Drug Guide
Azelastine Hydrochloride
Classification
Therapeutic: Allergy and Allergic Rhinitis Agent
Pharmacological: Antihistamine, H1 receptor antagonist
FDA Approved Indications
- Perennial allergic rhinitis
- Seasonal allergic rhinitis
- Allergic conjunctivitis
Mechanism of Action
Azelastine selectively antagonizes H1 histamine receptors, thereby inhibiting the allergic response and decreasing allergy symptoms.
Dosage and Administration
Adult: 2 sprays in each nostril twice daily; ocular formulation usually 1 drop in affected eye twice daily.
Pediatric: Children ≥5 years: 2 sprays in each nostril twice daily; ocular: 1 drop in affected eye twice daily. Adjustments depend on age and severity.
Geriatric: Use with caution; no specific dose adjustments, but consider renal/liver function.
Renal Impairment: Adjust dose based on severity of impairment; caution advised.
Hepatic Impairment: Use with caution; no specific dose adjustment recommended.
Pharmacokinetics
Absorption: Rapid absorption after intranasal and ocular administration.
Distribution: Extensively bound to plasma proteins (~91%).
Metabolism: Hepatic via CYP enzymes; extensive first-pass for oral forms.
Excretion: Primarily in urine as metabolites.
Half Life: Approx. 20 hours.
Contraindications
- Hypersensitivity to azelastine or any components.
- Use cautiously in patients with history of sedative effects.
Precautions
- Potential for drowsiness and sedation.
- Use caution when operating machinery or driving.
- Inform about possible bitter taste following nasal administration.
Adverse Reactions - Common
- Bitter or bad taste (Common)
- Somnolence (Common)
- Headache (Common)
- Nasal irritation or burning (intranasal) (Common)
Adverse Reactions - Serious
- Anaphylaxis (Rare)
- Somnolence that impairs activities (Rare)
Drug-Drug Interactions
- CNS depressants (enhanced sedative effect)
Drug-Food Interactions
- None well established
Drug-Herb Interactions
- Caution with herbs that cause sedation such as valerian or kava.
Nursing Implications
Assessment: Monitor for effectiveness in symptom relief, sedation levels, and adverse reactions.
Diagnoses:
- Risk for decreased activity tolerance due to sedation.
- Ineffective coping related to allergy symptoms.
Implementation: Administer intranasal sprays or ocular drops as prescribed. Educate patients on proper administration.
Evaluation: Assess reduction in allergy symptoms and monitor for adverse reactions.
Patient/Family Teaching
- Use the medication exactly as directed.
- Report excessive drowsiness or allergic reactions.
- Inform about the bitter taste after nasal use.
- Do not operate heavy machinery if sedated.
Special Considerations
Black Box Warnings:
- None as of current FDA updates.
Genetic Factors: None significant.
Lab Test Interference: None known.
Overdose Management
Signs/Symptoms: Drowsiness, sedation, hypotension, tachycardia.
Treatment: Supportive care, activated charcoal if ingestion was recent, and symptomatic management.
Storage and Handling
Storage: Store at room temperature, away from moisture, heat, and light.
Stability: Stable for the duration of the labeled shelf life.