Overview
Ciprofloxacin is a second generation fluoroquinolone that has spawned many derivative antibiotics. It is formulated for oral, intravenous, intratympanic, ophthalmic, and otic administration for a number of bacterial infections. The first ciprofloxacin containing product was FDA approved on 22 October 1987.
Indication
Ciprofloxacin is only indicated in infections caused by susceptible bacteria. Ciprofloxacin immediate release tablets, oral suspensions, and intravenous injections are indicated for the treatment of skin and skin structure infections, bone and joint infections, complicated intra-abdominal infections, nosocomial pneumonia, febrile neutropenia, adults who have inhaled anthrax, plague, chronic bacterial prostatitis, lower respiratory tract infections including acute exacerbations of chronic bronchitis, urinary tract infections, complicated urinary tract infections in pediatrics, complicated pyelonephritis in pediatrics, and acute sinusitis. A ciprofloxacin otic solution and otic suspension with hydrocortisone are indicated for acute otitis externa. Ciprofloxacin suspension with dexamethasone is indicated for acute otitis media in pediatric patients with tympanostomy tubes or acute otitis externa. A ciprofloxacin intratympanic injection is indicated for pediatric patients with bilateral otitis media with effusion who are having tympanostomy tubes placed or pediatric patients 6 months or older with acute otitis externa. A ciprofloxacin eye drop is indicated for bacterial corneal ulcers and conjunctivitis. A ciprofloxacin eye ointment is indicated for bacterial conjunctivitis. A ciprofloxacin extended release tablet is indicated for uncomplicated urinary tract infections, complicated urinary tract infections, and acute uncomplicated pyelonephritis.
Associated Conditions
- Acute Exacerbations of Chronic Bronchitis caused by Moraxella catarrhalis
- Acute Otitis Externa
- Acute Otitis Externa caused by Pseudomonas Aeruginosa
- Acute Otitis Media (AOM)
- Acute Sinusitis
- Acute Uncomplicated Pyelonephritis
- Bone and Joint Infections
- Chronic Otitis Media
- Complicated Intra-Abdominal Infections (cIAIs)
- Complicated Urinary Tract Infection
- Conjunctivitis caused by Haemophilus influenzae
- Conjunctivitis caused by Staphylococcus epidermidis
- Corneal Ulcers caused by Serratia marcescens
- Corneal Ulcers caused by Staphylococcus aureus
- Corneal Ulcers caused by Staphylococcus epidermidis
- Corneal Ulcers caused by Streptococcus Pneumoniae
- Corneal Ulcers caused by Streptococcus Viridans Group
- Corneal Ulcers caused by pseudomonas aeruginosa
- Escherichia urinary tract infection
- External ear infection NOS
- Febrile Neutropenia
- Infection of the outer ear caused by susceptible bacteria
- Infectious diarrhea
- Inhalational Anthrax
- Lower respiratory tract infection caused by Enterobacter cloacae
- Lower respiratory tract infection caused by Escherichia coli
- Lower respiratory tract infection caused by Haemophilus influenzae
- Lower respiratory tract infection caused by Haemophilus parainfluenzae
- Lower respiratory tract infection caused by Klebsiella pneumoniae
- Lower respiratory tract infection caused by Proteus mirabilis
- Lower respiratory tract infection caused by penicillin-susceptible Streptococcus pneumoniae
- Nosocomial Pneumonia
- Otitis Media (OM)
- Otitis Media, Purulent
- Plague caused by Yersinia pestis
- Skin Infections
- Typhoid fever caused by Salmonella typhi
- UTI caused by Citrobacter diversus
- UTI caused by Citrobacter frendii
- UTI caused by Entercococcus faecalis
- UTI caused by Enterobacter cloacae
- UTI caused by Klebsiella pneumoniae
- UTI caused by Morganella morganii
- UTI caused by Proteus mirabilis
- UTI caused by Providencia rettgeri
- UTI caused by Pseudomonas aeruginosa
- UTI caused by Serratia marcescens
- UTI caused by methicillin-susceptible Staphylococcus epidermidis
- Uncomplicated Urinary Tract Infections
- Acute otitis externa caused by Staphylococcus aureus
- Acute, uncomplicated Cystitis caused by Escherichia coli
- Acute, uncomplicated Cystitis caused by Staphylococcus saprophyticus
- Chronic Prostatitis caused by Escherichia coli
- Chronic Prostatitis caused by Proteus mirabilis
- Complicated Pyelonephritis caused by Escherichia coli
- Complicated Urinary Tract Infection caused by Escherichia Coli
- Uncomplicated Gonorrhea caused by Neisseria gonorrhoeae
Research Report
Ciprofloxacin (DB00537): A Comprehensive Monograph on its Pharmacology, Clinical Utility, Safety, and the Challenge of Antimicrobial Resistance
Executive Summary
Ciprofloxacin is a potent, broad-spectrum, second-generation fluoroquinolone antibiotic that has been a cornerstone of antimicrobial therapy for several decades. Identified by DrugBank ID DB00537 and CAS Number 85721-33-1, this small molecule agent exerts its bactericidal effect through the dual inhibition of bacterial DNA gyrase and topoisomerase IV, enzymes essential for DNA replication. Its pharmacokinetic profile, characterized by excellent oral bioavailability and extensive tissue penetration, has made it a versatile option for treating a wide array of serious infections, particularly those caused by Gram-negative pathogens such as Pseudomonas aeruginosa. It is available in numerous formulations, including oral, intravenous, ophthalmic, and otic preparations, allowing for flexible treatment paradigms.
