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Overview
Ciprofloxacin (otic) is an antibiotic that is FDA approved for the treatment of acute otitis externa. Common adverse reactions include site pain, ear pruritus, fungal ear superinfection, and headache.
The contents of one single use container (deliverable volume: 0.25 mL) should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days.
Wash hands before use. The solution should be warmed, by holding the container in the hands for at least 1 minute, to minimize the dizziness that may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then the solution should be instilled. This position should be maintained for at least 1 minute to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear.
DOSAGE FORMS AND STRENGTHS
Ciprofloxacin Otic Solution is a sterile, preservative-free, otic solution of ciprofloxacin hydrochloride equivalent to 0.2 % ciprofloxacin (0.5 mg in 0.25 mL) in each single use container.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ciprofloxacin (otic) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ciprofloxacin (otic) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Ciprofloxacin (otic) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ciprofloxacin (otic) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ciprofloxacin (otic) in pediatric patients.
Contraindications
Ciprofloxacin Otic Solution is contraindicated in persons with a history of hypersensitivity to ciprofloxacin.
Warnings
Otic Use Only
Ciprofloxacin Otic Solution is for otic use only. It should not be used for injection, for inhalation or for topical ophthalmic use.
Hypersensitivity
Ciprofloxacin Otic Solution should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
Growth of Resistant Organisms with Prolonged Use
As with other anti-infectives, use of Ciprofloxacin Otic Solution may result in overgrowth of nonsusceptible organisms, including yeast and fungi. If super-infection occurs, discontinue use and institute alternative therapy.
Lack of Clinical Response
If the infection is not improved after one week of therapy, cultures may help guide further treatment.
Adverse Reactions
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
In a randomized, active-controlled clinical trial, approximately 300 patients with clinical signs and symptoms of otitis externa were treated with Ciprofloxacin Otic Solution. The most frequently reported adverse reactions were application site pain, ear pruritus, fungal ear superinfection, and headache, each reported in approximately 2-3% of patients.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Ciprofloxacin (otic) in the drug label.
Drug Interactions
There is limited information regarding Ciprofloxacin (otic) Drug Interactions in the drug label.
Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and intravenous (IV) doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose. After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed.
Animal reproduction studies have not been conducted with Ciprofloxacin Otic Solution. No adequate and well-controlled studies have been performed in pregnant women. Caution should be exercised when Ciprofloxacin Otic Solution is used by a pregnant woman.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ciprofloxacin (otic) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ciprofloxacin (otic) during labor and delivery.
Nursing Mothers
Ciprofloxacin is excreted in human milk with systemic use. It is not known whether ciprofloxacin is excreted in human milk following otic use. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
The safety and effectiveness of Ciprofloxacin Otic Solution in infants below one year of age have not been established. The efficacy of Ciprofloxacin Otic Solution in treating otitis externa in pediatric patients one year or older has been demonstrated in controlled clinical trials.
There is no evidence that the otic administration of quinolones has any effect on weight bearing joints, even though systemic administration of some quinolones has been shown to cause arthropathy in immature animals.
Geriatic Use
No overall differences in safety and effectiveness have been observed between elderly and younger patients.
Gender
There is no FDA guidance on the use of Ciprofloxacin (otic) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ciprofloxacin (otic) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Ciprofloxacin (otic) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Ciprofloxacin (otic) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ciprofloxacin (otic) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ciprofloxacin (otic) in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Intravenous
Monitoring
There is limited information regarding Monitoring of Ciprofloxacin (otic) in the drug label.
Description
IV Compatibility
There is limited information regarding IV Compatibility of Ciprofloxacin (otic) in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Ciprofloxacin (otic) in the drug label.
Pharmacology
There is limited information regarding Ciprofloxacin (otic) Pharmacology in the drug label.