Lotemax SM (Ophthalmic)

Loteprednol is used to treat eye pain, redness, and swelling caused by certain eye problems or eye surgery. It is also used to temporarily treat itching of the eye caused by a condition called seasonal allergic conjunctivitis. This medicine is part of a group called corticosteroids (steroids or cortisone-like medicines).

Loteprednol is also used for short-term treatment of the signs and symptoms of dry eye disease.

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

It is very important for your eye doctor (ophthalmologist) to check your or your child's progress at regular visits to ensure the medicine is working properly and to look for any unwanted effects, especially if you will be using this medicine for 10 days or longer.

Loteprednol eye drops or eye gel are not for long-term use. Steroid eye drops may cause glaucoma (increased pressure inside the eye) or posterior subcapsular cataracts (a rare type of cataract) if used for too long. Slow or delayed healing may also happen while you are using this medicine after cataract surgery. You will need to have regular eye exams with your doctor to check for these issues.

Do not wear contact lenses while using Lotemax® or Lotemax® SM eye gel.

If you wear contact lenses, take them out before you put the drops in your eyes. Wait at least 15 minutes after using Eysuvis™ eye drops or Inveltys® eye drops before putting your contact lenses back in.

If you are using the 0.2% loteprednol: If your eyes are red, you should not wear contact lenses. If your eyes are not red, soft contact lenses should be taken out before you use this medicine. Wait at least 10 minutes after using the eye drops before putting the contact lenses back in.

If you hurt your eye or get an eye infection, talk to your doctor right away. You may need to change your medicine or stop using it.

If your symptoms do not improve within a few days or if they get worse, check with your eye doctor (ophthalmologist) right away.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. Here are important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies you have, including allergies to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on the effects of Eysuvis™ eye drops, Inveltys® eye drops, or Lotemax® SM eye gel in children. Safety and efficacy have not been established.

Studies done so far have not shown any pediatric-specific problems that would limit the usefulness of Lotemax® eye gel in children. Safety and efficacy have been established.

Geriatric

Studies done so far have not shown any geriatric-specific problems that would limit the usefulness of loteprednol in older adults.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. Your doctor may adjust the dose or take other precautions if you are taking this medicine along with others. It is very important for your healthcare professional to know if you are taking any of the following medicines. The interactions listed are based on their potential significance and may not be all-inclusive.

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

• Aspirin
• Bemiparin
• Lutetium Lu 177 Dotatate
• Macimorelin
• Nadroparin
• Sargramostim
• Somatrogon-ghla

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Auranofin

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Cataract surgery—Use with caution. May cause delayed healing.

• Certain eye diseases that thin the cornea—Use could lead to a hole forming (perforation).

• Fungal eye infection or
• Herpes simplex eye infection or
• Mycobacterial (tuberculosis) eye infection or
• Vaccinia (smallpox) eye infection or
• Varicella (chickenpox) eye infection—Should not be used in patients with these conditions.

• Glaucoma—Use with caution. May worsen this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Blurred vision or other changes in vision
• Redness or swelling of the eye
• Sensitivity of the eyes to light
• Swelling of the membrane covering the white part of the eye

Less common

• Decreased vision
• Discharge from the eye
• Eye discomfort, irritation, or pain
• Redness of the eyelid or inner lining of the eyelid
• Tiny bumps on the inner lining of the eyelid

Incidence not known

• Blindness
• Gradual blurring or loss of vision
• Loss of vision
• Nausea
• Slow wound healing
• Tearing
• Vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning feeling when medicine is applied
• Dry eyes
• Feeling of something in the eye
• Headache
• Itching
• Runny nose
• Sore throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Alrex
• Eysuvis
• Inveltys
• Lotemax
• Lotemax SM

Available Dosage Forms:

• Ointment
• Suspension
• Gel/Jelly

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.

To use the eye drops or eye gel:

• Wash your hands with soap and water before and after using this medicine.
• Turn the closed bottle upside down and shake it for 1 to 2 seconds before putting the medicine into your eye. Remove the cap with the bottle still being held upside down.
• Shake the Eysuvis™ eye drops for 2 to 3 seconds just before each use.
• 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, repeat the directions with 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. Serious damage to the eye and possible loss of vision may result from using contaminated eye medicines.

Wait at least 5 minutes after using Inveltys® eye drops before you use other eye medicines.

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 forms (eye drops or eye gel): For dry eye disease:Eysuvis™: Adults—Instill one to two drops into the affected eye 4 times a day for up to 2 weeks. Children—Use and dose must be determined by your doctor. For eye pain or inflammation after eye surgery: Inveltys®: Adults—Instill one to two drops into the affected eye 2 times a day, beginning 24 hours after surgery and for 2 weeks after. Children—Use and dose must be determined by your doctor. Lotemax®: Adults—Apply one or two drops into the affected eye 4 times a day, beginning 24 hours after surgery and for 2 weeks after. Children—Apply one or two drops into the affected eye 4 times a day, beginning 24 hours after surgery and for 2 weeks after. Lotemax® SM: Adults—Apply one drop into the affected eye 3 times a day, beginning 24 hours after surgery and for 2 weeks after. Children—Use and dose must be determined by your doctor. For seasonal allergic conjunctivitis: Adults—Use one drop of the 0.2% eye suspension in the affected eye 4 times a day. Children—Use and dose must be determined by your doctor. For other eye problems as determined by your doctor: Adults—Use one or two drops of the 0.5% eye suspension in the affected eye 4 times a day. During the first week, your doctor may want you to use the eye drops more often. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply 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.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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