Despite its efficacy, the clinical utility of ciprofloxacin is increasingly challenged by two major factors: a significant safety profile and escalating bacterial resistance. Post-marketing surveillance has revealed the potential for serious, disabling, and potentially irreversible adverse reactions, prompting the U.S. Food and Drug Administration (FDA) to issue its most stringent "Black Box Warning." These warnings highlight risks of tendinitis and tendon rupture, peripheral neuropathy, central nervous system effects, and exacerbation of myasthenia gravis. Consequently, regulatory bodies, particularly in Europe, have placed significant restrictions on its use, advising against it for uncomplicated or self-limiting infections where safer alternatives exist.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/19 | Phase 2 | Not yet recruiting | GERCOR - Multidisciplinary Oncology Cooperative Group | ||
2025/06/11 | Phase 4 | Not yet recruiting | Gadjah Mada University | ||
2025/01/29 | Phase 2 | Recruiting | Al-Mustafa University College | ||
2024/11/29 | Phase 4 | Recruiting | |||
2024/04/02 | Phase 2 | Active, not recruiting | |||
2024/01/31 | Phase 3 | Completed | |||
2023/11/13 | Phase 1 | Recruiting | Institute of Cancer Research, United Kingdom | ||
2023/10/23 | Phase 4 | Recruiting | Shanghai Pulmonary Hospital, Shanghai, China | ||
2023/07/25 | Phase 1 | Recruiting | |||
2023/06/23 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Proficient Rx LP | 82804-130 | ORAL | 500 mg in 1 1 | 4/1/2025 | |
| Unit Dose Services | 50436-0714 | OPHTHALMIC | 3 mg in 1 mL | 10/11/2011 | |
| RPK Pharmaceuticals, Inc. | 53002-2645 | ORAL | 500 mg in 1 1 | 6/26/2023 | |
| Baxter Healthcare Corporation | 36000-011 | INTRAVENOUS | 10 mg in 1 mL | 7/10/2020 | |
| Baxter Healthcare Corporation | 36000-029 | INTRAVENOUS | 2 mg in 1 mL | 7/10/2020 | |
| Aurolife Pharma LLC | 13107-077 | ORAL | 500 mg in 1 1 | 5/23/2012 | |
| RedPharm Drug, Inc. | 67296-1269 | ORAL | 750 mg in 1 1 | 1/20/2022 | |
| RedPharm Drug Inc. | 67296-0543 | ORAL | 500 mg in 1 1 | 6/24/2011 | |
| Blenheim Pharmacal, Inc. | 10544-604 | ORAL | 250 mg in 1 1 | 8/25/2010 | |
| RPK Pharmaceuticals, Inc. | 53002-2640 | ORAL | 500 mg in 1 1 | 5/5/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| C-FLOX 500 TABLETS 500 mg | SIN11303P | TABLET, FILM COATED | 555 mg | 4/7/2000 | |
| MICROFLOX-500 TABLET 500 mg | SIN12073P | TABLET, FILM COATED | 500 mg | 9/14/2002 | |
| POLI-CIFLOXIN 250 TABLET 250 mg | SIN10308P | TABLET, FILM COATED | 250 mg | 10/23/1998 | |
| QUPRON TABLETS 250 mg | SIN09569P | TABLET, FILM COATED | 250 mg | 12/5/1997 | |
| CIPROFLOXACIN TABLET 500 mg | SIN09604P | TABLET, FILM COATED | 500 mg | 1/10/1998 | |
| CIROK INJECTION 2 mg/ml | SIN11851P | INJECTION | 2 mg/ml | 3/15/2002 | |
| CIPRO-500 SANDOZ FILM COATED TABLETS 500MG | SIN14414P | TABLET, FILM COATED | 500.0mg | 10/4/2013 | |
| MICROFLOX-250 TABLET 250 mg | SIN08940P | TABLET, FILM COATED | 250 mg | 9/25/1996 | |
| C-FLOX 250 TABLETS 250 mg | SIN11302P | TABLET, FILM COATED | 250 mg | 4/7/2000 | |
