Vexol

• Before you use the eye drops, read the manufacturer's printed information leaflet from the pack. It will give you more information about the eye drops and will provide you with a full list of the side-effects which you could experience from using them.
• Use the eye drops exactly as your doctor tells you to. If you have had eye surgery, it is likely you will be asked to use the drops four times a day for two weeks. For other eye conditions, you may be asked to use the drops more often than this, or for longer than this.
• Rimexolone eye drops are only meant to be used for a short period of time - this means a maximum of four weeks. This is because they can cause problems within your eye when used for longer periods of time than recommended.
• Take care not to touch the tip of the dropper with your eye, fingers, or any other surface. This will help to prevent the risk of infection.
• When first put in, eye drops may cause blurred vision. This should quickly clear, but make sure you can see properly before you drive or before you use tools or machines, as otherwise you may put yourself and others at risk.
• If you are using any other eye drops or eye ointments, leave at least five minutes between applying each one. This is to prevent more liquid going into your eye than it can handle. Otherwise the drops will overflow from your eye and may not have the intended effect.
• If your symptoms do not improve within a few days, or if they become worse, you should check again with your doctor or eye clinic.
• If you normally wear contact lenses, please wear spectacles until your doctor advises you that it is suitable for you to wear your lenses again. There are two reasons for this - you should not wear lenses while your eyes are inflamed, and bottles of eye drops contain a preservative which can affect some soft contact lenses.

VEXOL® 1% 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 11α-Hydroxy-16β, 17β-dimethyl-17-propionylandrosta-l,4-diene-3-one. The chemical structure of rimexolone is presented below:

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.

You should not use this medication if you are allergic to rimexolone, or if you have a bacterial, viral, or fungal infection in your eye without also receiving proper anti-infective treatment.

You should not breast-feed while you are using rimexolone ophthalmic.

Your doctor may prescribe two separate bottles of rimexolone ophthalmic, one to use in each eye. This is to keep from passing infection from one eye to the other. Be sure to mark each bottle for the right or left eye, and use the eye drops from that bottle only in that eye.

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Stop using rimexolone ophthalmic and call your doctor at once if you have vision changes, eye pain, seeing halos around lights, pain behind your eyes, feeling like something is in your eye, or any signs of infection (eye swelling, redness, itching, severe discomfort, crusting or drainage).

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Rimexolone belongs to the group of medicines known as corticosteroids (cortisone-like medicines). It is used to treat inflammation of the eye, which may occur following eye surgery or with certain eye problems.

This medicine is available only with your doctor's prescription.

Shake the container very well before applying the eye drops.

To use:

• First, wash your hands. Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• If you think you did not get the drop of medicine into your eye properly, use another drop.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage form (eye drops):
  • For inflammation after surgery:
    • Adults—Use one or two drops in the affected eye four times a day beginning twenty-four hours after surgery and continuing throughout the first two weeks after surgery.
    • Children—Use and dose must be determined by your doctor.
  • For anterior uveitis (inflammation in the iris of the eye):
    • Adults—Use one or two drops in the affected eye every hour, while awake, for the first week. Then use one drop in the affected eye every two hours, while awake, for the second week. Then gradually decrease the number of times the medicine is used each day according to your physician's instructions.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

An ophthalmologist (eye doctor) should examine your eyes at regular visits while you are using this medicine.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Use care when driving or doing other tasks that call for clear eyesight.
• Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
• Have your eye pressure checked if you are on Vexol for a long time. Talk with your doctor.
• Do not use this medicine for longer than you were told by your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Vexol while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For the eye only.
• Keep using Vexol as you have been told by your doctor or other health care provider, even if you feel well.
• To gain the most benefit, do not miss doses.
• Wash your hands before and after use.
• Avoid wearing contacts unless told to wear them by your doctor.
• Do not touch the container tip to the eye, lid, or other skin.
• Shake well before use.
• Tilt your head back and drop drug into the eye.
• After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.
• If this medicine is being used after surgery on both eyes, do not use the same bottle for both eyes. Your doctor may order 2 eye drop bottles; one for each eye. Make sure you do not mix the 2 bottles up.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.
• Eye discharge.

General

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungal invasion must be considered in any persistent corneal ulceration where a steroid has been or is in use.

For ophthalmic use only. Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery.

The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be reevaluated.

If this product is used for 10 days or longer, intraocular pressure should be monitored even though it may be difficult in children and uncooperative patients (see WARNINGS).

Information for Patients

Do not touch dropper tip to any surface, as this may contaminate the suspension.

Carcinogenesis, mutagenesis, impairment of fertility

Rimexolone has been shown to be non-mutagenic in a battery of in vitro and in vivo mutagenicity assays.

Fertility and reproductive capability were not impaired in a study in rats with plasma levels (42 ng/mL) approximately 200 times those obtained in clinical studies after topical administration (<0.2 ng/mL). Long-term studies have not been conducted in animals or humans to evaluate the carcinogenic potential of rimexolone.

Pregnancy

Pregnancy Category C. Rimexolone has been shown to be teratogenic and embryotoxic in rabbits following subcutaneous administration at the lowest dose tested (0.5 mg/kg/day, approximately 2 times the recommended human ophthalmic dose). Corticosteroids are recognized to cause fetal resorptions and malformations in animals. There are no adequate and well-controlled studies in pregnant women. Vexol® 1% (rimexolone ophthalmic suspension) should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human breast milk. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman; a decision should be made whether to discontinue nursing or discontinue therapy, taking into consideration the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.