Difluprednate Ophthalmic .5 mg/mL
Difluprednate Ophthalmic · EMULSION · Sandoz Inc
Difluprednate Ophthalmic is a emulsion containing difluprednate ophthalmic at .5 mg/mL, taken ophthalmic. Manufactured by Sandoz Inc.
Key Facts
- Brand Name
- Difluprednate Ophthalmic
- Generic Name
- Difluprednate Ophthalmic
- NDC Code (Product)
0781-6000- Manufacturer
- Sandoz Inc
- Strength
- .5 mg/mL
- Dosage Form
- EMULSION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA022212
- Marketing Start
- 05/15/2013
Recall History
CIPLA
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
CIPLA
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
CIPLA
Lack of Assurance of Sterility: Complaints received of defective container closure.
CIPLA
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 ) 1.1 Ocular Surgery Difluprednate ophthalmic emulsion is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion 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…
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 )
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 Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda…
Frequently Asked Questions
What is Difluprednate Ophthalmic used for?
Difluprednate Ophthalmic contains Difluprednate Ophthalmic. It is a emulsion taken ophthalmic. Consult your doctor for specific uses.
Is Difluprednate Ophthalmic a controlled substance?
Difluprednate Ophthalmic is not classified as a controlled substance by the DEA.
What is the generic name for Difluprednate Ophthalmic?
The generic name for Difluprednate Ophthalmic is Difluprednate Ophthalmic. There are 4 other brand versions of Difluprednate Ophthalmic.
What is the NDC code for Difluprednate Ophthalmic .5 mg/mL?
The NDC (National Drug Code) for Difluprednate Ophthalmic .5 mg/mL is 0781-6000, listed by Sandoz Inc.