Zylet

Included as part of the PRECAUTIONS section.

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination.

In a 42 day safety study comparing Zylet to placebo, ocular adverse reactions included injection (approximately 20%) and superficial punctuate keratitis (approximately 15%). Increased intraocular pressure was reported in 10% (Zylet) and 4% (placebo) of subjects. Nine percent (9%) of Zylet subjects reported burning and stinging upon instillation.

Ocular reactions reported with an incidence less than 4% include vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders.

The incidence of non-ocular reactions reported in approximately 14% of subjects was headache; all other non ocular reactions had an incidence of less than 5%.

Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.

In a summation of controlled, randomized studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure ( ≥ 10 mm Hg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo.

The most frequent adverse reactions to topical tobramycin are hypersensitivity and localized ocular toxicity, including lid itching and swelling and conjunctival erythema. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics.

The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids.

The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.

Secondary bacterial ocular infection following suppression of host responses also occurs.

Read the entire FDA prescribing information for Zylet (Loteprednol Etabonate and Tobramycin)

You should not use this medicine if you have any type of fungal, viral, or bacterial infection in your eye (including herpes or chickenpox).

It is not likely that other drugs you take orally or inject will have an effect on loteprednol and tobramycin used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

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.

• If you have an allergy to loteprednol, tobramycin, or any other part of Zylet (loteprednol and tobramycin).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: A fungal, TB (tuberculosis), or viral infection of the eye.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Zylet with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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.

Intraocular Pressure (IOP) Increase

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma.

If this product is used for 10 days or longer, intraocular pressure should be monitored.

Cataracts

Use of corticosteroids may result in posterior subcapsular cataract formation.

Delayed Healing

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as a slit lamp biomicroscopy and, where appropriate, fluorescein staining.

Bacterial Infections

Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

Viral Infections

Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).

Fungal Infections

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

Aminoglycoside Hypersensitivity

Sensitivity to topically applied aminoglycosides may occur in some patients. If hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

You should not use Zylet if you have any type of fungal, viral, or bacterial infection in your eye (including herpes or chickenpox).

Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

If you wear contact lenses, remove them before applying Zylet. Ask your doctor if contact lenses can be reinserted after application of the medication. Zylet may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

You should not use Zylet if you are allergic to loteprednol or tobramycin, or other steroids. You should not use if you have any type of fungal, viral, or bacterial infection in your eye (including herpes or chickenpox).

To make sure Zylet is safe for you, tell your doctor if you have:

• glaucoma;

• cataracts (or if you have recently had cataract surgery); or

• herpes infection of your eye.

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

It is not known whether loteprednol and tobramycin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give Zylet to a child younger than 6 years old without medical advice.

Applies to loteprednol / tobramycin ophthalmic: ophthalmic suspension

Ocular

Very common (10% or more): Injection (20%), superficial punctuate keratitis (15%), intraocular pressure increased (10%)
Frequency not reported: Vision disorder, discharge, itching, lacrimation disorder, photophobia, corneal deposit, ocular discomfort, eyelid disorder, unspecified eye disorder

Loteprednol etabonate:
Frequency not reported: Intraocular pressure increased, visual acuity defect, field defect, posterior subcapsular cataract formation, delayed wound healing, secondary ocular infection

Tobramycin:
Frequency not reported: Lid itching, conjunctival erythema, lid swelling[Ref]

Nervous system

Very common (10% or more): Headache (14%)[Ref]

Hypersensitivity

Tobramycin:
Frequency not reported: Hypersensitivity[Ref]

General

The most frequently reported side effects were injections and superficial punctate keratitis, increased intraocular pressure, and burning and stinging upon instillation.[Ref]

Local

Common (1% to 10%): Burning, stinging

Tobramycin:
Frequency not reported: Localized ocular toxicity[Ref]

Some side effects of Zylet may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.