Generic Name

Ensifentrine

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Classification

FDA Approved Indications

• Chronic Obstructive Pulmonary Disease (COPD)

Mechanism of Action

Ensifentrine inhibits phosphodiesterase enzymes PDE3 and PDE4, leading to increased levels of cyclic nucleotides (cAMP and cGMP), resulting in bronchodilation and anti-inflammatory effects.

Dosage and Administration

Adult: The recommended dose for COPD is typically 1 inhalation (e.g., 75 mcg or 200 mcg, depending on the formulation) twice daily. For specific dosing, follow the prescribing information.

Pediatric: Not approved for pediatric use; safety and efficacy have not been established.

Geriatric: No specific dosage adjustments required beyond standard dosing; monitor for adverse effects.

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

Hepatic Impairment: No specific data; use with caution.

Pharmacokinetics

Absorption: Rapid absorption following inhalation.

Distribution: Limited data; primarily localized in respiratory tissues.

Metabolism: Metabolized minimally; mostly excreted unchanged.

Excretion: Excreted primarily via the feces; renal excretion minimal.

Half Life: Approximately 8 hours, supporting twice-daily dosing.

Contraindications

• Hypersensitivity to ensifentrine or any components of the formulation.

Precautions

• Use with caution in patients with cardiovascular disease, as PDE inhibitors may affect heart rate and blood pressure.
• Monitor for potential adverse effects such as nausea, headache, or dyspepsia.

Adverse Reactions - Common

• Nausea (Uncommon)
• Headache (Uncommon)
• Cough or throat irritation (Uncommon)

Adverse Reactions - Serious

• Cardiovascular events such as arrhythmias or increased heart rate (Rare)
• Hypersensitivity reactions, including rash or anaphylaxis (Rare)

Drug-Drug Interactions

• Other PDE inhibitors (caution to avoid excessive effects)
• Beta-agonists (potential additive bronchodilation)

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Use inhaler exactly as prescribed.
• Report any common side effects like nausea or headache.
• Warn about potential cardiovascular symptoms such as increased heart rate.
• Maintain regular follow-up appointments.

Special Considerations

Black Box Warnings: N/A

Genetic Factors: No specific genetic considerations identified.

Lab Test Interference: No known interference with laboratory tests.

Overdose Management

Signs/Symptoms: Excessive bronchodilation leading to tachycardia, hypotension, or CNS effects.

Treatment: Supportive care; manage symptoms; activated charcoal if ingestion was recent; consider hospitalization for monitoring.

Storage and Handling

Storage: Store in a cool, dry place away from light.

Stability: Stable at room temperature for the duration specified in the package insert.