ciprofloxacin
Tablet, Film Coated · Oral, Ophthalmic, Intravenous
Uses
Ciprofloxacin Injection is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: Skin and Skin Structure Infections ( 1.1 ) Bone and Joint Infections ( 1.2 ) Complicated Intra-Abdominal Infections ( 1.3 ) Nosocomial Pneumonia ( 1.4 ) Empirical Therapy for Febrile Neutropenic Patients ( 1.5 ) Inhalational Anthrax Post-Exposure in Adult and Pediatric Patients ( 1.6 ) Plague in Adult and Pediatric Patients ( 1.7 ) Chronic Bacterial Prostatitis ( 1.8 ) Lower Respiratory Tract Infections ( 1.9 ) Acute Exacerbation of Chronic Bronchitis Urinary Tract Infections ( 1.10 ) Urinary Tract Infections (UTI) Complicated UTI and Pyelonephritis in Pediatric Patients Acute Sinusitis ( 1.11 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Injection and other antibacterial drugs, Ciprofloxacin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.12 ) 1.1 Skin and Skin Structure Infections Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes. 1.2 Bone and Joint Infections Ciprofloxacin Injection is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa . 1.3 Complicated Intra-Abdominal Infections Ciprofloxacin Injection is indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis . 1.4 Nosocomial Pneumonia Ciprofloxacin Injection is indicated in adult patients for treatment of nosocomial pneumonia caused by Haemophilus influenzae or Klebsiella pneumoniae. 1.5 Empirical Therapy for Febrile Neutropenic Patients Ciprofloxacin Injection is indicated in adult patients for the treatment of febrile neutropenia in combination with piperacillin sodium [see Clinical Studies ( 14.1 )]. 1.6 Inhalational Anthrax (Post-Exposure) Ciprofloxacin Injection is indicated in adults and pediatric patients from birth to 17 years of age for treatment of inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis . Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication. 1 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001 [see Clinical Studies ( 14.3 )]. 1.7 Plague Ciprofloxacin Injection is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis ( Y. pestis ) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies of ciprofloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only [see Clinical Studies ( 14.4 )] . 1.8 Chronic Bacterial Prostatitis Ciprofloxacin Injection is indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis . 1.9 Lower Respiratory Tract Infections Ciprofloxacin Injection is indicated in adult patients for treatment of lower respiratory tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae . Ciprofloxacin Injection is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumonia . Ciprofloxacin Injection is indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by Moraxella catarrhalis. Because fluoroquinolones, including Ciprofloxacin Injection, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1 to 5.16 )] and for some patients AECB is self-limiting, reserve Ciprofloxacin Injection for treatment of AECB in patients who have no alternative treatment options. 1.10 Urinary Tract Infections Urinary Tract Infection in Adults Ciprofloxacin Injection is indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli , Klebsiella pneumoniae , Enterobacter cloacae , Serratia marcescens , Proteus mirabilis , Providencia rettgeri , Morganella morganii , Citrobacter koseri , Citrobacter freundii , Pseudomonas aeruginosa , methicillin-susceptible Staphylococcus epidermidis , Staphylococcus saprophyticus , or Enterococcus faecalis . Complicated Urinary Tract Infections and Pyelonephritis in Pediatric Patients Ciprofloxacin Injection is indicated in pediatric patients one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to Escherichia coli [see Use in Specific Populations ( 8.4 )] . Although effective in clinical trials, Ciprofloxacin Injection is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues.
Dosage and administration
Ciprofloxacin injection should be administered intravenously at dosages described in the appropriate Dosage Guidelines tables. Adult Dosage Guidelines Infection Dose Frequency Duration Skin and Skin Structure 400 mg every 8 to 12 hours 7 to 14 days Bone and Joint 400 mg every 8 to 12 hours 4 to 8 weeks Complicated Intra-Abdominal 400 mg every 12 hours 7 to 14 days Nosocomial Pneumonia 400 mg every 8 hours 10 to 14 days Empirical Therapy In Febrile Neutropenic Patients 400 mg and Piperacillin 50 mg/kg every 8 hours every 4 hours 7 to 14 days Inhalational anthrax (post-exposure) 400 mg every 12 hours 60 days Plague 400 mg every 8 to 12 hours 14 days Chronic Bacterial prostatitis 400 mg every 12 hours 28 days Lower Respiratory Tract 400 mg every 8 to 12 hours 7 to 14 days Urinary Tract 200 to 400 mg every 8 to 12 hours 7 to 14 days Acute Sinusitis 400 mg every 12 hours 10 days Adults with creatinine clearance 5 to 29 mL/min 250 to 500 mg q 18 h ( 2.3 ) Pediatric Intravenous Dosing Guidelines Infection Dose Frequency Duration Complicated UTI and Pyelonephritis (patients from 1 to 17 years of age) 6 mg/kg to 10 mg/kg (maximum 400 mg per dose) Every 8 hours 10 to 21 days 1 Inhalational Anthrax (Post-Exposure) 10 mg/kg (maximum 400 mg per dose) Every 12 hours 60 days Plague 10 mg/kg (maximum 400 mg per dose) Every 8 to 12 hours 14 days 2.1 Dosage in Adults The determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient's host-defense mechanisms, and the status of renal and hepatic function. Table 1: Adult Dosage Guidelines 1. Due to the designated pathogens (see Indications and Usage.) 2. Used in conjunction with metronidazole. 