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Pharmacologic Category
Histamine H1 Antagonist; Histamine H1 Antagonist, Second Generation
Dosing: Adult
Allergic conjunctivitis: Ophthalmic: Instill 1 drop into each eye twice daily. Continue throughout period of exposure, even in the absence of symptoms.
* See Dosage and Administration in AHFS Essentials for additional information.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment: Adult
No dosage adjustment provided in manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Dosing: Hepatic Impairment: Adult
No dosage adjustment provided in manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Dosing: Pediatric
Allergic conjunctivitis: Children ≥2 years and Adolescents: Ophthalmic: Instill 1 drop into each eye twice daily; continue throughout period of exposure, even in the absence of symptoms
Dosing: Renal Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely necessary due to low systemic absorption.
Dosing: Hepatic Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely necessary due to low systemic absorption.
Use: Labeled Indications
Treatment of allergic conjunctivitis
* See Uses in AHFS Essentials for additional information.
Comparative Efficacy
Administration: Ophthalmic
For ophthalmic use only; avoid touching tip of applicator to eye or other surfaces. Contact lenses should be removed prior to application, may be reinserted after 10 minutes. Do not wear contact lenses if eyes are red.
Administration: Pediatric
For ophthalmic use only; avoid touching tip of applicator to eye or other surfaces. Contact lenses should be removed prior to application; may be reinserted after 10 minutes. Do not wear contact lenses if eyes are red.
Storage/Stability
Store at controlled room temperature of 15°C to 25°C (59°F to 77°F). Keep tightly closed.
Medication Patient Education with HCAHPS Considerations
What is this drug used for?
• It is used to treat eye irritation due to allergies.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Burning
• Common cold symptoms
• Watery eyes
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Vision changes
• Eye pain
• Severe eye irritation
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Contraindications
There are no contraindications listed in the manufacturer's labeling.
Warnings/Precautions
Concerns related to adverse effects:
• Bacterial keratitis: Inadvertent contamination of multiple-dose ophthalmic solutions has caused bacterial keratitis.
Special populations:
• Contact lens wearers: Contains benzalkonium chloride which may be absorbed by contact lenses; remove contact lenses prior to use and wait 10 minutes before reinserting.
Other warnings/precautions:
• Appropriate use: For topical ophthalmic use only. Not for the treatment of contact lens irritation; do not wear contact lenses if eye is red.
* See Cautions in AHFS Essentials for additional information.
Geriatric Considerations
No difference in safety and efficacy was observed between elderly and younger patients. Evaluate the patient's or caregiver's ability to safely administer the correct dose of ophthalmic medication.
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse events were observed in some animal reproduction studies.
Breast-Feeding Considerations
It is not known if epinastine is excreted in breast milk. The manufacturer recommends that caution be exercised when administering epinastine to nursing women.
Briggs' Drugs in Pregnancy & Lactation
Adverse Reactions
Frequency not always defined.
1% to 10%:
Central nervous system: Headache (1% to 3%)
Infection: Infection (10%; defined as cold symptoms and upper respiratory tract infection)
Ophthalmic: Burning sensation of eyes, eye pruritus, follicular conjunctivitis, ocular hyperemia
Respiratory: Cough (1% to 3%), pharyngitis (1% to 3%), rhinitis (1% to 3%), sinusitis (1% to 3%)
<1%, postmarketing, and/or case reports: Increased lacrimation
* See Cautions in AHFS Essentials for additional information.
Allergy and Idiosyncratic Reactions
Toxicology
Metabolism/Transport Effects
None known.
Drug Interactions Open Interactions
There are no known significant interactions.
Advanced Practitioners Physical Assessment/Monitoring
For ophthalmic use only.
Nursing Physical Assessment/Monitoring
For ophthalmic use only.
Dosage Forms: US
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Ophthalmic, as hydrochloride:
Elestat: 0.05% (5 mL [DSC]) [contains benzalkonium chloride]
Generic: 0.05% (5 mL)
Anatomic Therapeutic Chemical (ATC) Classification
- S01GX10
Generic Available (US)
Yes
Pricing: US
Solution (Epinastine HCl Ophthalmic)
0.05% (per mL): $20.52 - $22.54
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Mechanism of Action
Selective H1-receptor antagonist; inhibits release of histamine from the mast cell; also has affinity for the H2, alpha1, alpha2, and the 5-HT2 receptors
Pharmacodynamics/Kinetics
Onset of action: 3-5 minutes
Duration: 8 hours
Absorption: Low systemic absorption following topical application
Distribution: Does not cross blood-brain barrier
Protein binding: 64%
Metabolism: <10% metabolized
Half-life elimination: 12 hours
Excretion: IV: Urine (55%); feces (30%)
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
No significant effects or complications reported
Effects on Bleeding
No information available to require special precautions
Index Terms
Epinastine Hydrochloride; Epinastrine HCl
FDA Approval Date
October 16, 2003
References
Elestat (epinastine hydrochloride) [prescribing information]. Irvine, CA: Allergan, Inc; January 2012.
Brand Names: International
Alesion (JP); Alket (AR); Allerginon (KR); Alpatin (BD); Aresten (KR); Atergit (PE); Elestat (CR, DO, GT, HN, NI, PA, SV); Epigen (BD); Epinast (BD, LK); Flurinol (CL, CO, CR, DO, EC, GT, HN, NI, PA, PE, PY, SV, UY, VE); Furinol (MX); Karmastin (EG); Optest (EG); Purivist (CZ, FR); Relestat (AE, AT, BE, BR, CH, CL, CO, DE, DK, EG, ES, GB, GR, HK, IE, IL, IN, IT, JO, KR, KW, LB, LK, LU, MY, NL, PE, PL, PT, SA, SG, TH, TR, TW, VN, ZW); Statergic (EG); Talerc (BR)
Last Updated 8/28/20
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