Difluprednate Ophthalmic Emulsion .5 mg/mL Emulsion — NDC 43598-588-11 (Billing 43598-0588-11)
This is a package of Difluprednate Ophthalmic Emulsion .5 mg/mL Emulsion from Dr. Reddy's Laboratories Inc., marketed since Dec 2022 and currently FDA-listed; retail pharmacies pay about $9.69 per mL (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 064354
- GCN: 13635
- GPI-14 (Medi-Span): 86300012001620
- HICL (First Databank): 011782
- AHFS class code: 52:08.08.00
- RxCUI (RxNorm): 804544
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Corticosteroids, potent (group III) class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It treats inflammation and pain after eye surgery. It is also used for endogenous anterior uveitis, which is inflammation in the front of the eye.
- Put one drop in the affected eye as prescribed. Usually that's several times a day at first, then tapering down. Keep the dropper tip from touching your eye or anything else so the...
- Take them out before using the drops. The preservative can be absorbed by soft lenses. You can put them back in after 10 minutes, if your eye doctor says it's okay.
- Eye pain, redness, light sensitivity, swelling, blurred vision and irritation are the most common. Some may be from the surgery itself. Call your doctor if things get worse or don'...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $9.687 | $48.43 / 5 ml |
| Medicaid paysCMS SDUD · 12 mo | $14.66 | $73.29 / 5 ml |
| Medicare drug plans payPart D · Q2 2026 | $18.89 | $94.44 / 5 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 43598-0588-11 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE | 2022-12-25 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Difluprednate .5 mg/mL 00378-7518-35 | Mylan | 1 bottle | $9.687 | AB | Availability likely | — |
| Difluprednate Ophthalmic .5 mg/mL 00781-6000-78 | Sandoz | 1 bottle | $9.687 | AB | Availability likely | — |
| Difluprednate .5 mg/mL 00832-6054-05 | Upsher-Smith | 1 bottle | $9.687 | AB | Availability likely | — |
| Difluprednate Ophthalmic Emulsion .5 mg/mLthis 43598-0588-11 | Dr. | 1 bottle | $9.687 | AB | Availability likely | — |
| Difluprednate .5 mg/mL 65145-0161-01 | Caplin | 1 bottle | $9.687 | AB | Availability likely | — |
| Difluprednate .5 mg/mL 69238-1380-03 | Amneal | 1 bottle | $9.687 | AB | Availability likely | — |
| Difluprednate .5 mg/mL 69315-0329-05 | Leading | 1 bottle | $9.687 | AB | Availability likely | — |
| Difluprednate .5 mg/mL 69097-0341-35 | Cipla | 1 bottle | $9.786 | AB | FDA listed | +1% |
| Durezol .5 mg/mL 66758-0086-75 | Sandoz | 1 bottle | $42.249 | AB | Availability likely | +336% |
| Difluprednate .5 mg/mL 46708-0750-05 | Alembic | 1 bottle | — | AB | FDA listed | — |
| Difluprednate .5 mg/mL 62332-0750-05 | Alembic | 1 bottle | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII R57ZHV85D4
Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
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UNII D5340Y2I9G
Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII NVG71ZZ7P0
A salt derived from acetic acid, sodium acetate anhydrous is used in medicines as a buffer to help maintain stable pH levels and sometimes as a preservative or bulking agent in solid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII X045WJ989B
Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Difluprednate ophthalmic emulsion (0.05%) is a corticosteroid indicated for: The treatment of inflammation and pain associated with ocular surgery ( 1.1 ) The treatment of endogenous anterior uveitis ( 1.2 )
1.1Ocular Surgery Difluprednate ophthalmic emulsion (0.05%) is indicated for the treatment of inflammation and pain associated with ocular surgery.
1.2Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion (0.05%) is indicated for the treatment of endogenous anterior uveitis.
1.1Ocular Surgery Difluprednate ophthalmic emulsion (0.05%) is indicated for the treatment of inflammation and pain associated with ocular surgery.
1.2Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion (0.05%) is indicated for the treatment of endogenous anterior uveitis.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For the treatment of inflammation and pain associated with ocular surgery instill one drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response. ( 2.1 ) For the treatment of endogenous anterior uveitis instill one drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated.
