Home Drug Guide Azelastine Hydrochloride and Fluticasone Propionate

Drug Guide

Generic Name

Azelastine Hydrochloride and Fluticasone Propionate

Brand Names Dymista

Classification

Therapeutic: Allergic Rhinitis, Nasal corticosteroid/antihistamine combination

Pharmacological: Antihistamine (Azelastine), Corticosteroid (Fluticasone)

FDA Approved Indications

Seasonal Allergic Rhinitis
Perennial Allergic Rhinitis

Mechanism of Action

Azelastine works as a selective antihistamine that blocks H1 receptors, reducing allergy symptoms. Fluticasone is a corticosteroid that reduces inflammation by suppressing multiple inflammatory genes.

Dosage and Administration

Adult: One spray in each nostril twice daily for adults.

Pediatric: Not established for children under 12; dosing should be determined by physician.

Geriatric: No specific dosage adjustment necessary but monitor for increased sensitivity.

Renal Impairment: No specific adjustments recommended.

Hepatic Impairment: Use with caution; no specific dose adjustment established.

Pharmacokinetics

Absorption: Rapid absorption after intranasal administration.

Distribution: Systemic distribution, primary localized effect in nasal tissues.

Metabolism: Azelastine is metabolized in the liver; Fluticasone extensively metabolized by CYP3A4.

Excretion: Metabolites are excreted primarily via urine and feces.

Half Life: Azelastine: approximately 22 hours; Fluticasone: approximately 7 hours.

Contraindications

Known hypersensitivity to azelastine, fluticasone, or any components of the formulation.

Precautions

Use with caution in patients with nasal infections, recent nasal surgery or injury, or ocular herpes.

Adverse Reactions - Common

Bad taste, nosebleed, headache (Common)
Drowsiness, fatigue (Less common)

Adverse Reactions - Serious

Allergic reactions including rash, swelling, difficulty breathing (Rare)
Nasal septum perforation (Rare)

Drug-Drug Interactions

CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase systemic corticosteroid effects.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor nasal symptoms and for adverse reactions like nasal irritation or bleeding.

Diagnoses:

Risk for nasal mucosal injury
Risk for systemic corticosteroid effects

Implementation: Administer intranasally as directed, instruct patient on proper spray technique.

Evaluation: Assess reduction in allergy symptoms and monitor for adverse effects.

Patient/Family Teaching

Use as directed, typically one spray per nostril twice daily.
Report any signs of allergic reactions or nasal irritation.
Avoid blowing nose immediately after administration.
Store at room temperature, away from moisture and heat.

Special Considerations

Black Box Warnings:

Systemic corticosteroid effects may occur, especially with long-term use.

Genetic Factors: No specific genetic considerations known.

Lab Test Interference: May affect adrenal function tests.

Overdose Management

Signs/Symptoms: Drowsiness, increased adrenergic effects, nasal mucosal irritation.

Treatment: Supportive care, symptomatic treatment, consult poison control.

Storage and Handling

Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F).

Stability: Stable for the duration of the shelf life indicated by the manufacturer.