Vexol

DRUG DESCRIPTION

VEXOL® 1% (rimexolone) Ophthalmic Suspension is a sterile, multi-dose topical ophthalmic suspension containing the corticosteroid, rimexolone. Rimexolone is a white, water-insoluble powder with an empirical formula of C24H34O3 and a molecular weight of 370.53. Its chemical name is 11?-Hydroxy-16?, 17?-dimethyl-17-propionylandrosta-1,4-diene-3-one. The chemical structure of rimexolone is presented below:

Vexol (rimexolone) structural formula illustration

Each mL Contains: Active ingredient: rimexolone 10 mg (1%). Preservative: benzalkonium chloride 0.01%. Inactive ingredients: carbomer 974P, polysorbate 80, sodium chloride, edetate disodium, sodium hydroxide and/or hydrochloric acid (to adjust pH) and purified water.

The pH of the suspension is 6.0 to 8.0 and the tonicity is 260 to 320 mOsmol/kg.

What are the possible side effects of rimexolone ophthalmic (Vexol)?

Serious side effects are not expected with this medication. Rarely, an increase in the pressure inside of the eye, formation of cataracts, or perforation of the cornea have been reported. Talk to your doctor about any possible side effects.

More commonly, some burning, stinging, irritation, itching, redness, blurred vision, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Vexol »

What are the precautions when taking rimexolone (Vexol)?

Before using rimexolone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, 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: eye infections, cataracts, glaucoma (open-angle type), severe nearsightedness (myopia), diabetes.

After you apply this drug, your vision may become temporarily blurred. 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,...

Read All Potential Precautions of Vexol »


Vexol 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. 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.

Use of this medication for prolonged periods or in high doses may cause serious eye problems (such as high pressure inside the eyes and cataracts). Tell your doctor immediately if any of these unlikely but serious side effects occur: vision problems, eye pain.

This medication may mask the signs of an eye infection. It may also put you at greater risk of developing an eye infection, especially with prolonged use. Report any new or worsening symptoms such as eye discharge/swelling/redness, vision problems, or no improvement of your current eye condition. Your doctor will need to adjust your treatment.

Tell your doctor immediately if any of these unlikely but serious side effects occur: headache, dizziness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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 rimexolone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, 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: eye infections, cataracts, glaucoma (open-angle type), severe nearsightedness (myopia), diabetes.

After you apply this drug, your vision may become temporarily blurred. 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).

If you develop a new eye infection or injury, or require eye surgery, ask your doctor if you should continue to use your current bottle of rimexolone eye drops or start a new bottle.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if the medication in this product passes into breast milk. Consult your doctor before breast-feeding.


Vexol Patient Information Including Side Effects

Brand Names: Vexol

Generic Name: rimexolone ophthalmic (Pronunciation: rye MEX oh lone)

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

What is rimexolone ophthalmic (Vexol)?

Rimexolone ophthalmic is in a class of drugs called corticosteroids. It inhibits processes in the body that cause inflammation. Therefore, the swelling and pain of inflammatory conditions is decreased.

Rimexolone ophthalmic is used to treat eye inflammation caused by infections, injury, surgery, or other conditions.

Rimexolone ophthalmic may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of rimexolone ophthalmic (Vexol)?

Serious side effects are not expected with this medication. Rarely, an increase in the pressure inside of the eye, formation of cataracts, or perforation of the cornea have been reported. Talk to your doctor about any possible side effects.

More commonly, some burning, stinging, irritation, itching, redness, blurred vision, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about rimexolone ophthalmic (Vexol)?

Do not stop using this medication suddenly if you have been using it for several weeks or more. Before stopping, you may need to reduce the dose over several days to prevent side effects.

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear ducts.

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