(a ZEL as teen)
- Azelastine HCl
- Azelastine Hydrochloride
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Ophthalmic, as hydrochloride:
Optivar: 0.05% (6 mL [DSC]) [contains benzalkonium chloride]
Generic: 0.05% (6 mL)
Brand Names: U.S.
- Optivar [DSC]
- Histamine H1 Antagonist
- Histamine H1 Antagonist, Second Generation
Competes with histamine for H1-receptor sites on effector cells and inhibits the release of histamine and other mediators involved in the allergic response
Plasma concentrations following ocular administration are low for azelastine (0.02-0.25 ng/mL) and n-desmethylazelastine (0.25-0.87 ng/mL)
Onset of Action
Peak effect: 3 minutes
Duration of Action
Use: Labeled Indications
Treatment of itching of the eye associated with seasonal allergic conjunctivitis
Hypersensitivity to azelastine or any component of the formulation
Seasonal allergic conjunctivitis: Ophthalmic: Instill 1 drop into affected eye(s) twice daily.
Refer to adult dosing.
Seasonal allergic conjunctivitis: Ophthalmic: Children ≥3 years: Refer to adult dosing.
Dosing: Renal Impairment
No dosage adjustment provided in the manufacturer’s labeling.
Dosing: Hepatic Impairment
No dosage adjustment provided in manufacturer’s labeling.
Store upright at controlled room temperature of 2°C to 25°C (36°F to 77°F).
There are no known significant interactions.
Central nervous system: Headache (15%)
Ocular: Transient burning/stinging (30%)
1% to 10%:
Central nervous system: Fatigue
Gastrointestinal: Bitter taste (10%)
Ocular: Conjunctivitis, eye pain, blurred vision (temporary)
Respiratory: Asthma, dyspnea, pharyngitis, rhinitis
Miscellaneous: Flu-like syndrome
Dosage form specific issues:
• Solution contains benzalkonium chloride; remove lens prior to administration and wait at least 10 minutes before reinserting. Do not use contact lenses if eyes are red.
Pregnancy Risk Factor
Animal reproduction studies have shown toxic effects to the fetus at maternally toxic doses.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache, burning, stinging, blurred vision, or bad taste. Have patient report immediately to prescriber vision changes, eye pain, or severe eye irritation (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
More about azelastine ophthalmic
- Other brands: Optivar