Voltaren Ophthalmic

DRUG DESCRIPTION

Voltaren Ophthalmic (diclofenac sodium ophthalmic solution) 0.1% solution 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:

 Voltaren Ophthalmic® (diclofenac sodium) Structural Formula Illustration

Voltaren Ophthalmic is available as a sterile solution which contains diclofenac sodium 0.1% (1 mg/mL).

Inactive Ingredients: polyoxyl 35 castor oil, Boric acid, tromethamine, sorbic acid (2 mg/mL), edetate disodium (1 mg/mL), and purified water.

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. Voltaren Ophthalmic 0.1% is an iso-osmotic solution with an osmolality of about 300 mOsmol/1000 g, buffered at approximately pH 7.2. Voltaren Ophthalmic solution has a faint characteristic odor of castor oil.

What are the possible side effects of diclofenac ophthalmic (Voltaren Ophthalmic)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe burning, stinging, or itching of your eyes;
  • eye pain, redness, or watering;
  • vision changes, increased sensitivity to light;
  • white patches on your eyes; or
  • crusting or drainage of your eyes.

Less serious side...

Read All Potential Side Effects and See Pictures of Voltaren Ophthalmic »

What are the precautions when taking diclofenac sodium ophthalmic solution (Voltaren Ophthalmic)?

Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as polyoxyethylated castor oil found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), other types of asthma, growths in the nose (nasal polyps), bleeding or clotting problems, other eye problems (such as cornea problems, dry eye syndrome, past eye surgeries), diabetes,...

Read All Potential Precautions of Voltaren Ophthalmic »


Voltaren Ophthalmic Consumer (continued)

SIDE EFFECTS: Stinging/burning of the eyes for 1 to 2 minutes and temporary blurred vision may occur when you apply this medication. Watery eyes may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: eye pain, decreased vision, bleeding in the eye (increased redness in the eye).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as polyoxyethylated castor oil found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), other types of asthma, growths in the nose (nasal polyps), bleeding or clotting problems, other eye problems (such as cornea problems, dry eye syndrome, past eye surgeries), diabetes, rheumatoid arthritis.

Your vision may be temporarily blurred after applying this medication. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed during the first 6 months. It is not recommended for use during the last 3 months of pregnancy due to possible harm to an unborn baby. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Voltaren Ophthalmic Patient Information Including Side Effects

Brand Names: Voltaren Ophthalmic

Generic Name: diclofenac ophthalmic (Pronunciation: dye KLOE feh nak)

  • What is diclofenac ophthalmic (Voltaren Ophthalmic)?
  • What are the possible side effects of diclofenac ophthalmic (Voltaren Ophthalmic)?
  • What is the most important information I should know about diclofenac ophthalmic (Voltaren Ophthalmic)?
  • What should I discuss with my healthcare provider before I use diclofenac ophthalmic (Voltaren Ophthalmic)?
  • How should I use diclofenac ophthalmic (Voltaren Ophthalmic)?
  • What happens if I miss a dose (Voltaren Ophthalmic)?
  • What happens if I overdose (Voltaren Ophthalmic)?
  • What should I avoid while using diclofenac ophthalmic (Voltaren Ophthalmic)?
  • What other drugs will affect diclofenac ophthalmic (Voltaren Ophthalmic)?
  • Where can I get more information?

What is diclofenac ophthalmic (Voltaren Ophthalmic)?

Diclofenac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Diclofenac works by reducing hormones that cause inflammation and pain in the body.

Diclofenac ophthalmic (for the eye) is used to reduce swelling, pain, and light sensitivity after cataract surgery or corneal refractive surgery.

Diclofenac ophthalmic may also be used for other purposes not listed in this medication guide.

What are the possible side effects of diclofenac ophthalmic (Voltaren Ophthalmic)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe burning, stinging, or itching of your eyes;
  • eye pain, redness, or watering;
  • vision changes, increased sensitivity to light;
  • white patches on your eyes; or
  • crusting or drainage of your eyes.

Less serious side effects may include:

  • mild burning, stinging, or itching of your eyes;
  • swollen or puffy eyelids;
  • nausea, vomiting, stomach pain;
  • weakness, fever or chills;
  • headache;
  • sleep problems (insomnia); or
  • runny nose.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about diclofenac ophthalmic (Voltaren Ophthalmic)?

You should not use this medication if you are allergic to diclofenac or other NSAIDs.

Before using diclofenac ophthalmic, tell your doctor if you are allergic to any medications, or if you have a bleeding or blood-clotting disorder, diabetes, arthritis, glaucoma, dry eye syndrome, or if you have had other recent eye surgeries.

Tell your doctor about all other medications you use, especially a blood thinner such as warfarin (Coumadin).

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label. Using the medication for longer than prescribed may increase the risk of serious side effects on your eyes.

For at least 3 days after your surgery, do not wear any contact lens that has not been approved by your doctor. Do not use any other eye medications unless your doctor has prescribed them.

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