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Epinastine Hydrochloride

Pronunciation: epp-ih-NAS-teen HIGH-droe-KLOR-ide
Class: Antihistamine, Ophthalmic

Trade Names

- Ophthalmic solution 0.05%


Direct H 1 -receptor antagonist that inhibits release of histamine from the mast cell.

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Low systemic exposure.


Plasma protein binding approximately 64%.


Less than 10% metabolized.


Terminal plasma elimination t ½ is about 12 h. Mainly excreted unchanged (after IV dosing about 55% in urine and 30% in feces). Renal elimination via active tubular secretion.

Indications and Usage

Prevention of itching associated with allergic conjunctivitis.


Standard considerations.

Dosage and Administration

Adults and children 3 yr of age and older

Ophthalmic 1 gtt in each eye twice daily, continuing treatment throughout the period of exposure (until pollen season is over or until exposure to offending allergen is terminated) even when symptoms are absent.

General Advice

  • For topical ophthalmic use only. Not for injection or oral use.
  • If using other topical ophthalmic drugs, separate each medication by at least 5 min.


Store ophthalmic solution at controlled room temperature (59°F to 77°F). Keep tightly closed.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions


Headache (1% to 3%).


Burning sensation in eye, folliculosis, hyperemia, pruritus (1% to 10%); rhinitis, sinusitis, pharyngitis (1% to 3%).


Upper respiratory infection (10%); increased cough (1% to 3%).


Symptoms of cold (10%).



Ocular/Systemic reactions

Monitor patient for ocular (eg, burning, stinging) and systemic (eg, headaches) reactions. Inform health care provider if noted and significant.

Ophthalmic symptoms

Assess ophthalmic symptoms (eg, itching) before and periodically throughout therapy. Notify health care provider if symptoms are not controlled with medication.


Category C .




Safety and efficacy not established in children under 3 yr of age.

Patient Information

  • Advise patient to read patient instruction sheet that accompanies each bottle of azelastine.
  • Advise patient that usual dose is 1 gtt instilled into the affected eyes twice daily.
  • Teach patient proper technique for instilling eye drops: wash hands; do not allow dropper tip to touch eye. Tilt head back, look up; pull lower eyelid down; instill prescribed number of gtt. Close eye for 1 to 2 min and apply gentle pressure to bridge of nose for 3 to 5 min. Do not rub eye.
  • Advise patient that medication should be used daily during the period of exposure to allergens in order to prevent symptoms from recurring.
  • Advise patient that if symptoms are not controlled not to increase the dose but to inform health care provider.
  • Advise patient that if more than 1 topical ophthalmic drug is being used, to administer the drugs at least 10 min apart.
  • Advise patient who wears contact lenses not to wear lenses if eyes are red.
  • Advise patient who wears contact lenses, and whose eyes are not red, to remove lenses before instilling this medicine and to wait at least 10 min after instilling eye drops before inserting lenses.
  • Inform patient that temporary redness, itching, burning, or stinging of the eye are the most common side effects and to contact health care provider if they occur and are bothersome.

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