Epinastine

Generic name: epinastine ophthalmic
Brand name: Elestat
Dosage form: ophthalmic solution (0.05%)
Drug class: Ophthalmic antihistamines and decongestants

Medically reviewed by  A Ras MD.

What is epinastine?

Epinastine is a prescription medicine that is used to treat eye irritation due to allergies.

Description

Epinastine HCl Ophthalmic Solution 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes.

Epinastine HCl is represented by the following structural formula:

Chemical Structure

        C16H15N3HCl Mol. Wt. 285.78

 

 

Chemical Name:

3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine hydrochloride

 

Each mL contains: Active: Epinastine HCl 0.05% (0.5 mg/mL) equivalent to epinastine 0.044% (0.44 mg/mL); Preservative: Benzalkonium chloride 0.01%; Inactives: Edetate disodium, dihydrate; purified water; sodium chloride; sodium phosphate, monobasic, anhydrous; and sodium hydroxide and/or hydrochloric acid (to adjust pH).

Epinastine HCl Ophthalmic Solution 0.05% has a pH of approximately 7 and an osmolality range of 250 to 310 mOsm/kg.

Mechanism of Action

Epinastine is a topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from the mast cell. Epinastine is selective for the histamine H1-receptor and has affinity for the histamine H2-receptor. Epinastine also possesses affinity for the α1, α2-, and 5-HT2–receptors.

 

Before taking epinastine, tell your doctor:

  • If you are allergic to epinastine; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take epinastine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take epinastine?

  • Tell all of your health care providers that you take epinastine. This includes your doctors, nurses, pharmacists, and dentists.
  • Do not use epinastine to treat contact lens irritation.
  • Do not wear contact lenses if your eyes are red.
  • Use as you have been told, even if your signs get better.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using epinastine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is epinastine best taken?

Use epinastine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • For the eye only.
  • Take out contact lenses before using epinastine. Lenses may be put back in 10 minutes after epinastine is given. Do not put contacts back in if your eyes are irritated or infected.
  • Wash hands before and after use.
  • Do not touch the container tip to the eye, lid, or other skin.
  • Tilt your head back and drop drug into the eye.
  • After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.
  • Do not use if solution changes color.

What do I do if I miss a dose?

  • Use a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not use 2 doses or extra doses.

What are the side effects of epinastine that I need to call my doctor about immediately?

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:

  • 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.
  • Change in eyesight, eye pain, or very bad eye irritation.

What are some other side effects of epinastine?

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.
  • More tears.
  • Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out epinastine?

  • Store at room temperature.
  • Keep lid tightly closed.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

 

Label

PRINCIPAL DISPLAY PANEL – 5 ML BOTTLE CARTON

  • NDC 51991-836-75
  • Epinastine HCl
    Ophthalmic
    Solution,
  • 0.05%
  • FOR USE IN THE
    EYES ONLY
  • sterile
  • Rx Only
    5 mL sterile
  • breckenridge |
    A Towa
    Company
Epinastine

SRC: NLM .