Formoterol Fumarate + Glycopyrrolate + Budesonide

Introduction: Formoterol Fumarate + Glycopyrrolate + Budesonide is a pressurized metered-dose inhaler that delivers a combination of micronized Budesonide (an inhaled corticosteroid), micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate (an inhaled long-acting beta2-adrenergic agonist).

How it works: Budesonide helps to decrease inflammation in the lungs. Glycopyrrolate and 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.

Important Information: This inhaler is not indicated for the relief of acute bronchospasm or for the treatment of asthma. Acute symptoms should be treated with an inhaled short-acting beta2-agonist. The recommended dosage is two inhalations twice daily, once in the morning and again in the evening.

• Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)

Combined bronchodilators

Inhaled Corticosteroid + Anticholinergic + LABA

This Inhaler is a pressurized metered-dose inhaler that delivers a combination of micronized Budesonide (an inhaled corticosteroid), micronized glycopyrrolate (an anticholinergic), and micronized formoterol fumarate (an inhaled long-acting beta2-adrenergic agonist). Budesonide helps to decrease inflammation in the lungs. Glycopyrrolate and 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.

Budesonide reduces inflammatory cell activity in the lungs. Glycopyrrolate dilates airways through anticholinergic effects. Formoterol relaxes bronchial smooth muscles through beta2-agonist effects.

Adult Dose (COPD):

• Two inhalations twice daily (morning and evening) by oral inhalation.
• Do not take more than two inhalations twice daily.
• After inhalation, rinse mouth with water without swallowing.

* Use as directed by the registered physician

Pressurized metered-dose inhaler for oral inhalation. Shake well before each use. Follow the instructions for use of the inhaler.

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:

• Candida albicans infection (mouth and pharynx)
• Increased risk of pneumonia
• Paradoxical bronchospasm
• Hypercorticism and adrenal suppression
• Reduction in bone mineral density
• Worsening of narrow-angle glaucoma and cataracts
• Worsening of urinary retention
• Cardiovascular effects (increased heart rate, arrhythmias)

Precautions:

• Safety and efficacy in patients with asthma have not been established - not indicated for the treatment of asthma.
• Should not be used as rescue therapy for acute symptoms.
• Physicians should remain vigilant for the possible development of pneumonia in COPD patients.
• Daily dosage should not be increased beyond the recommended dose.
• Should not be used with other LABA-containing medications.
• Use with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Contraindications:

• Hypersensitivity to budesonide, glycopyrrolate, formoterol, or any of the excipients

Drug Interactions:

• Strong CYP3A4 inhibitors (e.g., ritonavir) - use with caution (may cause systemic corticosteroid effects).
• Other adrenergic drugs may potentiate effect - use with caution.
• Diuretics, xanthine derivatives or steroids may potentiate hypokalemia or ECG changes - use with caution.
• MAO inhibitors and tricyclic antidepressants - use with extreme caution.
• Beta-blockers - use with caution (may block bronchodilatory effects).
• Anticholinergics - avoid administration with other anticholinergic-containing drugs.

Food Interactions: No interaction found/established.

Use in Pregnancy: No adequate and well-controlled studies in pregnant women. Use only if the expected benefit to the mother is greater than any possible risk to the fetus.

Use in Lactation: Budesonide is present in human milk. No data on presence of Glycopyrrolate or Formoterol Fumarate in human milk. Consider developmental and health benefits of breastfeeding along with the mother's clinical need.

Pediatric Use: Not indicated for use in children. Safety and effectiveness have not been established in pediatric patients.

Geriatric Use: No adjustment of dosage is necessary based on available data, but greater sensitivity in some older individuals cannot be ruled out.

Renal Impairment: In patients with severe renal impairment, use should be considered only if the potential benefit outweighs the risk.

Hepatic Impairment: Budesonide and formoterol fumarate systemic exposure may increase in patients with severe hepatic impairment. Monitor patients for signs of increased drug exposure.

Overdose:

• Budesonide: Excessive doses for prolonged periods may cause hypercorticism.
• Glycopyrrolate: High doses may lead to anticholinergic signs (nausea, vomiting, dizziness, blurred vision, difficulties in voiding).
• Formoterol Fumarate: Seizures, angina, hypertension/hypotension, tachycardia, arrhythmias, hyperglycemia, hypokalemia.

Storage: Pressurized canister - do not puncture, break or incinerate. Avoid exposure to direct sunlight or heat. Do not store above 30°C. Keep in a dry place. Protect from light and keep out of reach of children. Discard within three months after removing from the foil pouch.

Formoterol Fumarate + Glycopyrrolate + Budesonide Inhaler