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AZELASTINE HCL (AZELASTINE HCL)
- Allergic conjunctivitis
- Perennial allergic rhinitis
- Seasonal allergic rhinitis
- Vasomotor rhinitis
azelastine 137 mcg (0.1 %) nasal spray aerosol
- Spray 2 sprays in each nostril by intranasal route 2 times per day
azelastine 0.15 % (205.5 mcg) nasal spray
- Spray 1 spray (205.5 mcg) in each nostril by intranasal route 2 timesper day
0.05 % eye drops
- Instill 1 drop into affected eye(s) by ophthalmic route 2 times per day
azelastine 0.05 % eye drops
- Instill 1 drop into affected eye(s) by ophthalmic route 2 times per day
Allergic conjunctivitis
- Instill 1 drop into left eye by ophthalmic route 2 times per day
- Instill 1 drop into right eye by ophthalmic route 2 times per day
- Instill 1 drop into both eyes by ophthalmic route 2 times per day
- Instill 1 drop into affected eye(s) by ophthalmic route 2 times per day
Perennial allergic rhinitis
- Spray 2 sprays in each nostril by intranasal route 2 times per day
- Spray 2 sprays (411 mcg) in each nostril by intranasal route 2 times per day
Seasonal allergic rhinitis
- Spray 2 sprays in each nostril by intranasal route 2 times per day
- Spray 1 spray (205.5 mcg) in each nostril by intranasal route 2 timesper day
- Spray 2 sprays (411 mcg) in each nostril by intranasal route once daily
- Spray 2 sprays (411 mcg) in each nostril by intranasal route 2 times per day
Vasomotor rhinitis
- Spray 2 sprays in each nostril by intranasal route 2 times per day
- None
Contraindicated
- None
Severe
Moderate
- None
- None
Contraindicated
- None
Severe
Moderate
- Drowsy
- Ocular irritation
AZELASTINE HCL (AZELASTINE HCL)
- Allergic conjunctivitis
- Perennial allergic rhinitis
- Seasonal allergic rhinitis
- Vasomotor rhinitis
- None
- Drowsy
- Dysesthesia
- Dysgeusia
- Headache disorder
- Ocular irritation
- Ocular pain
More Frequent
Severe
Less Severe
- Asthma
- Cough
- Dyspnea
- Blurred vision
- Conjunctivitis
- Dizziness
- Epistaxis
- Fatigue
- Flu-like symptoms
- Myalgias
- Nasal passage irritation
- Nausea
- Pharyngitis
- Pruritus of skin
- Rhinitis
- Sneezing
- Weight gain
- Xerostomia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Anaphylaxis
- Atrial fibrillation
- Blurred vision
- Bronchospastic pulmonary disease
- Hematuria
- Ocular pain
- Pruritus of skin
- Skin rash
- Stomatitis
- Tachycardia
- Urinary retention
- Visual changes
Less Severe
- Acute confusion
- Aphthous stomatitis
- Chest pain
- Constipation
- Contact dermatitis
- Depression
- Diarrhea
- Dry eye
- Dyspnea
- Eczema
- Eye tearing
- Facial edema
- Flushing
- Folliculitis
- Furunculosis
- Gastroenteritis
- Glossitis
- Hyperkinesis
- Hypertension
- Hypesthesia
- Increased appetite
- Lacerations
- Lesion of nasal mucosa
- Loss of sense of smell
- Nervousness
- Palpitations
- Paresthesia
- Parosmia
- Sleep disorder
- Symptoms of anxiety
- Toothache
- Vomiting
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Azelastine (0.15% or combination)
Safety and efficacy not established age < 6 years. 0.1% azelastine approved for age 6 months and older.
Safety and efficacy not established age < 6 months.
Safety and efficacy not established age < 3 years.
- 1 Day – 6 Years
- Safety and efficacy not established age < 6 years. 0.1% azelastine approved for age 6 months and older.
