Medicine Overview
Adult Dose
| Clinical Information | Administration 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 Information | Administration 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 Information | Administration 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
- Upper respiratory tract infection (URTI) (5.7%)
- Pneumonia (4.6%)
- Dysphonia (3.3%)
- Muscle spasms (2.8-3.3%)
- Back pain (3.1%)
- Oral candidiasis (3%)
- Influenza (2.9%)
- Urinary Tract Infection (UTI) (2.7%)
- Cough (2.7%)
- Sinusitis (2.6%)
- Diarrhea (2.1%)
- Cataracts
- Hyperglycemia
- Anxiety
- Insomnia
- Headache
- Palpitations
- Nausea
- Hypersensitivity
- Depression
- Agitation
- Restlessness
- Nervousness
- Tremor
- Dizziness
- Angina pectoris
- Tachycardia
- Arrhythmias (eg atrial fibrillation, supraventricular tachycardia, extrasystoles)
- Throat irritation
- Bronchospasm
- Dry mouth
- Bruising
- Urinary retention
- Chest pain
- Sign or symptoms of systemic glucocorticoid steroid effects (eg hypofunctional adrenal gland)
- Abnormal behavior
Drug Interaction
Drug Interaction
| Drug Name | Risk Factors |
|---|---|
|
Strong CYP3A4 inhibitors
|
May increase budesonide systemic exposure
|
|
Other adrenergic drugs
|
May cause additive sympathetic effects
|
Disease Interaction
Disease Interaction
| Disease Name | Risk Factors |
|---|---|
|
No specific contraindications listed
|
Monitor for general drug reactions
|
Pregnancy
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.