3. Begin administration as soon as possible after suspected or confirmed exposure. Infection 1 Dose Frequency Usual Duration Skin and Skin Structure 400 mg every 8 to 12 hours 7 to 14 days Bone and Joint 400 mg every 8 to 12 hours 4 to 8 weeks Complicated Intra-Abdominal 2 400 mg every 12 hours 7 to 14 days Nosocomial Pneumonia 400 mg every 8 hours 10 to 14 days Empirical Therapy In Febrile Neutropenic Patients Ciprofloxacin 400 mg and Piperacillin 50 mg/kg every 8 hours every 4 hours 7 to 14 days Inhalational Anthrax (Post-Exposure) 3 400 mg every 12 hours 60 days Plague 3 400 mg every 8 to 12 hours 14 days Chronic Bacterial Prostatitis 400 mg every 12 hours 28 days Lower Respiratory Tract Infections 400 mg every 8 to 12 hours 7 to 14 days Urinary Tract Infections 200 mg to 400 mg every 8 to 12 hours 7 to 14 days Acute Sinusitis 400 mg every 12 hours 10 days Conversion of Intravenous to Oral Dosing in Adults Patients whose therapy is started with ciprofloxacin injection may be switched to ciprofloxacin tablets or oral suspension when clinically indicated at the discretion of the physician ( Table 2 ) [see Clinical Pharmacology ( 12.3 )] . Table 2: Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin Injection Dosage 250 mg Tablet every 12 hours 200 mg intravenous every 12 hours 500 mg Tablet every 12 hours 400 mg intravenous every 12 hours 750 mg Tablet every 12 hours 400 mg intravenous every 8 hours 2.2 Dosage in Pediatric Patients Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Table 3: Pediatric Dosage Guidelines 1. The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). 2. Begin drug administration as soon as possible after suspected or confirmed exposure. 3. Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis . Infection Dose (mg/kg) Frequency Total Duration Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) 1 6 mg/kg to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing more than 51 kg) Every 8 hours 10 to 21 days 1 Inhalational Anthrax (Post-Exposure) 2 10 mg/kg (maximum 400 mg per dose) Every 12 hours 60 days Plague 2,3 10 mg/kg (maximum 400 mg per dose) Every 8 to 12 hours 14 days 2.3 Dosage Modifications in Patients with Renal Impairment Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4 . Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal Function Creatinine Clearance (mL/min) Dose >30 See Usual Dosage. 5 to 29 200 to 400 mg every 18 to 24 hours When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance: Men - Creatinine clearance (mL/min) = Weight (kg) × (140 - age) 72 × serum creatinine (mg/dL) Women - 0.85 × the value calculated for men. The serum creatinine should represent a steady state of renal function. In patients with severe infections and severe renal impairment and hepatic insufficiency, careful monitoring is suggested. Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m 2 ).
Dosage forms and strengths
Ciprofloxacin Injection, USP (in 5% Dextrose) is a sterile, ready-for-use solution for intravenous infusion, available as: 200 mg per 100 mL (in 5% Dextrose) in Flexible Containers 400 mg per 200 mL (in 5% Dextrose) in Flexible Containers Ciprofloxacin Injection (in 5% Dextrose): 200 mg per 100 mL and 400 mg per 200 mL ( 3 )
Contraindications
Known hypersensitivity to ciprofloxacin injection or other quinolones ( 4.1 , 5.7 ) Concomitant administration with tizanidine ( 4.2 ) 4.1 Hypersensitivity Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components [see Warnings and Precautions ( 5.7 )] . 4.2 Tizanidine Concomitant administration with tizanidine is contraindicated [see Drug Interactions ( 7 )] .
Warnings and precautions
Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions (for example, anaphylactic reactions) may occur after first or subsequent doses of Ciprofloxacin Injection. Discontinue Ciprofloxacin Injection at the first sign of skin rash, jaundice or any sign of hypersensitivity. ( 4.1 , 5.6 , 5.7 ) Hepatotoxicity: Discontinue immediately if signs and symptoms of hepatitis occur. ( 5.8 ) Clostridioides difficile -Associated Diarrhea: Evaluate if colitis occurs. ( 5.11 ) QT Prolongation: Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval. ( 5.12 , 7 , 8.5 ) 5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting ciprofloxacin. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see Warnings and Precautions ( 5.2 , 5.3 , 5.4 )] . Discontinue ciprofloxacin immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including ciprofloxacin, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones. 5.2 Tendinitis and Tendon Rupture Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of tendinitis and tendon rupture in all ages [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.2 )] . This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur, within hours or days of starting ciprofloxacin, or as long as several months after completion of fluoroquinolone therapy. Tendinitis and tendon rupture can occur bilaterally. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Discontinue ciprofloxacin immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including ciprofloxacin, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture [see Adverse Reactions ( 6.2 )]. 5.3 Peripheral Neuropathy Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including ciprofloxacin. Symptoms may occur soon after initiation of ciprofloxacin and may be irreversible in some patients [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 , 6.2 )] . Discontinue ciprofloxacin immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness, or other alterations in sensations including light touch, pain, temperature, position sense and vibratory sensation, and/or motor strength in order to minimize the development of an irreversible condition. Avoid fluoroquinolones, including ciprofloxacin, in patients who have previously experienced peripheral neuropathy [see Adverse Reactions ( 6.1 , 6.2 )]. 5.4 Central Nervous System Effects Psychiatric Adverse Reactions Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of psychiatric adverse reactions, including: toxic psychosis, psychotic reactions progressing to suicidal ideations/thoughts, hallucinations, or paranoia; depression, or self-injurious behavior such as attempted or completed suicide; anxiety, agitation, or nervousness; confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; memory impairment. These reactions may occur following the first dose. Advise patients receiving ciprofloxacin to inform their healthcare provider immediately if these reactions occur, discontinue the drug, and institute appropriate care [see Adverse Reactions ( 6.1 )]. Central Nervous System Adverse Reactions Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (pseudotumor cerebri), dizziness, and tremors. Ciprofloxacin, like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold. Cases of status epilepticus have been reported.