| CILOXAN STERILE OPHTHALMIC AND OTIC SOLUTION 0.3% | SIN11929P | SOLUTION | 0.3 % w/v | 5/14/2002 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| CIPROFLOXACIN TABLETS USP 500MG | N/A | N/A | N/A | 11/17/2020 | |
| CIPROFLOXACIN TABLETS USP 250MG | N/A | N/A | N/A | 11/17/2020 | |
| APT-CIPROFLOXACIN TABLETS 250MG | N/A | N/A | N/A | 11/29/2024 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| CIPROFLOXACIN INTRAVENOUS INFUSION BP | N/A | Solution - Intravenous | 2 MG / ML | 3/27/2008 | |
| NU-CIPROFLOXACIN TABLETS | nu-pharm inc | 02249650 | Tablet - Oral | 750 MG | N/A |
| CIPROFLOXACIN INJECTION | fresenius kabi canada ltd | 02312123 | Solution - Intravenous | 2 MG / ML | N/A |
| CIPRO TAB 250MG | miles canada inc. - pharmaceutical division | 00817163 | Tablet - Oral | 250 MG / TAB | 12/31/1989 |
| CIPROFLOXACIN INJECTION USP | 02256789 | Solution - Intravenous | 10 MG / ML | 3/12/2007 | |
| CIPROFLOXACIN INTRAVENOUS INFUSION | teva canada limited | 02267462 | Solution - Intravenous | 2 MG / ML | 5/22/2008 |
| CIPROFLOXACIN INTRAVENOUS INFUSION, BP | 02304546 | Solution - Intravenous | 2 MG / ML | 3/27/2008 | |
| CIPROFLOXACIN INJECTION USP | 02301903 | Solution - Intravenous | 2 MG / ML | 4/8/2008 | |
| CIPROFLOXACIN INJECTION, USP | baxter corporation | 02289946 | Solution - Intravenous | 2 MG / ML | 8/25/2008 |
| NU-CIPROFLOXACIN TABLETS | nu-pharm inc | 02249626 | Tablet - Oral | 100 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| CIPROFLOXACINO NORMON 2 mg/ml SOLUCION PARA PERFUSION EFG | Laboratorios Normon S.A. | 62646 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| CETRAXAL OTICO 3 MG/ML GOTAS OTICAS EN SOLUCION | Laboratorios Salvat S.A. | 60883 | GOTAS ÓTICAS EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ACEOTO 3 MG/ML GOTAS ÓTICAS EN SOLUCIÓN | Zambon S.A.U. | 61791 | GOTAS ÓTICAS EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Commercialized |
| CIPROFLOXACINO STADA 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorio Stada S.L. | 62506 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| CIPROFLOXACINO ARISTO 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Aristo Pharma Iberia S.L. | 63143 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| CETRAXAL 500 mg SUSPENSION ORAL EN SOBRES UNIDOSIS | Laboratorios Salvat S.A. | 62603 | SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| CIPROFLOXACINO ALTAN 2 MG/ML SOLUCION PARA PERFUSION EFG | Altan Pharmaceuticals Sa | 67554 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| OFTACILOX 3 mg/ml COLIRIO EN SOLUCION | Ntc S.R.L. | 60608 | COLIRIO EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Commercialized |
| CIPROFLOXACINO SERRACLINICS 2 MG/ML SOLUCION PARA PERFUSION EFG | Laboratorios Serra Pamies S.A. | 83804 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
| CIPROFLOXACINO ANAGES 2 mg/ml, SOLUCION PARA PERFUSION | Altan Pharmaceuticals Sa | 58123 | SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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