Medicine Overview

Indication

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Adult Dose

Clinical InformationAdministration Information
Indication: Chronic Obstructive Pulmonary Disease
Condition: Maintenance treatment of bronchoconstriction
Dose: Oral Inhalation – 2 oral inhalations
Frequency: twice daily
Note: Maximum 2 inhalations twice daily
Condition: Hepatic impairment
Dose: Oral Inhalation
Note: Formal pharmacokinetic studies not conducted; however, budesonide and formoterol fumarate are predominantly cleared by hepatic metabolism

Child Dose

Clinical InformationAdministration Information
Indication: Asthma maintenance
Age: 12 years of age and older
Dose: Oral inhalation – 320 mcg budesonide, 18 mcg glycopyrrolate, and 9.6 mcg formoterol fumarate (2 inhalations of 160 mcg/9 mcg/4.8 mcg)
Frequency: Twice daily
Note: Max Dose: 2 inhalations twice daily

Renal Dose

Clinical InformationAdministration Information
Condition: Moderate renal impairment (estimated glomerular filtration rate 45 mL/minute)
Dose: Inhalation – Not specified
Note: Glycopyrronium systemic exposure increased with moderate renal impairment
Condition: Severe (creatinine clearance less than or equal to 30 mL/minute/1.73m2) or end-stage renal disease requiring dialysis
Dose: Inhalation – Not specified
Note: Use if expected benefit outweighs potential risk
Administration
  • Shake well before use
  • Take twice daily
Side Effect

Drug Interaction

Drug NameRisk Factors
Strong CYP3A4 inhibitors
May increase budesonide systemic exposure
Other adrenergic drugs
May cause additive sympathetic effects

Disease Interaction

Disease NameRisk Factors
No specific contraindications listed
Monitor for general drug reactions

Pregnancy

Lactation
Special Use
Precaution
Overdose
Pharmacology
Storage
Store at controlled room temperature 20°C to 25°C; excursions permitted to 15°C to 30°C. Keep in a dry place away from heat and sunlight.

Data Sources

Clinical & regulatory information on this page is compiled from the following government sources:

DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment.