Mediclarum
Medicine guide

Ciprofloxacin

750 mg · Tablet, Film Coated

  • Prescription only
  • Fluoroquinolone Antibacterial
Made by
Carlsbad Technology, Inc.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-02-05

What it is

Fluoroquinolone Antibacterial

Used for
  • Ciprofloxacin Tablets 250 mg, 500 mg, and 750 mg are a fluoroquinolone antibacterial indicated in
The label’s usual adult dose

Adult Dosage Guidelines Infection Dose Frequency Duration Skin and Skin Structure 500 -750 mg every 12 hours 7 to 14 days Bone and Joint 500-750 mg every 12 hours 4 to 8 weeks Complicated Intra-Abdominal 500 mg every 12 hours 7 to 14 days Infectious Diarrhea 500 mg every 12 hours 5 to 7 days Typhoid Fever 500 mg every 12 hours 10 days Uncomplicated Gonorrhea 250 mg single dose single dose Inhalational anthrax (post-exposure) 500 mg every 12 hours 60 days Plague 500–750 mg every 12 hours 14 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract 500 -750 mg every 12 hours 7 to 14 days Urinary Tract 250-500 mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days Acute Sinusitis 500 mg every 12 hours 10 days

Full directions ↓
Serious warning

SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including Ciprofloxacin, have been associated with disabling and potentially…

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
50other products contain Ciprofloxacin Hydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

adults (≥18 years of age) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated:

  • Ciprofloxacin Tablets 250 mg, 500 mg, and 750 mg are a fluoroquinolone antibacterial indicated in
  • Skin and Skin Structure Infections ( 1.1 ) Bone and Joint Infections ( 1.2 ) Complicated Intra-Abdominal Infections ( 1.3 ) Infectious Diarrhea ( 1.4 ) Typhoid Fever (Enteric Fever) ( 1.5 ) Uncomplicated Cervical and Urethral Gonorrhea ( 1.6 ) Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7 ) Plague in adult and pediatric patients ( 1.8 ) Chronic Bacterial Prostatitis ( 1.9 ) Lower Respiratory Tract Infections ( 1.10 ) Acute Exacerbation of Chronic Bronchitis Urinary Tract Infections ( 1.11 ) Urinary Tract Infections (UTI) Acute Uncomplicated Cystitis Complicated UTI and Pyelonephritis in Pediatric Patients Acute Sinusitis ( 1.12 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin and other antibacterial drugs, Ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • ( 1.13 )
  • 1.1 Skin and Skin Structure Infections Ciprofloxacin 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 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 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 Infectious Diarrhea Ciprofloxacin is indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii † , Shigella dysenteriae, Shigella flexneri or Shigella sonnei † when antibacterial therapy is indicated. † Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.
  • 1.5 Typhoid Fever (Enteric Fever) Ciprofloxacin is indicated in adult patients for treatment of typhoid fever (enteric fever ) caused by Salmonella typhi.
  • The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.
  • 1.6 Uncomplicated Cervical and Urethral Gonorrhea Ciprofloxacin is indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae [see Warnings and Precautions ( 5.16 )].
  • 1.7 Inhalational Anthrax (Post-Exposure) Ciprofloxacin is indicated in
  • adults and pediatric patients from birth to 17 years of age for 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 ( 14.2 )].
  • 1.8 Plague Ciprofloxacin 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 ( 14.3 )] .
  • 1.9 Chronic Bacterial Prostatitis Ciprofloxacin is indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.
  • 1.10 Lower Respiratory Tract Infections Ciprofloxacin 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 is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.
  • Ciprofloxacin is indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by Moraxella catarrhalis.
  • Because fluoroquinolones, including Ciprofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1 – 5.15 )] and for some patients AECB is self-limiting, reserve Ciprofloxacin for treatment of AECB in patients who have no alternative treatment options.
  • 1.11 Urinary Tract Infections Urinary Tract Infections in
  • Adults Ciprofloxacin 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 .
  • Acute Uncomplicated Cystitis Ciprofloxacin is indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus.
  • Because fluoroquinolones, including Ciprofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1 - 5.15 )] and for some patients acute uncomplicated cystitis is self-limiting, reserve Ciprofloxacin for treatment of acute uncomplicated cystitis in patients who have no alternative treatment options.
  • Complicated Urinary Tract Infection and Pyelonephritis in Pediatric Patients Ciprofloxacin is indicated in pediatric patients aged 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 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.
  • Ciprofloxacin, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals [see Warnings and Precautions ( 5.12 ), Adverse Reactions ( 6.1 ), Use in Specific Populations ( 8.4 ) and Nonclinical Toxicology ( 13.2 )].
  • 1.12 Acute Sinusitis Ciprofloxacin is indicated in adult patients for treatment of acute sinusitis caused by or Ciprofloxacin is indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.
  • Because fluoroquinolones, including Ciprofloxacin, have been associated with serious adverse reactions and for some patients acute sinusitis is self-limiting, reserve Ciprofloxacin for treatment of acute sinusitis in patients who have no alternative treatment options.
  • Because fluoroquinolones, including Ciprofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1 - 5.15 )] and for some patients acute sinusitis is self-limiting, reserve Ciprofloxacin for treatment of acute sinusitis in patients who have no alternative treatment options.
  • 1.13 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin and other antibacterial drugs, Ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
  • When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
  • In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
  • If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered.
  • Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to Ciprofloxacin.
  • Therapy with Ciprofloxacin may be initiated before results of these tests are known; once results become available appropriate therapy should be continued.
  • As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin.
  • Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.

