Cipro HC

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Cipro HC

Classes

Otic Corticosteroid/anti-infective Combinations

Administration

For storage information, see the specific product information in the How Supplied section.

Otic Administration

The suspension should be warmed by holding the bottle in the hand for 1—2 minutes to avoid the dizziness which may result from instillation of a cold solution into the ear canal. Shake well immediately before using.
The patient should lie with the affected ear upward during installation of the drops. The patient should continue to lie with the affected ear upward for 30—60 seconds to facilitate penetration of the drops into the ear. The dosage may be repeated, if necessary, for the opposite ear.

Adverse Reactions
Severe

hearing loss / Delayed / Incidence not known

Moderate

migraine / Early / 0-1.0
erythema / Early / Incidence not known
antimicrobial resistance / Delayed / Incidence not known

Mild

headache / Early / 1.2-1.2
rash / Early / 0-1.0
urticaria / Rapid / 0-1.0
paresthesias / Delayed / 0-1.0
hypoesthesia / Delayed / 0-1.0
alopecia / Delayed / 0-1.0
cough / Delayed / 0-1.0
pruritus / Rapid / 0.4-0.4
dizziness / Early / Incidence not known

Common Brand Names

Cipro HC

Dea Class

Rx

Description

Fluoroquinolone/corticosteroid combination otic suspension for acute otitis externa due to Proteus mirabilis, Pseudomonas aeruginosa, and Staphylococcus aureus.

Dosage And Indications
For the treatment of acute otitis externa due to susceptible organisms. Otic dosage (ciprofloxacin 0.2% and hydrocortisone 1% otic suspension) Adults, Adolescents, and Children 1 year and older

3 drops instilled into the affected ear(s) twice daily for 7 days.

Dosing Considerations
Hepatic Impairment

No dosage adjustments are needed.

Renal Impairment

No dosage adjustments are needed.

Drug Interactions

There are no drug interactions associated with Ciprofloxacin; Hydrocortisone products.

How Supplied

Cipro HC/Ciprofloxacin Hydrochloride, Hydrocortisone/Ciprofloxacin, Hydrocortisone Auricular (Otic) Susp: 0.2-1%

Maximum Dosage
Adults

6 drops/day to affected ear(s).

Geriatric

6 drops/day to affected ear(s).

Adolescents

6 drops/day to affected ear(s).

Children

6 drops/day to affected ear(s).

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mechanism Of Action

•Ciprofloxacin: Ciprofloxacin is bactericidal via inhibition of DNA gyrase (topoisomerase II), an enzyme responsible for counteracting the excessive supercoiling of DNA during replication or transcription and topoisomerase IV, an enzyme that helps separate the daughter DNA molecules. In gram-negative bacteria, the primary target is the DNA gyrase A subunit, while the primary target in gram-positive bacteria is generally topoisomerase IV.
•Hydrocortisone: The antiinflammatory actions are thought to involve phospholipase A2 inhibitory proteins, collectively called lipocortins. Lipocortins, in turn, control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of the precursor molecule arachidonic acid.

Pharmacokinetics

Cipro HC Otic is administered topically to the ear.

Topical Route

Pharmacokinetics of ciprofloxacin and hydrocortisone following topical administration to the ear were not evaluated. The manufacturer reports that plasma concentrations of ciprofloxacin were not measured because the systemic exposure to ciprofloxacin is expected to be below the limit of quantitation of the assay (i.e., <= 0.05 mcg/mL). Similarly, the predicted Cmax of hydrocortisone is within the range of endogenous hydrocortisone concentration (i.e., 0—150 ng/mL), and therefore hydrocortisone plasma concentrations resulting from topical administration to the ear cannot be differentiated from endogenous cortisol.

Pregnancy And Lactation
Pregnancy

No adequate and well controlled studies have been conducted in pregnant women. Animal reproduction studies have not been conducted with ciprofloxacin; hydrocortisone otic. Use ciprofloxacin; hydrocortisone otic with caution during pregnancy.

Ciprofloxacin is excreted into breast milk following systemic administration. It is not known if topical otic administration could result in sufficient systemic absorption to produce detectable concentrations in human breast milk. Plasma concentrations were not measured after 3 drops of otic suspension administration because systemic exposure to ciprofloxacin is expected to be below the quantitation limit of the assay (0.05 mcg/mL). However because of the potential for serious adverse reactions in the breast-feeding infant, discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother.