OTOVEL (ciprofloxacin hcl/fluocinolone acetonide)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Viral infection in the ear

There are 0 severe contraindications.

There are 0 moderate contraindications.

There are 6 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Acneiform eruption Contact dermatitis Hypercortisolism Infection Skin atrophy Skin striae

There are 11 less severe adverse reactions.

More Frequent	Less Frequent
None.	Ear itching Ear stinging Earache Fungal infection in the ear Headache disorder Irritability Pharyngitis Rhinorrhea

Rare/Very Rare
Ear irritation Ear itching Folliculitis

There are no adequate and controlled studies to date using ciprofloxacin ophthalmic solution or ointment in pregnant women, and these preparations should be used during pregnancy only when potential benefits justify possible risks to the fetus. There are no adequate and controlled studies using ciprofloxacin otic preparations, including fixed-combination preparations containing ciprofloxacin and a corticosteroid, in pregnant women, and these preparations should be used with caution during pregnancy. The manufacturer of the fixed combination of ciprofloxacin and fluocinolone acetonide states that negligible amounts of ciprofloxacin or fluocinolone acetonide are absorbed following topical administration of the otic solution and use of the fixed combination during pregnancy is not expected to result in fetal exposure to either drug.

Animal reproduction studies have not been performed using ciprofloxacin 6% otic suspension for intratympanic use and there are no adequate and well-controlled studies using the preparation in pregnant women. The manufacturer states that negligible systemic exposure is expected following intratympanic administration of the 6% otic suspension and there is minimal risk for maternal and fetal toxicity if the otic suspension is used during pregnancy. Reproduction studies in rats and mice receiving oral ciprofloxacin dosages up to 6 times the usual human oral dosage have not revealed evidence of harm to the fetus.

In rabbits, oral ciprofloxacin dosages of 30 and 100 mg/kg caused adverse GI effects resulting in maternal weight loss and an increased incidence of abortion, but there was no evidence of teratogenicity at either dosage. IV ciprofloxacin given to rabbits in dosages up to 20 mg/kg has not resulted in maternal toxicity, embryotoxicity, or teratogenicity.

It is not known whether ciprofloxacin is distributed into milk following topical application to the eye or ear; however, ciprofloxacin is distributed into milk following oral administration. Ciprofloxacin ophthalmic preparations should be used with caution in nursing women. Because of the potential for serious adverse reactions to the drug in nursing infants, a decision should be made whether to discontinue nursing or otic preparations containing ciprofloxacin, including fixed-combinations preparations containing ciprofloxacin and a corticosteroid, taking into account the importance of the drug to the woman.

The manufacturer of the fixed combination of ciprofloxacin and fluocinolone acetonide states that negligible amounts of ciprofloxacin and fluocinolone acetonide are absorbed following topical administration of the otic solution and use of the fixed-combination otic solution in the woman is not expected to result in exposure to either drug in her breast-feeding infant. The manufacturer of ciprofloxacin 6% otic suspension for intratympanic use states that breast-feeding infants of women treated with the otic preparation should not be affected since negligible systemic exposure is expected in the woman.

No enhanced Geriatric Use information available for this drug.