NDC 0065-0656 Ciloxan

Ciprofloxacin Hydrochloride

NDC Product Code 0065-0656

NDC 0065-0656-05

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 5 mL in 1 BOTTLE, PLASTIC

NDC 0065-0656-10

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 10 mL in 1 BOTTLE, PLASTIC

NDC 0065-0656-25

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 2.5 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Ciloxan with NDC 0065-0656 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 solution/ drops and is administered via ophthalmic form.

Labeler Name: Alcon Laboratories, Inc.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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/mL

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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • SODIUM ACETATE (UNII: 4550K0SC9B)
  • ACETIC ACID (UNII: Q40Q9N063P)
  • MANNITOL (UNII: 3OWL53L36A)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)

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: NDA019992 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: 01-15-1991 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: 12-31-2020 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...
[Read More]

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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 solution) is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. 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 mL of CILOXAN Ophthalmic Solution contains: Active: ciprofloxacin HCl 3.5 mg equivalent to 3 mg base. Preservative: benzalkonium chloride 0.006%. Inactives: sodium acetate, acetic acid, mannitol 4.6%, edetate disodium 0.05%, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm.

Clinical Pharmacology

Systemic Absorption: A systemic absorption study was performed in which CILOXAN Ophthalmic Solution was administered in each eye every two hours while awake for two days followed by every four hours while awake for an additional 5 days. The maximum reported plasma concentration of ciprofloxacin was less than 5 ng/mL. The mean concentration was usually 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 organisms both in vitro and in clinical infections [see Indications and Usage]:Gram-Positive:Staphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniaeStreptococcus (Viridans Group)Gram-Negative:Haemophilus influenzaePseudomonas aeruginosaSerratia marcescensCiprofloxacin has been shown to be active in vitro against most strains of the following organisms, however, the clinical significance of these data is unknown:Gram-Positive:Enterococcus faecalis (Many strains are only moderately susceptible)Staphylococcus haemolyticusStaphylococcus hominisStaphylococcus saprophyticusStreptococcus pyogenesGram-Negative:Acinetobacter calcoaceticus subsp. anitratusAeromonas caviaeAeromonas hydrophilaBrucella melitensisCampylobacter coliCampylobacter jejuniCitrobacter diversusCitrobacter freundiiEdwardsiella tardaEnterobacter aerogenesEnterobacter cloacaeEscherichia coliHaemophilus ducreyiHaemophilus parainfluenzaeKiebsiella pneumoniaeKlebsiella oxytocaLegionella pneumophilaMoraxella (Branhamella) catarrhalisMorganella morganiiNeisseria gonorrhoeaeNeisseria meningitidisPasteurella multocidaProteus mirabilisProteus vulgarisProvidencia rettgeriProvidencia stuartiiSalmonella enteritidisSalmonella typhiShigella sonneiiShigella flexneriVibrio choleraeVibrio parahaemolyticusVibrio vulnificusYersinia enterocoliticaOther Organisms: Chlamydia trachomatis (only moderately susceptible) and Mycobacterium tuberculosis (only moderately susceptible).Most strains of Pseudomonas cepacia and some strains of Pseudomonas 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.

Indications And Usage

CILOXAN Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:Corneal Ulcers: Pseudomonas aeruginosaSerratia marcescens *Staphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniaeStreptococcus (Viridans Group)*Conjunctivitis: Haemophilus influenzaeStaphylococcus aureusStaphylococcus epidermidisStreptococcus pneumoniae*Efficacy for this organism was studied in fewer than 10 infections.

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

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.Remove contact lenses before using.

Adverse Reactions

The most frequently reported drug related adverse reaction was local burning or discomfort. In corneal ulcer studies with frequent administration of the drug, white crystalline precipitates were seen in approximately 17% of patients [see Precautions]. Other reactions occurring in less than 10% of patients included lid margin crusting, crystals/scales, foreign body sensation, itching, conjunctival hyperemia and a bad taste following instillation. Additional events occurring in less than 1% of patients included corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision.

Overdosage

A topical overdose of CILOXAN Ophthalmic Solution may be flushed from the eye(s) with warm tap water.

Dosage And Administration

Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.

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.

Clinical Studies:

Following therapy with CILOXAN Ophthalmic Solution, 76% of the patients with corneal ulcers and positive bacterial cultures were clinically cured and complete re-epithelialization occurred in about 92% of the ulcers.In 3 and 7 day multicenter clinical trials, 52% of the patients with conjunctivitis and positive conjunctival cultures were clinically cured and 70-80% had all causative pathogens eradicated by the end of treatment. In a randomized, double-masked, multicenter, parallel-group clinical trial of pediatric patients with bacterial conjunctivitis, between birth and 31 days of age, patients were dosed with Ciloxan or another anti-infective agent. Clinical outcomes for the trial demonstrated a clinical cure rate of 80% at Day 9 and a microbiological eradication success rate of 85% at Day 9.Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials.©2003, 2004, 2006, 2016 NovartisAlcon®Distributed by:ALCON LABORATORIES, INC.Fort Worth, Texas 76134 USAT2017-40March 2017

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