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Overview
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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Epinastine hydrochloride ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.
Dosage
The recommended dosage is one drop in each eye twice a day.
Treatment 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 when symptoms are absent.
There is limited information regarding Off-Label Guideline-Supported Use of Epinastine hydrochloride in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Epinastine hydrochloride in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Epinastine hydrochloride in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Epinastine hydrochloride in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Epinastine hydrochloride in pediatric patients.
Contraindications
None
Warnings
Contamination of Tip and Solution
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Bottle should be kept tightly closed when not in use.
Use with Contact Lenses
Patients should be advised not to wear a contact lens if their eye is red. Epinastine hydrochloride ophthalmic solution should not be used to treat contact lens-related irritation.
The preservative in epinastine hydrochloride, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of epinastine hydrochloride ophthalmic solution and may be reinserted after 10 minutes following its administration.
Topical Ophthalmic Use Only
Epinastine hydrochloride is for topical ophthalmic use only and not for injection or oral use.
Adverse Reactions
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The most frequently reported ocular adverse reactions occurring in approximately 1 to 10% of patients were burning sensation in the eye, folliculosis, hyperemia, and pruritus.
The most frequently reported non-ocular adverse reactions were infection (cold symptoms and upper respiratory infections), seen in approximately 10% of patients, and headache, rhinitis, sinusitis, increased cough, and pharyngitis, seen in approximately 1 to 3% of patients.
Some of these reactions were similar to the underlying disease being studied.
Postmarketing Experience
The following reactions have been identified during postmarketing use of epinastine hydrochloride in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to epinastine hydrochloride, or a combination of these factors, include: lacrimation increased.
Drug Interactions
There is limited information regarding Epinastine hydrochloride Drug Interactions in the drug label.
In an embryofetal developmental study in pregnant rats, maternal toxicity with no embryofetal effects was observed at an oral dose that was approximately 150,000 times the maximum recommended ocular human dose (MROHD) of 0.0014 mg/kg/day on a mg/kg basis. Total resorptions and abortion were observed in an embryofetal study in pregnant rabbits at an oral dose that was approximately 55,000 times the MROHD. In both studies, no drug-induced teratogenic effects were noted.
Epinastine reduced pup body weight gain following an oral dose to pregnant rats that was approximately 90,000 times the MROHD.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, epinastine hydrochloride ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
