Indications
Prescribed for the maintenance treatment of chronic obstructive pulmonary disease (COPD), encompassing chronic bronchitis and/or emphysema. This inhaler combines Glycopyrronium Bromide, a long-acting muscarinic antagonist (LAMA), and Formoterol Fumarate, a long-acting β2-adrenergic agonist (LABA), for bronchodilation.
Composition
Each inhalation delivers Glycopyrronium Bromide EP 9 mcg and Formoterol Fumarate EP 4.8 mcg through the actuator, and Glycopyrronium Bromide EP 10.35 mcg and Formoterol Fumarate EP 5.52 mcg through the valve.
Pharmacology
Glycopyrronium inhibits M3 receptors, relaxing smooth muscles, while Formoterol stimulates adenylyl cyclase, increasing cyclic AMP for airway relaxation.
Dosage & Administration
Adults should administer 2 puffs twice daily, morning and evening. Consideration for severe renal impairment is advised based on risk-benefit analysis.
Interaction
Caution advised with other adrenergic drugs and medications affecting potassium levels or ECG changes. Extreme caution warranted with monoamine oxidase inhibitors and tricyclic antidepressants.
Contraindications
Contraindicated in asthma patients without long-term control medication and hypersensitivity to its components.
Side Effects
Common adverse reactions include cough and urinary tract infections, with potential for breathing difficulties, headache, tremors, and skin reactions.
Pregnancy & Lactation
Limited data available; caution advised, with benefits outweighing risks.
Precautions & Warnings
Avoid concurrent LABA use to prevent overdose. Not for acute bronchospasm relief. Caution in cardiovascular, convulsive, and endocrine disorders. Monitor for glaucoma and urinary retention.
Storage Conditions
Store below 30°C, avoiding temperatures exceeding 50°C, and keep out of children’s reach. Avoid piercing the container.
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