Pronunciation:

loe-te-PRED-nol et-a-BOE-nate, toe-bra-MYE-sin

Brand Names:

• Zylet

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Aminoglycoside/Corticosteroid Combination

Pharmacologic—

Loteprednol

Chemical—

Aminoglycoside

Uses of This Medicine:

Loteprednol and tobramycin ophthalmic (eye) solution or drops is used to treat inflammation or swelling in the eye that is caused by a bacterial infection.

Loteprednol and tobramycin solution is a combination of a steroid (loteprednol) and an antibiotic (tobramycin). Loteprednol reduces swelling and inflammation. Tobramycin works by killing the bacteria or preventing it from growing.

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

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of loteprednol and tobramycin eye drops in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of loteprednol and tobramycin eye drops in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other 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 this medicine, 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 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.

• Ataluren
• Desmopressin

Using this medicine 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.

• Alcuronium
• Aspirin
• Atracurium
• Bemiparin
• Carbamazepine
• Cholera Vaccine, Live
• Cidofovir
• Cisatracurium
• Colistimethate Sodium
• Cosyntropin
• Cyclosporine
• Decamethonium
• Doxacurium
• Emtricitabine
• Ethacrynic Acid
• Ethinyl Estradiol
• Fazadinium
• Foscarnet
• Furosemide
• Gallamine
• Hexafluorenium
• LetibotulinumtoxinA-wlbg
• Lutetium Lu 177 Dotatate
• Lysine
• Macimorelin
• Mannitol
• Metocurine
• Mivacurium
• Nadroparin
• Pancuronium
• Pipecuronium
• Rapacuronium
• Rocuronium
• Sargramostim
• Somatrogon-ghla
• Succinylcholine
• Tacrolimus
• Tenofovir Alafenamide
• Tubocurarine
• Upadacitinib
• Vancomycin
• Vecuronium

Using this medicine with any of the following medicines may cause an increased 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 of the medicines.

• Auranofin
• Cisplatin

Other interactions—

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataract surgery, recent or
• Cornea (part of the eye) problems, history of or
• Sclera (part of the eye) problems, history of—May cause side effects to become worse.

• Fungal (caused by a fungus) 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 make this condition worse.

Proper Use of This Medicine:

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 help clear up your eye infection completely, keep using this medicine for the full time of treatment, even if your eye feels better.

To use the eye drops:

• Wash your hands with soap and water before and after using this medicine.
• Shake the bottle well before taking the top off and before each dose.
• For the first dose, make sure the imprinted neck-band is on the bottle and holding the top in place.
• Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the eyelid away from the eye to make a space. Drop the medicine into this space.
• Let go of the eyelid and gently close the eye. Do not blink. Keep the eye closed 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 process 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.

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 eye infections:
    • Adults—Instill one or two drops in the affected eye every 4 to 6 hours. Your doctor may tell you to use the drops more often (every 1 to 2 hours) during the first 24 to 48 hours. Your doctor may adjust your dose as needed.
    • 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—

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.

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

Store the bottle upright.

Precautions While Using This Medicine:

If you will be using this medicine for more than a few weeks, your eye doctor will check your eyes at regular visits to make sure it is working properly and is not causing unwanted effects.

If your symptoms do not improve within a few days or if they become worse, check with your eye doctor.

Loteprednol and tobramycin eye drops is 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 too long. Slow or delayed healing may also occur while you are using this medicine after cataract surgery. You will need to have regular eye exams with your doctor to check for these problems.

Do not wear contact lenses while you are using this medicine.

Side Effects of This Medicine:

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

change in vision

feeling like something is in the eye

increased pressure in the eye

loss of vision

pain or irritation of the clear front part of the eye

sensitivity of the eyes to light

Less common

Blurred vision or seeing blue-green halos around objects

chest tightness

decreased vision

difficulty seeing at night

discharge from the eye

dry eyes

eyelid burning, redness, itching, pain, or tenderness

fast heartbeat

fever

hives, itching, skin rash

hoarseness

irritation and swelling of the eye

joint pain

lid itching and swelling

pain in the eye

redness of the eyelid

redness of the skin

stiffness or swelling

swelling of the eyelids, face, lips, hands, or feet

trouble breathing or swallowing

Incidence not known

Redness of the eye

tearing

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 of the eye

headache

increased sensitivity of the eyes to light

stinging of the eye

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.