DUREZOL .5 mg/mL

difluprednate · EMULSION · Sandoz Inc

No Recall History

Plain English

DUREZOL is a emulsion containing difluprednate at .5 mg/mL, taken ophthalmic. Manufactured by Sandoz Inc.

Key Facts

Brand Name: DUREZOL
Generic Name: difluprednate
NDC Code (Product): 66758-086
Manufacturer: Sandoz Inc
Strength: .5 mg/mL
Dosage Form: EMULSION
Route: OPHTHALMIC
Marketing Status
Application #: NDA022212
Marketing Start: 01/25/2011

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

intraocular pressure increased528 reports

drug ineffective241 reports

eye pain231 reports

vision blurred186 reports

off label use171 reports

eye irritation167 reports

cataract158 reports

visual impairment153 reports

fatigue130 reports

headache122 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE DUREZOL ® 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 DUREZOL is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis DUREZOL 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 DUREZOL, 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. DUREZOL 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 DUREZOL used for?

DUREZOL contains difluprednate. It is a emulsion taken ophthalmic. Consult your doctor for specific uses.

Is DUREZOL a controlled substance?

DUREZOL is not classified as a controlled substance by the DEA.

What is the generic name for DUREZOL?

The generic name for DUREZOL is difluprednate. There are 10 other brand versions of difluprednate.

What is the NDC code for DUREZOL .5 mg/mL?

The NDC (National Drug Code) for DUREZOL .5 mg/mL is 66758-086, listed by Sandoz Inc.

Product NDC

66758-086

Package NDC

66758-086-75

Other Difluprednate Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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