Diclofenac label

Diclofenac

Diclofenac Recall

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Side Effects & Adverse Reactions

The refractive stability of patients undergoing corneal refractive procedures and treated with Diclofenac Sodium Ophthalmic Solution 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.

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, 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.

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 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt, with an empirical formula of C14H10Cl2NO2Na. The structural formula of Diclofenac Sodium is:

Structural Formula

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.

Diclofenac Manufacturers

  • Lake Erie Medical Dba Quality Care Products Llc
    Diclofenac | Lake Erie Medical Dba Quality Care Products Llc
    No Recall

    Diclofenac | Lake Erie Medical Dba Quality Care Products Llc

    Diclofenac | Lake Erie Medical Dba Quality Care Products Llc

    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.

  • Diclofenac | Tya Pharmaceuticals
    No Recall

    Diclofenac | Tya Pharmaceuticals

    Diclofenac | Tya Pharmaceuticals

    The usual dietary potassium intake by the average adult is 50 to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of potassium from the total body store.

    Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40-100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose.

    Potassium chloride extended-release tablets provide 8 mEq, 10 mEq and 20 mEq of potassium chloride.

    Potassium chloride extended-release tablets should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation (see ). WARNINGS

    Potassium chloride extended-release tablets are to be swallowed whole without crushing, chewing or sucking the tablets. NOTE: