Ciprofloxacin Hydrochloride/Hydrocortisone

Pronunciation: (Sip-ROW-FLOX-uh-sin HIGH-droe-KLOR-ide/HIGH-droe-core-tih-sone)Class: Steroid and antibiotic combination

Trade Names:Cipro HC Otic- Suspension 2 mg ciprofloxacin, 10 mg hydrocortisone/mL

Pharmacology

Ciprofloxacin

Interferes with microbial DNA synthesis.

Hydrocortisone

Depresses formation, release, and activity of endogenous mediators of inflammation as well as modifying body's immune response.

Indications and Usage

Treatment of acute otitis externa in adults and children caused by susceptible strains of Pseudomonas aeruginosa , Staphylococcus aureus , and Proteus mirabilis .

Contraindications

Viral infections of the external canal, including varicella and herpes simplex infections; perforated tympanic membrane; hypersensitivity to hydrocortisone, ciprofloxacin, or any member of the quinolone class of antimicrobial agents.

Dosage and Administration

Adults and Children (1 yr of age and older)

Otic Instill 3 drops of suspension into affected ear twice daily for 7 days.

General Advice

For otic use only. Not for oral, nasal, or ocular use.
Hold bottle in hand for 1 to 2 min to warm suspension.
Shake well immediately before using.
Do not touch ear with dropper.
Do not rinse dropper after use.

Storage/Stability

Store below 77°F. Avoid freezing. Protect from light.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache; migraine.

Dermatologic

Pruritus; fungal dermatitis; rash; alopecia; urticaria.

Respiratory

Cough.

Miscellaneous

Hypesthesia; paresthesia.

Precautions

Monitor

Infection

Monitor patient for improvement of symptoms of infection.

Sensitivity

Monitor patient for sensitization or irritation and report to health care provider if noted.

Pregnancy

Category C .

Lactation

Ciprofloxacin and hydrocortisone are excreted in breast milk following oral administration.

Children

Safety and efficacy in children 2 yr of age and older have been established; although no data are available on patients less than 2 yr of age, there are no known safety concerns or differences in the disease process in this population that would preclude use in patients 1 yr of age and older.

Hypersensitivity

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones.

Superinfection

Prolonged use may result in bacterial or fungal overgrowth of nonsusceptible microorganisms.

Bacterial resistance

Bacterial resistance to components of the product may develop.

Patient Information

Remind patient, family, or caregiver that medication is for use in the ear only.
Teach patient proper technique for instilling ear drops: Wash hands; warm solution by holding bottle in hand for 1 to 2 min; shake well. Tilt head to side or lie on side with affected ear upward; instill prescribed number of drops and maintain position for 30 to 60 sec to allow drops to penetrate ear canal. Repeat, if necessary, for the opposite ear. Do not allow dropper to touch ear; replace dropper.
Advise patient, family, or caregiver to only use supplied dropper and not to rinse dropper after use.
Advise patient, family, or caregiver to notify health care provider if symptoms do not improve or if irritation, inflammation, or itching of ear canal is noted.