelukast should be discontinued and alternative treatment options discussed with the patient.
4. Refer to paediatric and adult asthma guidance for further information on the use of montelukast in the management of asthmatic patients.
5. MHRA Drug Safety Update (April 2024): Montelukast: reminder of the risk of neuropsychiatric reactions
   1. The warnings in the Patient Information Leaflet and SmPC for all montelukast products in the UK have been strengthened and highlighted with a black box for greater emphasis
   2. Be alert for neuropsychiatric reactions in patients taking montelukast; events have been reported in adults, adolescents, and children.
   3. Neuropsychiatric reactions reported in association with montelukast include:
      1. sleep disturbances, depression and agitation including aggressive behaviour (may affect up to 1 in 100 people taking montelukast)
      2. disturbances of attention or memory (up to 1 in 1,000 people)
      3. very rarely, hallucinations and suicidal thinking and behaviour (up to 1 in 10,000 people )
   4. Discontinue montelukast if patients experience new or worsening symptoms of neuropsychiatric reactions
   5. Advise patients and their caregivers to carefully read the list of neuropsychiatric reactions in the Patient Information Leaflet and to seek medical advice immediately should they occur
   6. Refer to the Drug Safety Update for additional advice to give to patients

3.3.3 Phosphodiesterase type-4 inhibitors

Roflumilast

• Tablets 250micrograms, 500micrograms

Notes

1. NICE TA461: Roflumilast (Daxas), as an add-on to bronchodilator therapy, is recommended as an option for treating severe chronic obstructive pulmonary disease in adults with chronic bronchitis (July 2017), only if:
   1. the disease is severe, defined as a forced expiratory volume in 1 second (FEV1) after a bronchodilator of less than 50% of predicted normal, and
   2. the person has had 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.
   3. Treatment with roflumilast should be started by a specialist in respiratory medicine.