Diclofenac Sodium Solution label

Diclofenac Sodium Solution

Diclofenac Sodium Solution Recall

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Side Effects & Adverse Reactions

The refractive stability of patients undergoing corneal refractive procedures and treated with diclofenac sodium 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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

Diclofenac sodium ophthalmic solution, 0.1% is a sterile, topical, nonsteroidal, anti-inflammatory product for ophthalmic use. Diclofenac sodium is designated chemically as Benzeneacetic acid, 2-[(2,6-dichlorophenyl)amino] monosodium salt, with a molecular formula of C14H10Cl2NNaO2. 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, polyoxyl 35 castor oil, sorbic acid, tromethamine, and water for injection.

Diclofenac sodium is a white or slightly yellow crystalline powder. It is freely soluble in methanol, soluble in alcohol, sparingly soluble in water, and slightly soluble in acetone. Its molecular weight is 318.1. Diclofenac sodium ophthalmic solution, 0.1% is an iso-osmotic solution with an osmolality between 270 mOsmols/kg and 310 mOsmols/kg, buffered at a pH between 6.0 to 8.0. Diclofenac sodium ophthalmic solution has a faint characteristic odor of castor oil.

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Diclofenac Sodium Solution Recall

Side Effects & Adverse Reactions

FDA Safety Alerts

Manufacturer Warnings

FDA Labeling Changes

Other Information

Trending Topics

Diclofenac Sodium Solution Manufacturers

Apotex Corp.
No Recall
Diclofenac Sodium Solution | Apotex Corp.

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 post operative 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.
Apotex Corp.
No Recall
Diclofenac Sodium Solution | Apotex Corp.
2.1 General Instructions
For the relief of the signs and symptoms of osteoarthritis of the knee(s), the recommended dose is 40 drops per knee, 4 times a day.

Apply diclofenac sodium topical solution to clean, dry skin.

To avoid spillage, dispense diclofenac sodium topical solution 10 drops at a time either directly onto the knee or first into the hand and then onto the knee. Spread diclofenac sodium topical solution evenly around front, back and sides of the knee. Repeat this procedure until 40 drops have been applied and the knee is completely covered with solution.

To treat the other knee, if symptomatic, repeat the procedure.

Application of diclofenac sodium topical solution in an amount exceeding or less than the recommended dose has not been studied and is therefore not recommended.
2.2 Special Precautions
• Avoid showering/bathing for at least 30 minutes after the application of diclofenac sodium topical solution to the treated knee.

• Wash and dry hands after use.

• Do not apply diclofenac sodium topical solution to open wounds.

• Avoid contact of diclofenac sodium topical solution with eyes and mucous membranes.

• Do not apply external heat and/or occlusive dressings to treated knees.

• Avoid wearing clothing over the diclofenac sodium topical solution-treated knee(s) until the treated knee is dry.

• Protect the treated knee(s) from sunlight.

• Wait until the treated area is dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to the same knee you have just treated with diclofenac sodium topical solution.

• Until the treated knee(s) is completely dry, avoid skin-to-skin contact between other people and the treated knee(s).
Sandoz Inc
No Recall
Diclofenac Sodium Solution | Sandoz Inc
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 post-operative 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.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Pharmaceutica North America, Inc
No Recall
Diclofenac Sodium Solution | Pharmaceutica North America, Inc
2.1 General Instructions
For the relief of the signs and symptoms of osteoarthritis of the knee(s), the recommended dose is 40 drops per knee, 4 times a day.

Apply diclofenac sodium topical solution to clean, dry skin.

To avoid spillage, dispense diclofenac sodium topical solution 10 drops at a time either directly onto the knee or first into the hand and then onto the knee. Spread diclofenac sodium topical solution evenly around front, back and sides of the knee. Repeat this procedure until 40 drops have been applied and the knee is completely covered with solution.

To treat the other knee, if symptomatic, repeat the procedure.

Application of diclofenac sodium topical solution in an amount exceeding or less than the recommended dose has not been studied and is therefore not recommended.
2.2 Special Precautions Avoid showering/bathing for at least 30 minutes after the application of diclofenac sodium topical solution to the treated knee. Wash and dry hands after use. Do not apply diclofenac sodium topical solution to open wounds. Avoid contact of diclofenac sodium topical solution with eyes and mucous membranes. Do not apply external heat and/or occlusive dressings to treated knees. Avoid wearing clothing over the diclofenac sodium topical solution-treated knee(s) until the treated knee is dry. Protect the treated knee(s) from sunlight. Wait until the treated area is dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to the same knee you have just treated with diclofenac sodium topical solution. Until the treated knee(s) is completely dry, avoid skin-to-skin contact between other people and the treated knee(s).