Ilevro™ (nepafenac ophthalmic suspension) 0.3%

What is Ilevro?

Ilevro is a sterile, nonsteroidal and anti-inflammatory ophthalmic suspension topical medication prodrug.

How Does Ilevro Work?

Ilevro penetrates the cornea and is converted by eye tissue hydrolases into amfenac which is a nonsteroidal anti-inflammatory drug. The mechanism of action of nepafenac and amfenac is thought to be by inhibiting the action of prostaglandin production.

Reason for Using Ilevro

Ilevro is indicated for the treatment of pain and inflammation in association with a patient having cataract surgery.

Contraindications for Using Ilevro

Ilevro is contraindicated in patients with a prior history of hypersensitivity to any of the ingredients in Ilevro or to any other nonsteroidal anti-inflammatory medications or NSAIDs.

Precautions or Warnings for Ilevro

Increased Bleeding Times

As with other NSAIDs, there is the potential for increased bleeding times secondary to its interference with thrombocyte aggregation. It is recommended that Ilevro be used with caution in patients with known bleeding problems and/or who are taking medications that prolong bleeding.

Delayed Healing

As with other NASIDs, Ilevro may decrease or slow the healing response in patients. The use Ilevro and corticosteroids together may decrease the healing response even further.

Corneal Effects

As with other NSAIDs, Ilevro may cause keratitis or corneal disease. In some instances, there may be corneal breakdown, corneal ulceration, corneal erosion, corneal thinning, or corneal perforation.

Contact Lens Wear

Ilevro should not be instilled into the eye while wearing contact lenses.

Use in Pregnant and Nursing Women

There are well-controlled studies in pregnant or nursing women. Ilevro should not be used unless the potential benefits outweigh the risks.

Use in Children

Ilevro has not been studied in children below 10 years of age.

Side Effects for Ilevro

Ocular Side Effects

Side Effects in 5 to 10 % of Patients

Decreased vision

Capsular opacification

Increased intraocular pressure

Sticky sensation

Foreign body sensation

Side Effects in 1 to 5 % of Patients

Conjunctival edema

Corneal edema

Eyelid crusting

Red eye

Ocular pain and discomfort

Ocular pruritus

Photophobia

Tearing

 Vitreous detachment

 

Non-Ocular Side Effects

Side Effects in 1 to 4 % of Patients

Headache

Sinusitis

Nausea/vomiting

Hypertension

Administration and Dosage of Ilevro

Ilevro should be started 1 day before cataract surgery and for 14 days following surgery one drop per day in the operated eye.

How is Ilevro Supplied?

Ilevro is supplied in a sterile, white, oval, eye drop dispensing bottle. There is 1.7 mL of medication in a 4ml bottle.

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