Omidenepag Isopropyl Ophthalmic

Omidenepag Isopropyl Ophthalmic is a prescription medication used for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

• Omidenepag Isopropyl Ophthalmic is available under the following different brand names: Omlonti

Common side effects of Omidenepag Isopropyl Ophthalmic include:

• eye redness
• sensitivity to light
• blurred vision
• dry eye
• instillation site pain
• eye pain
• punctate keratitis
• headache
• eye irritation
• visual impairment

Serious side effects of Omidenepag Isopropyl Ophthalmic include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• visual impairment
• chest pain
• coughing
• wheezing
• swelling in the arms or legs
• nausea
• pain
• itching
• increased sensitivity to light
• blurred vision
• dry eye
• pain in the eye
• excessive tearing
• white discharge from the eye
• swollen eyelids
• intense itching of the eye
• feeling like something is in the eye

Rare side effects of Omidenepag Isopropyl Ophthalmic include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Ophthalmic solution

• 0.002% (0.02 mg/mL)

Glaucoma or Ocular Hypertension

Adult dosage

• 1 drop in affected eye(s) every day in the night

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Omidenepag Isopropyl Ophthalmic has no noted severe interactions with any other drugs.
• Omidenepag Isopropyl Ophthalmic has no noted serious interactions with any other drugs.
• Omidenepag Isopropyl Ophthalmic has no noted moderate interactions with any other drugs.
• Omidenepag Isopropyl Ophthalmic has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Omidenepag Isopropyl Ophthalmic?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Omidenepag Isopropyl Ophthalmic?”

Cautions

• May gradually change eyelashes and vellus hair in the treated eye; changes include increased length, thickness, and number of lashes or hair; eyelash changes are usually reversible upon discontinuing treatment
• Ocular inflammation reported; use with caution in patients with active ocular inflammation, including iritis/uveitis
• Macular edema, including cystoid macular edema, reported; exercise caution in aphakic patients, pseudophakic patients, or patients with known risk factors for macular edema
• Advise patients to avoid touching the bottle tip to eye or any surface, as this may contaminate the solution
• Advise patients not to touch the tip of their eye to avoid the potential for injury to the eye
• Pigmentation changes
  • Pigmentation changes are expected to occur and increase if omidenepag Isopropyl Ophthalmic solution is administered
  • Pigmentation change is due to increased melanin content in melanocytes rather than an increased number of melanocytes
  • Iris color change may not be noticeable for several months to years
  • Long-term effects of pigmentation are not known
  • The brown pigmentation around the pupil may spread concentrically towards the periphery of the iris, and the entire iris or parts of the iris become more brownish
  • Neither nevi nor freckles of the iris appear to be affected by treatment, while treatment can be continued in patients who develop noticeably increased iris pigmentation; examine them regularly
  • After discontinuing, iris pigmentation is likely to be permanent, while pigmentation of periorbital tissue and eyelash changes are reversible in most patients
  • Inform the patients receiving prostaglandin analogs about possible increased pigmentation, including permanent changes

Pregnancy and Lactation

• Data are unavailable on the drug’s use in pregnant women
• Lactation
  • There are no data on the drug’s presence in human milk, its effects on breastfed infants, or milk production
  • Systemic exposure to omidenepag following topical ocular administration is low, and it is unknown whether measurable levels of omidenepag would be present in maternal milk following topical ocular administration