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Azelastine (Ophthalmic)

Pronunciation

Pronunciation

(a ZEL as teen)

Index Terms

  • Azelastine HCl
  • Azelastine Hydrochloride
  • Optivar

Dosage Forms

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]

Pharmacologic Category

  • Histamine H1 Antagonist
  • Histamine H1 Antagonist, Second Generation

Pharmacology

Competes with histamine for H1-receptor sites on effector cells and inhibits the release of histamine and other mediators involved in the allergic response

Absorption

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

8 hours

Use: Labeled Indications

Treatment of itching of the eye associated with seasonal allergic conjunctivitis

Contraindications

Hypersensitivity to azelastine or any component of the formulation

Dosing: Adult

Seasonal allergic conjunctivitis: Ophthalmic: Instill 1 drop into affected eye(s) twice daily.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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.

Storage

Store upright at controlled room temperature of 2°C to 25°C (36°F to 77°F).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>10%:

Central nervous system: Headache (15%)

Ocular: Transient burning/stinging (30%)

1% to 10%:

Central nervous system: Fatigue

Dermatologic: Pruritus

Gastrointestinal: Bitter taste (10%)

Ocular: Conjunctivitis, eye pain, blurred vision (temporary)

Respiratory: Asthma, dyspnea, pharyngitis, rhinitis

Miscellaneous: Flu-like syndrome

Warnings/Precautions

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

C

Pregnancy Considerations

Animal reproduction studies have shown toxic effects to the fetus at maternally toxic doses.

Patient Education

• 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.

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