( 2.2 )
2.1Ocular Surgery Instill one drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response.
2.2Endogenous Anterior Uveitis Instill one drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated.
2.3Prescribing Guidelines The initial prescription and renewal of the medication order beyond one bottle should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be reevaluated. Not more than one bottle should be prescribed initially, and the prescription should not be refilled without further evaluation.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ophthalmic emulsion containing 0.05% difluprednate. Ophthalmic emulsion: 0.05%. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Difluprednate ophthalmic emulsion (0.05%), as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. Difluprednate ophthalmic emulsion (0.05%) is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Intraocular Pressure (IOP) Increase: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If difluprednate ophthalmic emulsion (0.05%) is used for 10 days or longer, IOP should be monitored. ( 5.1 ) Cataracts : Use of corticosteroids may result in posterior subcapsular cataract formation.
( 5.2 ) Delayed Healing: The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation. ( 5.3 ) Corneal and Scleral Melting: In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. ( 5.4 ) Bacterial Infections: Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections.
In acute purulent conditions, corticosteroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. ( 5.5 ) Viral Infections: Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.
Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). ( 5.6 ) Fungal Infections: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use.
( 5.7 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 5.1 lntraocular Pressure (IOP) Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision.
Corticosteroids should be used with caution in the presence of glaucoma. If difluprednate ophthalmic emulsion (0.05%) is used for 10 days or longer, IOP should be routinely monitored.
5.2Cataracts The use of corticosteroids may result in posterior subcapsular cataract formation.
5.3Delayed Healing The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order beyond 28 days should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
5.4Corneal and Scleral Meling Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation of the globe.
5.5Bacterial Infections Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, corticosteroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
5.6Viral Infections Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex ). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.
5.7Fungal Infections Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious reactions are found elsewhere in the labeling: lntraocular Pressure (IOP) Increase [see Warnings and Precautions ( 5. 1 )] Cataracts [see Warnings and Precautions ( 5.2 )] Delayed Healing [see Warnings and Precautions ( 5.3 )] Corneal and Scleral Melting [see Warnings and Precautions ( 5.4 )] Bacterial Infections [see Warnings and Precautions ( 5.5 )] Viral Infections [see Warnings and Precautions ( 5.6 )] Fungal Infections [see Warnings and Precautions ( 5. 7 )] For treatment of inflammation and pain associated with ocular surgery, most common adverse reactions (incidence 5% to 15%) are corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacificalion, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharilis.
For treatment of endogenous anterior uveilis, most common adverse reactions (incidence 5% to 10%) are blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratilis, and uveitis. To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Ocular Surgery Ocular adverse reactions occurring in 5% to 15% of subjects in clinical studies with difluprednate ophthalmic emulsion (0.05%) 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.
6.2Endogenous Anterior Uveitis A total of 200 subjects participated in the clinical trials for endogenous anterior uveitis, of which 106 were exposed to difluprednate ophthalmic emulsion (0.05%). The most common adverse reactions of those exposed to difluprednate ophthalmic emulsion (0.05%) 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.
6.1Ocular Surgery Ocular adverse reactions occurring in 5% to 15% of subjects in clinical studies with difluprednate ophthalmic emulsion (0.05%) 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on difluprednate ophthalmic emulsion (0.05%) use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Systemic exposure to difluprednate ophthalmic emulsion (0.05%) following ocular administration is low [see Clinical Pharmacology ( 12.3 )] . Consequently, the systemic exposure of a pregnant woman to difluprednate is expected to be minimal following topical ocular administration.
In animal reproductive studies, subcutaneous administration of difluprednate to pregnant rabbits and rats throughout organogenesis produced maternal toxicity, embryo-fetal toxicity and teratogenicity in rabbits and fetotoxicity in rats. Administration of difluprednate to rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15%to 20%, respectively. Data Animal Data In embryofetal development studies, subcutaneous administration of difluprednate to pregnant rats during the period of organogenesis decreased the placental weight, at doses greater than or equal to 10 mcg/kg/day (approximately 0.48-fold higher than the maximum recommended human ophthalmic dose [MRHOD] of 0.2 mg/day, on a mg/m2 basis and assuming 100% absorption of the dose).
