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Ciprofolxacin

FDA Drug Information • Also known as: Ciprofloxacin

Brand Names
Ciprofloxacin
Route
ORAL
Dosage Form
TABLET
Product Type
HUMAN PRESCRIPTION DRUG

⚠ Boxed Warning (Black Box)

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 irreversible serious adverse reactions that have occurred together [see Warnings and Precautions ( Error! Hyperlink reference not valid. )] including:
  • Tendinitis and tendon rupture [see Warnings and Precautions ( Error! Hyperlink reference not valid. )]
  • Peripheral neuropathy [see Warnings and Precautions ( Error! Hyperlink reference not valid. )]
  • Central nervous system effects [see Warnings and Precautions ( Error! Hyperlink reference not valid. )]
  • 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 ( Error! Hyperlink reference not valid. )] . 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 ( Error! Hyperlink reference not valid. )] .
  • Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions ( Error! Hyperlink reference not valid. – Error! Hyperlink reference not valid. )] , 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 ( Error! Hyperlink reference not valid. )]
  • Acute uncomplicated cystitis [see Indications and Usage ( Error! Hyperlink reference not valid. )]
  • Acute sinusitis [see Indications and Usage ( Error! Hyperlink reference not valid. )] 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 ( Error! Hyperlink reference not valid.), including:
  • Tendinitis and tendon rupture ( Error! Hyperlink reference not valid.)
  • Peripheral neuropathy ( Error! Hyperlink reference not valid.)
  • Central nervous system effects ( Error! Hyperlink reference not valid.) Discontinue ciprofloxacin immediately and avoid the use of fluoroquinolones, including ciprofloxacin, in patients who experience any of these serious adverse reactions ( Error! Hyperlink reference not valid.)
  • Fluoroquinolones, including ciprofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis. ( Error! Hyperlink reference not valid.)
  • Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions ( Error! Hyperlink reference not valid.- Error! Hyperlink reference not valid.), reserve ciprofloxacin for use in patients who have no alternative treatment options for the following indications:
  • Acute exacerbation of chronic bronchitis ( Error! Hyperlink reference not valid.)
  • Acute uncomplicated cystitis ( Error! Hyperlink reference not valid.)
  • Acute sinusitis ( Error! Hyperlink reference not valid.)

    • Description

    11 DESCRIPTION Ciprofloxacin Tablets, USP 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 C17H18FN3O3 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 and 500 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin Tablets, USP are white. The inactive ingredients are colloidal silicon dioxide, corn starch, partially pregelatinized maize starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (starch from non-GMO potatoes), hypromellose, titanium dioxide and PEG. C17H18FN3O3
  • HCl
  • H2O C17H18FN3O3

    • What Is Ciprofolxacin Used For?

    1 INDICATIONS AND USAGE Click here to enter Indications Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated:

  • Skin and Skin Structure Infections ( Error! Hyperlink reference not valid. )
  • Bone and Joint Infections ( Error! Hyperlink reference not valid. )
  • Complicated Intra-Abdominal Infections ( Error! Hyperlink reference not valid. )
  • Infectious Diarrhea ( Error! Hyperlink reference not valid. )
  • Typhoid Fever (Enteric Fever) ( Error! Hyperlink reference not valid. )
  • Uncomplicated Cervical and Urethral Gonorrhea ( Error! Hyperlink reference not valid. )
  • Inhalational Anthrax post-exposure in adult and pediatric patients ( Error! Hyperlink reference not valid. )
  • Plague in adult and pediatric patients ( Error! Hyperlink reference not valid. )
  • Chronic Bacterial Prostatitis ( Error! Hyperlink reference not valid. )
  • Lower Respiratory Tract Infections ( Error! Hyperlink reference not valid. )
  • Acute Exacerbation of Chronic Bronchitis
  • Urinary Tract Infections ( Error! Hyperlink reference not valid. )
  • Urinary Tract Infections (UTI)
  • Acute Uncomplicated Cystitis
  • Complicated UTI and Pyelonephritis in Pediatric Patients
  • Acute Sinusitis ( Error! Hyperlink reference not valid. ) 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. ( Error! Hyperlink reference not valid. ) 1.1 Skin and Skin Structure Infections Ciprofloxacin tablets are 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 tablets are 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 tablets are 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 tablets are 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...

    • Dosage and Administration

    2 DOSAGE AND ADMINISTRATION 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 ( Error! Hyperlink reference not valid. )
  • Adults with creatinine clearance 5–29 mL/min 250–500 mg q 18 h ( Error! Hyperlink reference not valid. )
  • Patients on hemodialysis or peritoneal dialysis 250–500 mg q 24 h (after dialysis) ( Error! Hyperlink reference not valid. ) 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 14days 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. Ciprofloxacin Tablets may be administered to adult patients when clinically indicted at the discretions of the physician. Table 1: Adult Dosage Guidelines 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 1 Generally ciprofloxacin should be continued for at least 2 days after the signs and...

    • Side Effects (Adverse Reactions)

    6 ADVERSE REACTIONS 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 ( Error! Hyperlink reference not valid. )]
  • Tendinitis and Tendon Rupture [see Warnings and Precautions ( Error! Hyperlink reference not valid. )]
  • Peripheral Neuropathy [see Warnings and Precautions ( Error! Hyperlink reference not valid. )]
  • Central Nervous System Effects [see Warnings and Precautions ( Error! Hyperlink reference not valid. )] Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( Error! Hyperlink reference not valid. )]
  • Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions ( 5.6 )]
  • Hypersensitivity Reactions [see Warnings and Precautions ( Error! Hyperlink reference not valid. )]
  • Hepatotoxicity [see Warnings and Precautions ( Error! Hyperlink reference not valid. )]
  • Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions ( Error! Hyperlink reference not valid. )]
  • Serious Adverse Reactions with Concomitant Theophylline [see Warnings and Precautions ( Error! Hyperlink reference not valid. )]
  • Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions ( Error! Hyperlink reference not valid. )]
  • Prolongation of the QT Interval [see Warnings and Precautions ( Error! Hyperlink reference not valid. )]
  • Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions ( Error! Hyperlink reference not valid. )]
  • Photosensitivity/Phototoxicity [see Warnings and Precautions ( Error! Hyperlink reference not valid. )]
  • Development of Drug Resistant Bacteria [see Warnings and Precautions ( Error! Hyperlink reference not valid. )] The most common adverse reactions ≥1% were nausea, diarrhea, liver function tests abnormal, vomiting, and rash. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact [Solco Healthcare US, LLC at 1-866-257-2597] 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 5: 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 Respiratory Dyspnea Laryngeal Edema Hemoptysis Bronchospasm Skin/Hypersensitivity Anaphylactic Reactions including life-threatening anaphylactic shock Erythema Multiforme/Stevens-Johnson Syndrome Exfoliative...

    • Drug Interactions

    7 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 ( Error! Hyperlink reference not valid. )]. 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 ( Error! Hyperlink reference not valid. )]. 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 ( Error! Hyperlink reference not valid. ) and Use in Specific Populations ( Error! Hyperlink reference not valid. )]. 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 ( Error! Hyperlink reference not valid. )]. 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...

    Contraindications

    4 CONTRAINDICATIONS Click here to enter Contraindications

  • Known hypersensitivity to ciprofloxacin or other quinolones ( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. Error! Hyperlink reference not valid. )
  • Concomitant administration with tizanidine Error! Hyperlink reference not valid. 4.1 Hypersensitivity Ciprofloxacin tablets are 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 ( Error! Hyperlink reference not valid. )]. 4.2 Tizanidine Concomitant administration with tizanidine is contraindicated [see Drug Interactions ( Error! Hyperlink reference not valid. )].

    • Pregnancy and Breastfeeding

    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...

    Overdosage

    10 OVERDOSAGE 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.

    How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING Ciprofloxacin Tablets, USP 500 mg are available as oval shaped, white film-coated tablets, debossed with “Y102” on one side. Ciprofloxacin Tablets, USP 500 mg are available in bottles of 6, 10, 14 and 20. Strength NDC Code Tablet Identification Bottles of 6 500 mg NDC 82804-130-06 Y102 Bottles of 10 500 mg NDC 82804-130-10 Y102 Bottles of 14 500 mg NDC 82804-130-14 Y102 Bottles of 20 500 mg NDC 82804-130-20 Y102 Bottles of 30 500 mg NDC 82804-130-30 Y102 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Preserve in well-closed container.

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.