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Ciprofloxacin and Dexamethasone

Pronunciation

(sip roe FLOKS a sin & deks a METH a sone)

Index Terms

  • Ciprofloxacin Hydrochloride and Dexamethasone
  • Dexamethasone and Ciprofloxacin

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, otic:

Ciprodex: Ciprofloxacin 0.3% and dexamethasone 0.1% (7.5 mL) [contains benzalkonium chloride]

Brand Names: U.S.

  • Ciprodex

Pharmacologic Category

  • Antibiotic, Otic
  • Antibiotic/Corticosteroid, Otic
  • Corticosteroid, Otic

Pharmacology

Ciprofloxacin: Inhibits DNA-gyrase in susceptible organisms; inhibits relaxation of supercoiled DNA and promotes breakage of double-stranded DNA.

Dexamethasone: Decreases inflammation by suppression of neutrophil migration, decreased production of inflammatory mediators, and reversal of increased capillary permeability; suppresses normal immune response.

Absorption

Otic: Ciprofloxacin: Peak: 0.1% of oral administration peak concentrations; Dexamethasone: Peak: 14% of oral administration peak concentrations

Time to Peak

Plasma: Otic: 15 minutes to 2 hours

Use: Labeled Indications

Acute otitis media: Treatment of acute otitis media in pediatric patients ≥6 months of age with tympanostomy tubes due to susceptible isolates of Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenza, Moraxella catarrhalis, and Pseudomonas aeruginosa.

Acute otitis externa: Treatment of acute otitis externa in pediatric patients ≥6 months of age and adults due to susceptible isolates of Staphylococcus aureus and Pseudomonas aeruginosa.

Contraindications

Hypersensitivity to ciprofloxacin, other fluoroquinolones, dexamethasone, or any component of the formulation; viral infection of the external canal, including herpes simplex infections; fungal otic infections.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to other corticosteroids.

Dosing: Adult

Acute otitis externa: Otic: Instill 4 drops into affected ear(s) twice daily for 7 days

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Acute otitis externa: Infants ≥6 months of age, Children, and Adolescents: Otic: Refer to adult dosing.

Acute otitis media in patients with tympanostomy tubes: Infants ≥6 months of age, Children, and Adolescents: Otic: Instill 4 drops into affected ear(s) twice daily for 7 days

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Administration

Otic: For otic use only; not intended for injection or ophthalmic use. Prior to instillation, bottle should be warmed in hands for 1 to 2 minutes; dizziness can occur if a cold suspension is instilled. Shake suspension well immediately before using. Patient should lie with affected ear upward and remain in this position for 60 seconds following application. For acute otitis media, drops should be instilled directly into tympanostomy tube and tragus should be pumped 5 times to facilitate penetration into the middle ear.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F); avoid freezing. Protect from light.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Also see individual agents.

1% to 10%:

Dermatologic: Pruritus of ear (2%)

Otic: Otalgia (≤3%)

<1% (Limited to important or life-threatening): Auditory impairment, oral candidiasis, superinfection

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Severe and occasionally fatal hypersensitivity reactions, including anaphylaxis, have occurred with systemic fluoroquinolone therapy. Prompt discontinuation of drug should occur if skin rash or other symptoms of hypersensitivity arise.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection. If superinfection occurs, discontinue use and institute appropriate therapy.

• Tendon inflammation/rupture: There have been reports of tendon inflammation and/or rupture with systemic fluoroquinolones. Exposure following otic administration is substantially lower than with systemic therapy. Discontinue at first sign of tendon inflammation or pain.

Other warnings/precautions:

• Appropriate use: For otic use only; not intended for injection or ophthalmic use. Prior to instillation, suspension should be warmed in hands to prevent dizziness, which may occur following use of a cold solution.

Monitoring Parameters

Resolution of infection; if infection persists after one week of treatment, obtain cultures to guide further treatment. If otorrhea persists after a full course of therapy, or if ≥2 episodes occur within 6 months, evaluate to exclude an underlying condition (eg, cholesteatoma, foreign body, tumor).

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination. See individual agents.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience itching or ear discomfort or pain. Have patient report immediately to prescriber severe ear irritation, dizziness, tachycardia, or abnormal heartbeat (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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