wade through Cipro HC Otic Generic Name: ciprofloxacin hydrochloride and hydrocortisone Dosage Form: otic suspension Overview Side Effects Dosage Professional Pregnancy More User Reviews Support Group Q & A Compare Alternatives Pricing & Coupons 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 17 H 18 FN 3 O 3 HCI H 2 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 21 H 30 O 5 and its chemical structure is: Slideshow Sexual Health Q+A: Your Questions Answered 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 max 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. Hydrocortisone has been added to aid in the resolution of the inflammatory response accompanying bacterial infection. Microbiology 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 INDICATIONS AND USAGE section: Aerobic gram-positive microorganism Staphylococcus aureus Aerobic gram-negative microorganisms Proteus mirabilis Pseudomonas aeruginosa INDICATIONS AND USAGE 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 . CONTRAINDICATIONS 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. WARNINGS 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. The dropper cap contains natural rubber (latex) which may cause severe allergic reactions. PRECAUTIONS GENERAL: 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. Information for Patients: 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. Carcinogenesis, Mutagenesis, Impairment of Fertility: Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below: Salmonella/Microsome Test (Negative) E. coli DNA Repair Assay (Negative) Mouse Lymphoma Cell Forward Mutation Assay (Positive) Chinese Hamster V79 Cell HGPRT Test (Negative) Syrian Hamster Embryo Cell Transformation Assay (Negative) Saccharomyces cerevisiae Point Mutation Assay (Negative) Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative) 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. Pregnancy: Teratogenic Effects: 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. Nursing Mothers: 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. Pediatric Use: 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. ADVERSE REACTIONS 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. The following reactions have been identified during post-approval use of CIPRO HC OTIC in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to CIPRO HC OTIC, or a combination of these factors, include: dizziness, ear canal erythema, ear congestion, hypoacusis and medication residue. DOSAGE AND ADMINISTRATION 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. HOW SUPPLIED CIPRO HC OTIC is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser. NDC 0065-8531-10 Store below 77 F (25 C). Avoid freezing. Protect from light. U.S. Pat.: www.alconpatents.com CIPRO is a registered trademark of Bayer Intellectual Property GmbH, licensed to Alcon by Bayer Intellectual Property AG. Distributed by: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 2006, 2009, 2016 Novartis T2017-38 March 2017 PRINCIPAL DISPLAY PANEL NDC 0065-8531-10 CIPRO HC OTIC (ciprofloxacin 0.2% HCl and hydrocortisone 1% otic suspension) NOT FOR OPHTHALMIC OR ORAL USE 10 mL Rx Only Alcon CIPRO HC ciprofloxacin hydrochloride and hydrocortisone suspension Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0065-8531 Route of Administration AURICULAR (OTIC) DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN) CIPROFLOXACIN 2 mg in 1 mL HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYVINYL ALCOHOL SODIUM CHLORIDE SODIUM ACETATE ACETIC ACID LECITHIN, SOYBEAN POLYSORBATE 20 WATER SODIUM HYDROXIDE HYDROCHLORIC ACID BENZYL ALCOHOL Packaging # Item Code Package Description 1 NDC:0065-8531-10 10 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020805 03/15/1999 Labeler - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Operations Alcon Cusi, S.A. 462029349 MANUFACTURE(0065-8531) Revised: 03/2017 Alcon Laboratories, Inc. Next Pregnancy Warnings Print this page Add to My Med List More about Cipro HC (ciprofloxacin / hydrocortisone otic) Side Effects During Pregnancy Dosage Information Compare Alternatives Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: otic steroids with anti-infectives Consumer resources Cipro HC otic Cipro HC Cipro HC (Advanced Reading) Other Formulations Cipro Cipro I.V. injection Cipro XR Related treatment guides Acute Otitis Externa} Antibiotics 101 Everything you need to know about antibiotics: List of Common Antibiotics & Types Antibiotics & Drinking Alcohol - Is it Safe? Antibiotics For UTI - What Are My Options? FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Novartis Pharmaceuticals Corporation Drug Class Otic steroids with anti-infectives Related Drugs otic steroids with anti-infectives Ciprodex , Cortisporin Otic , Cortisporin-TC , Coly-Mycin S , Acetasol HC , Vosol HC Acute Otitis Externa ciprofloxacin otic , dexamethasone ophthalmic , Cortisporin-TC , Maxidex , benzocaine otic , Coly-Mycin S , Cetraxal , Floxin Otic , Otocain , finafloxacin otic , Americaine Otic , Benzotic , Xtoro , Cyotic , Cortic-ND , Pramox-HC , Oticin HC , AK-Dex , Cortane-B , More... Cipro HC Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } track
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