Decreased weight gain and delayed ossification of the fetus were observed at a dose of 100 mcg/kg/day (approximately 4.8-fold higher than the MRHOD). The no-observed-effect level (NOEL) for teratogenic effects was 10 mcg/kg/day. In rabbits, subcutaneous administration of difluprednate during the period of organogenesis produced maternal toxicity, embryofetal lethality, fetal growth retardation and teratogenicity (cleft palate, cerebral hernia, exencephaly, hypogenesis of the first digit of the forelimbs, club hand, umbilical hernia and others) at 10 mcg/kg/day (approximately 0.97-fold the MRHOD on a mg/m2 basis and assuming 100% absorption of the dose).
The NOEL was 1 mcg/kg/day. In a peri- or pre-/postnatal study in rats, subcutaneous administration of difluprednate during late gestation through lactation resulted in no abnormalities in postnatal development, growth and behavior or reproductive potential. The NOEL was greater than or equal to 10 mcg/kg/day (the highest dose tested; approximately 0.48-fold higher than the MRHOD on a mg/m2 basis and assuming 100% absorption of the dose).
8.2Lactation There are no data on the presence of difluprednate ophthalmic emulsion (0.05%) in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of difluprednate ophthalmic emulsion (0.05%) to an infant during lactation. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. The systemic exposure of a breastfeeding woman to difluprednate is expected to be minimal following topical ocular administration, however, the possibility of harm to the breastfed child cannot be ruled out.The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for difluprednate ophthalmic emulsion (0.05%) and any potential adverse effects on the breast-fed child from difluprednate ophthalmic emulsion (0.05%) or from the underlying maternal condition.
8.3Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemi… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on difluprednate ophthalmic emulsion (0.05%) use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Systemic exposure to difluprednate ophthalmic emulsion (0.05%) following ocular administration is low [see Clinical Pharmacology ( 12.3 )] . Consequently, the systemic exposure of a pregnant woman to difluprednate is expected to be minimal following topical ocular administration.
In animal reproductive studies, subcutaneous administration of difluprednate to pregnant rabbits and rats throughout organogenesis produced maternal toxicity, embryo-fetal toxicity and teratogenicity in rabbits and fetotoxicity in rats. Administration of difluprednate to rats during late gestation through lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15%to 20%, respectively. Data Animal Data In embryofetal development studies, subcutaneous administration of difluprednate to pregnant rats during the period of organogenesis decreased the placental weight, at doses greater than or equal to 10 mcg/kg/day (approximately 0.48-fold higher than the maximum recommended human ophthalmic dose [MRHOD] of 0.2 mg/day, on a mg/m2 basis and assuming 100% absorption of the dose).
Decreased weight gain and delayed ossification of the fetus were observed at a dose of 100 mcg/kg/day (approximately 4.8-fold higher than the MRHOD). The no-observed-effect level (NOEL) for teratogenic effects was 10 mcg/kg/day. In rabbits, subcutaneous administration of difluprednate during the period of organogenesis produced maternal toxicity, embryofetal lethality, fetal growth retardation and teratogenicity (cleft palate, cerebral hernia, exencephaly, hypogenesis of the first digit of the forelimbs, club hand, umbilical hernia and others) at 10 mcg/kg/day (approximately 0.97-fold the MRHOD on a mg/m2 basis and assuming 100% absorption of the dose).
The NOEL was 1 mcg/kg/day. In a peri- or pre-/postnatal study in rats, subcutaneous administration of difluprednate during late gestation through lactation resulted in no abnormalities in postnatal development, growth and behavior or reproductive potential. The NOEL was greater than or equal to 10 mcg/kg/day (the highest dose tested; approximately 0.48-fold higher than the MRHOD on a mg/m2 basis and assuming 100% absorption of the dose).
🧒 Pediatric Use ▾
8.4Pediatric Use Difluprednate ophthalmic emulsion (0.05%) was evaluated in a 3-month, multicenter, double‑masked trial in 79 pediatric patients (39 difluprednate ophthalmic emulsion (0.05%); 40 prednisolone acetate) 0 to 3 years of age for the treatment of inflammation following cataract surgery. A similar safety profile was observed in pediatric patients comparing difluprednate ophthalmic emulsion (0.05%) to prednisolone acetate ophthalmic suspension, 1%.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Corticosteroids inhibit the inflammatory response to a variety of inciting agents and may delay or slow healing. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids.
