Drug Catalog - Product Detail
DICLOFENAC SODIUM ER OPHTH. SOL. SOL 0.001 5ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 24208-0457-05 | BAUSCH HEALTH | 5 | 0.1% | SOLUTION |
PACKAGE FILES
Generic Name
DICLOFENAC SODIUM
Substance Name
DICLOFENAC SODIUM
Product Type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Application Number
ANDA078792
Description
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 C 14 H 10 Cl 2 NO 2 Na. The structural formula of diclofenac sodium is: Diclofenac sodium ophthalmic solution 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, purified water, sorbic acid (2 mg/mL), and tromethamine. Diclofenac sodium is a white to off-white, 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 has a faint characteristic odor of castor oil. Diclofenac Sodium (structural formula)
How Supplied
HOW SUPPLIED 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 a polypropylene gray cap. The 2.5 mL fill and the 5 mL fill are supplied in a 7.5 mL size bottle. 2.5 mL NDC 24208-457-25 5 mL NDC 24208-457-05 Store at 20°C to 25°C (68°F to 77°F). PROTECT FROM LIGHT. Dispense in original, unopened container only.
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION 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 postoperative 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.