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Cipro HC
Overview
What is Cipro HC?
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 CHFNO•HCI•HO and its chemical structure is
as follows:
What does Cipro HC look like?
What are the available doses of Cipro HC?
Sorry No records found.
What should I talk to my health care provider before I take Cipro HC?
Sorry No records found
How should I use Cipro HC?
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.
SHAKE WELL IMMEDIATELY BEFORE USING.
For children (age 1 year and older) and adults, 3 drops of the suspension
should be instilled into the affected ear twice daily for seven days. The
suspension should be warmed by holding the bottle in the hand for 1-2 minutes to
avoid the dizziness which may result from the instillation of a cold solution
into the ear canal. The patient should lie with the affected ear upward and then
the drops should be instilled. This position should be maintained for 30-60
seconds to facilitate penetration of the drops into the ear. Repeat, if
necessary, for the opposite ear. Discard unused portion after therapy is
completed.
What interacts with Cipro HC?
Sorry No Records found
What are the warnings of Cipro HC?
Sorry No Records found
What are the precautions of Cipro HC?
Sorry No Records found
What are the side effects of Cipro HC?
Sorry No records found
What should I look out for while using Cipro HC?
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 perforated. Use of this
product is contraindicated in viral infections of the external canal including
varicella and herpes simplex infections.
What might happen if I take too much Cipro HC?
Sorry No Records found
How should I store and handle Cipro HC?
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.CIPRO HC OTIC is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser.NDC 0065-8531-10Store below 77° F (25° C). Avoid freezing. Protect from light.U.S. Patent Nos. 4,670,444; 4,844,902; 5,843,930; 5,965,549.CIPRO is a registered trademark of Bayer AG.Licensed by Bayer AGRx OnlyMfd. by:ALCON CUSÍ, S.A.08320 El Masnou - BarcelonaSPAIN6-13-930CIPRO HC OTIC is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser.NDC 0065-8531-10Store below 77° F (25° C). Avoid freezing. Protect from light.U.S. Patent Nos. 4,670,444; 4,844,902; 5,843,930; 5,965,549.CIPRO is a registered trademark of Bayer AG.Licensed by Bayer AGRx OnlyMfd. by:ALCON CUSÍ, S.A.08320 El Masnou - BarcelonaSPAIN6-13-930CIPRO HC OTIC is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser.NDC 0065-8531-10Store below 77° F (25° C). Avoid freezing. Protect from light.U.S. Patent Nos. 4,670,444; 4,844,902; 5,843,930; 5,965,549.CIPRO is a registered trademark of Bayer AG.Licensed by Bayer AGRx OnlyMfd. by:ALCON CUSÍ, S.A.08320 El Masnou - BarcelonaSPAIN6-13-930CIPRO HC OTIC is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser.NDC 0065-8531-10Store below 77° F (25° C). Avoid freezing. Protect from light.U.S. Patent Nos. 4,670,444; 4,844,902; 5,843,930; 5,965,549.CIPRO is a registered trademark of Bayer AG.Licensed by Bayer AGRx OnlyMfd. by:ALCON CUSÍ, S.A.08320 El Masnou - BarcelonaSPAIN6-13-930CIPRO HC OTIC is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser.NDC 0065-8531-10Store below 77° F (25° C). Avoid freezing. Protect from light.U.S. Patent Nos. 4,670,444; 4,844,902; 5,843,930; 5,965,549.CIPRO is a registered trademark of Bayer AG.Licensed by Bayer AGRx OnlyMfd. by:ALCON CUSÍ, S.A.08320 El Masnou - BarcelonaSPAIN6-13-930CIPRO HC OTIC is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser.NDC 0065-8531-10Store below 77° F (25° C). Avoid freezing. Protect from light.U.S. Patent Nos. 4,670,444; 4,844,902; 5,843,930; 5,965,549.CIPRO is a registered trademark of Bayer AG.Licensed by Bayer AGRx OnlyMfd. by:ALCON CUSÍ, S.A.08320 El Masnou - BarcelonaSPAIN6-13-930CIPRO HC OTIC is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser.NDC 0065-8531-10Store below 77° F (25° C). Avoid freezing. Protect from light.U.S. Patent Nos. 4,670,444; 4,844,902; 5,843,930; 5,965,549.CIPRO is a registered trademark of Bayer AG.Licensed by Bayer AGRx OnlyMfd. by:ALCON CUSÍ, S.A.08320 El Masnou - BarcelonaSPAIN6-13-930CIPRO HC OTIC is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser.NDC 0065-8531-10Store below 77° F (25° C). Avoid freezing. Protect from light.U.S. Patent Nos. 4,670,444; 4,844,902; 5,843,930; 5,965,549.CIPRO is a registered trademark of Bayer AG.Licensed by Bayer AGRx OnlyMfd. by:ALCON CUSÍ, S.A.08320 El Masnou - BarcelonaSPAIN6-13-930CIPRO HC OTIC is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser.NDC 0065-8531-10Store below 77° F (25° C). Avoid freezing. Protect from light.U.S. Patent Nos. 4,670,444; 4,844,902; 5,843,930; 5,965,549.CIPRO is a registered trademark of Bayer AG.Licensed by Bayer AGRx OnlyMfd. by:ALCON CUSÍ, S.A.08320 El Masnou - BarcelonaSPAIN6-13-930CIPRO HC OTIC is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser.NDC 0065-8531-10Store below 77° F (25° C). Avoid freezing. Protect from light.U.S. Patent Nos. 4,670,444; 4,844,902; 5,843,930; 5,965,549.CIPRO is a registered trademark of Bayer AG.Licensed by Bayer AGRx OnlyMfd. by:ALCON CUSÍ, S.A.08320 El Masnou - BarcelonaSPAIN6-13-930CIPRO HC OTIC is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser.NDC 0065-8531-10Store below 77° F (25° C). Avoid freezing. Protect from light.U.S. Patent Nos. 4,670,444; 4,844,902; 5,843,930; 5,965,549.CIPRO is a registered trademark of Bayer AG.Licensed by Bayer AGRx OnlyMfd. by:ALCON CUSÍ, S.A.08320 El Masnou - BarcelonaSPAIN6-13-930CIPRO HC OTIC is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser.NDC 0065-8531-10Store below 77° F (25° C). Avoid freezing. Protect from light.U.S. Patent Nos. 4,670,444; 4,844,902; 5,843,930; 5,965,549.CIPRO is a registered trademark of Bayer AG.Licensed by Bayer AGRx OnlyMfd. by:ALCON CUSÍ, S.A.08320 El Masnou - BarcelonaSPAIN6-13-930
Clinical Information
Chemical Structure
No Image foundClinical 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 Cmax of hydrocortisone is within the range of
endogenous hydrocortisone concentration (0-150 ng/mL), and therefore can not 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.
