Omidenepag isopropyl (Ophthalmic)

Omidenepag isopropyl eye drops are used to reduce eye pressure caused by open-angle glaucoma or a condition known as ocular (eye) hypertension.

This medicine is available only with a prescription from your doctor.

It is very important that your doctor checks 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 (the colored part) of your treated eye(s) may slowly become more brown in color. The change in color of the iris is usually noticeable within several months or years after starting 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 go back to normal 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.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it will provide. This is a decision you will make together with your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to see how omidenepag isopropyl affects children. Its safety and effectiveness have not been established in the pediatric population.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of omidenepag isopropyl eye drops.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if there might be an interaction. In these cases, your doctor may change the dose or take other precautions. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around meal times or with specific foods due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

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

• Active eye problems (e.g., iritis, uveitis)—Use with caution. This may worsen these conditions.

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

In the U.S.

• Omlonti

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.