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Ciprofloxacin and Hydrocortisone

Pronunciation

(sip roe FLOKS a sin & hye droe KOR ti sone)

Index Terms

  • Ciprofloxacin Hydrochloride and Hydrocortisone
  • Hydrocortisone and Ciprofloxacin

Dosage Forms

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

Suspension, otic:

Cipro® HC: Ciprofloxacin hydrochloride 0.2% and hydrocortisone 1% (10 mL) [contains benzyl alcohol]

Brand Names: U.S.

  • Cipro® HC

Pharmacologic Category

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

Use: Labeled Indications

Acute otitis externa: Treatment of acute otitis externa due to susceptible isolates of Staphylococcus aureus, Proteus mirabilis, and Pseudomonas aeruginosa.

Contraindications

Hypersensitivity to hydrocortisone, ciprofloxacin, or any member of the quinolone class of antimicrobial agents; viral infections of the external canal, including varicella and herpes simplex infections; perforated tympanic membrane (known or suspected).

Dosing: Adult

Acute otitis externa: Otic: Instill 3 drops into affected ear twice daily for 7 days.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Acute otitis externa: Children ≥1 year and Adolescents: Otic: Refer to adult dosing.

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

For otic use only. Not for oral, nasal, or ocular use. Prior to instillation, bottle should be warmed by holding 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 30 to 60 seconds following instillation. Repeat, if necessary, for the opposite ear.

Storage

Store below 25°C (77°F); avoid freezing. Protect from light.

Drug Interactions

There are no known significant interactions.

Test Interactions

See individual agents.

Adverse Reactions

1% to 10%: Central nervous system: Headache (1%)

<1% (Limited to important or life-threatening): Alopecia, fungal dermatitis, hypersensitivity reaction, migraine, paresthesia

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.

• Infection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment. 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.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

Other warnings/precautions:

• Appropriate use: For otic use only; not intended for injection or ophthalmic use.

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination.

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?)

• Have patient report immediately to prescriber severe ear irritation (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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