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epinastine hcl 0.05% eye drops generic elestat

In stock Manufacturer BRECKENRIDGE 51991083675
$115.29 / 5 Milliliters Drop Btl

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Allergic Conjunctivitis

Epinastine is used for the prevention of ocular itching associated with allergic conjunctivitis. Safety and efficacy of epinastine for this use have been evaluated in conjunctival antigen challenge studies and in environmental field studies in over 300 patients 9 years of age and older with allergic conjunctivitis. Results of these studies indicate that epinastine hydrochloride 0.05% solution was more effective than vehicle in providing relief of ocular itching associated with allergic conjunctivitis.

Avoidance of allergen and other triggering factors (e.g., irritants) and application of cold compresses and lubricating eye drops are the initial means of managing allergic conjunctivitis. Drug therapy generally is reserved for use when such avoidance is not possible or is ineffective and can include both prophylactic (e.g., mast-cell stabilizers) and symptomatic (e.g., topical and/or systemic antihistamines, topical vasoconstrictors, topical steroid and nonsteroidal anti-inflammatory agents [NSAIAs]) therapy. The specific therapy(ies) employed will depend on the characteristics and severity of the allergic conjunctivitis. For patients with seasonal allergic conjunctivitis, prophylaxis with a mast-cell stabilizer often is initiated before and maintained throughout the pollen season, and symptomatic therapy with other agents (e.g., topical antihistamines, topical NSAIAs) generally is initiated as necessary to provide acute relief. Topical corticosteroids usually are reserved for short-term use in patients with moderate to severe symptoms of allergic conjunctivitis.

Dosage and Administration


Epinastine hydrochloride is applied topically to the eye as an ophthalmic solution. The ophthalmic solution is not for injection or oral use.

The recommended dosage of epinastine hydrochloride for the prevention of itching associated with allergic conjunctivitis in adults and children 3 years of age and older is 1 drop of a 0.05% solution in each eye twice daily. Therapy with epinastine has been shown to be safe and effective for at least 8 weeks, with no evidence of tachyphylaxis. The manufacturer states that therapy with epinastine should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even in the absence of symptoms.



Known hypersensitivity to epinastine or any ingredient in the formulation.


General Precautions


For topical ophthalmic use only. Not for injection or oral use.

Specific Populations


Category C. (See Users Guide.)


Epinastine is distributed into milk in rats. It is not known whether the drug is distributed into human milk; therefore, caution should be exercised when ocular epinastine is administered to a nursing woman.

Pediatric Use

Safety and efficacy not established in children younger than 3 years of age.

Geriatric Use

No overall differences in safety and efficacy relative to younger patients.

Common Adverse Effects

Adverse ocular effects reported in approximately 1-10% of patients include ocular burning, folliculosis, hyperemia, and pruritus.

The most frequently reported adverse nonocular effect is infection (e.g., cold symptoms, upper respiratory infections), which occurred in approximately 10% of patients. Other adverse nonocular effects reported in approximately 1-3% of patients include headache, rhinitis, sinusitis, increased cough, and pharyngitis.

Some events may be related to the underlying ocular disease rather than epinastine.

Drug Interactions

No formal drug interaction studies have been performed.

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