Omlonti (omidenepag isopropyl)

No dosing information is available for this tab.

Omidenepag isopropyl is administered once daily in the evening.

If more than 1 topical ophthalmic drug is being used, administer the drugs at least 5 minutes apart. Remove contact lenses prior to administration of omidenepag isopropyl, and reinsert 15 minutes after administration.

Store omidenepag isopropyl at 2-8degreesC. Once a bottle is opened for use, it can be stored for up to 31 days at up to 30degreesC.

No dosing information is available for this tab.

No dosing information is available for this tab.

Omidenepag isopropyl is rapidly metabolized in the eye to omidenepag (the active moiety) by carboxylesterase-1. The pharmacologically active form, omidenepag, is further metabolized in the liver through oxidation, N-dealkylation, glucuronidation, sulfate conjugation, or taurine conjugation.

Formal drug interaction studies of omidenepag isopropyl have not been performed.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

Moderate Interaction: Assess the risk to the patient and take action as needed.

Iop-Lowering Prostaglandin Analogs/Bimatoprost Topical

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: When used ophthalmically to lower intraocular pressure, prostaglandin analogs may be at the top of the dose-response curve. Use of an additional prostaglandin may result in decreased effectiveness.(1)

CLINICAL EFFECTS: Concurrent use of topical bimatoprost may result in decreased effectiveness of ophthalmic prostaglandin analogs and an increase in intraocular pressure.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Patients using ophthalmic prostaglandin analogs to lower intraocular pressure should be monitored for changes in their intraocular pressure.(1) Use of topical bimatoprost may need to be discontinued in patients who stop responding to their ophthalmic prostaglandin analogue.

DISCUSSION: Studies have shown that the ophthalmic administration of bimatoprost twice daily is less effective at lowering intraocular pressure than ophthalmic bimatoprost administered once daily. Concurrent use of topical bimatoprost may decrease the effectiveness of ophthalmic prostaglandin analogs.(1)

*None.

There are no contraindication contraindications for this drug.

• Aphakia
• Cystoid macular edema
• Iritis
• Pseudophakia
• Uveitis

There are no moderate contraindications for this drug.

The most common adverse reactions with incidence >=1% are conjunctival hyperemia, photophobia, blurred vision, dry eye, instillation site pain, eye pain, ocular hyperemia, punctate keratitis, headache, eye irritation, and visual impairment.

Less Frequent

• Blurred vision

More Frequent

• Conjunctival hyperemia

Less Frequent

• Cystoid macular edema
• Dry eye
• Headache disorder
• Macular retinal edema
• Ocular inflammation
• Ocular irritation
• Ocular pain
• Photophobia
• Punctate keratitis
• Vision impairment

No enhanced messaging available.

The safety and effectiveness of omidenepag isopropyl have not been established in pediatric patients.

There are no available data on the use of omidenepag isopropyl in pregnant patients. In animal studies, subcutaneous administration of omidenepag isopropyl at doses higher than the recommended human dose resulted in fetal skeletal anomalies in rabbits, and was not teratogenic in rats.

There are no data on the presence of omidenepag isopropyl in human milk, the effects on the breast-fed infant, or the effects on milk production. However, systemic exposure to omidenepag following topical ocular administration is low and it is not known whether measurable levels of omidenepag would be present in maternal milk following topical ocular administration. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for omidenepag isopropyl and any unknown potential adverse effects on the breast-fed child from omidenepag isopropyl.

The manufacturer makes no specific dosage recommendations for geriatric patients.

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.