WockAIR® Safety & Tolerability Profile

  • Since WockAIR contains both budesonide and formoterol, the same pattern of undesirable effects as reported for these substances may occur.1
  • The most common drug-related adverse reactions are pharmacologically predictable side-effects of ß2-adrenoceptor agonist therapy, such as tremor and palpitations; these tend to be mild and usually disappear within a few days of treatment.1
WockAIR Safety

Since WockAIR® contains both budesonide and formoterol, the same pattern of undesirable effects as reported for these substances may occur. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds. The most common drug related adverse reactions are pharmacologically predictable side effects of β2adrenoceptor agonist therapy, such as tremor and palpitations. These tend to be mild and usually disappear within a few days of treatment.

WockAIR® is contraindicated in the case of hypersensitivity to the active substances or to the excipients.

Please consult the Summary of Product Characteristics for full details on the safety profile  (including special warnings and precautions) and adverse effects of WockAIR® and before prescribing.

The lowest effective dose of WockAIR® should be used. Patients should be advised to have their rescue inhaler available at all times and to take maintenance therapy as prescribed even when asymptomatic.

Patient should rinse their mouth out with water after inhaling the maintenance dose, and after the as-needed inhalations if oropharyngeal thrush occurs.

It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly. 

Serious asthma-related adverse events and exacerbations may occur during treatment with WockAIR®. 

Patients should not be initiated on WockAIR® during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.

WockAIR® contains lactose monohydrate (<1 mg/inhalation). This amount does not normally cause problems in lactose intolerant people. The excipient lactose contains small amounts of milk proteins, which may cause allergic reactions.

Concomitant treatment with itraconazole, ritonavir or other potent CYP3A4 inhibitors should be avoided. In patients using potent CYP3A4 inhibitors, WockAIR® maintenance and reliever therapy is not recommended.

WockAIR® should be administered with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.

Caution should be observed in patients with QTc prolongation. Formoterol may induce QTc prolongation.

Potentially serious hypokalaemia may result from high doses of β2 adrenoceptor agonists. 

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. Possible systemic effects include Cushing’s syndrome, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma, and more rarely, a range of psychological or behavioural effects.

Treatment with supplementary systemic steroids or inhaled budesonide should not be stopped abruptly.

Paradoxical bronchospasm may occur with inhalation therapy. If the patient experiences paradoxical bronchospasm WockAIR® should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary. 

The height of children receiving prolonged treatment with ICS should be regularly monitored. If growth is slowed, therapy should be re-evaluated.

There are no clinical study data on WockAIR® available in COPD patients with a pre-bronchodilator FEV1 >50% predicted normal and with a post-bronchodilator FEV1 <70% predicted normal.

An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been observed in patients with COPD receiving inhaled corticosteroids. 

Adverse events should be reported. Reporting forms and information can be found at: https://yellowcard.mhra.gov.uk/

Adverse events should also be reported to Wockhardt UK. Please contact us or email us at drug.safety@wockhardt.co.uk


1. WockAIR® Summary of Product Characteristics