ZYLET (tobramycin/loteprednol etabonate)

There are 4 contraindications. Absolute contraindication.

Contraindication List
Fungal infection of eye
Herpes simplex dendritic keratitis
Tuberculosis of the eye
Vaccinia virus keratitis

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Glaucoma
Ocular hypertension

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
No disease contraindications

There are 20 severe adverse reactions.

More Frequent	Less Frequent
Chemosis	Keratoconjunctivitis Ocular inflammation Ocular itching Ocular redness Uveitis

Rare/Very Rare
Anaphylaxis Bacterial eye infection Cataracts Erythema multiforme Fungal infection of eye Glaucoma Globe perforation Hypersensitivity drug reaction Impaired wound healing Ocular infection Posterior capsule opacification Punctate keratitis Stevens-johnson syndrome Viral ocular infection

There are 24 less severe adverse reactions.

More Frequent	Less Frequent
Anterior chamber inflammation Blurred vision Conjunctival hyperemia Corneal edema Dry eye Eye tearing Headache disorder Ocular itching Ocular pain Ocular redness Pharyngitis Photophobia Rhinitis Visual changes	Blurred vision Conjunctival hyperemia Conjunctivitis Eyelid erythema Ocular discharge Ocular hypertension Ocular irritation Ocular pain

Rare/Very Rare
Eyelid edema Foreign body sensation of eye

Animal reproduction studies using systemic tobramycin dosages up to 33 times the usual human systemic dosage have not revealed evidence of impaired fertility or harm to the fetus. There are no controlled studies to date using tobramycin ophthalmic preparations in pregnant women. Tobramycin ophthalmic ointment and ophthalmic solution should be used during pregnancy only if clearly needed.

Fixed-combination ophthalmic preparations containing tobramycin and a corticosteroid (i.e., dexamethasone or loteprednol etabonate) should be used during pregnancy only if potential benefits justify potential risks to the fetus.

A decision should be made whether to discontinue nursing or discontinue tobramycin ophthalmic preparations, taking into account the importance of the drug to the woman. The manufacturers state that caution is advised if fixed-combination ophthalmic preparations containing tobramycin and a corticosteroid are used in nursing women.

No enhanced Geriatric Use information available for this drug.