Hydrocortisone has been added to aid in the resolution of the inflammatory
response accompanying bacterial infection.
Ciprofloxacin has in vitro activity against a wide range of
gram-positive and gram-negative microorganisms. The bactericidal action of
ciprofloxacin results from interference with the enzyme, DNA gyrase, which is
needed for the synthesis of bacterial DNA. Cross-resistance has been observed
between ciprofloxacin and other fluoroquinolones. There is generally no
cross-resistance between ciprofloxacin and other classes of antibacterial agents
such as beta-lactams or aminoglycosides.
Ciprofloxacin has been shown to be active against most strains of the
following microorganisms, both in vitro and in clinical infections of acute
otitis externa as described in the
section:
Aerobic gram-positive microorganism
Staphylococcus aureus
Aerobic gram-negative microorganisms
Proteus mirabilis
Pseudomonas aeruginosa
Non-Clinical Toxicology
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 perforated. Use of this product is contraindicated in viral infections of the external canal including varicella and herpes simplex infections.When a diuretic is added to the therapy of a patient receiving lisinopril, an additional antihypertensive effect is usually observed. Studies with ACE inhibitors in combination with diuretics indicate that the dose of the ACE inhibitor can be reduced when it is given with a diuretic. (See )
Antidiabetics:
Non-steroidal Anti-inflammatory Agents:
Other Agents:
Agents Increasing Serum Potassium:
Lithium:
Gold:
NOT FOR OPHTHALMIC USE. NOT FOR INJECTION.
CIPRO HC OTIC should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Serious acute hypersensitivity reactions may require immediate emergency treatment.
As with other antibiotic preparations, use of this product may result in overgrowth of nonsusceptible organisms, including fungi. If the infection is not improved after one week of therapy, cultures should be obtained to guide further treatment.
If rash or allergic reaction occurs, discontinue use immediately and contact your physician.
Do not use in the eyes.
Avoid contaminating the dropper with material from the ear, fingers, or other sources.
Protect from light.
Shake well immediately before using.
Discard unused portion after therapy is completed.
Eight mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below:
Salmonella/Microsome Test (Negative)
E. coli
Mouse Lymphoma Cell Forward Mutation Assay (Positive)
Chinese Hamster V Cell HGPRT Test (Negative)
Syrian Hamster Embryo Cell Transformation Assay (Negative)
Saccharomyces cerevisiae
Saccharomyces cerevisiae
Rat Hepatocyte DNA Repair Assay (Positive)
Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems gave negative results:
Rat Hepatocyte DNA Repair Assay
Micronucleus Test (Mice)
Dominant Lethal Test (Mice)
Long-term carcinogenicity studies in mice and rats have been completed for ciprofloxacin. After daily oral doses of 750 mg/kg (mice) and 250 mg/kg (rats) were administered for up to 2 years, there was no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects in these species. No long term studies of CIPRO HC OTIC suspension have been performed to evaluate carcinogenic potential.
Fertility studies performed in rats at oral doses of ciprofloxacin up to 100 mg/kg/day revealed no evidence of impairment. This would be over 1000 times the maximum recommended clinical dose of ototopical ciprofloxacin based upon body surface area, assuming total absorption of ciprofloxacin from the ear of a patient treated with CIPRO HC OTIC twice per day.
Long term studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical hydrocortisone. Mutagenicity studies with hydrocortisone were negative.
Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and IV doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose. After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed.
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
Animal reproduction studies have not been conducted with CIPRO HC OTIC. No adequate and well controlled studies have been performed in pregnant women. Caution should be exercised when CIPRO HC OTIC is used by a pregnant woman.
Ciprofloxacin is excreted in human milk with systemic use. It is not known whether ciprofloxacin is excreted in human milk following topical otic administration. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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. Although no data are available on patients less than age 2 years, there are no known safety concerns or differences in the disease process in this population which would preclude use of this product in patients one year and older. See DOSAGE AND ADMINISTRATION.
In Phase 3 clinical trials, a total of 564 patients were treated with CIPRO HC OTIC. Adverse events with at least remote relationship to treatment included headache (1.2%) and pruritus (0.4%). The following treatment-related adverse events were each reported in a single patient: migraine, hypesthesia, paresthesia, fungal dermatitis, cough, rash, urticaria, and alopecia.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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