- 1 Day – 179 Days
- Safety and efficacy not established age < 6 years. 0.1% azelastine approved for age 6 months and older.
- 1 Day – 3 Years
- Safety and efficacy not established age < 6 years. 0.1% azelastine approved for age 6 months and older.
Azelastine (Nasal 0.1%)
Safety and efficacy not established age < 6 years. 0.1% azelastine approved for age 6 months and older.
Safety and efficacy not established age < 6 months.
Safety and efficacy not established age < 3 years.
- 1 Day – 6 Years
- Safety and efficacy not established age < 6 months.
- 1 Day – 179 Days
- Safety and efficacy not established age < 6 months.
- 1 Day – 3 Years
- Safety and efficacy not established age < 6 months.
Azelastine (Ophth 0.05%)
Safety and efficacy not established age < 6 years. 0.1% azelastine approved for age 6 months and older.
Safety and efficacy not established age < 6 months.
Safety and efficacy not established age < 3 years.
- 1 Day – 6 Years
- Safety and efficacy not established age < 3 years.
- 1 Day – 179 Days
- Safety and efficacy not established age < 3 years.
- 1 Day – 3 Years
- Safety and efficacy not established age < 3 years.
Azelastine
- Severity Level:
2
- Additional Notes: Insufficient human data available.
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Azelastine
Insufficient data available.
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient data available. |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- None
| Allergic conjunctivitis | |
| H10.1 | Acute atopic conjunctivitis |
| H10.10 | Acute atopic conjunctivitis, unspecified eye |
| H10.11 | Acute atopic conjunctivitis, right eye |
| H10.12 | Acute atopic conjunctivitis, left eye |
| H10.13 | Acute atopic conjunctivitis, bilateral |
| H10.44 | Vernal conjunctivitis |
| H10.45 | Other chronic allergic conjunctivitis |
| H16.26 | Vernal keratoconjunctivitis, with limbar and corneal involvement |
| H16.261 | Vernal keratoconjunctivitis, with limbar and corneal involvement, right eye |
| H16.262 | Vernal keratoconjunctivitis, with limbar and corneal involvement, left eye |
| H16.263 | Vernal keratoconjunctivitis, with limbar and corneal involvement, bilateral |
| H16.269 | Vernal keratoconjunctivitis, with limbar and corneal involvement, unspecified eye |
| Perennial allergic rhinitis | |
| J31.0 | Chronic rhinitis |
| Seasonal allergic rhinitis | |
| J30.1 | Allergic rhinitis due to pollen |
| J30.2 | Other seasonal allergic rhinitis |
| Vasomotor rhinitis | |
| J30.0 | Vasomotor rhinitis |
| 0-9 | A-Z |
|---|---|
| H10.1 | Acute atopic conjunctivitis |
| H10.10 | Acute atopic conjunctivitis, unspecified eye |
| H10.11 | Acute atopic conjunctivitis, right eye |
| H10.12 | Acute atopic conjunctivitis, left eye |
| H10.13 | Acute atopic conjunctivitis, bilateral |
| H10.44 | Vernal conjunctivitis |
| H10.45 | Other chronic allergic conjunctivitis |
| H16.26 | Vernal keratoconjunctivitis, with limbar and corneal involvement |
| H16.261 | Vernal keratoconjunctivitis, with limbar and corneal involvement, right eye |
| H16.262 | Vernal keratoconjunctivitis, with limbar and corneal involvement, left eye |
| H16.263 | Vernal keratoconjunctivitis, with limbar and corneal involvement, bilateral |
| H16.269 | Vernal keratoconjunctivitis, with limbar and corneal involvement, unspecified eye |
| J30.0 | Vasomotor rhinitis |
| J30.1 | Allergic rhinitis due to pollen |
| J30.2 | Other seasonal allergic rhinitis |
| J31.0 | Chronic rhinitis |
Formulary Reference Tool