Side effects
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: Disabling and Potentially Irreversible Serious Adverse Reactions [see Warnings and Precautions ( 5.1 )] Tendinitis and Tendon Rupture [see Warnings and Precautions ( 5.2 )] Peripheral Neuropathy [see Warnings and Precautions ( 5.3 )] Central Nervous System Effects [see Warnings and Precautions ( 5.4 )] Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.5 )] Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions ( 5.6 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] Hepatotoxicity [see Warnings and Precautions ( 5.8 )] Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions ( 5.9 )] Serious Adverse Reactions with Concomitant Theophylline [see Warnings and Precautions ( 5.10 )] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions ( 5.11 )] Prolongation of the QT Interval [see Warnings and Precautions ( 5.12 )] Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions ( 5.13 )] Photosensitivity/Phototoxicity [see Warnings and Precautions ( 5.14 )] Development of Drug Resistant Bacteria [see Warnings and Precautions ( 5.15 )] The most common adverse reactions ≥1% were nausea, diarrhea, liver function tests abnormal, vomiting, central nervous system disturbance, local intravenous site reactions eosinophilia, headache, restlessness, and rash. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Patients During clinical investigations with oral and parenteral ciprofloxacin, 49,038 patients received courses of the drug. The most frequently reported adverse reactions, from clinical trials of all formulations, all dosages, all drug-therapy durations, and for all indications of ciprofloxacin therapy were nausea (2.5%), diarrhea (1.6%), liver function tests abnormal (1.3%), vomiting (1%), and rash (1%). In clinical trials the following adverse reactions were reported in greater than 1% of patients treated with intravenous ciprofloxacin: nausea, diarrhea, central nervous system disturbance, local intravenous site reactions, liver function tests abnormal, eosinophilia, headache, restlessness, and rash. Local intravenous site reactions are more frequent if the infusion time is 30 minutes or less. These may appear as local skin reactions that resolve rapidly upon completion of the infusion. Subsequent intravenous administration is not contraindicated unless the reactions recur or worsen. Table 5: Medically Important Adverse Reactions That Occurred in less than 1% Ciprofloxacin Patients System Organ Class Adverse Reactions Body as a Whole Abdominal Pain/Discomfort Pain Cardiovascular Cardiopulmonary Arrest Myocardial Infarction Tachycardia Syncope Hypertension Angina Pectoris Vasodilation Central Nervous System Restlessness Seizures (including Status Epilepticus) Paranoia Psychosis (toxic) Depression (potentially culminating in self-injurious behavior, such as suicidal ideations/thoughts and attempted or completed suicide) Phobia Depersonalization Manic Reaction Unresponsiveness Ataxia Hallucinations Dizziness Paresthesia Tremor Insomnia Nightmares Irritability Malaise Abnormal Gait Migraine Gastrointestinal Ileus Gastrointestinal Bleeding Pancreatitis Hepatic Necrosis Intestinal Perforation Dyspepsia Constipation Oral Ulceration Mouth Dryness Anorexia Flatulence Hepatitis Hemic/Lymphatic Agranulocytosis Prolongation of Prothrombin Time Petechia Metabolic/Nutritional Hyperglycemia Hypoglycemia Musculoskeletal Arthralgia Joint Stiffness Muscle Weakness Renal/Urogenital Renal Failure Interstitial Nephritis Hemorrhagic Cystitis Renal Calculi Frequent Urination Gynecomastia Crystalluria Cylindruria Hematuria Albuminuria Respiratory Respiratory Arrest Dyspnea Laryngeal Edema Hemoptysis Bronchospasm Skin/Hypersensitivity Allergic Reactions Anaphylactic Reactions including life-threatening anaphylactic shock Erythema Multiforme/Stevens-Johnson Syndrome Exfoliative Dermatitis Toxic Epidermal Necrolysis Vasculitis Angioedema Extremities Purpura Fever Pruritus Urticaria Increased Perspiration Erythema Nodosum Thrombophlebitis Burning Photosensitivity/Phototoxicity Reaction Special Senses Decreased Visual Acuity Blurred Vision Disturbed Vision (diplopia, chromatopsia, and photopsia) Anosmia Hearing Loss Tinnitus Nystagmus Bad Taste In several instances, nausea, vomiting, tremor, irritability, or palpitation were judged by investigators to be related to elevated serum levels of theophylline possibly as a result of drug interaction with ciprofloxacin. In randomized, double-blind controlled clinical trials comparing ciprofloxacin (Intravenous and Intravenous/Oral sequential) with intravenous beta-lactam control antibiotics, the CNS adverse reaction profile of ciprofloxacin was comparable to that of the control drugs. Pediatric Patients Short (6 weeks) and long term (1 year) musculoskeletal and neurological safety of oral/intravenous ciprofloxacin was compared to a cephalosporin for treatment of cUTI or pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4 years) in an international multicenter trial. The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with a range of 1 to 88 days). A total of 335 ciprofloxacin- and 349 comparator-treated patients were enrolled.
