Diclofenac Information
Diclofenac ()
Diclofenac () Description:
Diclofenac () Sodium Ophthalmic Solution, 0.1% is a sterile, topical, nonsteroidal anti-inflammatory product for ophthalmic use. Diclofenac () Sodium is designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt, with an empirical formula of CHCINONa. The structural formula of Diclofenac () Sodium is:
Diclofenac () Sodium Ophthalmic Solution, 0.1% is available as a sterile solution which contains Diclofenac () sodium 0.1% (1 mg/mL).
Diclofenac () Sodium is a faintly yellow-white to light-beige, slightly hygroscopic crystalline powder. It is freely soluble in methanol, sparingly soluble in water, very slightly soluble in acetonitrile, and insoluble in chloroform and in 0.1N hydrochloric acid. Its molecular weight is 318.14. Diclofenac () Sodium Ophthalmic Solution is an iso-osmotic solution with an osmolality of about 300 mOsmol/1000 g, buffered at approximately pH 7.2. Diclofenac () Sodium Ophthalmic Solution has a faint characteristic odor of castor oil.
Diclofenac () Indications And Usage:
Diclofenac () Sodium Ophthalmic Solution, 0.1% is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.
Diclofenac () Contraindications:
Diclofenac () Sodium Ophthalmic Solution, 0.1% is contraindicated in patients who are hypersensitive to any component of the medication.
Diclofenac () Warnings:
The refractive stability of patients undergoing corneal refractive procedures and treated with Diclofenac () Sodium Ophthalmic Solution has not been established. Patients should be monitored for a year following use in this setting.
With some nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs can cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.
There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
Diclofenac () Precautions:
All topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
Use of topical NSAIDs may result in keratitis. In some susceptible patients continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal infiltrates, corneal erosion, corneal ulceration, and corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.
Postmarketing experience with topical NSAIDs suggest that patients experiencing complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface disease (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period-of-time may be at increased risk for corneal adverse events, which may become sight threatening. Topical NSAIDs should be used with caution in these patients.
Postmarketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk for occurrence and severity of corneal adverse events.
It is recommended that Diclofenac () Sodium Ophthalmic Solution, like other NSAIDs, be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
Results from clinical studies indicate that Diclofenac () Sodium Ophthalmic Solution has no significant effect upon ocular pressure. However, elevation in intraocular pressure may occur following cataract surgery.
Diclofenac () Adverse Reactions:
Clinical Practice:
Ocular:
The following adverse reactions were reported in approximately 5% or less of the patients: abnormal vision, acute elevated IOP, blurred vision, conjunctivitis, corneal deposits, corneal edema, corneal opacity, corneal lesions, discharge, eyelid swelling, injection, iritis, irritation, itching, lacrimation disorder and ocular allergy.
Systemic:
Diclofenac () Overdosage:
Overdosage will not ordinarily cause acute problems. If Diclofenac () Sodium Ophthalmic Solution is accidentally ingested, fluids should be taken to dilute the medication.
Diclofenac () Dosage And Administration:
Cataract Surgery: One drop of Diclofenac () Sodium Ophthalmic Solution, 0.1% should be applied to the affected eye, 4 times daily beginning 24 hours after cataract surgery and continuing throughout the first 2 weeks of the post operative period.
Corneal Refractive Surgery: One or two drops of Diclofenac () Sodium Ophthalmic Solution, 0.1% should be applied to the operative eye within the hour prior to corneal refractive surgery. Within 15 minutes after surgery, one or two drops should be applied to the operative eye and continued 4 times daily for up to 3 days.
Diclofenac () How Supplied:
Diclofenac () Sodium Ophthalmic Solution, 0.1% (1 mg/mL) Solution is supplied in a low density polyethylene (LDPE) white bottle with a LDPE Dropper Tip and Polypropylene grey closure. The 2.5 ml_ fill is supplied in a 10 mL size bottle. The 5.0 mL fill is also supplied in a 10.0 mL size bottle.
Bottles of 2.5 mL NDC 17478-892-25
Bottles of 5 mL NDC 17478-892-10
Diclofenac ()
Diclofenac ()
