DESCRIPTION
id: 51f744b3-294c-4e76-8f90-819b8687f563
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 C14H10Cll2NO2Na. 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% (1mg/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 ophthalmic solution, 0.1% 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
id: 02bc25c8-8c73-4e42-8d2d-0b0d1d8b337f
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: 4d81caed-11ed-4160-9f56-fc5645c507f4
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: 0f60d31b-1403-4bb7-82d4-ba065a40bcca
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
The refractive stability of patients undergoing corneal refractive procedures and treated with Diclofenac sodium ophthalmic solution, 0.1% 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 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 nonsteroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
OVERDOSAGE
id: 02cff378-affb-4aa0-ba76-c8c0b268539e
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Overdosage will not ordinarily cause acute problems. If Diclofenac sodium ophthalmic solution, 0.1% is accidentally ingested, fluids should be taken to dilute the medication.
HOW SUPPLIED
id: a6460573-17c8-4b7f-8036-feaa4618cb7d
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 bottle with a LDPE Dropper Tip and Polypropylene grey closure. The 2.5 mL is supplied in a 7.5 mL size bottle and the 5 mL is supplied in a 10 mL size bottle.
Bottles of 2.5 mL
Bottles of 5 mL
Store at 20° to 25°C (68° to 77°F).
Dispense in original, unopened container only
.
[LOGO]ALTAIRE PHARMACEUTICALS, INC.
311 West Lane, PO Box 849
Aquebogue, NY 11931
Altaire 2014
PRINCIPAL DISPLAY PANEL
id: 12bab933-9410-432d-9dff-51b6e33e8231
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Rx Only
Dicloenac sodium
ophthalmic solution,
0.1%
FOR USE IN THE EYES ONLY
2.5 mL
PRINCIPAL DISPLAY PANEL
id: 4470f557-e8d4-4e92-a38b-a636ff267856
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Rx Only
Dicloenac sodium
ophthalmic solution,
0.1%
FOR USE IN THE EYES ONLY
5 mL
