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: POLYQUAD® polyquaternium-1, 0.05 mg/mL, as preservative, tocophersolan, boric acid, mannitol, hydrochloric acid and/or sodium hydroxide (to adjust pH to 6.7) and purified water. DM-00Diclofenac 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/1000g.
INDICATIONS AND USAGE
displayName: INDICATIONS AND USAGE section
FDA Article Code: 34067-9
Diclofenac Sodium Ophthalmic Solution, 0.1% is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.
displayName: CONTRAINDICATIONS section
FDA Article Code: 34070-3
Diclofenac Sodium Ophthalmic Solution, 0.1% is contraindicated in patients who are hypersensitive to any component of the medication.
displayName: WARNINGS section
FDA Article Code: 34071-1
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 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: OVERDOSAGE section
FDA Article Code: 34088-5
Overdosage will not ordinarily cause acute problems. If accidentally ingested, fluids should be taken to dilute the medication.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE AND ADMINISTRATION section
FDA Article Code: 34068-7
One drop of Diclofenac Sodium Ophthalmic Solution, 0.1% should be applied to the affected eye four times daily beginning 24 hours after cataract surgery and continuing throughout the first 2 weeks of the postoperative period.
displayName: How Supplied section
FDA Article Code: 34069-5
Diclofenac Sodium Ophthalmic Solution, 0.1% is supplied in opaque, plastic DROP-TAINER® dispenser in the following sizes:2.5 mL: NDC 61314-231-265.0 mL: NDC 61314-231-05Store between 59° -86° F (15° -30° C). Protect from light. Dispense in original, unopened container only.Rx Only U.S. Patent Nos. 5,603,929 and 5,653,972Distributed by:
FALCON Pharmaceuticals, Ltd.
Fort Worth, Texas 76134 USAManufactured by:
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USAFebruary 1999342458-0299