DICLOFENAC SODIUM, OPHTHALMIC SOLUTION, 0.1%

/DICLOFENAC SODIUM, OPHTHALMIC SOLUTION, 0.1%
DICLOFENAC SODIUM, OPHTHALMIC SOLUTION, 0.1%2018-09-06T09:12:40+00:00

Prescription Drug Name:

DICLOFENAC SODIUM, OPHTHALMIC SOLUTION, 0.1%

ID:

08e78394-f61d-4c74-8e9e-ce8032678349

Code:

34391-3

DESCRIPTION:


id: df8f736d-e373-4118-b915-d356d9085a32
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: boric acid, edetate disodium (1 mg/mL), polyoxyl 35 castor oil, water for injection, sorbic acid (2 mg/mL), tromethamine. 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.

INDICATIONS AND USAGE:


id: dbe5171f-92f9-4445-88d4-0d79f00bac40
displayName: INDICATIONS & 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 and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.

CONTRAINDICATIONS:


id: 3536f948-6f11-4d01-ad57-bac3d64531bb
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.

WARNINGS:


id: 159e1242-92df-48af-8921-8678cda4e9a2
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 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.

Overdosage:


id: c7febaed-6fcf-4b01-888c-77c25f4922b0
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:


id: 4970ad87-b21a-4cb9-a695-e8a0e4f81aa0
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

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.

HOW SUPPLIED:


id: 63af47db-4fa8-4c1e-b09d-0f570c74cb09
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

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