Generic Name

Formoterol Fumarate; Glycopyrrolate

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Classification

FDA Approved Indications

• Chronic obstructive pulmonary disease (COPD)

Mechanism of Action

Formoterol is a long-acting beta2-adrenergic agonist that relaxes airway smooth muscle, leading to bronchodilation. Glycopyrrolate is a muscarinic receptor antagonist that inhibits the parasympathetic nervous system's effect on airway muscles, preventing bronchoconstriction. The combination provides sustained bronchodilation.

Dosage and Administration

Adult: The recommended dosage is two inhalations (opposite each nostril if using the inhaler device) twice daily. Dose adjustments are not typically required based on age or renal function; however, monitor patients closely.

Pediatric: Not approved for use in children under 18 years of age.

Geriatric: Use with caution; adjust dose based on response and tolerability, as elderly may have increased risk of adverse effects.

Renal Impairment: No specific dose adjustment required; monitor for increased sensitivity.

Hepatic Impairment: No specific data; use with caution and monitor for adverse effects.

Pharmacokinetics

Absorption: Rapid when inhaled; systemic absorption is low.

Distribution: Widely distributed; no significant plasma protein binding data available.

Metabolism: Formoterol metabolized primarily via glucuronidation and oxidative pathways; Glycopyrrolate undergoes minimal metabolism.

Excretion: Mainly via feces; minor urinary excretion.

Half Life: Formoterol approximately 10-12 hours; Glycopyrrolate variable, approximately 1-2 hours.

Contraindications

• Hypersensitivity to glycopyrrolate, formoterol, or components of the inhaler.
• Monitoring required in patients with hypersensitivity to atropine or related drugs.

Precautions

• Use with caution in patients with cardiovascular disorders, hypertension, or arrhythmias.
• Potential for paradoxical bronchospasm; discontinue if occurs.
• Use cautiously in patients with glaucoma, urinary retention, or prostate enlargement.

Adverse Reactions - Common

• Headache (Common)
• Muscle tremor (Common)
• Throat irritation (Common)
• Cough (Common)

Adverse Reactions - Serious

• Paradoxical bronchospasm (Rare)
• Cardiac arrhythmias (Rare)
• Allergic reactions, including hypersensitivity (Rare)

Drug-Drug Interactions

• Other beta2-agonists, leading to increased risk of adverse cardiovascular effects.
• MAO inhibitors and tricyclic antidepressants, increasing the risk of cardiovascular effects.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Use inhaler correctly, follow dosing schedule.
• Report worsening symptoms or adverse effects.
• Avoid exposure to known allergens or irritants.

Special Considerations

Black Box Warnings:

• Not specifically flagged; however, LABAs have a boxed warning for increased risk of asthma-related deaths when used as monotherapy in asthma, not COPD.
• Monitor for signs of allergic reactions.

Genetic Factors: Pharmacogenetic variability in response not well established.

Lab Test Interference: None noted.

Overdose Management

Signs/Symptoms: Severe tachycardia, hypertension, hypokalemia, tremors, palpitations.

Treatment: Discontinue drug, provide supportive care, monitor cardiac status, and manage symptoms as necessary. Use of beta-blockers may be considered with caution.

Storage and Handling

Storage: Store at controlled room temperature, away from moisture and heat.

Stability: Stable until the expiration date on the package.