CIPRO HC- ciprofloxacin hydrochloride and hydrocortisone suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - UNII:5E8K9I0O4U), HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

A-S Medication Solutions

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Composition:

CIPROFLOXACIN 2 mg in 1 mL

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CIPRO® HC OTIC is indicated for the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa , Staphylococcus aureus , and Proteus mirabilis . CIPRO® HC OTIC is contraindicated in persons with a history of hypersensitivity to hydrocortisone, ciprofloxacin or any member of the quinolone class of antimicrobial agents. This nonsterile product should not be used if the tympanic membrane is known or suspected to be perforated. Use of this product is contraindicated in viral infections of the external canal including varicella and herpes simplex infections. The safety and efficacy of CIPRO® HC OTIC have been established in pediatric patients 2 years and older (131 patients) in adequate and well-controlled clinical trials. Efficacy has been extrapolated for patients, age 1 year and above based on studies in adults and older pediatric patients.

Product summary:

Product: 50090-1656 NDC: 50090-1656-0 10 mL in a BOTTLE, GLASS

Authorization status:

New Drug Application

Summary of Product characteristics

CIPRO HC- CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE SUSPENSION
A-S MEDICATION SOLUTIONS
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CIPRO® HC OTIC
(CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE OTIC SUSPENSION)
DESCRIPTION
CIPRO® HC OTIC (ciprofloxacin hydrochloride and hydrocortisone otic
suspension)
contains the synthetic broad spectrum antibacterial agent,
ciprofloxacin hydrochloride,
combined with the anti-inflammatory corticosteroid, hydrocortisone, in
a preserved,
nonsterile suspension for otic use. Each mL of CIPRO® HC OTIC
contains ciprofloxacin
hydrochloride (equivalent to 2 mg ciprofloxacin), 10 mg
hydrocortisone, and 9 mg
benzyl alcohol as a preservative. The inactive ingredients are
polyvinyl alcohol, sodium
chloride, sodium acetate, glacial acetic acid, phospholipon 90H
(modified lecithin),
polysorbate, and purified water. Sodium hydroxide or hydrochloric acid
may be added
for adjustment of pH.
Ciprofloxacin, a fluoroquinolone, is available as the
monohydrochloride monohydrate salt
of
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic
acid.
Its empirical formula is C
H
FN O •HCI•H O and its chemical structure is as follows:
Hydrocortisone, pregn-4-ene-3, 20-dione, 11, 17,
21-trihydroxy-(11(β)-, is an anti-
inflammatory corticosteroid. Its empirical formula is C
H
O and its chemical structure
is:
17
18
3
3
2
21
30
5
CLINICAL PHARMACOLOGY
The plasma concentrations of ciprofloxacin were not measured following
three drops of
otic suspension administration because the systemic exposure to
ciprofloxacin is
expected to be below the limit of quantitation of the assay (0.05
μg/mL).
Similarly, the predicted C
of hydrocortisone is within the range of endogenous
hydrocortisone concentration (0-150 ng/mL), and therefore cannot be
differentiated
from the endogenous cortisol.
Preclinical studies have shown that CIPRO® HC OTIC was not toxic to
the guinea pig
cochlea when administered intratympanically twice daily for 30 days
and was only weakly
irritating to rabbit skin upon repeated exposure.
Hydrocort