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Ciprofloxacin

Brand Name: Cipro, Cipro XR, ProQuin XR

Generic Name: Ciprofloxacin

Drug Class: Fluoroquinolones

What Is Ciprofloxacin and How Does It Work?

Ciprofloxacin is used to treat a variety of bacterial infections. Ciprofloxacin belongs to a class of drugs called quinolone antibiotics. It works by stopping the growth of bacteria.

This antibiotic treats only bacterial infections. It will not work for virus infections (such as common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

Ciprofloxacin is available under the following different brand names: Cipro, Cipro XR, and ProQuin XR.

Susceptible organisms

  • Aeromonas hydrophila, Bacillus anthracis, Bacteroides fragilis, Campylobacter jejuni, Citrobacter freundii, Citrobacter diversus, Enterobacter cloacae, Enterococcus faecalis, Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Morganella morganii, Moraxella catarrhalis, certain mycobacteria, Neisseria gonorrhoeae, Proteus mirabilis, Providencia spp, Pseudomonas aeruginosa, Salmonella typhi, Serratia spp, Shigella spp, methicillin-sensitive Staphylococcus aureus (MSSA), Staphylococcus epidermis, Staphylococcus saprophyticus, Streptococcus pneumoniae, Vibrio cholerae, Yersinia enterocolitica
  • First-line therapy: B anthracis, C freundii, C jejuni, Enterobacter spp, Hafnia alvei, S typhi, Salmonella spp, Shigella spp; no unanimity on others (e.g., K pneumoniae, M morganii, V cholerae, Y enterocolitica)

What Are the Dosages of Ciprofloxacin?

Dosage of Ciprofloxacin:

Adult and Pediatric Dosage Forms and Strengths

Infusion solution

  • 200 mg/100mL
  • 200 mg/20mL
  • 400 mg/40mL
  • 400 mg/200mL

Oral suspension

  • 250 mg/5mL
  • 500 mg/5mL

Tablet

  • 100 mg (adult only)
  • 250 mg
  • 500 mg
  • 750 mg

Tablet, extended-release

  • 500 mg
  • 1000 mg

Dosage Considerations – Should be Given as Follows:

Acute Sinusitis

  • Mild/moderate: 500 mg orally every 12 hours or 400 mg intravenously (IV) every 12 hours for 10 days
  • Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute sinusitis

Bone and Joint Infections

  • Mild/moderate: 500 mg orally every 12 hours or 400 mg IV every 12 hours for 4-6 weeks or more
  • Severe/complicated: 750 mg orally every 12 hours or 400 mg IV every 8 hours for 4-6 weeks or more

Chronic Bacterial Prostatitis

  • Indicated for chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis
  • Mild/moderate: 500 mg orally every 12 hours or 400 mg IV every 12 hours for 28 days

Infectious Diarrhea

  • Mild/moderate/severe: 500 mg orally every 12 hours for 5-7 days

Empirical Therapy in Febrile Neutropenic Patients

  • Severe: 400 mg IV every 8 hours for 7-14 days

Lower Respiratory Tract Infections

  • Mild/moderate: 500 mg orally every 12 hours or 400 mg IV every 12 hours for 7-14 days
  • Severe/complicated: 750 mg orally every 12 hours or 400 mg IV every 8 hours for 7-14 days
  • Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis

Nosocomial Pneumonia

  • Mild/moderate/severe: 400 mg IV every 8 hours for 10-14 days

Skin/Skin Structure Infections

  • Mild/moderate: 500 mg orally every 12 hours or 400 mg IV every 12 hours for 7-14 days
  • Severe/complicated: 750 mg orally every 12 hours or 400 mg IV every 8 hours for 7-14 days

Urinary Tract Infections

  • Acute uncomplicated: Immediate-release, 250 mg orally every 12 hours for 3 days; extended-release, 500 mg orally every 24 hours for 3 days
  • Mild/moderate: 250 mg orally every 12 hours or 200 mg IV every 12 hours for 7-14 days
  • Severe/complicated: 500 mg orally every 12 hours or 400 mg IV every 12 hours for 7-14 days
  • Complicated Urinary Tract Infections or Pyelonephritis in Children
  • Younger than 1 year: Safety and efficacy not established
  • 1 year or older (IV): 6-10 mg/kg every 8 hours; individual dose not to exceed 400 mg for 10-21 days
  • 1 year or older (oral): 10-20 mg/kg every 12 hours; individual dose not to exceed 750 mg every 12 hours for 10-21 days
  • Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for uncomplicated urinary tract infections

Urethral and Cervical Gonococcal Infections

  • Uncomplicated: 250-500 mg orally once

Cholera - Pediatric

  • Single-dose: 30 mg/kg orally
  • Multiple doses: 30 mg/kg/day orally divided every 12 hours for 3 days

Anthrax Infection

  • Post-exposure therapy
  • Inhalation (prophylaxis/post-exposure): 500 mg orally every 12 hours or 400 mg IV every 12 hours for 60 days
  • Cutaneous: 500 mg orally every 12 hours or 400 mg IV every 12 hours for 60 days
  • Pediatric, Post-exposure therapy (Off-Label)
  • IV: 10 mg/kg every 12 hours for 60 days; individual dose not to exceed 400 mg
  • Oral: 15 mg/kg every 12 hours for 60 days; individual dose not to exceed 500 mg
  • Change antibiotic to amoxicillin as soon as penicillin susceptibility confirmed

Plague

  • Indication for treatment and prophylaxis of plague due to Yersinia pestis:
  • 500-750 mg orally every 12 hours x14 days, OR
  • 400 mg IV every 8-12 hours x 14 days
  • Indication for treatment and prophylaxis of plague due to Yersinia pestis in pediatric patients from birth to 17 years of age:
  • 15 mg/kg orally every 8-12 hours x10-21 days; not to exceed 500 mg/dose, OR
  • 10 mg/kg IV every 8-12 hours x 10-21 days; not to exceed 400 mg/dose

