`
`Source: http://www.medicinenet.com/script/main/art.asp?articlekey=44126
`
`GENERIC NAME: RIMEXOLONE SUSPENSION - OPHTHALMIC (ri-
`MEX-oh-lone)
`BRAND NAME(S): Vexol
`
`Medication Uses | How To Use | Side Effects | Precautions | Drug Interactions |
`Overdose | Notes | Missed Dose | Storage
`
`USES: This medication is used to treat certain eye conditions due to inflammation
`or injury. It is also used after eye surgery. Rimexolone works by relieving
`symptoms such as swelling and redness. It belongs to a class of drugs known as
`corticosteroids.
`
`HOW TO USE: Unless otherwise directed by your doctor, do not wear contact
`lenses while you are using this medicine. Sterilize contact lenses according to the
`manufacturer's directions, and check with your doctor before you begin using
`them again.If your doctor does approve the wearing of contact lenses during
`treatment with this medication, remove the lenses before using the eye drops.
`The preservative in this product may be absorbed by contact lenses. Wait at least
`15 minutes after each dose of the eye drop before wearing the lenses again.To
`apply eye drops, wash your hands first. Shake the bottle well before using. To
`avoid contamination, do not touch the dropper tip or let it touch your eye or any
`other surface.Tilt your head back, look upward, and pull down the lower eyelid to
`make a pouch. Hold the dropper directly over your eye and place 1 drop into the
`pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one
`finger at the corner of your eye (near the nose) and apply gentle pressure. This
`will prevent the medication from draining out. Try not to blink and do not rub your
`eye. Repeat these steps for your other eye if so directed and if your dose is for
`more than 1 drop.Apply as often as directed by your doctor. Do not rinse the
`dropper. Replace the dropper cap after each use.If you are using another kind of
`eye medication (for example, other drops or ointments), wait at least 5 to 10
`minutes before applying other medications. Use eye drops before eye ointments
`to allow the drops to enter the eye.Use this medication regularly in order to get
`the most benefit from it. To help you remember, use it at the same time(s) each
`day.The dosage and length of treatment are based on your medical condition and
`response to treatment. Do not use this medication more often or for longer than
`prescribed because doing so may increase your risk of side effects.Continue to
`use this medication for the full time prescribed. Do not stop using this medication
`without consulting your doctor. Some conditions may become worse when the
`drug is suddenly stopped. Your dose may need to be gradually decreased.Do not
`use this product if it becomes contaminated (for example, drops turn cloudy or a
`dark color). Use of contaminated eye medication can cause infection, serious
`damage to the eye, and loss of vision. Contact your doctor or pharmacist for more
`information.Tell your doctor if your condition does not improve after 2 days or if it
`worsens.
`
`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
`
`http://www.medicinenet.com/rimexolone-ophthalmic/article.htm?pf=2
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`MYLAN - EXHIBIT 1092
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
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`Page 2 of 2
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`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.
`
`DRUG INTERACTIONS: The effects of some drugs can change if you take other
`drugs or herbal products at the same time. This can increase your risk for serious
`side effects or may cause your medications not to work correctly. These drug
`interactions are possible, but do not always occur. Your doctor or pharmacist can
`often prevent or manage interactions by changing how you use your medications
`or by close monitoring.To help your doctor and pharmacist give you the best care,
`be sure to tell your doctor and pharmacist about all the products you use
`(including prescription drugs, nonprescription drugs, and herbal products) before
`starting treatment with this product. While using this product, do not start, stop, or
`change the dosage of any other medicines you are using without your doctor's
`approval.Keep a list of all the products you use. Share the list with your doctor
`and pharmacist to reduce your risk for serious medication problems.
`
`OVERDOSE: This medicine may be harmful if swallowed. If swallowing or
`overdose is suspected, contact a poison control center or emergency room
`immediately. US residents can call their local poison control center at 1-800-222-
`1222. Canada residents can call a provincial poison control center.
`
`NOTES: Do not share this medication with others.This medication has been
`prescribed for your current condition only. Do not use it later for another eye
`condition unless told to do so by your doctor. A different medication may be
`necessary in that case.Laboratory and/or medical tests (such as eye exams,
`measurement of the pressure inside the eyes) may be performed periodically to
`monitor your progress or check for side effects. Consult your doctor for more
`details.
`
`MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near
`the time of the next dose, skip the missed dose and resume your usual dosing
`schedule. Do not double the dose to catch up.
`
`STORAGE: Store the US product between 36-77 degrees F (2-25 degrees
`C).Store the Canadian product between 36-86 degrees F (2-30 degrees C).Store
`away from light and moisture. Do not freeze. Do not store in the bathroom. Keep
`the bottle upright and tightly closed when not in use. Keep all medicines away
`from children and pets.Do not flush medications down the toilet or pour them into
`a drain unless instructed to do so. Properly discard this product when it is expired
`or no longer needed. Consult your pharmacist or local waste disposal company
`for more details about how to safely discard your product.
`
`Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
`
`© 2017 MedicineNet, Inc. All rights reserved.
`MedicineNet does not provide medical advice, diagnosis or treatment.
`See additional information
`
`http://www.medicinenet.com/rimexolone-ophthalmic/article.htm?pf=2
`
`