Drug interactions
Ciprofloxacin is an inhibitor of human cytochrome P450 1A2 (CYP1A2) mediated metabolism. Co-administration of ciprofloxacin with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the co-administered drug. Table 8: Drugs That are Affected by and Affecting Ciprofloxacin Drugs That are Affected by Ciprofloxacin Drug(s) Recommendation Comments Tizanidine Contraindicated Concomitant administration of tizanidine and ciprofloxacin is contraindicated due to the potentiation of hypotensive and sedative effects of tizanidine [see Contraindications ( 4.2 )] . Theophylline Avoid Use (Plasma Exposure Likely to be Increased and Prolonged) Concurrent administration of ciprofloxacin with theophylline may result in increased risk of a patient developing central nervous system (CNS) or other adverse reactions. If concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate [see Warnings and Precautions ( 5.10 )]. Drugs Known to Prolong QT Interval Avoid Use Ciprofloxacin may further prolong the QT interval in patients receiving drugs known to prolong the QT interval (for example, class IA or III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) [see Warnings and Precautions ( 5.12 ) and Use in Specific Populations ( 8.5 )]. Oral antidiabetic drugs Use with caution Glucose-lowering effect potentiated Hypoglycemia sometimes severe has been reported when ciprofloxacin and oral antidiabetic agents, mainly sulfonylureas (for example, glyburide, glimepiride), were co-administered, presumably by intensifying the action of the oral antidiabetic agent. Fatalities have been reported. Monitor blood glucose when ciprofloxacin is co-administered with oral antidiabetic drugs [see Adverse Reactions ( 6.1 )]. Phenytoin Use with caution Altered serum levels of phenytoin (increased and decreased) To avoid the loss of seizure control associated with decreased phenytoin levels and to prevent phenytoin overdose-related adverse reactions upon ciprofloxacin discontinuation in patients receiving both agents, monitor phenytoin therapy, including phenytoin serum concentration during and shortly after co-administration of ciprofloxacin with phenytoin. Cyclosporine Use with caution (transient elevations in serum creatinine) Monitor renal function (in particular serum creatinine) when ciprofloxacin is co-administered with cyclosporine. Anti-coagulant drugs Use with caution (Increase in anticoagulant effect) The risk may vary with the underlying infection, age and general status of the patient so that the contribution of ciprofloxacin to the increase in INR (international normalized ratio) is difficult to assess. Monitor prothrombin time and INR frequently during and shortly after co-administration of ciprofloxacin with an oral anti-coagulant (for example, warfarin). Methotrexate Use with caution Inhibition of methotrexate renal tubular transport potentially leading to increased methotrexate plasma levels Potential increase in the risk of methotrexate associated toxic reactions. Therefore, carefully monitor patients under methotrexate therapy when concomitant ciprofloxacin therapy is indicated. Ropinirole Use with caution Monitoring for ropinirole-related adverse reactions and appropriate dose adjustment of ropinirole is recommended during and shortly after co-administration with ciprofloxacin [see Warnings and Precautions ( 5.16 )] . Clozapine Use with caution Careful monitoring of clozapine associated adverse reactions and appropriate adjustment of clozapine dosage during and shortly after co-administration with ciprofloxacin are advised. NSAIDs Use with caution Non-steroidal anti-inflammatory drugs (but not acetyl salicylic acid) in combination of very high doses of quinolones have been shown to provoke convulsions in pre-clinical studies and in postmarketing. Sildenafil Use with caution Two-fold increase in exposure Monitor for sildenafil toxicity [see Clinical Pharmacology ( 12.3 )] . Duloxetine Avoid Use Five-fold increase in duloxetine exposure If unavoidable, monitor for duloxetine toxicity. Caffeine/Xanthine Derivatives Use with caution Reduced clearance resulting in elevated levels and prolongation of serum half-life Ciprofloxacin inhibits the formation of paraxanthine after caffeine administration (or pentoxifylline containing products). Monitor for xanthine toxicity and adjust dose as necessary. Zolpidem Avoid Use Co-administration with ciprofloxacin may increase blood levels of zolpidem, concurrent use is not recommended. Drug(s) Affecting Pharmacokinetics of Ciprofloxacin Probenecid Use with caution (interferes with renal tubular secretion of ciprofloxacin and increases ciprofloxacin serum levels) Potentiation of ciprofloxacin toxicity may occur. Interacting Drug Interaction Theophylline Serious and fatal reactions. Avoid concomitant use. Monitor serum level ( 7 ) Warfarin Anticoagulant effect enhanced. Monitor prothrombin time, INR, and bleeding ( 7 ) Antidiabetic agents Hypoglycemia including fatal outcomes have been reported. Monitor blood glucose ( 7 ) Phenytoin Monitor phenytoin level ( 7 ) Methotrexate Monitor for methotrexate toxicity ( 7 ) Cyclosporine May increase serum creatinine. Monitor serum creatinine ( 7 )
Use in specific populations
Lactation: Breastfeeding is not recommended during treatment, but a lactating woman may pump and discard breastmilk during treatment and an additional 2 days after the last dose. In patients treated for inhalational anthrax (post exposure), consider the risks and benefits of continuing breastfeeding. See full prescribing information for pediatric patients ( 8.4 ) and use in geriatric ( 8.5 ) 8.1 Pregnancy Risk Summary Prolonged experience with ciprofloxacin in pregnant women over several decades, based on available published information from case reports, case control studies and observational studies on ciprofloxacin administered during pregnancy, have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data ) . Oral administration of ciprofloxacin during organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30 mg/kg to pregnant rabbits did not cause fetal malformations (see Data ) . These doses were up to 0.3, 0.6, and 0.4 times the maximum recommended clinical oral dose in mice, rats, and rabbits, respectively, based on body surface area. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data While available studies cannot definitively establish the absence of risk, published data from prospective observational studies over several decades have not established an association with ciprofloxacin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available studies have methodological limitations including small sample size and some of them are not specific for ciprofloxacin. A controlled prospective observational study followed 200 women exposed to fluoroquinolones (52.5% exposed to ciprofloxacin and 68% first trimester exposures) during gestation. In utero exposure to fluoroquinolones during embryogenesis was not associated with increased risk of major malformations. The reported rates of major congenital malformations were 2.2% for the fluoroquinolone group and 2.6% for the control group (background incidence of major malformations is 1 to 5%). Rates of spontaneous abortions, prematurity and low birth weight did not differ between the groups and there were no clinically significant musculoskeletal dysfunctions up to one year of age in the ciprofloxacin exposed children. Another prospective follow-up study reported on 549 pregnancies with fluoroquinolone exposure (93% first trimester exposures). There were 70 ciprofloxacin exposures, all within the first trimester. The malformation rates among live-born babies exposed to ciprofloxacin and to fluoroquinolones overall were both within background incidence ranges. No specific patterns of congenital abnormalities were found. The study did not