Drug Catalog - Product Detail
DICLOFENAC SODIUM ER OPHTH. SOL 0.001 5ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 17478-0892-10 | AKORN | 5 | 0.1% | SOLUTION |
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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, 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. Structural Formula
How Supplied
HOW SUPPLIED: 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 STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing and light. Dispense in original, unopened container only. Akorn Manufactured by: Akorn Inc. Lake Forest, IL 60045 DC00N Rev. 12/12
Indications & Usage
INDICATIONS AND USAGE: 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION: 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.