Indications
This inhaler is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). It is not intended for the relief of acute bronchospasm or for the treatment of asthma.
Pharmacology
This inhaler is a pressurized metered-dose inhaler that delivers a combination of micronized Budesonide, an inhaled corticosteroid (ICS), micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate, an inhaled long-acting beta2-adrenergic agonist (a LABA), for oral inhalation. ICS medicines such as budesonide help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems. Anticholinergic medicines, such as glycopyrrolate, and LABA medicines, such as formoterol fumarate help the muscles around the airways in the lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.
Dosage & Administration
The recommended dosage is two inhalations twice daily, once in the morning and again in the evening, by oral inhalation. Do not take more than two inhalations twice daily. After inhalation, rinse mouth with water without swallowing.
Interaction
Strong caution is advised with other adrenergic drugs, diuretics, xanthine derivatives, and certain antidepressants. Beta-blockers should be used with caution.
Contraindications
Contraindications include hypersensitivity to budesonide, glycopyrrolate, formoterol, or any of the excipients.
Side Effects
Adverse reactions may include serious asthma-related events, infections, cardiovascular effects, and hypersensitivity reactions.
Pregnancy & Lactation
Limited data available; caution advised, with benefits outweighing risks.
Precautions & Warnings
Caution advised in various conditions including cardiovascular disorders. Not indicated for acute bronchospasm relief.
Special Populations
Monitor hepatic/renal impairment. Not indicated for pediatric use.
Overdose Effects
Symptoms vary depending on the component; overdose may lead to severe adverse effects.
Therapeutic Class
Combined bronchodilators.
Storage Conditions
Avoid extreme conditions. Keep away from children. Discard after three months from pouch opening.
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