reveal any clear adverse reactions due to in utero exposure to ciprofloxacin. No differences in the rates of prematurity, spontaneous abortions, or birth weight were seen in women exposed to ciprofloxacin during pregnancy. However, these small postmarketing epidemiology studies, of which most experience is from short term, first trimester exposure, are insufficient to evaluate the risk for less common defects or to permit reliable and definitive conclusions regarding the safety of ciprofloxacin in pregnant women and their developing fetuses. Animal Data Developmental toxicology studies have been performed with ciprofloxacin in rats, mice, and rabbits. In rats and mice, oral doses up to 100 mg/kg administered during organogenesis (Gestation Days, GD, 6 to 17) were not associated with adverse developmental outcomes, including embryofetal toxicity or malformations. In rats and mice, a 100 mg/kg dose is approximately 0.6 and 0.3 times the maximum daily human oral dose (1500 mg/day) based upon body surface area, respectively. In a series of rabbit developmental toxicology studies, doses received oral or intravenous ciprofloxacin for one of the following 5 day periods: GD 6 to 10, GD 10 to 14, or GD 14 to 18, intended to cover the period of organogenesis. This was an attempt to mitigate the gastrointestinal intolerance observed in rabbits that receive antibacterials manifested by reduced maternal food consumption and weight loss, that can lead to embryofetal resorption or spontaneous abortion. An oral ciprofloxacin dose of 100 mg/kg (approximately 1.3 times the highest recommended clinical oral dose based on body surface area) caused excessive maternal toxicity confounding evaluation of the fetuses. A 30 mg/kg oral dose (approximately 0.4 times the highest recommended clinical oral dose) was associated with suppression of maternal and fetal body weight gain, but fetal malformations were not observed. Intravenous administration of doses up to 20 mg/kg (approximately 0.3 times the highest recommended clinical oral dose based upon body surface area) to pregnant rabbits was not maternally toxic and neither embryofetal toxicity nor fetal malformations were observed. In peri- and post-natal studies, rats received ciprofloxacin doses up to 200 mg/kg/day (oral) or up to 30 mg/kg/day (subcutaneous) from GD 16 to 22 days postpartum. The 200 mg/kg dose is approximately 1.3-times the maximum recommended clinical oral dose based on body surface area. Neither maternal toxicity nor adverse effects on growth and development of the pups were observed, including no sign of arthropathy on the rear leg joints of the pups. Ciprofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested when administered directly [see Warnings and Precautions ( 5.13 ) and Nonclinical Toxicology ( 13.2 )] .
Pregnancy
8.1 Pregnancy Risk Summary Prolonged experience with ciprofloxacin in pregnant women over several decades, based on available published information from case reports, case control studies and observational studies on ciprofloxacin administered during pregnancy, have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data ) . Oral administration of ciprofloxacin during organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30 mg/kg to pregnant rabbits did not cause fetal malformations (see Data ) . These doses were up to 0.3, 0.6, and 0.4 times the maximum recommended clinical oral dose in mice, rats, and rabbits, respectively, based on body surface area. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data While available studies cannot definitively establish the absence of risk, published data from prospective observational studies over several decades have not established an association with ciprofloxacin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available studies have methodological limitations including small sample size and some of them are not specific for ciprofloxacin. A controlled prospective observational study followed 200 women exposed to fluoroquinolones (52.5% exposed to ciprofloxacin and 68% first trimester exposures) during gestation. In utero exposure to fluoroquinolones during embryogenesis was not associated with increased risk of major malformations. The reported rates of major congenital malformations were 2.2% for the fluoroquinolone group and 2.6% for the control group (background incidence of major malformations is 1 to 5%). Rates of spontaneous abortions, prematurity and low birth weight did not differ between the groups and there were no clinically significant musculoskeletal dysfunctions up to one year of age in the ciprofloxacin exposed children. Another prospective follow-up study reported on 549 pregnancies with fluoroquinolone exposure (93% first trimester exposures). There were 70 ciprofloxacin exposures, all within the first trimester. The malformation rates among live-born babies exposed to ciprofloxacin and to fluoroquinolones overall were both within background incidence ranges. No specific patterns of congenital abnormalities were found. The study did not reveal any clear adverse reactions due to in utero exposure to ciprofloxacin. No differences in the rates of prematurity, spontaneous abortions, or birth weight were seen in women exposed to ciprofloxacin during pregnancy. However, these small postmarketing epidemiology studies, of which most experience is from short term, first trimester exposure, are insufficient to evaluate the risk for less common defects or to permit reliable and definitive conclusions regarding the safety of ciprofloxacin in pregnant women and their developing fetuses. Animal Data Developmental toxicology studies have been performed with ciprofloxacin in rats, mice, and rabbits. In rats and mice, oral doses up to 100 mg/kg administered during organogenesis (Gestation Days, GD, 6 to 17) were not associated with adverse developmental outcomes, including embryofetal toxicity or malformations. In rats and mice, a 100 mg/kg dose is approximately 0.6 and 0.3 times the maximum daily human oral dose (1500 mg/day) based upon body surface area, respectively. In a series of rabbit developmental toxicology studies, doses received oral or intravenous ciprofloxacin for one of the following 5 day periods: GD 6 to 10, GD 10 to 14, or GD 14 to 18, intended to cover the period of organogenesis. This was an attempt to mitigate the gastrointestinal intolerance observed in rabbits that receive antibacterials manifested by reduced maternal food consumption and weight loss, that can lead to embryofetal resorption or spontaneous abortion. An oral ciprofloxacin dose of 100 mg/kg (approximately 1.3 times the highest recommended clinical oral dose based on body surface area) caused excessive maternal toxicity confounding evaluation of the fetuses. A 30 mg/kg oral dose (approximately 0.4 times the highest recommended clinical oral dose) was associated with suppression of maternal and fetal body weight gain, but fetal malformations were not observed. Intravenous administration of doses up to 20 mg/kg (approximately 0.3 times the highest recommended clinical oral dose based upon body surface area) to pregnant rabbits was not maternally toxic and neither embryofetal toxicity nor fetal malformations were observed. In peri- and post-natal studies, rats received ciprofloxacin doses up to 200 mg/kg/day (oral) or up to 30 mg/kg/day (subcutaneous) from GD 16 to 22 days postpartum. The 200 mg/kg dose is approximately 1.3-times the maximum recommended clinical oral dose based on body surface area. Neither maternal toxicity nor adverse effects on growth and development of the pups were observed, including no sign of arthropathy on the rear leg joints of the pups. Ciprofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested when administered directly [see Warnings and Precautions ( 5.13 ) and Nonclinical Toxicology ( 13.2 )] .
