Chronic obstructive pulmonary disease

Anticholinergic Agent, Long-Acting; Beta2-Adrenergic Agonist, Long-Acting; Corticosteroid, Inhalant
1.Budesonide: A corticosteroid that controls the rate of protein synthesis, depresses the migration of polymorphonuclear leukocytes/fibroblasts, and reverses capillary permeability and lysosomal stabilization at the cellular level to prevent or control inflammation.
2.Formoterol: Relaxes bronchial smooth muscle by selective action on beta-2 receptors with little effect on heart rate; formoterol has a long-acting effect.
3.Glycopyrrolate: Competitively and reversibly inhibits the action of acetylcholine at muscarinic receptor.

See individual agents.

Hypersensitivity to budesonide, glycopyrrolate, formoterol, or any component of the formulation.

Budesonide is present in breast milk following oral inhalation; excretion of formoterol and glycopyrrolate are not known.
The decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

1.Gastrointestinal: Diarrhea (2%), oral candidiasis (3%)
2.Genitourinary: Urinary tract infection (3%)
3.Infection: Influenza (3%)
4.Nervous system: Voice disorder (3%)
5.Neuromuscular & skeletal: Back pain (3%), muscle spasm (3%)
6.Ophthalmic: Cataract ((1%)
7.Respiratory: Cough (3%), pneumonia (2% to 5%), sinusitis (3%), upper respiratory tract infection (6%)

Chronic obstructive pulmonary disease: Metered-dose inhaler (budesonide 160 mcg/glycopyrrolate 9 mcg/formoterol 4.8 mcg per actuation): Oral inhalation: 2 inhalations twice daily; maximum dose: 2 inhalations twice daily.