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Pulmicort Respules 0.5mg/2mL Nebulizer Suspension
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Indications & Clinical Uses
- Pulmicort Respules (budesonide) 0.5 mg/2 mL is an inhaled corticosteroid supplied as a single-dose ampoule of suspension for use in a jet nebulizer, not a dry-powder or metered-dose inhaler.
- It is indicated for the maintenance treatment and prevention of asthma symptoms, and is specifically approved in the US for children 12 months to 8 years of age who cannot reliably use a hand-held inhaler; the equivalent UK/EU product, Pulmicort Nebuliser Suspension, is also used for croup in hospitalised infants from around 6 months.
- It is not a rescue treatment and will not relieve a sudden asthma attack.
- Respules is a nebulized liquid, a different delivery device from Pulmicort Flexhaler, a dry-powder inhaler approved from age 6 years; the two forms are not interchangeable dose-for-dose and should not be substituted for one another.
Side Effects
- The most commonly reported side effects of Pulmicort Respules in children include respiratory tract infection, runny nose, cough, ear infection, viral infection, oral thrush, stomach upset, vomiting, diarrhoea, nosebleeds and eye redness; oral thrush can be reduced by rinsing the mouth with water after each treatment and spitting it out.
- Less common but more serious effects include lowered resistance to infection, adrenal suppression if transferred from oral steroids, reduced growth velocity with long-term use, and rarely, sudden worsening of wheeze right after a dose (paradoxical bronchospasm), glaucoma or cataracts.
- This label carries no boxed warning.
- Seek urgent medical help if breathing difficulty worsens immediately after a dose, or if facial swelling, hives or other signs of a severe allergic reaction appear.
Precautions & Warnings
- Pulmicort Respules is for inhalation via a jet nebulizer only; it must not be injected or swallowed, and should not be used with an ultrasonic nebulizer, which does not aerosolize the suspension correctly.
- Children transferring from oral corticosteroids to this inhaled form need careful, gradual monitoring, since adrenal insufficiency can appear during and after the switch and can become dangerous during illness, surgery or injury.
- Growth should be checked regularly in children on long-term treatment.
- Use with caution in active or past tuberculosis or in untreated fungal, bacterial, viral or parasitic infections, and avoid exposure to chickenpox or measles in unvaccinated children, seeking prompt medical advice if exposure occurs.
- Tell the healthcare provider if the child is pregnant, breastfeeding, or has liver impairment, since dose adjustment may be needed.
Avoid Interactions
- Strong CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir and other HIV protease inhibitors, and clarithromycin can markedly raise budesonide blood levels and increase steroid side effects, so these combinations are generally avoided or used only with close monitoring.
- Live or live-attenuated vaccines should not be given to children on high-dose inhaled or systemic corticosteroids because the immune response may be reduced; discuss vaccination timing with the healthcare provider.
- Do not mix Respules suspension in the nebulizer chamber with other medicines unless compatibility is specifically confirmed, and use an ampoule within 12 hours once removed from its light-protective foil strip.
- Tell the healthcare provider about all other medicines, including other corticosteroids, the child is taking.
References
Frequently Asked Questions
Pulmicort Respules (budesonide) is an inhaled steroid liquid used for daily asthma prevention in children, US-approved from 12 months to 8 years. In the UK it is also used in hospital for croup in infants. It will not stop a sudden asthma attack.
Pour the contents of one ampoule into a jet nebulizer and have your child breathe the mist through a mask or mouthpiece, usually once or twice daily. Do not use Respules in an ultrasonic nebulizer, which will not aerosolize it properly.
Common side effects include oral thrush, cough, runny nose, sore throat and ear infections. Rinsing the mouth with water after each dose lowers thrush risk. Seek urgent help if breathing suddenly worsens right after a dose.
Avoid strong CYP3A4 inhibitors such as ketoconazole, ritonavir and clarithromycin, which can raise budesonide levels and steroid side effects. Live vaccines are not recommended for a child on high-dose treatment; check timing with the healthcare provider first.
Once an ampoule is taken out of its light-protective foil strip, use it within 12 hours, and discard any suspension left over in an opened ampoule. Store unopened Respules upright, in their foil strip, between 20°C and 25°C, protected from light, and never freeze them.
No. Both contain budesonide, but Respules is a liquid breathed in through a jet nebulizer from 12 months of age, while Flexhaler is a dry-powder inhaler approved from age 6. The two devices are not interchangeable dose-for-dose.
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