Pediatric use
8.4 Pediatric Use Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls. Quinolones, including ciprofloxacin, cause arthropathy (arthralgia, arthritis), in juvenile animals [see Warnings and Precautions ( 5.13 ) and Nonclinical Toxicology ( 13.2 )]. Complicated Urinary Tract Infection and Pyelonephritis Ciprofloxacin is indicated for the treatment of cUTI and pyelonephritis due to Escherichia coli in pediatric patients 1 to 17 years of age. Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to the controls, including events related to joints and/or surrounding tissues [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.2 )]. Inhalational Anthrax (Post-Exposure) Ciprofloxacin is indicated in pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure). The risk-benefit assessment indicates that administration of ciprofloxacin to pediatric patients is appropriate [see Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.3 )] . Plague Ciprofloxacin is indicated in pediatric patients from birth to 17 years of age, for treatment of plague, including pneumonic and septicemic plague due to Yersinia pestis (Y. pestis) and prophylaxis for plague. Efficacy studies of ciprofloxacin could not be conducted in humans with pneumonic plague for feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals. The risk-benefit assessment indicates that administration of ciprofloxacin to pediatric patients is appropriate [see Indications and Usage ( 1.7 ), Dosage and Administration ( 2.2 ), and Clinical Studies ( 14.4 )].
Geriatric use
8.5 Geriatric Use Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as ciprofloxacin. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing ciprofloxacin to elderly patients especially those on corticosteroids. Patients should be informed of this potential adverse reaction and advised to discontinue ciprofloxacin and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur [see Boxed Warning , Warnings and Precautions ( 5.2 ), and Adverse Reactions ( 6.2 )]. Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients [see Warnings and Precautions ( 5.9 )] . In a retrospective analysis of 23 multiple-dose controlled clinical trials of ciprofloxacin encompassing over 3500 ciprofloxacin-treated patients, 25% of patients were greater than or equal to 65 years of age and 10% were greater than or equal to 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals on any drug therapy cannot be ruled out. Ciprofloxacin is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. No alteration of dosage is necessary for patients greater than 65 years of age with normal renal function. However, since some older individuals experience reduced renal function by virtue of their advanced age, care should be taken in dose selection for elderly patients, and renal function monitoring may be useful in these patients [see Dosage and Administration ( 2.3 ) and Clinical Pharmacology ( 12.3 )]. In general, elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using ciprofloxacin with concomitant drugs that can result in prolongation of the QT interval (for example, class IA or class III antiarrhythmics) or in patients with risk factors for torsade de pointes (for example, known QT prolongation, uncorrected hypokalemia) [see Warnings and Precautions ( 5.12 )].
Overdosage
In the event of acute overdosage, reversible renal toxicity has been reported in some cases. Observe the patient carefully and give supportive treatment, including monitoring of renal function, urinary pH and acidify, if required, to prevent crystalluria. Adequate hydration must be maintained. Only a small amount of ciprofloxacin (less than 10%) is removed from the body after hemodialysis or peritoneal dialysis. In mice, rats, rabbits and dogs, significant toxicity including tonic/clonic convulsions was observed at intravenous doses of ciprofloxacin between 125 mg/kg and 300 mg/kg.
Description
Ciprofloxacin Injection, USP (in 5% Dextrose Injection) is a synthetic antimicrobial agent for intravenous (IV) administration. Ciprofloxacin, a fluoroquinolone, is 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 and its chemical structure is: Ciprofloxacin is a faint to light yellow crystalline powder with a molecular weight of 331.4. It is soluble in dilute (0.1N) hydrochloric acid and is practically insoluble in water and ethanol. Ciprofloxacin Injection, USP solution is a sterile 0.2% ready-for-use infusion solution in 5% Dextrose Injection. The formula contains lactic acid 0.644 mg per mL as a solubilizing agent and hydrochloric acid for pH adjustment. The pH range for the 0.2% ready-for-use infusion solutions is 3.5 to 4.6. The flexible container is fabricated from a specially formulated non-plasticized, thermoplastic copolyolephine. The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. The glucose content for the 100 mL bag is 5 g and 10 g for the 200 mL flexible container. Chemical Structure
Mechanism of action
12.1 Mechanism of Action Ciprofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology ( 12.4 )].
How supplied
Ciprofloxacin Injection, USP (in 5% Dextrose Injection) is available in 200 mg and 400 mg strengths supplied in flexible containers as follows: Ciprofloxacin Injection, USP in NDC 5% Dextrose (2 mg per mL) Package Factor 25021-192-82 200 mg per 100 mL single-dose 24 bags per carton flexible container bag 25021-192-87 400 mg per 200 mL single-dose 24 bags per carton flexible container bag Ciprofloxacin Injection, USP (ciprofloxacin) is available as a clear, colorless to slightly yellowish solution. Storage Conditions Store between 5° and 25°C (41° and 77°F). Protect from light. Avoid excessive heat. Protect from freezing. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free. The container and container closure are not made with natural rubber latex.
Storage
Storage Conditions Store between 5° and 25°C (41° and 77°F). Protect from light. Avoid excessive heat. Protect from freezing. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free. The container and container closure are not made with natural rubber latex.
