NDC 0065-0654 Ciloxan

Ciprofloxacin Hydrochloride

NDC Product Code 0065-0654

NDC 0065-0654-35

Package Description: 3.5 g in 1 TUBE

NDC Product Information

Ciloxan with NDC 0065-0654 is a a human prescription drug product labeled by Alcon Laboratories, Inc.. The generic name of Ciloxan is ciprofloxacin hydrochloride. The product's dosage form is ointment and is administered via ophthalmic form.

Labeler Name: Alcon Laboratories, Inc.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Ciloxan Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CIPROFLOXACIN HYDROCHLORIDE 3 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MINERAL OIL (UNII: T5L8T28FGP)
  • PETROLATUM (UNII: 4T6H12BN9U)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.
  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Quinolone Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Quinolones - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Alcon Laboratories, Inc.
Labeler Code: 0065
FDA Application Number: NDA020369 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-02-1998 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Ciprofloxacin Ophthalmic

Ciprofloxacin Ophthalmic is pronounced as (sip roe flox' a sin)

Why is ciprofloxacin ophthalmic medication prescribed?
Ciprofloxacin ophthalmic solution is used to treat bacterial infections of the eye including conjunctivitis (pinkeye; infection of the membrane that covers the outside of...
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Ciloxan Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description:

CILOXAN® (ciprofloxacin ophthalmic ointment) is a synthetic, sterile, multiple dose, antimicrobial for topical use. Ciprofloxacin is a fluoroquinolone antibacterial. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Ciprofloxacin is a faint to light yellow crystalline powder with a molecular weight of 385.82. Its empirical formula is C17H18FN3O3•HCl•H2O and its chemical structure is as follows:Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position.Each gram of CILOXAN®(ciprofloxacin ophthalmic ointment) contains: Active: ciprofloxacin HCl 3.33 mg equivalent to 3 mg base. Inactives: mineral oil, white petrolatum.

Clinical Pharmacology:

Systemic Absorption: Absorption studies in humans with the ciprofloxacin ointment have not been conducted, however, based on studies with ciprofloxacin solution, 0.3%, mean maximal concentrations are expected to be less than 2.5 ng/mL.Microbiology: Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms. The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.Ciprofloxacin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections (SEE INDICATIONS AND USAGE section).Aerobic gram-positive microorganisms:Staphylococcus aureus (methicillin-susceptible strains) Staphylococcus epidermidis (methicillin-susceptible strains) Streptococcus pneumoniaeStreptococcus Viridans GroupAerobic gram-negative microorganisms: Haemophilus influenzaeThe following in vitro data are available; but their clinical significance in ophthalmologic infections is unknown. The safety and effectiveness of ciprofloxacin in treating conjunctivitis due to these microorganisms have not been established in adequate and well controlled trials.The following organisms are considered susceptible when evaluated using systemic breakpoints. However, a correlation between the in vitro systemic breakpoint and ophthalmological efficacy has not been established. Ciprofloxacin exhibits in vitro minimal inhibitory concentrations (MIC’s) of 1 mcg/mL or less (systemic susceptible breakpoint) against most (≥ 90%) strains of the following ocular pathogens.Aerobic gram-positive microorganisms:Bacillus speciesCorynebacterium speciesStaphylococcus haemolyticusStaphylococcus hominis              Aerobic gram-negative microorganisms:Acinetobacter calcoaceticusEnterobacter aerogenesEscherichia coliHaemophilus parainfluenzaeKlebsielle pneumoniaeMoraxella catarrhalisNeisseria gonorrhoeaeProteus mirabilisPseudomonas aeruginosaSerratia marcesensMost strains of Burkholderia cepacia and some strains of Stenotrophomonas maltophilia are resistant to ciprofloxacin as are most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile.The minimal bactericidal concentration (MBC) generally does not exceed the minimal inhibitory concentration (MIC) by more than a factor of 2. Resistance to ciprofloxacin in vitro usually develops slowly (multiple-step mutation). Ciprofloxacin does not cross-react with other antimicrobial agents such as beta-lactams or aminoglycosides; therefore, organisms resistant to these drugs may be susceptible to ciprofloxacin. Organisms resistant to ciprofloxacin may be susceptible to beta-lactams or aminoglycosides.Clinical Studies: In multicenter clinical trials, approximately 75% of the patients with signs and symptoms of bacterial conjunctivitis and positive conjunctival cultures were clinically cured and approximately 80% had presumed pathogens eradicated by the end of treatment (day 7).

Indications And Usage:

CILOXAN® (ciprofloxacin ophthalmic ointment) is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the microorganisms listed below:Gram-Positive:Staphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniaeStreptococcus Viridans GroupGram-Negative:Haemophilus influenzae

Contraindications:

A history of hypersensitivity to ciprofloxacin or any other component of the medication is a contraindication to its use. A history of hypersensitivity to other quinolones may also contraindicate the use of ciprofloxacin.

Warnings:

FOR TOPICAL OPHTHALMIC USE ONLY.NOT FOR INJECTION INTO THE EYE.Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated.

General Precautions

General: As with other antibacterial preparations, prolonged use of ciprofloxacin may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction. Ophthalmic ointments may retard corneal healing and cause visual blurring. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.

Information For Patients

Information for Patients: Do not touch tip to any surface as this may contaminate the ointment.Do not use the product if the imprinted carton seals have been damaged, or removed.

Drug Interactions

Drug Interactions: Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant, warfarin, and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

Carcinogenesis & Mutagenesis & Impairment Of Fertility

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, two of the eight tests were positive, but the results of the following three 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. After daily oral dosing for up to two years, there is no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects in these species.

Pregnancy

Pregnancy: Pregnancy Category C. Reproduction studies have been performed in rats and mice at doses up to six times the usual daily human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to ciprofloxacin. In rabbits, as with most antimicrobial agents, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion. No teratogenicity was observed at either dose. After intravenous administration, at doses up to 20 mg/kg, no maternal toxicity was produced and no embryotoxicity or teratogenicity was observed. There are no adequate and well controlled studies in pregnant women. CILOXAN® (ciprofloxacin ophthalmic ointment) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Nursing Mothers: It is not known whether topically applied ciprofloxacin is excreted in human milk. However, it is known that orally administered ciprofloxacin is excreted in the milk of lactating rats and oral ciprofloxacin has been reported in human breast milk after a single 500 mg dose. Caution should be exercised when CILOXAN® (ciprofloxacin ophthalmic ointment) is administered to a nursing mother.

Pediatric Use

Pediatric Use: Safety and effectiveness of CILOXAN® (ciprofloxacin ophthalmic ointment) 0.3% in pediatric patients below the age of two years have not been established. Although ciprofloxacin and other quinolones may cause arthropathy in immature Beagle dogs after oral administration, topical ocular administration of ciprofloxacin to immature animals did not cause any arthropathy and there is no evidence that the ophthalmic dosage form has any effect on the weight bearing joints.

Geriatric Use

Geriatric Use: No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

Adverse Reactions:

The following adverse reactions (incidences) were reported in 2% of the patients in clinical studies for CILOXAN® (ciprofloxacin ophthalmic ointment): discomfort, keratopathy. Other reactions associated with ciprofloxacin therapy occurring in less than 1% of patients included allergic reactions, blurred vision, corneal staining, decreased visual acuity, dry eye, edema, epitheliopathy, eye pain, foreign body sensation, hyperemia, irritation, keratoconjunctivitis, lid erythema, lid margin hyperemia, photophobia, pruritus, and tearing. Systemic adverse reactions related to ciprofloxacin therapy occurred at an incidence below 1% and included dermatitis, nausea and taste perversion.

Dosage And Administration:

Apply a ½ inch ribbon into the conjunctival sac three times a day on the first two days, then apply a ½ inch ribbon two times a day for the next five days.

How Supplied

How Supplied: 3.5 gram STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. 3.5 gram - NDC 0065-0654-35Storage: Store at 2° C to 25°C (36°F to 77°F).

Animal Pharmacology:

Ciprofloxacin and related drugs have been shown to cause arthropathy in immature animals of most species tested following oral administration. However, a one month topical ocular study using immature Beagle dogs did not demonstrate any articular lesions.© 2002, 2008, 2016 NovartisDistributed by:ALCON LABORATORIES, INCFort Worth, Texas 76134 USA                  T2017-22February 2017

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