Durezol

Difluprednate ophthalmic is used to treat eye swelling and pain after eye surgery. Difluprednate ophthalmic is in a class of medications called corticosteroids. It works by stopping the release of certain natural substances that cause swelling and pain.

Appropriate studies have not been performed on the relationship of age to the effects of difluprednate eye drops in the pediatric population. Safety and efficacy have not been established.

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pain behind your eyes, sudden vision changes, severe headache;

• sudden eye redness, itching, or other irritation;

• slow healing after your eye surgery;

• signs of new eye infection, such as swelling, draining, or crusting of your eyes;

• eye pain, tunnel vision, or seeing halos around lights; or

• changes in the color or appearance of your iris (the colored part of your eye).

Common side effects may include:

• headache;

• blurred vision;

• mild burning, stinging, or itching of your eyes;

• dry or watery eyes;

• feeling like something is in your eye; or

• increased sensitivity of your eyes to light.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Difluorinated corticosteroid.1 2

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic emulsion.1

Not for intraocular administration.1

Avoid contamination of the preparation container.1

Do not wear contact lenses during therapy.1

If used with other topical ophthalmic drugs (e.g., β-adrenergic blocking agents, carbonic anhydrase inhibitors, α-agonists, cycloplegics, mydriatics) separate administration by 10 minutes.3

Dosage

Adults

Initially, 1 drop into the conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours after surgery and continuing for 2 weeks.1 Then decrease to 1 drop twice daily for 1 week.1 Thereafter, taper based on response.1

Special Populations

No special population dosage recommendations at this time.1 3

Absorption

Bioavailability

Corticosteroids are absorbed through the aqueous humor; because only low doses are given, little if any systemic absorption occurs.1 a

Distribution

Extent

Systemically absorbed corticosteroids are distributed into milk; not known whether topical corticosteroids could produce detectable levels in human milk.1 a

Elimination

Metabolism

Deacetylated to active metabolite.1

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of difluprednate eye drops in the pediatric population. Safety and efficacy have not been established.

Geriatric

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

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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:

• Cataract surgery—Use with caution. May cause delayed healing.

• Eye infection (fungus, mycobacterial) or
• Eye infection, virus (e.g., herpes simplex)—Should not be used in patients with these conditions.

• Glaucoma—Use with caution. May make this condition worse.

• Store at room temperature. Do not freeze.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Ocular Surgery

Durezol® (difluprednate ophthalmic emulsion) 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery.

Endogenous Anterior Uveitis

Durezol is also indicated for the treatment of endogenous anterior uveitis.

The following serious reactions are found elsewhere in the labeling:

• Elevated IOP [see Warnings and Precautions (5.1)]
• Posterior subcapsular cataract formation [see Warnings and Precautions (5.2)]
• Secondary ocular infection [see Warnings and Precautions (5.4)]
• Perforation of the globe [see Warnings and Precautions (5.3)]

Ocular Surgery

Ocular adverse reactions occurring in 5% to 15% of subjects in clinical studies with Durezol included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis.  Other ocular adverse reactions occurring in 1% to 5% of subjects included reduced visual acuity, punctate keratitis, eye inflammation, and iritis.  Ocular adverse reactions occurring in less than 1% of subjects included application site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritis, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, sclera hyperemia, and uveitis.  Most of these reactions may have been the consequence of the surgical procedure.

Endogenous Anterior Uveitis

A total of 200 subjects participated in the clinical trials for endogenous anterior uveitis, of which 106 were exposed to Durezol.  The most common adverse reactions of those exposed to Durezol occurring in 5% to 10% of subjects included blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis.  Adverse reactions occurring in 2% to 5% of subjects included anterior chamber flare, corneal edema, dry eye, iridocyclitis, photophobia, and reduced visual acuity.

Ocular Surgery

Clinical efficacy was evaluated in 2 randomized, double-masked, placebo-controlled trials in which subjects with an anterior chamber cell grade greater than or equal to "2" (a cell count of 11 or higher) after cataract surgery were assigned to Durezol or placebo (vehicle) following surgery. One drop of Durezol or vehicle was self-instilled either 2 times per day or 4 times per day for 14 days, beginning the day after surgery. The presence of complete clearing (a cell count of 0) was assessed 3, 8 and 15 days post surgery using a slit lamp binocular microscope. In the intent-to-treat analyses of both studies, a significant benefit was seen in the 4 times per day Durezol-treated group in ocular inflammation, at Days 8 and 15, and reduction of pain, at Days 3, 8 and 15, when compared with placebo. The consolidated clinical trial results are provided below.

Figure 1 Percent of Subjects With Anterior Chamber Cells Clearing (Cell Count = 0)

Figure 2 Percent of Subjects Who Were Pain Free

Endogenous Anterior Uveitis

Clinical efficacy was evaluated in two randomized, double masked active controlled trials in which patients who presented with endogenous anterior uveitis were treated with either Durezol 4 times daily or prednisolone acetate ophthalmic suspension, 1%, 8 times daily for 14 days.  Both studies demonstrated that Durezol was equally effective as prednisolone acetate ophthalmic suspension, 1% in treating subjects with endogenous anterior uveitis. The results are found in Table 1 below.

NDC 0065-9240-07

Rx Only

Durezol®
(difluprednate ophthalmic emulsion) 0.05%

Alcon®
a Novartis company

Sterile
5 mL

Applies to difluprednate ophthalmic: ophthalmic emulsion

Ocular

Common (1% to 10%): Corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, blepharitis, reduced visual acuity, punctate keratitis, eye inflammation, iritis, blurred vision, eye irritation
Uncommon (0.1% to 1%): Corneal pigmentation and striae, episcleritis, eye pruritus, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, sclera hyperemia, uveitis, increased intraocular pressure, iritis, limbal and conjunctival hyperemia, dry eye, iridocyclitis[Ref]

General

The most commonly reported side effects were elevated intraocular pressure, visual acuity and field defects, and posterior subcapsular cataract formation.[Ref]

Local

Uncommon (0.1% to 1%): Application site discomfort or irritation[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

Some side effects of Durezol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.