Difluprednate Ophthalmic Emulsion .5 mg/mL
Difluprednate Ophthalmic · EMULSION · Dr. Reddy's Laboratories Inc.
Difluprednate Ophthalmic Emulsion is a emulsion containing difluprednate ophthalmic at .5 mg/mL, taken ophthalmic. Manufactured by Dr. Reddy's Laboratories Inc..
Key Facts
- Brand Name
- Difluprednate Ophthalmic Emulsion
- Generic Name
- Difluprednate Ophthalmic
- NDC Code (Product)
43598-588- Manufacturer
- Dr. Reddy's Laboratories Inc.
- Strength
- .5 mg/mL
- Dosage Form
- EMULSION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA214894
- Marketing Start
- 12/25/2022
Recall History
No Recall HistoryFull Prescribing Information
Indications & 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 ) 1.1 Ocular Surgery Difluprednate ophthalmic emulsion (0.05%) is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion (0.05%) is indicated for the treatment of endogenous anterior uveitis.
Dosage & 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 ) 2.1 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. 2.2 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. 2.3 Prescribing 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 ma…
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 )
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 ww…
Frequently Asked Questions
What is Difluprednate Ophthalmic Emulsion used for?
Difluprednate Ophthalmic Emulsion contains Difluprednate Ophthalmic. It is a emulsion taken ophthalmic. Consult your doctor for specific uses.
Is Difluprednate Ophthalmic Emulsion a controlled substance?
Difluprednate Ophthalmic Emulsion is not classified as a controlled substance by the DEA.
What is the generic name for Difluprednate Ophthalmic Emulsion?
The generic name for Difluprednate Ophthalmic Emulsion is Difluprednate Ophthalmic. There are 4 other brand versions of Difluprednate Ophthalmic.
What is the NDC code for Difluprednate Ophthalmic Emulsion .5 mg/mL?
The NDC (National Drug Code) for Difluprednate Ophthalmic Emulsion .5 mg/mL is 43598-588, listed by Dr. Reddy's Laboratories Inc..