TOBREX (tobramycin)

There are 0 contraindications.

There are 0 severe contraindications.

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 8 severe adverse reactions.

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

Rare/Very Rare
Anaphylaxis Erythema multiforme Hypersensitivity drug reaction Punctate keratitis Stevens-johnson syndrome

There are 5 less severe adverse reactions.

More Frequent	Less Frequent
None.	Blurred vision Conjunctival hyperemia Ocular irritation Ocular pain

Rare/Very Rare
Eyelid edema

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.