Emadine

EMADINE (emedastine difumarate ophthalmic solution) 0.05% is supplied as follows: 5 mL in opaque, plastic DROP-TAINER® dispensers.

5 mL: NDC 0065-2000-05

Storage

Store at 4°C - 30°C (39° - 86°F)

Revised: August 2002. Alcon Laboratories, Inc. Fort Worth, Texas 76134. FDA rev date: 5/12/2003

Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

Do not wear contact lenses during treatment with emedastine ophthalmic if your eyes are red. If you wear soft contact lenses, and your eyes are not red, wait at least 10 minutes after using emedastine ophthalmic before inserting contact lenses.

Do not use other eye medications during treatment with emedastine ophthalmic without first talking to your doctor.

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.

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.

Storage

Ophthalmic

Tightly closed bottle at 4–30°C.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.

Do not wear contact lenses if your eyes are red. If your eyes are not red, contact lenses should be removed before you use this medicine. Also, you should wait at least 10 minutes after using this medicine before putting the contact lenses back in.

To use:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 to 2 minutes to allow the medicine to be absorbed by the eye.
• If you think you did not get the drop of medicine into your eye properly, use another drop.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage form (eye drops):
  • For eye allergy:
    • Adults and children 3 years of age and older—Use one drop in the affected eye one to four times a day.
    • Children younger than 3 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

• If you have an allergy to emedastine or any other part of Emadine (emedastine).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

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 this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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.

Somnolence and malaise have been reported following daily oral administration. Oral ingestion of the contents of a 15 mL DROP-TAINER® dispenser would be equivalent to 7.5 mg. In case of overdosage, treatment is symptomatic and supportive.

The recommended dose is one drop in the affected eye up to four times daily.

Emadine® (emedastine difumarate ophthalmic solution) 0.05% is supplied as follows:

5 mL in opaque, plastic DROP-TAINER® dispenser.

5 mL: NDC 0065-0325-05

STORAGE: Store at 4° - 30°C (39° - 86°F).

Rx Only

U.S. Patents Nos. 5,441,958.

Revised: May 2009

ALCON LABORATORIES, INC.

6201 South Freeway

Fort Worth, Texas 76134 USA

1-800-757-9195

MedInfo@AlconLabs.com

Printed in USA

©2002, 2003, 2009 Alcon, Inc.

340326-0509

Applies to emedastine ophthalmic: ophthalmic solution

General

The most common side effect reported was headache.[Ref]

Ocular

Common: Eye pain, eye pruritus, conjunctival hyperemia
Uncommon: Corneal infiltrates, corneal staining, blurred vision, eye irritation, dry eye, foreign body sensation in eyes, increased tearing, asthenopia, ocular hyperemia
Frequency not reported: Discomfort, keratitis[Ref]

Nervous system

Very Common: Headache (11%)
Uncommon: Sinus headache, dysgeusia[Ref]

Hypersensitivity

Uncommon: Rash[Ref]

Dermatologic

Frequency not reported: Dermatitis[Ref]

Psychiatric

Uncommon: Abnormal dreams[Ref]

Cardiovascular

Frequency not reported: Tachycardia[Ref]

Respiratory

Frequency not reported: Rhinitis, sinusitis[Ref]

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

Animal studies using doses up to 15,000 times the maximum human ophthalmic dose have revealed no evidence of teratogenicity. Increased external, visceral and skeletal anomalies were observed in rats at doses 70,000 times the maximum recommended ocular dose. There are no controlled data in human pregnancy. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should be used during pregnancy only if clearly needed. US FDA pregnancy category: B