Patient information
Advise the patient to read the FDA-approved patient labeling ( Medication Guide ) Serious Adverse Reactions Advise patients to stop taking ciprofloxacin if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug. Inform patients of the following serious adverse reactions that have been associated with ciprofloxacin or other fluoroquinolone use: Disabling and potentially irreversible serious adverse reactions that may occur together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of ciprofloxacin and may occur together in the same patient. Inform patients to stop taking ciprofloxacin immediately if they experience an adverse reaction and to call their healthcare provider. Tendon Disorders: Instruct patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue ciprofloxacin treatment. Symptoms may be irreversible. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Peripheral Neuropathies: Inform patients that peripheral neuropathies have been associated with ciprofloxacin use, symptoms may occur soon after initiation of therapy and may be irreversible. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, immediately discontinue ciprofloxacin and tell them to contact their physician. Central nervous system effects (for example, convulsions, dizziness, lightheadedness, increased intracranial pressure): Inform patients that convulsions have been reported in patients receiving fluoroquinolones, including ciprofloxacin. Instruct patients to notify their physician before taking this drug if they have a history of convulsions. Inform patients that they should know how they react to ciprofloxacin before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. Instruct patients to notify their physician if persistent headache with or without blurred vision occurs. Exacerbation of Myasthenia Gravis: Instruct patients to inform their physician of any history of myasthenia gravis. Instruct patients to notify their physician if they experience any symptoms of muscle weakness, including respiratory difficulties. Hypersensitivity Reactions: Inform patients that ciprofloxacin can cause hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (for example, swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction. Hepatotoxicity: Inform patients that severe hepatotoxicity (including acute hepatitis and fatal events) has been reported in patients taking ciprofloxacin. Instruct patients to inform their physician if they experience any signs or symptoms of liver injury including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes, light colored bowel movements or dark colored urine. Aortic Aneurysm and Dissection: Inform patients to seek emergency medical care if they experience sudden chest, stomach, or back pain. Diarrhea: Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, instruct patients to contact their physician as soon as possible. Prolongation of the QT Interval: Instruct patients to inform their physician of any personal or family history of QT prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia; if they are taking any Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Instruct patients to notify their physician if they have any symptoms of prolongation of the QT interval, including prolonged heart palpitations or a loss of consciousness. Musculoskeletal Disorders in Pediatric Patients: Instruct parents to inform their child's physician if the child has a history of joint-related problems before taking this drug. Inform parents of pediatric patients to notify their child's physician of any joint-related problems that occur during or following ciprofloxacin therapy [see Warnings and Precautions ( 5.13 ) and Use in Specific Populations ( 8.4 )]. Tizanidine: Instruct patients not to use ciprofloxacin if they are already taking tizanidine. Ciprofloxacin increases the effects of tizanidine (Zanaflex ® ). Theophylline: Inform patients that ciprofloxacin may increase the effects of theophylline. Life-threatening CNS effects and arrhythmias can occur. Advise the patients to immediately seek medical help if they experience seizures, palpitations, or difficulty breathing. Caffeine: Inform patients that ciprofloxacin may increase the effects of caffeine. There is a possibility of caffeine accumulation when products containing caffeine are consumed while taking quinolones. Photosensitivity/Phototoxicity: Inform patients that photosensitivity/phototoxicity has been reported in patients receiving fluoroquinolones.
Label text from the FDA structured product label by Sagent Pharmaceuticals (revised Aug 4, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Ciprofloxacin Hydrochloride in 166 products
- Ciprofloxacin in 2 products
ciprofloxacin NDC products (170)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-5373 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-1648 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-1649 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-2146 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-3791 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-3852 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-4217 | Ciprofloxacin Hydrochloride 3 mg/mL Solution | A-S Medication Solutions | ANDA |
| 50090-4600 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7297 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7581 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 80425-0499 | Ciprofloxacin Hydrochloride 3 mg/mL Solution | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0492 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | Advanced Rx of Tennessee, LLC | ANDA |
| 60687-860 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 60687-947 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 69238-2434 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet, Film Coated | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-2433 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-2432 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Amneal Pharmaceuticals NY LLC | ANDA |
| 71610-109 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-081 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-159 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 76420-045 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA |
| 76420-214 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA |
| 76420-588 | Ciprofloxacin Hydrochloride 3 mg/mL Solution | Asclemed USA, Inc. | ANDA |
| 76420-928 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 76420-929 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 65862-076 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-866 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-867 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-873 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-976 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-078 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-977 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 59651-978 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-077 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 71335-1024 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-0408 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-3868 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 72162-2425 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1741 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 72162-1740 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-1010 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-0070 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1229 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Coated | Bryant Ranch Prepack | ANDA |
| 71335-2046 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2054 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Coated | Bryant Ranch Prepack | ANDA |
| 71335-2097 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Coated | Bryant Ranch Prepack | ANDA |
| 71335-2450 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1347 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2502 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1152 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Coated | Bryant Ranch Prepack | ANDA |
| 71335-1867 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 55154-0193 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 61442-222 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Carlsbad Technology, Inc. | ANDA |
| 61442-223 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Carlsbad Technology, Inc. | ANDA |
| 61442-224 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet, Film Coated | Carlsbad Technology, Inc. | ANDA |
| 62135-392 | Kit | Chartwell RX, LLC | ANDA |
| 62135-393 | Kit | Chartwell RX, LLC | ANDA |
| 62135-308 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Chartwell RX, LLC. | ANDA |
| 62135-309 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Chartwell RX, LLC. | ANDA |
| 62135-310 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet, Film Coated | Chartwell RX, LLC. | ANDA |
| 67046-1537 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-1460 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-1528 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet | Coupler LLC | ANDA |
| 72189-111 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | DIRECT RX | ANDA |
| 72189-323 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Coated | Direct Rx | ANDA |
| 72189-627 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 72189-616 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | Direct_Rx | ANDA |
| 72189-623 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | Direct_Rx | ANDA |
