displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
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 C14H10Cl2NO2Na. 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).
Inactive Ingredients: polyoxyl 35 castor oil, boric acid, tromethamine, sorbic acid (2 mg/mL), edetate disodium (1 mg/mL), and purified water.
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, 0.1% is an iso-osmotic solution with an osmolality of about 300 mOsmol/1000 g, buffered at approximately pH 7.2. Diclofenac Sodium Ophthalmic Solution, 0.1% has a faint characteristic odor of castor oil.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Diclofenac Sodium Ophthalmic Solution 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.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Diclofenac Sodium Ophthalmic Solution is contraindicated in patients who are hypersensitive to any component of the medication.
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
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 non-steroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied non-steroidal anti-inflammatory drugs may 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 non-steroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Clinical Practice: The following events have been identified during postmarketing use of topical diclofenac sodium ophthalmic solution, 0.1% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical diclofenac sodium ophthalmic solution, 0.1% or a combination of these factors, include corneal erosion, corneal infiltrates, corneal perforation, corneal thinning, corneal ulceration, epithelial breakdown, and superficial punctate keratitis, (see
Ocular: Transient burning and stinging were reported in approximately 15% of patients across studies with the use of Diclofenac Sodium Ophthalmic Solution. In cataract surgery studies, keratitis was reported in up to 28% of patients receiving Diclofenac Sodium Ophthalmic Solution, although in many of these cases keratitis was initially noted prior to the initiation of treatment. Elevated intraocular pressure following cataract surgery was reported in approximately 15% of patients undergoing cataract surgery.
Lacrimation complaints were reported in approximately 30% of case studies undergoing incisional refractive surgery.
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 (redness), iritis, irritation, itching, lacrimation disorder and ocular allergy.
Systemic: The following adverse reactions were reported in 3% or less of the patients: abdominal pain, asthenia, chills, dizziness, facial edema, fever, headache, insomnia, nausea, pain, rhinitis, viral infection, and vomiting.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Overdosage will not ordinarily cause acute problems. If Diclofenac Sodium Ophthalmic Solution is accidentally ingested, fluids should be taken to dilute the medication.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Cataract Surgery: One drop of Diclofenac Sodium Ophthalmic Solution 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 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.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Diclofenac Sodium Ophthalmic Solution, 0.1% (1 mg/mL) Sterile Solution is supplied in a low density polyethylene (LDPE) white DROP-TAINER* bottle with a natural LDPE dropper tip and a gray polypropylene closure in the following sizes:
2.5 mL fill in 4 mL container NDC 61314-014-25
5 mL fill in 8 mL container NDC 61314-014-05
*DROP-TAINER is a registered trademark of Alcon Research, Ltd.
STORAGE CONDITIONS: Store at
20° – 25°C (68° – 77°F), excursions permitted to
15° – 30°C (59° – 86°F).
Protect from light.
Dispense in original, unopened container only.
PRINCIPAL DISPLAY PANEL
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 61314-014-25 Rx Only
2.5 mL STERILE