Ciprofloxacin
Ciprofloxacin Hydrochloride Solution
Direct Rx
Human Prescription Drug
NDC 61919-491Ciprofloxacin also known as Ciprofloxacin Hydrochloride Solution is a human prescription drug labeled by 'Direct Rx'. National Drug Code (NDC) number for Ciprofloxacin is 61919-491. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Ciprofloxacin drug includes Ciprofloxacin Hydrochloride - 3 mg/mL . The currest status of Ciprofloxacin drug is Active.
Drug Information:
| Drug NDC: | 61919-491 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Ciprofloxacin |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Ciprofloxacin Hydrochloride Solution |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Direct Rx |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CIPROFLOXACIN HYDROCHLORIDE - 3 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 15 Mar, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 13 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA019992 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | DIRECT RX
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 309307
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| UNII: | 4BA73M5E37
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Quinolone Antimicrobial [EPC]
Quinolones [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 61919-491-05 | 5 mL in 1 BOTTLE (61919-491-05) | 15 Mar, 2018 | N/A | No |
| 61919-491-25 | 1 mL in 1 BOTTLE (61919-491-25) | 15 Mar, 2018 | N/A | No |
| 61919-491-50 | 1 mL in 1 BOTTLE (61919-491-50) | 15 Mar, 2018 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Ciprofloxacin ciprofloxacin hydrochloride solution benzalkonium chloride mannitol edetate disodium sodium acetate acetic acid water ciprofloxacin hydrochloride ciprofloxacin sodium hydroxide hydrochloric acid
Indications and Usage:
Indications & usage section ciprofloxacin 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 aeruginosa serratia marcescens * staphylococcus aureus staphylococcus epidermidis streptococcus pneumoniae streptococcus (viridans group) * conjunctivitis: haemophilus influenzae staphylococcus aureus staphylococcus epidermidis streptococcus pneumoniae * efficacy for this organism was studied in fewer than 10 infections.
Warnings:
Warnings section 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.
Dosage and Administration:
Dosage & administration section 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. how supplied: as a sterile ophthalmic solution, in a plastic dispenser: 2.5 ml ndc16571-120-25 5 ml ndc16571-120-50 storage: store at 25°c (77°f); excursions permitted to15 - 30°
Read more...c (59 - 86°f) [see usp controlled room temperature]. protect from light. retain in carton until contents are used.
Contraindications:
Contraindications section 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.
Adverse Reactions:
Adverse reactions section 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. to report suspected adverse reactions call 1-800-332-1088 to report suspected adverse reactions call 1-800-332-1088
Overdosage:
Overdosage section a topical overdose of ciprofloxacin ophthalmic solution may be flushed from the eye(s) with warm tap water.
Description:
Description section ciprofloxacin ophthalmic solution is a synthetic, sterile, multiple dose, antimicrobial for topical 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 c17h18fn3o3â¢hclâ¢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 ciprofloxacin 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 water for injection. the ph is approximately 4.5 and the osmolality is approximately 300 mosm. image description
Clinical Pharmacology:
Clinical pharmacology section systemic absorption: a systemic absorption study was performed in which ciprofloxacin 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 microorganisms both in vitro and in clinical infections (see indications and usage section): gram-positive: staphylococcus aureus staphylococcus epidermidis streptococcus pneumoniae streptococcus (viridans group) gram-negative: haemophilus influe
Read more...nzae pseudomonas aeruginosa serratia marcescens ciprofloxacin 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 haemolyticus staphylococcus hominis staphylococcus saprophyticus streptococcus pyogenes gram-negative acinetobacter calcoaceticus escherichia coli proteus mirabilis subsp. anitratus haemophilus ducreyi proteus vulgaris aeromonas caviae haemophilus parainfluenzae providencia rettgeri aeromonas hydrophila kiebsiella pneumoniae providencia stuartii brucella melitensis kiebsiella oxytoca salmonella enteritidis campylobacter coli legionella pneumophila salmonella typhi campylobacter jejuni moraxella (branhamella) shigella sonneii citrobacter diversus catarrhalis shigella flexneri citrobacter freundii morganella morganii vibrio cholerae edwardsiella tarda neisseria gonorrhoeae vibrio parahaemolyticus enterobacter aerogenes neisseria meningitidis vibrio vulnificus enterobacter cloacae pasteurella multocida yersinia enterocolitica other 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. clinical studies: following therapy with ciprofloxacin 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.
Package Label Principal Display Panel:
491
61919-491-05