Pronunciation:

loe-ti-LAN-er

Brand Names:

• Xdemvy

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Ophthalmologic Agent

Uses of This Medicine:

Lotilaner eye drops are used to treat Demodex blepharitis, an eye condition caused by Demodex mites.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lotilaner eye drops in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lotilaner eye drops in the elderly.

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.

Other 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

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.

Proper Use of This Medicine:

Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.

To use the eye drops:

• Wash your hands with soap and water before and after you use this medicine.
• While squeezing, turn the bottle upside down and release the pressure (drawing air into the bottle).
• Tilt the head back and, place the bottle above your eye and squeeze it again to release a drop into your eye.
• 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. Serious damage to the eye and possible loss of vision may result from using contaminated eye drops.

Remove contact lenses before you use the eye drops. Wait for at least 15 minutes before putting the contact lenses back in.

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 forms (eye drops):
  • For Demodex blepharitis:
    • Adults—Instill one drop into each eye 2 times a day for 6 weeks.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply 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.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your eye doctor (ophthalmologist) check your progress at regular visits to make sure the medicine is working properly and to check for unwanted effects.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Burning and stinging of the eye

Less common

Blurred vision

feeling like there is something in your eye

increased sensitivity of the eyes to light

swelling, redness, pain, or tenderness of the eyelid

tearing and irritation of the eye

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.