Emedastine Ophthalmic

Do not wear contact lenses while using this medicine if your eyes are red.

Do not use other eye medications unless your doctor tells you to.

It is not likely that other drugs you take orally or inject will have an effect on emedastine used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

In the U.S.

• Emadine

Available Dosage Forms:

• Solution

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Antihistamine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For emedastine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to emedastine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on emedastine have been done only in adult patients, and there is no specific information comparing use of ophthalmic emedastine in children younger than 3 years of age with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of ophthalmic emedastine in the elderly with use in other age groups.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking emedastine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using emedastine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion
• Donepezil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

You should not use emedastine ophthalmic if you are allergic to it.

To make sure emedastine ophthalmic is safe for you, tell your doctor if you have:

• an infection in your eye (unless you are also using medicine to treat it).

FDA pregnancy category B. Emedastine ophthalmic is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether emedastine ophthalmic passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Emedastine ophthalmic is not approved for use by children younger than 3 years of age.

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.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

• headache;

• mild burning or stinging after using the eye drops;

• blurred vision, dry eyes; or

• strange dreams.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Data not available

Administration advice:
-For ophthalmic use only

Patient advice:
-Patients should be instructed not to touch bottle tip to eyes, hands, or any other surface in order to prevent contamination of the bottle.
-Patients should be instructed not use the solution if it becomes discolored.
-Patients should be instructed to remove contact lenses prior to drug administration; lenses may be reinserted 15 minutes after administering eye drops.