TOBRADEX (tobramycin/dexamethasone)

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
Amebic infection of the eye
Ocular hypertension

There are 5 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Diabetes mellitus
Krukenberg spindle
No disease contraindications
Open angle glaucoma
Severe myopia

There are 26 severe adverse reactions.

More Frequent	Less Frequent
None.	Ocular hypertension Ocular inflammation Ocular itching Ocular redness

Rare/Very Rare

Adrenocortical insufficiency Anaphylaxis Cataracts Central serous chorioretinopathy Corneal degeneration Corneal edema Corneal erosion Corneal ulcer Erythema multiforme Fungal infection of eye Glaucoma Globe perforation Hypercortisolism Hypersensitivity drug reaction Keratitis Optic nerve damage Punctate keratitis Reduced visual acuity Stevens-johnson syndrome Uveitis Visual changes Visual field defect

There are 27 less severe adverse reactions.

More Frequent	Less Frequent
Blurred vision	Blurred vision Conjunctival hyperemia Headache disorder Iritis Ocular irritation Ocular pain

Rare/Very Rare
Accommodation disorder Allergic dermatitis Blepharoptosis Calcification of cornea Chemosis Conjunctival hyperemia Conjunctivitis Dizziness Dysgeusia Eye tearing Eyelid edema Foreign body sensation of eye Impaired wound healing Mydriasis Ocular infection Ocular irritation Ocular itching Ocular redness Photophobia Urticaria

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.