Epinastine

FDA label, Somerset Therapeutics, LLC, ophthalmic, effective 2025-03-22. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Contraindications

None None

Pregnancy and lactation

Lactation

8.3 Nursing Mothers 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 epinastine HCl ophthalmic solution is administered to a nursing woman.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

Drug shortage status

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Source: FDA Drug Shortages Database via openFDA

Recalls (last 24 months)

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Source: FDA Enforcement Reports via openFDAFDA recalls and safety alerts

Therapeutic equivalence (Orange Book)

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Source: FDA Orange Book data filesSearch the Orange Book

Price ladder

Not the price at the counter
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These are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.

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