Difluprednate .5 mg/mL Emulsion
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroids, potent (group III) class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
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.
Read the full MedlinePlus article ↗- Difluprednate ophthalmic emulsion is a steroid eye drop used for two things: reducing inflammation and pain in the eye after eye surgery, and treating a condition called anterior u...
- Start by removing your contact lenses — the preservative in these drops can soak into soft lenses. Tilt your head back, pull down your lower eyelid, and place one drop inside. Try...
- Some mild side effects are common and usually settle down, including eye redness, light sensitivity, eye pain, blurred vision, and some irritation or crusting around the eyelid. Th...
- What side effects should I expect, and which ones mean I should call my doctor?
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.Inactive ingredient FAQ
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💲 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 | $8.918 | $44.59 / 5 ml |
| Medicaid paysCMS SDUD · 12 mo | $10.89 | $54.46 / 5 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Difluprednate .5 mg/mLthis 00378-7518-35 | Mylan | 1 bottle | $8.918 | AB | Availability likely | — |
| Difluprednate Ophthalmic .5 mg/mL 00781-6000-78 | Sandoz | 1 bottle | $8.918 | AB | Availability likely | — |
| Difluprednate .5 mg/mL 00832-6054-05 | Upsher-Smith | 1 bottle | $8.918 | AB | Availability likely | — |
| Difluprednate Ophthalmic Emulsion .5 mg/mL 43598-0588-11 | Dr. | 1 bottle | $8.918 | AB | Availability likely | — |
| Difluprednate .5 mg/mL 65145-0161-01 | Caplin | 1 bottle | $8.918 | AB | Availability likely | — |
| Difluprednate .5 mg/mL 69238-1380-03 | Amneal | 1 bottle | $8.918 | AB | Availability likely | — |
| Difluprednate .5 mg/mL 69315-0329-05 | Leading | 1 bottle | $8.918 | AB | Availability likely | — |
| Difluprednate .5 mg/mL 69097-0341-35 | Cipla | 1 bottle | $9.786 | AB | FDA listed | +10% |
| Durezol .5 mg/mL 66758-0086-75 | Sandoz | 1 bottle | $42.249 | AB | Availability likely | +374% |
| 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?
⏳ 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?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00378-7518-35 You're viewing this | 1 BOTTLE in 1 CARTON (0378-7518-35) / 5 mL in 1 BOTTLE | 2025-09-26 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Difluprednate ophthalmic emulsion 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 is indicated for the treatment of inflammation and pain associated with ocular surgery.
1.2Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion 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, 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 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 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 reevaluated. ( 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 )
5.1Intraocular 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 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 Melting 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 reevaluated.
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 culture should be taken when appropriate.
5.8Topical Ophthalmic Use Difluprednate ophthalmic emulsion is not indicated for intraocular administ…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious reactions are found elsewhere in the labeling: • Intraocular 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 opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis.
For treatment of endogenous anterior uveitis, most common adverse reactions (incidence 5% to 10%) are blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis. To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) 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 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 pruritus, 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. The most common adverse reactions of those exposed to difluprednate ophthalmic emulsion 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on difluprednate ophthalmic emulsion 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 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/m 2 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/m 2 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/m 2 basis and assuming 100% absorption of the dose).
8.2Lactation Risk Summary There are no data on the presence of difluprednate in human milk, the effects on the breastfed infants, or the effects on milk production to inform risk of difluprednate ophthalmic emulsion 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 and any potential adverse effects on the breast-fed child from difluprednate ophthalmic emulsion or from the underlying maternal condition.
8.4Pediatric Use Difluprednate ophthalmic emulsion was evaluated in a 3-month multicenter, double-masked trial in 79 pediatric patients (39 difluprednate ophthalmic emulsion; 40 prednisolone acetate) 0 to 3 years of age for the treatment of inflammati…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on difluprednate ophthalmic emulsion 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 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/m 2 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/m 2 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/m 2 basis and assuming 100% absorption of the dose).
🧒 Pediatric Use ▾
8.4Pediatric Use Difluprednate ophthalmic emulsion was evaluated in a 3-month multicenter, double-masked trial in 79 pediatric patients (39 difluprednate ophthalmic emulsion; 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 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%) 4 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 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, white opaque to slightly translucent topical ophthalmic emulsion supplied in a white opaque plastic bottle with a controlled drop tip and a pink cap in the following size: NDC 0378-7518-35 5 mL in a 5 mL bottle Storage and Handling Store at 15° to 25°C (59° to 77°F). Do not freeze. Protect from light. When not in use, keep the bottles in the protective carton.
📋 Description ▾
11 DESCRIPTION Difluprednate ophthalmic emulsion 0.05% is a sterile, white opaque to slightly translucent topical anti-inflammatory corticosteroid for topical ophthalmic use. The chemical name is 6α, 9-difluoro-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 empirical formula is C 27 H 34 F 2 O 7 .
Each mL of difluprednate ophthalmic emulsion contains: Active: difluprednate 0.5 mg (0.05%); Inactive: boric acid, castor oil, glycerin, polysorbate 80, water for injection, sodium acetate, edetate disodium, sodium hydroxide (to adjust the pH to 5.2 to 5.8). Preservative: sorbic acid 0.1%. The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsm/kg.
Difluprednate Structural Formula
💬 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 while wearing contact lenses.
Advise patients to remove contact lenses prior to instillation of difluprednate ophthalmic emulsion. Lenses may be reinserted after 10 minutes following administration of difluprednate ophthalmic emulsion [see Warnings and Precautions (5.9) ] . Distributed by: Mylan Pharmaceuticals Inc., a Viatris Company Morgantown, WV 26505 U.S.A Manufactured by: Mylan Laboratories Limited Bangalore, India Revised: 4/2026 M:DIFLUPR:R1