Skip to Content

Azelastine (Ophthalmic)

Medically reviewed by Drugs.com. Last updated on Jun 29, 2020.

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.

Solution, Ophthalmic, as hydrochloride:

Generic: 0.05% (6 mL)

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

Allergic conjunctivitis: Treatment of itching of the eye associated with allergic conjunctivitis

Contraindications

Hypersensitivity to azelastine or any component of the formulation

Dosing: Adult

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

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Seasonal allergic conjunctivitis: Children ≥3 years and Adolescents: Ophthalmic: Instill 1 drop into affected eye(s) twice daily

Administration

For topical ophthalmic use only. Wash hands prior to use. Do not touch tip of container to any surface, the eyelids, or surrounding areas. After instilling drops, wait at least 10 minutes before inserting contact lenses. Do not insert contacts if eyes are red.

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

What is this drug used for?

• It is used to ease allergy signs in the eye.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache

• Burning

• Stinging

• Bad taste

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Vision changes

• Eye pain

• Severe eye irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.