Pronunciation:

oh-mi-DEN-e-pag eye-soe-PROE-pil

Brand Names:

• Omlonti

Uses of This Medicine:

Omidenepag isopropyl eye drops is used to lower pressure in the eye that is caused by open-angle glaucoma or a condition called ocular (eye) hypertension.

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 omidenepag isopropyl in the pediatric population. Safety and efficacy have not been established.

Older adults—

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

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Aphakia (no lens in the eyes) or
• Patients with torn artificial lens—Use with caution. May increase the risk of a serious side effect called macular edema.

• Eye problems, active (eg, iritis, uveitis)—Use with caution. May make these conditions worse.

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.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Shake the medicine well just before each use.

If you are wearing contact lenses, remove them before you use the eye drops. Wait for at least 15 minutes before putting the contact lenses back in.

To use the eye drops:

• Wash your hands with soap and water before and after you use this medicine.
• 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.
• Blink for few times so the medicine can spread across your eyes. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 2 minutes to allow the medicine to be absorbed by the 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.

This medicine can be used with other eye drops. Wait at least 5 minutes before using other eye drops.

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 glaucoma or ocular hypertension:
    • Adults—One drop in the affected eye(s) once a day in the evening.
    • 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—

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.

Store in the refrigerator. Do not freeze.

You may store the opened medicine at room temperature for up to 31 days.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

While you are using this medicine, the iris (colored part) of your treated eye(s) may slowly become more brown in color. The change in color of the iris is noticeable usually within several months or years from the start of treatment with omidenepag isopropyl. Check with your doctor if you have any concerns about this.

Your eyelashes may become longer and thicker. These changes to the lashes may be reversible after stopping the treatment. Also, these changes to the lashes will affect only the eye being treated with omidenepag isopropyl. Check with your doctor if you have any concerns about this.

This medicine may cause blurred vision or other vision problems. If any of these occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well. If these reactions are especially bothersome, check with your doctor.

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

Blurred vision

change in color vision

difficulty seeing at night

eye irritation, redness, or swelling not present before treatment

increased sensitivity of the eyes to sunlight

Less common

Dry eye

eye pain or tearing

Incidence not known

Increase in brown color in the colored part of the eye

longer, thicker, and darker eyelashes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Headache

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.