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Drug overview for DUREZOL (difluprednate):
Generic name: DIFLUPREDNATE (DYE-floo-PRED-nate)
Drug class: Ophthalmic Steroids
Therapeutic class: Ophthalmic Agents
Difluprednate is a difluorinated corticosteroid.
No enhanced Uses information available for this drug.
Generic name: DIFLUPREDNATE (DYE-floo-PRED-nate)
Drug class: Ophthalmic Steroids
Therapeutic class: Ophthalmic Agents
Difluprednate is a difluorinated corticosteroid.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for DUREZOL (difluprednate) have been approved by the FDA:
Indications:
Anterior uveitis
Post-op ocular inflammation
Postoperative ocular pain
Professional Synonyms:
Post-op ocular pain
Postoperative eye pain
Postoperative ocular inflammation
Postoperative ophthalmic inflammation
Indications:
Anterior uveitis
Post-op ocular inflammation
Postoperative ocular pain
Professional Synonyms:
Post-op ocular pain
Postoperative eye pain
Postoperative ocular inflammation
Postoperative ophthalmic inflammation
The following dosing information is available for DUREZOL (difluprednate):
The recommended initial adult dosage of difluprednate for the treatment of postoperative inflammation and pain in patients who have undergone ocular surgery is 1 drop of a 0.05% emulsion in the affected eye(s) 4 times daily, beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period. After 2 weeks of therapy, dosage should be reduced to 1 drop twice daily for 1 week and then gradually tapered according to response.
Difluprednate is applied topically in the conjunctival sac of the affected eye(s) as an ophthalmic emulsion. Care should be taken to avoid contamination of the emulsion container. Patients should refrain from wearing contact lenses during therapy with difluprednate ophthalmic emulsion unless specifically directed by a clinician.
Difluprednate ophthalmic emulsion may be used in conjunction with other topical ophthalmic drugs such as beta-adrenergic blocking agents, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics, and mydriatics. If the patient is receiving more than one topical ophthalmic drug, the drugs should be administered 10 minutes apart from difluprednate administration.
Difluprednate ophthalmic emulsion may be used in conjunction with other topical ophthalmic drugs such as beta-adrenergic blocking agents, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics, and mydriatics. If the patient is receiving more than one topical ophthalmic drug, the drugs should be administered 10 minutes apart from difluprednate administration.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| DUREZOL 0.05% EYE DROPS | Maintenance | Adults instill 1 drop into affected eye(s) by ophthalmic route 4 times per day ;start 24hrs post op x 2 wks; then 2 times/day x 7 days; then taper |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| DIFLUPREDNATE 0.05% EYE DROP | Maintenance | Adults instill 1 drop into affected eye(s) by ophthalmic route 4 times per day ;start 24hrs post op x 2 wks; then 2 times/day x 7 days; then taper |
The following drug interaction information is available for DUREZOL (difluprednate):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for DUREZOL (difluprednate):
Drug contraindication overview.
Most active viral diseases of the cornea and conjunctiva (including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella (chickenpox)); mycobacterial infection of the eye; and fungal diseases of ocular structures. Known hypersensitivity to difluprednate, other corticosteroids, or any ingredient in the formulation.
Most active viral diseases of the cornea and conjunctiva (including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella (chickenpox)); mycobacterial infection of the eye; and fungal diseases of ocular structures. Known hypersensitivity to difluprednate, other corticosteroids, or any ingredient in the formulation.
There are 5 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Fungal keratitis |
| Herpes simplex dendritic keratitis |
| Herpes zoster keratitis |
| Tuberculosis of the eye |
| Vaccinia virus keratitis |
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Bacterial keratitis |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Ocular hypertension |
The following adverse reaction information is available for DUREZOL (difluprednate):
Adverse reaction overview.
Adverse ocular effects reported in 5-15% of patients receiving difluprednate include corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis. Adverse ocular effects reported in 1-5% of patients include reduced visual acuity, punctate keratitis, eye inflammation, and iritis.