From the official label · 2025-02-05 · DailyMed

How it works

From this product’s own US prescribing label.

Ciprofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology ( 12.4 )].

Half-life4 h
Mostly cleared after≈ 20 hfive half-lives — our arithmetic
How it leaves the body

Approximately 40 to 50% of an orally administered dose is excreted in the urine as unchanged drug.

With food

The pharmacokinetics of ciprofloxacin given as the suspension are also not affected by food.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-02-05

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

  • SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including Ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions ( 5.1 )] including :
  • 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 )] Discontinue Ciprofloxacin immediately and
  • avoid the use of fluoroquinolones, including Ciprofloxacin, in patients who experience any of these serious adverse reactions [see Warnings and Precautions ( 5.1 )] .Fluoroquinolones, including Ciprofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis.
  • Avoid Ciprofloxacin in patients with known history of myasthenia gravis [see Warnings and Precautions ( 5.5 )].
  • Because fluoroquinolones, including Ciprofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1 – 5.15 )] , reserve Ciprofloxacin for use in patients who have no alternative treatment options for the following indications:
  • Acute exacerbation of chronic bronchitis [see Indications and Usage ( 1.10 )] Acute uncomplicated cystitis [see Indications and Usage ( 1.11 )] Acute sinusitis [see Indications and Usage ( 1.12 )] WARNING:
  • SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS See full prescribing information for complete boxed warning.
  • Fluoroquinolones, including Ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together ( 5.1 ), including:
  • Tendinitis and tendon rupture( 5.2 ) Peripheral neuropathy ( 5.3 ) Central nervous system effects( 5.4 ) Discontinue Ciprofloxacin immediately and
  • avoid the use of fluoroquinolones, including Ciprofloxacin, in patients who experience any of these serious adverse reactions ( 5.1 ) Fluoroquinolones, including Ciprofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis.
  • Avoid Ciprofloxacin in patients with known history of myasthenia gravis.
  • ( 5.5 ) Because fluoroquinolones, including Ciprofloxacin, have been associated with serious adverse reactions ( 5.1 - 5.15 ), reserve Ciprofloxacin for use in patients who have no alternative treatment options for the following indications:
  • Acute exacerbation of chronic bronchitis ( 1.10 ) Acute uncomplicated cystitis ( 1.11 ) Acute sinusitis ( 1.12 )

Quoted from the official label, section “Boxed Warning”.

Do not take it if

  • Known hypersensitivity to Ciprofloxacin or other quinolones ( 4.1 , 5.6 , 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 )].

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Ciprofloxacin Tablets should be administered orally as described in the appropriate Dosage Guidelines tables.
  • Adult Dosage Guidelines Infection Dose Frequency Duration Skin and Skin Structure 500 -750 mg every 12 hours 7 to 14 days Bone and Joint 500-750 mg every 12 hours 4 to 8 weeks Complicated Intra-Abdominal 500 mg every 12 hours 7 to 14 days Infectious Diarrhea 500 mg every 12 hours 5 to 7 days Typhoid Fever 500 mg every 12 hours 10 days Uncomplicated Gonorrhea 250 mg single dose single dose Inhalational anthrax (post-exposure) 500 mg every 12 hours 60 days Plague 500–750 mg every 12 hours 14 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract 500 -750 mg every 12 hours 7 to 14 days Urinary Tract 250-500 mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days Acute Sinusitis 500 mg every 12 hours 10 days
  • Adults with creatinine clearance 30–50 mL/min 250–500 mg q 12 h ( 2.3 )
  • Adults with creatinine clearance 5–29 mL/min 250–500 mg q 18 h ( 2.3 ) Patients on hemodialysis or peritoneal dialysis 250–500 mg q 24 h (after dialysis) ( 2.3 ) Pediatric Oral Dosage Guidelines Infection Dose Frequency Duration Complicated UTI and Pyelonephritis (1 to 17 years of age) 10–20 mg/kg (maximum 750 mg per dose) Every 12 hours 10–21 days Inhalational Anthrax (Post-Exposure) 15 mg/kg (maximum 500 mg per dose) Every 12 hours 60 days Plague 15mg/kg (maximum 500 mg per dose) Every 8 to 12 hours 10–21 days
  • 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.
  • 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.
  • Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). 1.
  • Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). 2.
  • Used in conjunction with metronidazole. 2.
  • Used in conjunction with metronidazole. 3.
  • 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.
  • Infection Dose Frequency Usual Durations 1 Skin and Skin Structure 500–750 mg every 12 hours 7 to 14 days Bone and Joint 500–750 mg every 12 hours 4 to 8 weeks Complicated Intra–Abdominal 2 500 mg every 12 hours 7 to 14 days Infectious Diarrhea 500 mg every 12 hours 5 to 7 days Typhoid Fever 500 mg every 12 hours 10 days Uncomplicated Urethral and Cervical Gonococcal Infections 250 mg single dose single dose Inhalational anthrax (post-exposure) 3 500 mg every 12 hours 60 days Plague 3 500–750 mg every 12 hours 14 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract Infections 500–750 mg every 12 hours 7 to 14 days Urinary Tract Infections 250–500 mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days Acute Sinusitis 500 mg every 12 hours 10 days Conversion of IV to Oral Dosing in
  • Adults Patients whose therapy is started with Ciprofloxacin IV 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 IV 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.
  • Ciprofloxacin should be administered as described in Table 3 .
  • 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 Frequency Total Duration Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg) Every 12 hours 10–21 days 1 Inhalational Anthrax (Post-Exposure) 2 15 mg/kg (maximum 500 mg per dose) Every 12 hours 60 days Plague 2,3 15 mg/kg (maximum 500 mg per dose) Every 8 to 12 hours 10–21 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 > 50 See Usual Dosage. 30–50 250–500 mg every12 hours 5–29 250–500 mg every 18 hours Patients on hemodialysis or Peritoneal dialysis 250–500 mg every 24 hours (after dialysis) 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) x (140–age) 72 x serum creatinine (mg/dL) Women - 0.85 x 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, a unit dose of 750 mg may be administered at the intervals noted above.
  • Patients should be carefully monitored.
  • 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 ).
  • 2.4 Important Administration Instructions With Multivalent Cations Administer Ciprofloxacin at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate;
  • Videx ® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.
  • With Dairy Products Concomitant administration of Ciprofloxacin with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, Ciprofloxacin may be taken with a meal that contains these products.
  • Hydration of Patients Receiving Ciprofloxacin Assure adequate hydration of patients receiving Ciprofloxacin to prevent the formation of highly concentrated urine.
  • Crystalluria has been reported with quinolones.
  • Instruct the patient of the appropriate Ciprofloxacin administration [see Patient Counseling Information ( 17 )].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Hypersensitivity and other serious reactions:
  • Serious and sometimes fatal reactions (for example, anaphylactic reactions) may occur after the first or subsequent doses of Ciprofloxacin.
  • Discontinue Ciprofloxacin 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 ) Clostridium difficile -associated diarrhea: Evaluate if colitis occurs.
  • ( 5.10 ) 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.
  • ( 5.11 , 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 Fluoroquinolones, including Ciprofloxacin, have been associated with an increased risk of central nervous system (CNS) effects, including. convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis.
  • Ciprofloxacin may also cause central nervous system (CNS) events including:
  • nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and psychotic reactions have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide.
  • 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.
  • Ciprofloxacin, like other fluoroquinolones, is known to trigger seizures or lower the seizure threshold.
  • As with all fluoroquinolones, use Ciprofloxacin with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (for example, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (for example, certain drug therapy, renal dysfunction).
  • Use Ciprofloxacin when the benefits of treatment exceed the risks, since these patients are endangered because of possible undesirable CNS side effects.
  • Cases of status epilepticus have been reported.
  • If seizures occur, discontinue Ciprofloxacin [see Adverse Reactions ( 6.1 ) and Drug Interactions ( 7 )].
  • 5.5 Exacerbation of Myasthenia Gravis Fluoroquinolones, including Ciprofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis.
  • Postmarketing serious adverse reactions, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in patients with myasthenia gravis.
  • Avoid Ciprofloxacin in patients with known history of myasthenia gravis [see Adverse Reactions ( 6.2 )].
  • 5.6 Other Serious and Sometimes Fatal Adverse Reactions Other serious and sometimes fatal adverse reactions, some due to hypersensitivity, and some due to uncertain etiology, have been reported in patients receiving therapy with quinolones, including Ciprofloxacin.
  • These events may be severe and generally occur following the administration of multiple doses.
  • Clinical manifestations may include one or more of the following:
  • Fever, rash, or severe dermatologic reactions (for example, toxic epidermal necrolysis, Stevens Johnson syndrome);
  • Vasculitis; arthralgia; myalgia; serum sickness;
  • Allergic pneumonitis;
  • Interstitial nephritis; acute renal insufficiency or failure;
  • Hepatitis; jaundice; acute hepatic necrosis or failure;
  • Anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.
  • Discontinue Ciprofloxacin immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted [see Adverse Reactions ( 6.1 , 6.2 )].
  • 5.7 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving fluoroquinolone therapy, including Ciprofloxacin.
  • Some reactions were accompanied by cardiovascular collapse, acute myocardial ischemia with or without myocardial infarction, 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, including intubation, as indicated [see Adverse Reactions ( 6.1 )].
  • 5.8 Hepatotoxicity Cases of severe hepatotoxicity, including hepatic necrosis, life-threatening hepatic failure, and fatal events, have been reported with Ciprofloxacin.
  • Acute liver injury is rapid in onset (range 1–39 days), and is often associated with hypersensitivity.
  • The pattern of injury can be hepatocellular, cholestatic, or mixed.
  • Most patients with fatal outcomes were older than 55 years old.
  • In the event of any signs and symptoms of hepatitis (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), discontinue treatment immediately.
  • There can be a temporary increase in transaminases, alkaline phosphatase, or cholestatic jaundice, especially in patients with previous liver damage, who are treated with Ciprofloxacin [see Adverse Reactions ( 6.2 , 6.3 )].
  • 5.9 Serious Adverse Reactions with Concomitant Theophylline Serious and fatal reactions have been reported in patients receiving concurrent administration of Ciprofloxacin and theophylline.
  • These reactions have included cardiac arrest, seizure, status epilepticus, and respiratory failure.
  • Instances of nausea, vomiting, tremor, irritability, or palpitation have also occurred.
  • Although similar serious adverse reactions have been reported in patients receiving theophylline alone, the possibility that these reactions may be potentiated by Ciprofloxacin cannot be eliminated.
  • If concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate [see Drug Interactions ( 7 )].
  • 5.10 Clostridium difficile -Associated Diarrhea Clostridium difficile (C. difficile)- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ciprofloxacin, and may range in severity from mild diarrhea to fatal colitis.
  • Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
  • C. difficile produces toxins A and B which contribute to the development of CDAD.
  • Hypertoxin producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
  • CDAD must be considered in all patients who present with diarrhea following antibacterial use.
  • Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
  • If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued.
  • Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and institute surgical evaluation as clinically indicated [see Adverse Reactions ( 6.1 )].
  • 5.11 Prolongation of the QT Interval Some fluoroquinolones, including Ciprofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and cases of arrhythmia.
  • Cases of torsade de pointes have been reported during postmarketing surveillance in patients receiving fluoroquinolones, including Ciprofloxacin.
  • Avoid Ciprofloxacin in patients with known prolongation of the QT interval, risk factors for QT prolongation or torsade de pointes (for example, congenital long QT syndrome, uncorrected electrolyte imbalance, such as hypokalemia or hypomagnesemia and cardiac disease, such as heart failure, myocardial infarction, or bradycardia), and patients receiving Class IA antiarrhythmic agents (quinidine, procainamide), or Class III antiarrhythmic agents (amiodarone, sotalol), tricyclic antidepressants, macrolides, and antipsychotics.
  • Elderly patients may also be more susceptible to drug-associated effects on the QT interval [see Adverse Reactions ( 6.2 ), Use in Specific Populations ( 8.5 )].
  • 5.12 Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals Ciprofloxacin is indicated in pediatric patients (less than 18 years of age) only for cUTI, prevention of inhalational anthrax (post exposure), and plague [see Indications and Usage ( 1.7 , 1.8 , 1.11 )] .
  • An increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues, has been observed [see Adverse Reactions ( 6.1 )] .
  • In pre-clinical studies, oral administration of Ciprofloxacin caused lameness in immature dogs.
  • Histopathological examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage.
  • Related quinolone-class drugs also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species [see Use in Specific Populations ( 8.4 ) and Nonclinical Toxicology ( 13.2 )].
  • 5.13 Photosensitivity/Phototoxicity Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (for example, burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of quinolones including Ciprofloxacin after sun or UV light exposure.
  • Therefore, avoid excessive exposure to these sources of light.
  • Discontinue Ciprofloxacin if phototoxicity occurs [see Adverse Reactions ( 6.1 )].
  • 5.14 Development of Drug Resistant Bacteria Prescribing Ciprofloxacin Tablets and Ciprofloxacin Oral Suspension in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
  • 5.15 Potential Risks with Concomitant Use of Drugs Metabolized by Cytochrome P450 1A2 Enzymes Ciprofloxacin is an inhibitor of the hepatic CYP1A2 enzyme pathway.
  • Co-administration of Ciprofloxacin and other drugs primarily metabolized by CYP1A2 (for example, theophylline, methylxanthines, caffeine, tizanidine, ropinirole, clozapine, olanzapine) results in increased plasma concentrations of the co-administered drug and could lead to clinically significant pharmacodynamic adverse reactions of the co-administered drug [see Drug Interactions ( 7 ) and Clinical Pharmacology ( 12.3 )].
  • 5.16 Interference with Timely Diagnosis of Syphilis Ciprofloxacin has not been shown to be effective in the treatment of syphilis.
  • Antimicrobial agents used in high dose for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis.
  • Perform a serologic test for syphilis in all patients with gonorrhea at the time of diagnosis.
  • Perform follow-up serologic test for syphilis three months after Ciprofloxacin treatment.
  • 5.17 Crystalluria Crystals of ciprofloxacin have been observed rarely in the urine of human subjects but more frequently in the urine of laboratory animals, which is usually alkaline [see Nonclinical Toxicology ( 13.2 )].
  • Crystalluria related to Ciprofloxacin has been reported only rarely in humans because human urine is usually acidic.
  • Avoid alkalinity of the urine in patients receiving Ciprofloxacin.
  • Hydrate patients well to prevent the formation of highly concentrated urine [see Dosage and Administration ( 2.4 )] .

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Pregnancy Category C There are no adequate and well-controlled studies in pregnant women.
  • Ciprofloxacin should not be used during pregnancy unless the potential benefit justifies the potential risk to both fetus and mother.
  • An expert review of published data on experiences with ciprofloxacin use during pregnancy by TERIS–the Teratogen Information System–concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (quantity and quality of data=fair), but the data are insufficient to state that there is no risk. 2 A controlled prospective observational study followed 200 women exposed to fluoroquinolones (52.5% exposed to ciprofloxacin and 68% first trimester exposures) during gestation. 3 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 1–5%).
  • 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). 4 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. 2, 3 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.
  • Reproduction studies have been performed in rats and mice using oral doses up to 100 mg/kg (0.6 and 0.3 times the maximum daily human dose based upon body surface area, respectively) and have revealed no evidence of harm to the fetus due to ciprofloxacin.
  • In rabbits, oral ciprofloxacin dose levels of 30 and 100 mg/kg (approximately 0.4- and 1.3-times the highest recommended therapeutic dose based upon body surface area) produced gastrointestinal toxicity resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose level.
  • After intravenous administration of doses up to 20 mg/kg (approximately 0.3-times the highest recommended therapeutic dose based upon body surface area), no maternal toxicity was produced and no embryo toxicity or teratogenicity was observed.
  • Ciprofloxacin is excreted in human milk.
  • The amount of ciprofloxacin absorbed by the nursing infant is unknown.
  • Because of the potential risk of serious adverse reactions (including articular damage) in infants nursing from mothers taking Ciprofloxacin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
  • IN SPECIFIC POPULATIONS See full prescribing information for use in pediatric and geriatric patients ( 8.4 , 8.5 ) Revised:
  • 09/2024
  • 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women.
  • Ciprofloxacin should not be used during pregnancy unless the potential benefit justifies the potential risk to both fetus and mother.
  • An expert review of published data on experiences with ciprofloxacin use during pregnancy by TERIS–the Teratogen Information System–concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (quantity and quality of data=fair), but the data are insufficient to state that there is no risk. 2 A controlled prospective observational study followed 200 women exposed to fluoroquinolones (52.5% exposed to ciprofloxacin and 68% first trimester exposures) during gestation. 3 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 1–5%).
  • 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). 4 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. 2, 3 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.
  • Reproduction studies have been performed in rats and mice using oral doses up to 100 mg/kg (0.6 and 0.3 times the maximum daily human dose based upon body surface area, respectively) and have revealed no evidence of harm to the fetus due to ciprofloxacin.
  • In rabbits, oral ciprofloxacin dose levels of 30 and 100 mg/kg (approximately 0.4- and 1.3-times the highest recommended therapeutic dose based upon body surface area) produced gastrointestinal toxicity resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose level.
  • After intravenous administration of doses up to 20 mg/kg (approximately 0.3-times the highest recommended therapeutic dose based upon body surface area), no maternal toxicity was produced and no embryo toxicity or teratogenicity was observed.
  • 8.3 Nursing Mothers Ciprofloxacin is excreted in human milk.
  • The amount of ciprofloxacin absorbed by the nursing infant is unknown.
  • Because of the potential risk of serious adverse reactions (including articular damage) in infants nursing from mothers taking Ciprofloxacin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
  • 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 in juvenile animals [see Warnings and Precautions ( 5.12 ) 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 ( 14.1 )].
  • 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 ( 14.2 )].
  • 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 ( 1.8 ), Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.3 )].
  • 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 )].
  • 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 ( 5.11 )].
  • 8.6 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 [see Dosage and Administration ( 2.3 ) and Clinical Pharmacology ( 12.3 )].
  • 8.7 Hepatic Impairment In preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in ciprofloxacin pharmacokinetics have been observed.
  • The pharmacokinetics of ciprofloxacin in patients with acute hepatic insufficiency, have not been studied.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • 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 9:
  • 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 ( 5.9 )].
  • 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 ( 5.11 ) 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 If unavoidable, monitor for duloxetine toxicity Five-fold increase in duloxetine exposure Caffeine/Xanthine Use with caution Ciprofloxacin inhibits the formation of paraxanthine after caffeine Derivatives Reduced clearance resulting in elevated levels and prolongation of serum half-life administration (or pentoxifylline containing products).
  • Monitor for xanthine toxicity and adjust dose as necessary.
  • Drug(s) Affecting Pharmacokinetics of Ciprofloxacin Antacids, Sucralfate, Multivitamins and Other Products Containing Multivalent Cations (magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate); sucralfate;
  • Videx ® (didanosine) chewable/buffered tablets or pediatric powder; other highly buffered drugs; or products containing calcium, iron, or zinc and dairy products) Ciprofloxacin should be taken at least two hours before or six hours after Multivalent cation-containing products administration [see Dosage and Administration ( 2.4 )].
  • Decrease Ciprofloxacin absorption, resulting in lower serum and urine levels 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 ) Multivalent cation-containing products including antacids, metal cations or didanosine Decreased Ciprofloxacin absorption.
  • Take 2 hours before or 6 hours after Ciprofloxacin ( 7 )

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • In the event of acute overdosage, reversible renal toxicity has been reported in some cases.
  • Empty the stomach by inducing vomiting or by gastric lavage.
  • Observe the patient carefully and give supportive treatment, including monitoring of renal function, urinary pH and acidify, if required, to prevent crystalluria and administration of magnesium, aluminum, or calcium containing antacids which can reduce the absorption of ciprofloxacin.
  • Adequate hydration must be maintained.
  • Only a small amount of ciprofloxacin (less than 10%) is removed from the body after hemodialysis or peritoneal dialysis.

Quoted from the official label, section “Overdosage”.

Use in children

  • 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 in juvenile animals [see Warnings and Precautions ( 5.12 ) 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 ( 14.1 )].
  • 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 ( 14.2 )].
  • 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 ( 1.8 ), Dosage and Administration ( 2.2 ) and Clinical Studies ( 14.3 )].

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • 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 )].
  • 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 ( 5.11 )].

Quoted from the official label, section “Geriatric Use”.

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 )] Serious Adverse Reactions with Concomitant Theophylline [see Warnings and Precautions ( 5.9 )] Clostridium difficile-Associated Diarrhea [see Warnings and Precautions ( 5.10 )] Prolongation of the QT Interval [see Warnings and Precautions ( 5.11 )] Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions ( 5.12 )] Photosensitivity/Phototoxicity [see Warnings and Precautions ( 5.13 )] Development of Drug Resistant Bacteria [see Warnings and Precautions ( 5.14 )] The most common adverse reactions ≥1% were nausea, diarrhea, liver function test abnormal, vomiting, and rash.
  • ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Carlsbad Technology, Inc. at 1-855-397-9777 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%).
  • Table 6:
  • Medically Important Adverse Reactions That Occurred In less than 1% of Ciprofloxacin Patients System Organ Class Adverse Reactions Body as a Whole Headache Abdominal Pain/Discomfort Pain Cardiovascular Syncope Angina Pectoris Myocardial Infarction Cardiopulmonary Arrest Tachycardia Hypotension Central Nervous System Restlessness Dizziness Insomnia Nightmares Hallucinations Paranoia Psychosis (toxic) Manic Reaction Irritability Tremor Ataxia Seizures (including Status Epilepticus) Malaise Anorexia Phobia Depersonalization Depression (potentially culminating in self-injurious behavior (such as suicidal ideations/thoughts and attempted or completed suicide) Paresthesia Abnormal Gait Migraine Gastrointestinal Intestinal Perforation Gastrointestinal Bleeding Cholestatic Jaundice Hepatitis Pancreatitis Hemic/Lymphatic Petechia Metabolic/Nutritional Hyperglycemia Hypoglycemia Musculoskeletal Arthralgia Joint Stiffness Muscle Weakness Renal/Urogenital Interstitial Nephritis Renal Failure System Organ Class Adverse Reactions Respiratory Dyspnea Laryngeal Edema Hemoptysis Bronchospasm Skin/Hypersensitivity Anaphylactic Reactions including life-threatening anaphylactic shock Erythema Multiforme/Stevens-Johnson Syndrome Exfoliative Dermatitis Toxic Epidermal Necrolysis Pruritus Urticaria Photosensitivity/Phototoxicity reaction Flushing Fever Angioedema Erythema Nodosum Sweating Special Senses Blurred Vision Disturbed Vision (chromatopsia and photopsia) Decreased Visual Acuity Diplopia Tinnitus Hearing Loss Bad Taste In randomized, double-blind controlled clinical trials comparing Ciprofloxacin tablets [500 mg two times daily (BID)] to cefuroxime axetil (250 mg–500 mg BID) and to clarithromycin (500 mg BID) in patients with respiratory tract infections, Ciprofloxacin demonstrated a CNS adverse reaction profile comparable to 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.
  • An Independent Pediatric Safety Committee (IPSC) reviewed all cases of musculoskeletal adverse reactions including abnormal gait or abnormal joint exam (baseline or treatment-emergent).
  • Within 6 weeks of treatment initiation, the rates of musculoskeletal adverse reactions were 9.3% (31/335) in the ciprofloxacin-treated group versus 6% (21/349) in comparator-treated patients.
  • All musculoskeletal adverse reactions occurring by 6 weeks resolved (clinical resolution of signs and symptoms), usually within 30 days of end of treatment.
  • Radiological evaluations were not routinely used to confirm resolution of the adverse reactions.
  • Ciprofloxacin-treated patients were more likely to report more than one adverse reaction and on more than one occasion compared to control patients.
  • The rate of musculoskeletal adverse reactions was consistently higher in the ciprofloxacin group compared to the control group across all age subgroups.
  • At the end of 1 year, the rate of these adverse reactions reported at any time during that period was 13.7% (46/335) in the ciprofloxacin-treated group versus 9.5% (33/349) in the comparator-treated patients ( Table 7 ).
  • Table 7: Musculoskeletal Adverse Reactions 1 as Assessed by the IPSC 1.
  • Included:
  • arthralgia, abnormal gait, abnormal joint exam, joint sprains, leg pain, back pain, arthrosis, bone pain, pain, myalgia, arm pain, and decreased range of motion in a joint (knee, elbow, ankle, hip, wrist, and shoulder) 2.
  • The study was designed to demonstrate that the arthropathy rate for the Ciprofloxacin group did not exceed that of the control group by more than + 6%.
  • At both the 6 week and 1 year evaluations, the 95% confidence interval indicated that it could not be concluded that the Ciprofloxacin group had findings comparable to the control group.
  • Ciprofloxacin Comparator All Patients (within 6 weeks) 31/335 (9.3%) 21/349 (6%) 95% Confidence Interval 2 (-0.8%, +7.2%) Age Group 12 months < 24 months 1/36 (2.8%) 0/41 2 years < 6 years 5/124 (4%) 3/118 (2.5%) 6 years < 12 years 18/143 (12.6%) 12/153 (7.8%) 12 years to 17 years 7/32 (21.9%) 6/37 (16.2 %) All Patients (within 1 year) 46/335 (13.7%) 33/349 (9.5%) 95% Confidence Interval 1 (-0.6%, + 9.1%) The incidence rates of neurological adverse reactions within 6 weeks of treatment initiation were 3% (9/335) in the Ciprofloxacin group versus 2% (7/349) in the comparator group and included dizziness, nervousness, insomnia, and somnolence.
  • In this trial, the overall incidence rates of adverse reactions within 6 weeks of treatment initiation were 41% (138/335) in the ciprofloxacin group versus 31% (109/349) in the comparator group.
  • The most frequent adverse reactions were gastrointestinal:
  • 15% (50/335) of ciprofloxacin patients compared to 9% (31/349) of comparator patients.
  • Serious adverse reactions were seen in 7.5% (25/335) of ciprofloxacin treated patients compared to 5.7% (20/349) of control patients.
  • Discontinuation of drug due to an adverse reaction was observed in 3% (10/335) of ciprofloxacin-treated patients versus 1.4% (5/349) of comparator patients.
  • Other adverse reactions that occurred in at least 1% of ciprofloxacin patients were diarrhea 4.8%, vomiting 4.8%, abdominal pain 3.3%, dyspepsia 2.7%, nausea 2.7%, fever 2.1%, asthma 1.8% and rash 1.8%.
  • Short-term safety data for ciprofloxacin was also collected in a randomized, double-blind clinical trial for the treatment of acute pulmonary exacerbations in cystic fibrosis patients (ages 5–17 years).
  • Sixty seven patients received Ciprofloxacin IV 10 mg/kg/dose every 8 hours for one week followed by Ciprofloxacin tablets 20 mg/kg/dose every 12 hours to complete 10–21 days treatment and 62 patients received the combination of ceftazidime intravenous 50 mg/kg/dose every 8 hours and tobramycin intravenous 3 mg/kg/dose every8 hours for a total of 10–21 days.
  • Periodic musculoskeletal assessments were conducted by treatment blinded examiners.
  • Patients were followed for an average of 23 days after completing treatment (range 0– 93 days).
  • Musculoskeletal adverse reactions were reported in 22% of the patients in the ciprofloxacin group and 21% in the comparison group.
  • Decreased range of motion was reported in 12% of the subjects in the ciprofloxacin group and 16% in the comparison group.
  • Arthralgia was reported in 10% of the patients in the ciprofloxacin group and 11% in the comparison group.
  • Other adverse reactions were similar in nature and frequency between treatment arms.
  • The efficacy of Ciprofloxacin for the treatment of acute pulmonary exacerbations in pediatric cystic fibrosis patients has not been established.
  • In addition to the adverse reactions reported in pediatric patients in clinical trials, it should be expected that adverse reactions reported in
  • adults during clinical trials or postmarketing experience may also occur in pediatric patients.
  • 6.2 Postmarketing Experience The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including Ciprofloxacin.
  • Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure ( Table 8 ).
  • Table 8:
  • Postmarketing Reports of Adverse Drug Reactions System Organ Class Adverse Reactions Cardiovascular QT prolongation Torsade de Pointes Vasculitis and ventricular arrhythmia Acute myocardial ischemia with or without myocardial infarction occurring as part of an allergic reaction Central Nervous System Hypertonia Myasthenia Exacerbation of myasthenia gravis Peripheral neuropathy Polyneuropathy Twitching Eye Disorders Nystagmus Gastrointestinal Pseudomembranous colitis Hemic/Lymphatic Pancytopenia (life threatening or fatal outcome) Methemoglobinemia Hepatobiliary Hepatic failure (including fatal cases) Infections and Infestations Candidiasis (oral, gastrointestinal, vaginal) Investigations Prothrombin time prolongation or decrease Cholesterol elevation (serum) Potassium elevation (serum) Musculoskeletal Myalgia Myoclonus Tendinitis Tendon rupture Psychiatric Disorders Agitation Confusion Delirium Skin/Hypersensitivity Acute generalize exanthematous pustulosis (AGEP) Fixed eruption Serum sickness-like reaction Special Senses Anosmia Hyperesthesia Hypesthesia Taste loss
  • 6.3 Adverse Laboratory Changes Changes in laboratory parameters while on Ciprofloxacin are listed below:
  • Hepatic –Elevations of ALT (SGPT), AST (SGOT), alkaline phosphatase, LDH, serum bilirubin.
  • Hematologic–Eosinophilia, leukopenia, decreased blood platelets, elevated blood platelets, pancytopenia.
  • Renal–Elevations of serum creatinine, BUN, crystalluria, cylindruria, and hematuria have been reported.
  • Other changes occurring were:
  • elevation of serum gammaglutamyl transferase, elevation of serum amylase, reduction in blood glucose, elevated uric acid, decrease in hemoglobin, anemia, bleeding diathesis, increase in blood monocytes, and leukocytosis.

Quoted from the official label, section “Adverse Reactions”.

Strengths and forms

  • FORMS AND STRENGTHS Tablets: 250 mg, 500 mg, 750 mg ( 3 )
  • 3.1 Tablets Ciprofloxacin Tablets USP (white to off-white round tablets) containing 250 mg of ciprofloxacin and engraved with "CTI 222" Ciprofloxacin Tablets USP (white to off-white capsule-shaped tablets) containing 500 mg of ciprofloxacin and engraved with "CTI 223" Ciprofloxacin Tablets USP (white to off-white capsule-shaped tablets) containing 750 mg of ciprofloxacin and engraved with "CTI 224"

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • Ciprofloxacin Tablets USP (white to off-white round tablets) containing 250 mg of Ciprofloxacin and engraved with “CTI 222” Bottle of 100.............................................................................(NDC 61442-222-01) Bottle of 1,000..........................................................................(NDC 61442-222-10) Ciprofloxacin Tablets USP (white to off-white capsule-shaped tablets) containing 500 mg of ciprofloxacin and engraved with “CTI 223” Bottle of 100.............................................................................(NDC 61442-223-01) Bottle of 500.............................................................................(NDC 61442-223-05) Ciprofloxacin Tablets USP (white to off-white capsule-shaped tablets) containing 750 mg of ciprofloxacin and engraved with “CTI 224” Bottle of 50...............................................................................(NDC 61442-224-50) Bottle of 100.............................................................................(NDC 61442-224-01) Bottle of 400.............................................................................(NDC 61442-224-04)
  • Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Quoted from the official label, section “How Supplied”.

What is in it

  • Ciprofloxacin (Ciprofloxacin hydrochloride) Tablets are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C 17 H 18 FN 3 O 3
  • HCl
  • H 2 O and its chemical structure is as follows:
  • Ciprofloxacin 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 molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:
  • Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin tablets are white to slightly yellowish. The inactive ingredients are Lactose Monohydrate, Magnesium Stearate, Sodium Starch Gylcolate, and Starch 1500 (Modified Corn Starch). Chemical Structure Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • LactoseLactose MonohydrateMilk sugar: matters with lactose intolerance or a milk allergy.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

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Details

Made byCarlsbad Technology, Inc.
Active substanceCiprofloxacin Hydrochloride
Used inAntibiotics, antivirals and antifungals taken into the body
Strength750 mg
FormTablet, Film Coated
RouteOral
Packs400 TABLET, FILM COATED in 1 BOTTLE · 50 TABLET, FILM COATED in 1 BOTTLE
NDC61442-224

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

122 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

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Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Ciloxan3 mg/gPrescription onlyOintment Sandoz Inc · Ciprofloxacin HydrochlorideCipro500 mgPrescription onlyTablet, Film Coated Bayer HealthCare Pharmaceuticals Inc. · Ciprofloxacin HydrochlorideCipro250 mgPrescription onlyTablet, Film Coated Bayer HealthCare Pharmaceuticals Inc. · Ciprofloxacin HydrochlorideCiprofloxacin500 mgPrescription onlyTablet, Film Coated NCS HealthCare of KY, LLC dba Vangard Labs · Ciprofloxacin HydrochlorideCiprofloxacin250 mgPrescription onlyTablet, Film Coated A-S Medication Solutions · Ciprofloxacin HydrochlorideCiprofloxacin500 mgPrescription onlyTablet, Film Coated A-S Medication Solutions · Ciprofloxacin Hydrochloride

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