Ciprofloxacin and Dexamethasone: FDA label

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Indications

Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis , and Pseudomonas aeruginosa.

Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa . Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:

Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis , and Pseudomonas aeruginosa. ( 1 )
Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa . ( 1 )

Contraindications

Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. Use of this product is contraindicated in viral infections of the external canal, including herpes simplex infections and fungal otic infections.

Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication. ( 4 )
Use of this product is contraindicated in viral infections of the external canal, including herpes simplex infections and fungal otic infections. (4)

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no available data on ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Because of the minimal systemic absorption of ciprofloxacin and dexamethasone following topical otic administration of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension, this product is expected to be of minimal risk for maternal and fetal toxicity when administered to pregnant women [see Clinical Pharmacology ( 12.3 )].

Animal reproduction studies have not been conducted with ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension. Oral administration of ciprofloxacin during organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30 mg/kg to pregnant rabbits did not cause fetal malformations (see Data). These doses were at least 200 times the recommended otic human dose (ROHD in mice, rats, and rabbits, respectively, based on body surface area (BSA).

With dexamethasone, malformations have been observed in animal studies after ocular and systemic administration. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and of miscarriage is 15% to 20% respectively.

Data Animal Data Ciprofloxacin Developmental toxicology studies have been performed with ciprofloxacin in rats, mice, and rabbits. The doses used in these studies are, at a minimum, approximately 200 times greater than the recommended otic human dose based on body surface area. In rats and mice, oral doses up to 100 mg/kg administered during organogenesis (Gestation Days (GD), 6-17) were not associated with adverse developmental outcomes, including embryofetal toxicity or malformations.

A 30 mg/kg oral dose was associated with suppression of maternal and fetal body weight gain, but fetal malformations were not observed. Intravenous administration of doses up to 20 mg/kg to pregnant rabbits was not maternally toxic and neither embryofetal toxicity nor fetal malformations were observed. To mitigate maternal toxicity in these studies, groups of rabbits received ciprofloxacin for a different 5 day dosing period covering organogenesis (GD 6-18).

Dexamethasone Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application. In a rat oral developmental toxicity study, no adverse effects were observed at 0.01 mg/kg/day (0.1 times the ROHD based on BSA), although embryotoxicity was observed at higher doses.

Adverse reactions

The following serious adverse reactions are described elsewhere in the labeling:

Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )]
Potential for Microbial Overgrowth with Prolonged Use [see Warnings and Precautions ( 5.2)] Most common adverse reactions were ear discomfort (3%), ear pain (2.3%), and ear pruritus (1.5%). (6) To report SUSPECTED ADVERSE REACTIONS, contact NorthStar RxLLC, at 1-800-206- 7821or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. In Phases II and III clinical trials, a total of 937 patients were treated with ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension. This included 400 patients with acute otitis media with tympanostomy tubes (AOMT) and 537 patients with AOE.

The reported adverse reactions are listed below: Acute Otitis Media in Pediatric Patients with Tympanostomy Tubes The following adverse reactions occurred in 0.5% or more of the patients with non-intact tympanic membranes. Ad v erse Reactions In cidence (N=400) Ear discomfort 3.0% Ear pain 2.3% Ear precipitate (residue) 0.5% Irritability 0.5% Taste Perversion 0.5% The following adverse reactions were each reported in a single patient: tympanostomy tube blockage; ear pruritus; tinnitus; oral moniliasis; crying; dizziness; and erythema.

Acute Otitis Externa The following adverse reactions occurred in 0.4% or more of the patients with intact tympanic membranes. Ad v erse Reactions In cidence (N=537) Ear pruritus 1.5% Ear debris 0.6% Superimposed ear infection 0.6% Ear congestion 0.4% Ear pain 0.4% Erythema 0.4% The following adverse reactions were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling).

6.2Postmarketing Experience

The following adverse reactions have been identified during post approval use of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: auricular swelling, headache, hypersensitivity, otorrhea, skin exfoliation, rash erythematous, and vomiting.

Ciprofloxacin and Dexamethasone

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Hypersensitivity Reactions Ciprofloxacin 0.3%

5.2Potential for Microbial Overgrowth with Prolonged Use

5.3Continued or Recurrent Otorrhea

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance

Guidelines