Rimexolone Ophthalmic

Pregnancy Category: C

Lactation: ophthalmic corticosteroids have not been reported to cause problems in nursing babies

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Absorption: following topical instillation of corticosteroids into the conjunctival sac, is absorbed into the aqueous humor, & systemic absorption occurs

Mechanism of Action

Synthetic nonfluorinated corticosteroid

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

Stop using rimexolone ophthalmic and call your doctor at once if you have a serious side effect such as:

• vision changes, eye pain, or seeing halos around lights;
• pain behind your eyes;
• feeling like something is in your eye; or
• eye swelling, redness, itching, severe discomfort, crusting or drainage (may be signs of infection).

Less serious side effects may include:

• blurred vision;
• dry or watery eyes;
• eyes being more sensitive to light;
• headache;
• runny nose, sore throat; or
• unusual or unpleasant taste in your mouth.

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.

Do not use other eye medications during treatment with rimexolone ophthalmic unless your doctor tells you to.

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.

If you wear contact lenses, ask your doctor if you should wear them during treatment with rimexolone ophthalmic.

Tell your doctor about all other medicines you use, especially an oral, nasal, inhaled, or injectable steroid medicine.

This list is not complete and other drugs may interact with rimexolone ophthalmic. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For rimexolone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to rimexolone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on rimexolone have been done only in adult patients, and there is no specific information comparing use of rimexolone in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of rimexolone in the elderly with use in other age groups.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking rimexolone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using rimexolone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

Using rimexolone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bemiparin
• Bupropion
• Nadroparin
• Pixantrone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of rimexolone. Make sure you tell your doctor if you have any other medical problems, especially:

• Certain eye diseases that cause the cornea to get thin—Use of ophthalmic rimexolone could cause a hole to form (perforation)

• Fungus infection of the eye or
• Herpes infection of the eye or
• Virus infection of the eye or
• Yeast infection of the eye or
• Any other eye infection—Ophthalmic rimexolone may make existing infections worse or cause new infections

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.

FDA pregnancy category C. It is not known whether rimexolone ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether rimexolone ophthalmic passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using rimexolone ophthalmic.

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

Stop using rimexolone ophthalmic and call your doctor at once if you have a serious side effect such as:

• vision changes, eye pain, or seeing halos around lights;

• pain behind your eyes;

• feeling like something is in your eye; or

• eye swelling, redness, itching, severe discomfort, crusting or drainage (may be signs of infection).

Less serious side effects may include:

• blurred vision;

• dry or watery eyes;

• eyes being more sensitive to light;

• headache;

• runny nose, sore throat; or

• unusual or unpleasant taste in your mouth.

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.

Usual Adult Dose for Postoperative Ocular Inflammation:

1 to 2 drops instilled into the conjunctival sac of the affected eye four times per day beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period

Use: Treatment of postoperative inflammation following ocular surgery

Usual Adult Dose for Uveitis:

1 to 2 drops instilled into the conjunctival sac of the affected eye every hour during waking hours for the first week, 1 drop every 2 hours during waking hours of the second week, and then taper until uveitis is resolved

Use: Treatment of anterior uveitis

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.