Adverse ocular effects reported in 5-15% of patients receiving difluprednate include corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis. Adverse ocular effects reported in 1-5% of patients include reduced visual acuity, punctate keratitis, eye inflammation, and iritis.
There are 20 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Ocular hypertension |
| Rare/Very Rare |
|---|
|
Adrenocortical insufficiency Cataracts Central serous chorioretinopathy Corneal degeneration Corneal edema Corneal erosion Corneal ulcer Fungal infection of eye Glaucoma Globe perforation Hypercortisolism Hypersensitivity drug reaction Keratitis Optic nerve damage Punctate keratitis Reduced visual acuity Uveitis Visual changes Visual field defect |
There are 23 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Blurred vision |
Headache disorder Iritis Ocular pain |
| Rare/Very Rare |
|---|
|
Accommodation disorder Allergic dermatitis Blepharoptosis Calcification of cornea Chemosis Conjunctival hyperemia Conjunctivitis Dizziness Dysgeusia Eye tearing Foreign body sensation of eye Impaired wound healing Mydriasis Ocular infection Ocular irritation Ocular itching Ocular redness Photophobia Urticaria |
The following precautions are available for DUREZOL (difluprednate):
Safety and efficacy not established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide)
Systemically administered corticosteroids distribute into milk and may suppress growth, interfere with endogenous corticosteroid production, or cause other adverse effects. It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk; caution if used in nursing women.
No substantial differences in safety and efficacy relative to younger adults.
The following prioritized warning is available for DUREZOL (difluprednate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for DUREZOL (difluprednate)'s list of indications:
| Anterior uveitis | |
| H20 | Iridocyclitis |
| H20.0 | Acute and subacute iridocyclitis |
| H20.00 | Unspecified acute and subacute iridocyclitis |
| H20.01 | Primary iridocyclitis |
| H20.011 | Primary iridocyclitis, right eye |
| H20.012 | Primary iridocyclitis, left eye |
| H20.013 | Primary iridocyclitis, bilateral |
| H20.019 | Primary iridocyclitis, unspecified eye |
| H20.02 | Recurrent acute iridocyclitis |
| H20.021 | Recurrent acute iridocyclitis, right eye |
| H20.022 | Recurrent acute iridocyclitis, left eye |
| H20.023 | Recurrent acute iridocyclitis, bilateral |
| H20.029 | Recurrent acute iridocyclitis, unspecified eye |
| H20.03 | Secondary infectious iridocyclitis |
| H20.031 | Secondary infectious iridocyclitis, right eye |
| H20.032 | Secondary infectious iridocyclitis, left eye |
| H20.033 | Secondary infectious iridocyclitis, bilateral |
| H20.039 | Secondary infectious iridocyclitis, unspecified eye |
| H20.04 | Secondary noninfectious iridocyclitis |
| H20.041 | Secondary noninfectious iridocyclitis, right eye |
| H20.042 | Secondary noninfectious iridocyclitis, left eye |
| H20.043 | Secondary noninfectious iridocyclitis, bilateral |
| H20.049 | Secondary noninfectious iridocyclitis, unspecified eye |
| H20.1 | Chronic iridocyclitis |
| H20.10 | Chronic iridocyclitis, unspecified eye |
| H20.11 | Chronic iridocyclitis, right eye |
| H20.12 | Chronic iridocyclitis, left eye |
| H20.13 | Chronic iridocyclitis, bilateral |
| H20.2 | Lens-induced iridocyclitis |
| H20.20 | Lens-induced iridocyclitis, unspecified eye |
| H20.21 | Lens-induced iridocyclitis, right eye |
| H20.22 | Lens-induced iridocyclitis, left eye |
| H20.23 | Lens-induced iridocyclitis, bilateral |
| H20.9 | Unspecified iridocyclitis |
| Post-op ocular inflammation | |
| H57.8 | Other specified disorders of eye and adnexa |
| Postoperative ocular pain | |
| H57.1 | Ocular pain |
| H57.10 | Ocular pain, unspecified eye |
| H57.11 | Ocular pain, right eye |
| H57.12 | Ocular pain, left eye |
| H57.13 | Ocular pain, bilateral |
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