OCUFLOX (ofloxacin)

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 2 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Stevens-johnson syndrome Toxic epidermal necrolysis

There are 13 less severe adverse reactions.

More Frequent	Less Frequent
Ocular irritation	Blurred vision Dry eye Eye tearing Foreign body sensation of eye Ocular itching Ocular pain Ocular redness Periorbital edema Photophobia

Rare/Very Rare
Dizziness Facial edema Nausea

There are no adequate and controlled studies to date using ofloxacin 0.3% ophthalmic solution or ofloxacin 0.3% otic solution in pregnant women, and these preparations should be used during pregnancy only when potential benefits justify possible risks to the fetus.

Reproductive studies in rats and rabbits using oral ofloxacin dosages as high as 810 and 160 mg/kg daily (equivalent to 9000 and 1800 times the maximum recommended daily ophthalmic dosage, respectively) did not reveal evidence of teratogenicity. However, embryocidal effects were reported in rats and rabbits receiving such dosages. Decreased fetal body weight and retardation in the degree of ossification and minor skeletal variations, such as cervical ribs and shortened or absent 13th ribs, were reported in the rats; increased fetal mortality was reported in the rabbits. Perinatal and postnatal studies in rats given oral ofloxacin dosages up to 360 mg/kg daily (4000 times the maximum recommended daily ophthalmic dosage) revealed a decrease in food intake during gestation and an increase in food and water intake during lactation, but did not reveal evidence of adverse effects on late fetal development, labor, delivery, lactation, neonatal viability, or growth of the offspring.

It is not known whether ofloxacin is distributed into milk following topical application to the eye or ear; however, ofloxacin is distributed into milk following oral administration. Because of the potential for serious adverse effects of ofloxacin in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

No enhanced Geriatric Use information available for this drug.