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Diclofenac Sodium

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Overview

What is Diclofenac?

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 CHClNONa. 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:

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.



What does Diclofenac look like?



What are the available doses of Diclofenac?

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What should I talk to my health care provider before I take Diclofenac?

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How should I use Diclofenac?

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.

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 through the first 2 weeks of the postoperative period.


What interacts with Diclofenac?

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What are the warnings of Diclofenac?

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What are the precautions of Diclofenac?

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What are the side effects of Diclofenac?

Sorry No records found


What should I look out for while using Diclofenac?

Diclofenac sodium ophthalmic solution, 0.1% is contraindicated in patients who are hypersensitive to any component of the medication.

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.


What might happen if I take too much Diclofenac?

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 should I store and handle Diclofenac?

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). [LOGO]ALTAIRE PHARMACEUTICALS, INC.311 West Lane, PO Box 849Aquebogue, NY 11931Altaire 2014Diclofenac 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). [LOGO]ALTAIRE PHARMACEUTICALS, INC.311 West Lane, PO Box 849Aquebogue, NY 11931Altaire 2014Diclofenac 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). [LOGO]ALTAIRE PHARMACEUTICALS, INC.311 West Lane, PO Box 849Aquebogue, NY 11931Altaire 2014Diclofenac 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). [LOGO]ALTAIRE PHARMACEUTICALS, INC.311 West Lane, PO Box 849Aquebogue, NY 11931Altaire 2014


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Diclofenac sodium is one of a series of phenylacetic acids that has demonstrated anti-inflammatory and analgesic properties in pharmacological studies. It is thought to inhibit the enzyme cyclooxygenase, which is essential in the biosynthesis of prostaglandins.

Non-Clinical Toxicology
Diclofenac sodium ophthalmic solution, 0.1% is contraindicated in patients who are hypersensitive to any component of the medication.

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.

Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. When the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased.

All topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

Use of topical NSAIDs may result in keratitis. In some susceptible patients continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal infiltrates, corneal erosion, corneal ulceration, and corneal perforation. These events may be sight-threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.

Postmarketing experience with topical NSAIDs suggests that patients experiencing complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface disease (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events, which may become sight-threatening. Topical NSAIDs should be used with caution in these patients.

Postmarketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days postsurgery may increase patient risk for occurrence and severity of corneal adverse events.

It is recommended that Diclofenac sodium ophthalmic solution, 0.1%, like other NSAIDs, be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery.

Results from clinical studies indicate that Diclofenac sodium ophthalmic solution, 0.1% has no significant effect upon ocular pressure. However, elevations in intraocular pressure may occur following cataract surgery.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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