Elestat

Before using epinastine eye drops,

• tell your doctor and pharmacist if you are allergic to epinastine or any other medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Your doctor may need to adjust the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using epinastine, call your doctor.
• tell your doctor if you wear contact lenses. You should not wear contact lenses if your eyes are red or irritated, and you should not use epinastine eye drops to treat irritation that you think may be caused by contact lenses. You should also not instill epinastine eye drops while you are wearing contact lenses. Remove your contact lenses before you instill epinastine eye drops and do not replace them for at least 10 minutes afterward. You may find it convenient to instill the eye drops before you put your lenses on in the morning and after you take them out in the evening.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

This medication is usually used only for a short time until allergy season ends.

Epinastine ophthalmic is usually used twice per day. Follow your doctor's instructions.

Wash your hands before using eye medication.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
• Use only the number of drops your doctor has prescribed.
• Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.
• If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.
• Also wait at least 10 minutes before using any other eye drops that your doctor has prescribed.

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

An overdose of epinastine ophthalmic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

No Elestat drug interactions have been reported by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Elestat including the following:

• Infection. Tell your healthcare provider right away if you have some or all of the following symptoms of an infection.
  • sore throat
  • fever or chills

Avoid allowing the tip of the Elestat container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination by common bacteria known to cause eye infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated Elestat. The bottle should be kept tightly closed when not in use.

Do not take Elestat if you are allergic to Elestat or to any of its ingredients.

Before using Elestat, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Elestat or to any of its ingredients
• are pregnant or breastfeeding
• wear contact lenses

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

An overdose of epinastine ophthalmic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

It is not likely that other drugs you take orally or inject will have an effect on epinastine used in the eyes. But many drugs can interact with each other. Tell your doctor about all medicines you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Allergic Conjunctivitis

Prevention of ocular itching associated with allergic conjunctivitis.1

Storage

Ophthalmic

Tightly closed bottle at 15–25°C.1

• Inhibits the release of mediators (e.g., histamine) from cells involved in hypersensitivity reactions (e.g., mast cells).1 2

• Exhibits mast-cell stabilizing properties.2

• Exhibits some affinity for histamine H2, α1- and α2-adrenergic, and 5-HT2 receptors.1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Elestat, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.

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 brief summary of general information about Elestat. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Elestat.

Review Date: October 4, 2017

Pregnancy

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.

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 Elestat® ophthalmic solution is administered to a nursing woman.

Pediatric Use

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

Geriatric Use

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

Sterility of Dropper Tip

Patients should be advised not to touch dropper tip to any surface, as this may contaminate the contents (see WARNINGS AND PRECAUTIONS, 5.1).

Concomitant Use of Contact Lenses

Patients should be advised not to wear a contact lens if their eye is red. Patients should be advised that Elestat® should not be used to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of Elestat®. The preservative in Elestat®, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Elestat®.

Topical Ophthalmic Use Only

For topical ophthalmic administration only.

Rx only
© 2012 Allergan, Inc.
Irvine, CA 92612, U.S.A.
Allergan corporate signature logo is a registered trademark of Allergan, Inc.
Elestat is a registered trademark of Boehringer Ingelheim International GmbH and is licensed to Allergan, Inc.
Made in the U.S.A.

72499US10

ALLERGAN NDC 0023-9201-05

Elestat®

(epinastine HCI

ophthalmic solution) 0.05%

5 mL Rx only sterile

ALLERGAN

NDC 0023-9201-05

Elestat®

(epinastine HCl

ophthalmic solution) 0.05%

Rx Only

5 mL sterile

An overdose of Elestat is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Applies to epinastine ophthalmic: ophthalmic solution

General

The most common ocular side effects reported were a burning sensation following instillation, folliculosis, hyperemia, and pruritus of the eye.[Ref]

Ocular

Common: Burning, irritation, pruritus
Uncommon: Hyperemia, discharge, dryness, visual disturbance
Postmarketing reports: Increased lacrimation, eye pain[Ref]

Respiratory

Uncommon: Asthma, nasal irritation, rhinitis[Ref]

Nervous system

Uncommon: Headache, dysgeusia[Ref]

Some side effects of Elestat may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.