Glycopyrronium Bromide + Formoterol Fumarate

Introduction: Glycopyrronium Bromide + Formoterol Fumarate is a combination inhaler used for maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

How it works: Glycopyrronium is a long-acting muscarinic antagonist (LAMA) and Formoterol is a long-acting β₂-adrenergic agonist (LABA) with a rapid onset of action. Glycopyrronium causes bronchodilation by inhibiting M3 receptors and Formoterol relaxes airway smooth muscle by activating adenylyl cyclase.

Important Information: Administer as 2 puffs twice daily, in the morning and in the evening. Not for acute bronchospasm.

• Chronic obstructive pulmonary disease (COPD): including chronic bronchitis and/or emphysema

Combined bronchodilators

LAMA + LABA

Glycopyrronium is a long-acting muscarinic antagonist (LAMA) and Formoterol is a long-acting β₂-adrenergic agonist (LABA) with a rapid onset of action. Glycopyrronium has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of the M3 receptor at the smooth muscle leading to bronchodilation. Formoterol causes direct relaxation of airway smooth muscle as a consequence of the increase in cyclic AMP through activation of adenylyl cyclase.

Glycopyrronium inhibits M3 receptors and Formoterol activates β₂-adrenergic receptors to dilate the airways.

Adult Dose:

• 2 puffs twice daily, in the morning and in the evening

Severe Renal Impairment:

• Should be used only if potential benefit outweighs the risk

* Use as directed by the registered physician

Inhalation (pressurized metered-dose inhaler). Shake well before use. Place mouthpiece in mouth, press down to release medicine while breathing in deeply, hold breath for 10 seconds.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and follow your regular schedule.

Common Side Effects:

• Cough
• Urinary tract infection
• Dry mouth
• Headache
• Tremor
• Nervousness
• Increased blood pressure
• Chest pain
• Irregular heartbeat
• Muscle spasm
• Urinary retention

Precautions:

• Should not be used with additional LABA-containing medicine (risk of overdose)
• Not indicated for acute bronchospasm
• If paradoxical bronchospasm occurs, discontinue
• Use with caution in cardiovascular disorders
• Use with caution in narrow-angle glaucoma, prostatic hyperplasia

Contraindications:

• Asthma without use of long-term asthma control medication
• Hypersensitivity to glycopyrronium bromide, formoterol fumarate or any component

Drug Interactions:

• Other adrenergic drugs may potentiate effect
• Xanthine derivatives, steroids, diuretics may cause hypokalemia
• MAOIs and tricyclic antidepressants - use with extreme caution
• Beta-blockers - use with caution
• Avoid with other anticholinergic-containing drugs

Food Interactions: No interaction found/established.

Use in Pregnancy: No data on use in pregnant women. Use only if potential benefit justifies potential risk to the fetus.

Use in Lactation: Unknown if glycopyrronium and formoterol are excreted in human milk. Use with caution.

Pediatric Use: Safety and efficacy in children have not been established.

Geriatric Use: No specific dosage adjustment is necessary for elderly patients.

Renal Impairment: Use in severe renal impairment should be considered only if potential benefit outweighs the risk.

Hepatic Impairment: No specific restrictions.

Overdose: Formoterol overdose may cause angina, hypertension/hypotension, tachycardia, arrhythmias, hypokalemia, hyperglycemia. Symptomatic treatment should be given.

Storage: Do not store above 30°C. Do not expose to temperatures higher than 50°C. Do not pierce the pressurized container.

Glycopyrronium Bromide + Formoterol Fumarate Inhaler