ELESTAT Ophthalmic solution Ref.[50724] Active ingredients: Epinastine

5.1 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.

5.2 Use with Contact Lenses

Patients should be advised not to wear a contact lens if their eye is red. ELESTAT ophthalmic solution should not be used to treat contact lens-related irritation.

The preservative in ELESTAT, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of ELESTAT ophthalmic solution and may be reinserted after 10 minutes following its administration.

5.3 Topical Ophthalmic Use Only

ELESTAT is for topical ophthalmic use only and not for injection or oral use.

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 1-10% 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 1-3% of patients.

Some of these reactions were similar to the underlying disease being studied.

The following reactions have been identified during postmarketing use of ELESTAT 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 ELESTAT, or a combination of these factors, include: lacrimation increased.

Teratogenic Effects

Pregnancy Category C.

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, ELESTAT ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

A study in lactating rats revealed excretion of epinastine in the breast milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ELESTAT ophthalmic solution is administered to a nursing woman.

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

No overall differences in safety or effectiveness have been observed between elderly and younger patients.