However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotreines by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.Difluprednate is structurally similar to other corticosteroids.
12.3Pharmacokinetics Difluprednate undergoes deacetylation in-vivo to 6α, 9-difluoroprednisolone 17-butyrate (DFB), an active metabolite of difluprednate. Clinical pharmacokinetic studies of difluprednate after repeat ocular instillation of 2 drops of difluprednate (0.01 % or 0.05 %) four times per day for 7 days showed that DFB levels in blood were below the quantification limit (50 ng/mL) at all time points for all subjects, indicating that the systemic absorption of difluprednate after ocular instillation of difluprednate ophthalmic emulsion (0.05%) is limited.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Corticosteroids inhibit the inflammatory response to a variety of inciting agents and may delay or slow healing. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids.
However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotreines by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.Difluprednate is structurally similar to other corticosteroids.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Difluprednate ophthalmic emulsion (0.05%) is a sterile, aqueous topical ophthalmic emulsion supplied in an opaque plastic bottle with a controlled drop tip and a pink cap in the following size: 5 mL in one bottle (NDC 43598-588-11) Storage and Handling Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Difluprednate ophthalmic emulsion (0.05%) is a sterile, topical anti-inflammatory corticosteroid for topical ophthalmic use. The chemical name is 6α,9difluoro-11β,17,21- trihydroxypregna-1,4- diene-3,20-dione 21-acetate 17-butyrate (CAS number 23674-86-4). Difluprednate is represented by the following structural formula: Difluprednate has a molecular weight of 508.55 g/mol, and the molecular formula is C 27 H 34 F 2 O 7 .
Each mL difluprednate ophthalmic emulsion (0.05%) contains: ACTIVE: difluprednate 0.5 mg (0.05%); INACTIVE: boric acid, castor oil, glycerin, polysorbate 80, water for injection, sodium acetate anhydrous, edetate disodium dihydrate, sodium hydroxide (to adjust the pH between 5.2 and 5.8). The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsm/kg. PRESERVATIVE: sorbic acid 0.1%.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION When to Consult a Physician Advise patients to consult a physician if pain develops, or if redness, itching, or inflammation becomes aggravated [see Warnings and Precautions (5.5)]. Risk of Contamination Advise patients to not allow the dropper tip to touch the eye, eyelids, or any surface, as this may contaminate the ophthalmic emulsion. Contact Lens Wear Advise patients to not use difluprednate ophthalmic emulsion (0.05%) while wearing contact lenses.
Advise patients to remove contact lenses prior to instillation of difluprednate ophthalmic emulsion (0.05%). Lenses may be reinserted after 10 minutes following administration of difluprednate ophthalmic emulsion (0.05%) [see Warnings and Precautions (5.9)]. Rx Only Distributor: Dr.
Reddy’s Laboratories Inc., Princeton, NJ 08540 Product of Italy Issued: 09/2025
🍼 Nursing Mothers ▾
8.3Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when difluprednate ophthalmic emulsion (0.05%) is administered to a nursing woman.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Difluprednate undergoes deacetylation in-vivo to 6α, 9-difluoroprednisolone 17-butyrate (DFB), an active metabolite of difluprednate. Clinical pharmacokinetic studies of difluprednate after repeat ocular instillation of 2 drops of difluprednate (0.01 % or 0.05 %) four times per day for 7 days showed that DFB levels in blood were below the quantification limit (50 ng/mL) at all time points for all subjects, indicating that the systemic absorption of difluprednate after ocular instillation of difluprednate ophthalmic emulsion (0.05%) is limited.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Ocular 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 difluprednate ophthalmic emulsion (0.05%) or placebo (vehicle) following surgery. One drop of difluprednate ophthalmic emulsion (0.05%) 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 (QID) difluprednate ophthalmic emulsion (0.05%)-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
14.2Endogenous 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 difluprednate ophthalmic emulsion (0.05%) 4 times daily or prednisolone acetate ophthalmic suspension, 1%, 8 times daily for 14 days. Both studies demonstrated that difluprednate ophthalmic emulsion (0.05%) was equally effective as prednisolone acetate ophthalmic suspension, 1% in treating subjects with endogenous anterior uveitis.