| 72189-300 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | DirectRx | ANDA |
| 72189-304 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | DirectRx | ANDA |
| 60429-042 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 51407-776 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 51407-775 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 51407-165 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Golden State Medical Supply, Inc. | ANDA |
| 85534-0075 | Ciprofloxacin Hydrochloride 3 mg/mL Solution | HAWAII REPACK, INC | ANDA |
| 85534-0081 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet, Film Coated | HAWAII REPACK, INC. | ANDA |
| 85534-0069 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | HAWAII REPACK, INC. | ANDA |
| 85534-0047 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | HAWAII REPACK, INC. | ANDA |
| 0143-9928 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9929 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet, Film Coated | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9927 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Hikma Pharmaceuticals USA Inc. | ANDA |
| 69315-308 | Ciprofloxacin Hydrochloride 3 mg/mL Solution | Leading Pharma, LLC | ANDA |
| 0904-7243 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 58657-675 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Coated | Method Pharmaceuticals, LLC | ANDA |
| 58657-676 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Coated | Method Pharmaceuticals, LLC | ANDA |
| 0615-8630 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 82868-102 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 82868-070 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-086 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-216 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-490 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Coated | Northwind Health Company, LLC | ANDA |
| 68071-3699 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | NuCare Pharmaceutical, Inc. | ANDA |
| 68071-3737 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | NuCare Pharmaceutical, Inc. | ANDA |
| 68071-3693 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 66267-919 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 66267-716 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-2267 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2269 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2383 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2384 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4679 | Ciprofloxacin Hydrochloride 3 mg/mL Solution | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4672 | Ciprofloxacin Hydrochloride 3 mg/mL Solution | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4260 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2404 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3610 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3901 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4122 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 72789-124 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-065 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-108 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-118 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-125 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-193 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-330 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-511 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-519 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-520 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-923 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-869 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-767 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-547 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-410 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 54348-662 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | PharmPak, Inc. | ANDA |
| 54348-663 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | PharmPak, Inc. | ANDA |
| 68788-8200 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8136 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8875 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8692 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7500 | Ciprofloxacin Hydrochloride 3 mg/mL Solution | Preferred Pharmaceuticals, Inc. | ANDA |
| 71205-997 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-300 | Ciprofloxacin Hydrochloride 3 mg/mL Solution | Proficient Rx LP | ANDA |
| 71205-636 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-649 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-749 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Coated | Proficient Rx LP | ANDA |
| 82804-130 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-256 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | Proficient Rx LP | ANDA |
| 63187-017 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | Proficient Rx LP | ANDA |
| 63187-142 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | Proficient Rx LP | ANDA |
| 63187-990 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet | Proficient Rx LP | ANDA |
| 42708-088 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | QPharma Inc | ANDA |
| 42708-192 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | QPharma, Inc. | ANDA |
| 67296-2291 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Redpharm Drug | ANDA |
| 67296-1848 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Coated | Redpharm Drug | ANDA |
| 67296-2169 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | Redpharm Drug | ANDA |
| 67296-2135 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | Redpharm Drug | ANDA |
| 67296-1703 | Ciprofloxacin Hydrochloride 3 mg/mL Solution | Redpharm Drug | ANDA |
| 70518-4229 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-2837 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-3063 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4133 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4214 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 16571-412 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Rising Pharma Holdings, Inc. | ANDA |
| 16571-411 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Film Coated | Rising Pharma Holdings, Inc. | ANDA |
| 16571-413 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet, Film Coated | Rising Pharma Holdings, Inc. | ANDA |
| 25021-192 | Ciprofloxacin 2 mg/mL Injection, Solution | Sagent Pharmaceuticals | ANDA |
| 25021-114 | Ciprofloxacin 2 mg/mL Injection, Solution | Sagent Pharmaceuticals | ANDA |
| 43547-688 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | Solco Healthcare US, LLC | ANDA |
| 43547-689 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | Solco Healthcare US, LLC | ANDA |
| 85766-099 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | Sportpharm LLC | ANDA |
| 85766-100 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | Sportpharm LLC | ANDA |
| 85766-023 | Ciprofloxacin Hydrochloride 3 mg/mL Solution | Sportpharm LLC | ANDA |
| 60760-676 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Coated | St. Mary's Medical Park Pharmacy | ANDA |
| 60760-689 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | ST. MARY'S MEDICAL PARK PHARMACY | ANDA |
| 60760-690 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA |
| 16252-515 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA |
| 85293-003 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet | Umasuto, LLC | ANDA |
| 85293-004 | Ciprofloxacin Hydrochloride 750 mg/1 Tablet | Umasuto, LLC | ANDA |
| 85293-002 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet | Umasuto, LLC | ANDA |
| 69117-0009 | Ciprofloxacin Hydrochloride 500 mg/1 Tablet, Coated | Yiling Pharmaceutical, Inc. | ANDA |
| 69117-0008 | Ciprofloxacin Hydrochloride 250 mg/1 Tablet, Coated | Yiling Pharmaceutical, Inc. | ANDA |
ciprofloxacin recalls
- D-0282-2025 Mar 26, 2025 · Class II · Ongoing
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle - D-0182-2025 Jan 15, 2025 · Class II · Ongoing
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle - D-0623-2024 Aug 7, 2024 · Class II · Ongoing
Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. - D-220-2013 Apr 3, 2013 · Class II · Terminated
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet. - D-1422-2012 Jul 25, 2012 · Class III · Terminated
Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.
Frequently asked questions
What is ciprofloxacin used for?
Ciprofloxacin Injection is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: Skin and Skin Structure Infections ( 1.1 ) Bone and Joint Infections ( 1.2 ) Complicated Intra-Abdominal Infections ( 1.3 ) Nosocomial Pneumonia ( 1.4 ) Empirical Therapy for Febrile…
What are the side effects of ciprofloxacin?
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: Disabling and Potentially Irreversible Serious Adverse Reactions [see Warnings and Precautions ( 5.1 )] Tendinitis and Tendon Rupture [see Warnings and Precautions ( 5.2 )] Peripheral Neuropathy [see Warnings and Precautions ( 5.3 )] Central Nervous System Effects… See the full label for the complete list.
Who makes ciprofloxacin?
ciprofloxacin is listed by 47 labelers in the FDA NDC directory, including A-S Medication Solutions, Advanced Rx of Tennessee, LLC, American Health Packaging, Amneal Pharmaceuticals NY LLC.
Has ciprofloxacin been recalled?
The FDA enforcement database lists 5 recalls for ciprofloxacin, most recently D-0282-2025 (class ii): Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle