Dulera Inhaler 50/5 μg, 100/5 μg, 200/5 μg Pressurised metered-dose inhaler, liquid suspension

Dulera Inhaler 50/5 μg, 100/5 μg, 200/5 μg Pressurised metered-dose inhaler, liquid suspension

S4
PDF Leaflet Revision Date: 26 August 2022


Clinical Summary

Quick overview from the medicine insert

Indication

Prophylactic maintenance treatment of asthma and COPD.

Dosage (summary)

Adults: 2 inhalations twice daily. Children 5-12 years: 2 inhalations of 50/5 u03bcg twice daily.

Special Populations

  • Paediatric patients < 5 years
  • Geriatric patients u2265 65 years

Pregnancy & Breastfeeding

Safety not established; monitor infants for hypoadrenalism.

Key Drug Interactions

  • Strong CYP3A4 inhibitors
  • Beta-adrenergic blockers
  • Xanthine derivatives

Contraindications

  • Hypersensitivity to components
  • Active tuberculosis

Common side effects

  • Dysphonia
  • Oral candidiasis
  • Headache

Counselling Points

  • Rinse mouth after use
  • Use short-acting beta-agonist for acute symptoms
  • Monitor for signs of infection

Serious warnings

  • Not for acute asthma/COPD episodes
  • Risk of adrenal suppression
  • Potential for inhalation-induced bronchospasm
Important Disclaimer

The Dulera Inhaler 50/5 μg, 100/5 μg, 200/5 μg Pressurised metered-dose inhaler, liquid suspension professional information leaflet below is the property of Organon South Africa and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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