The results are found in Table 1 below. Table 1: Mean Change From Baseline in Anterior Chamber Cell Grade* Study 1 time point Difluprednate Ophthalmic Emulsion (0.05%) N=57 Prednisolone Acetate N=53 Difference † (95% CI) Baseline 2.6 2.5 0.0 (-0.22, 0.28) Day 3 -1.0 -1.0 -0.1 (-0.35, 0.25) Day 7 -1.6 -1.5 -0.0 (-0.31, 0.25) Day 14 -2.0 -1.8 -0.2 (-0.46, 0.10) Day 21 -2.2 -1.9 -0.3 (-0.53, 0.01) Day 28 -2.2 -2.1 -0.1 (-0.37, 0.18) Day 35 -2.1 -2.0 -0.1 (-0.39, 0.20) Day 42 -2.1 -2.1 0.0 (-0.27, 0.34) Study 2 time point Difluprednate Ophthalmic Emulsion (0.05%) N=50 Prednisolone Acetate N=40 Difference † (95% CI) Baseline 2.4 2.4 0.0 (-0.21, 0.29) Day 3 -0.9 -0.9 -0.0 (-0.34, 0.25) Day 7 -1.7 -1.6 -0.1 (-0.35, 0.21) Day 14 -1.9 -1.8 -0.1 (-0.34, 0.20) Day 21 -2.0 -2.0 0.0 (-0.25, 0.28) Day 28 -2.0 -2.0 0.0 (-0.21, 0.26) Day 35 -2.1 -2.0 -0.1 (-0.32, 0.16) Day 42 -2.0 -1.9 -0.1 (-0.36, 0.24) * With 5 grades: 0 = 0 cells; 1 = 1 to 10 cells; 2 = 11 to 20 cells; 3 = 21 to 50 cells; and 4 = greater than 50 cells † Adjusted for baseline AC cell grade and study center and based on ITT dataset with LOCF for missing data
14.1Ocular 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 difluprednate ophthalmic emulsion (0.05%) or placebo (vehicle) following surgery. One drop of difluprednate ophthalmic emulsion (0.05%) 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 (QID) difluprednate ophthalmic emulsion (0.05%)-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
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenesis Long-term studies have not been conducted to evaluate the carcinogenic potential of difluprednate. Mutagenesis Difluprednate was not genotoxic in vitro in the Ames test, and in cultured mammalian cells (CHUIU; a fibroblastic cell line derived from the lungs of newborn female Chinese hamsters) or in an in vivo micronucleus test of difluprednate in mice. Impairment of Fertility Treatment of male and female rats with subcutaneous difluprednate up to 10 mcg/kg/day prior to and during mating did not impair fertility in either gender.
13.2Animal Toxicology and/or Pharmacology In multiple studies performed in rodents and non-rodents, subchronic and chronic toxicity tests of difluprednate showed systemic effects such as suppression of body weight gain; a decrease in lymphocyte count; atrophy of the lymphatic glands and adrenal gland; and for local effects, thinning of the skin; all of which were due to the pharmacologic action of the molecule and are well known glucocorticosteroid effects. Most, if not all of these effects were reversible after drug withdrawal.
The NOEL for the subchronic and chronic toxicity tests were consistent between species and ranged from 1 to 1.25 mcg/kg/day.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenesis Long-term studies have not been conducted to evaluate the carcinogenic potential of difluprednate. Mutagenesis Difluprednate was not genotoxic in vitro in the Ames test, and in cultured mammalian cells (CHUIU; a fibroblastic cell line derived from the lungs of newborn female Chinese hamsters) or in an in vivo micronucleus test of difluprednate in mice. Impairment of Fertility Treatment of male and female rats with subcutaneous difluprednate up to 10 mcg/kg/day prior to and during mating did not impair fertility in either gender.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION Difluprednate Ophthalmic Emulsion (0.05%) - Bottle Label
Difluprednate Ophthalmic Emulsion (0.05%) - Carton Label