Bronchiectasis (Orphan)

  • Orphan indication sponsor
    • Aradigm Corporation, 3929 Point Eden Way, Hayward, CA 94545

Cystic Fibrosis, Pediatric (Off-label)

  • Oral: 40 mg/kg/day divided every 12 hours; not to exceed 2 g/day
  • IV: 20-30 mg/kg/day divided every 8-12 hours; not to exceed 1.2 g/day

Noncystic Fibrosis Bronchiectasis (Orphan)

  • Dry powder for inhalation: Orphan designation for patients with NCFB who suffer from frequent severe acute pulmonary bacterial exacerbations which lead to further inflammation, airway, and lung parenchyma damage
  • Sponsor: Bayer HealthCare

Dosage Modifications

Renal impairment

  • CrCl greater than 50 mL/min: Dose adjustment not necessary
  • CrCl 30-50 mL/min: 250-500 mg orally every 12 hours
  • CrCl less than 30 mL/min: Extended-release, 500 mg orally every 24 hours
  • CrCl 5-29 mL/min: 250-500 mg orally every 18 hours or 200-400 mg IV every 18-24 hours
  • Some clinicians suggest decreasing the dose but not the frequency of administration
  • Hemodialysis: 0.25-0.5 g orally every 12 hours or 0.2-0.4 g IV every 24 hours
  • Peritoneal dialysis: 0.25-0.5 g orally every 8 hours or 0.2-0.4 g IV every 24 hours

Dosing Considerations

  • ProQuin XR should be taken with the main meal, preferably the evening meal
  • Cipro XR may be taken with or without a meal; drink fluids liberally

What Are Side Effects Associated with Using Ciprofloxacin?

Common Side effects of Ciprofloxacin include:

Less common side effects of ciprofloxacin include:

Side effects of ciprofloxacin from postmarketing reports include:

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

What Other Drugs Interact with Ciprofloxacin?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe Interactions of ciprofloxacin include:

Ciprofloxacin has serious interactions with at least 37 different drugs.

Ciprofloxacin has moderate interactions with at least 182 different drugs.

Ciprofloxacin has mild interactions with at least 34 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

What Are Warnings and Precautions for Ciprofloxacin?

Warnings

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including: tendinitis and tendon rupture, peripheral neuropathy, and CNS effects.

Discontinue the drug immediately and avoid use of systemic fluoroquinolones in patients who experience any of these serious adverse reactions.

May exacerbate muscle weakness in patients with myasthenia gravis; avoid fluoroquinolones with known history of myasthenia gravis.

Serious adverse effects and limitations-of-use

  • Both oral and injectable fluroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system
  • These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent
  • Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated UTIs, that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options
  • For some serious bacterial infections, including anthrax, plague, and bacterial pneumonia among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option

This medication contains ciprofloxacin. Do not take Cipro, Cipro XR, or ProQuin XR if you are allergic to ciprofloxacin or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

  • Documented hypersensitivity; concurrent tizanidine administration

Effects of Drug Abuse

  • No information available

Short-Term Effects

  • Both oral and injectable fluroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system. These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent.
  • Moderate-to-severe phototoxicity reactions reported; avoid excessive sunlight and take precautions to limit exposure; discontinue use if phototoxicity occurs.
  • See "What Are Side Effects Associated with Using Ciprofloxacin?"

Long-Term Effects

  • Both oral and injectable fluroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system. These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent.
  • See "What Are Side Effects Associated with Using Ciprofloxacin?"

Cautions

  • Use in pregnancy, though generally contraindicated for all quinolones, is allowed for life-threatening situations; limited data from use of ciprofloxacin in pregnancy show no higher rate of birth defects than background.
  • Do not use oral suspension in nasogastric tube; to prepare, add microcapsules to diluent.
  • No longer recommended for gonorrhea in United States, because of widespread resistance.
  • 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 therapy, including in patients of any age or without pre-existing risk factors; discontinue therapy immediately at first signs or symptoms of any serious adverse reaction; in addition, avoid use of fluoroquinolones, in patients who have experienced any serious adverse reactions associated with fluoroquinolones.
  • Peripheral neuropathy: Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported; peripheral neuropathy may occur rapidly after initiating and may potentially become permanent.
  • In prolonged therapy, perform periodic evaluations of organ system functions (eg, renal, hepatic, hematopoietic); adjust dose in renal impairment; superinfections may occur with prolonged or repeated antibiotic therapy; discontinue use immediately if signs and symptoms of hepatitis occur.
  • Not drug of first choice in pediatrics (except in anthrax), because of increased incidence of adverse events in comparison with control subjects, including arthropathy; no data exist on dosing for pediatric patients with renal impairment (i.e., CrCl less than 50 mL/min).
  • Fluoroquinolones are associated with increased risk of tendinitis and tendon rupture in all ages; this risk is further increased in older patients (usually older than 60 years); in patients taking corticosteroids; and in kidney, heart, or lung transplant recipients; discontinue therapy immediately at first signs or symptoms of any serious adverse reaction; in addition, avoid use of fluoroquinolones, in patients who have experienced any serious adverse reactions associated with fluoroquinolones.
  • Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis are reported with fluoroquinolones; psychotic reactions have progressed to suicidal ideations or thoughts and self-injurious behavior.
  • Avoid IV administration in patients who have known QT prolongation, carry risk factors for prolonged QT, or are taking class 1A or class III antiarrhythmic drugs.
  • Crystalluria may occur; urine alkalinity may increase risk; ensure adequate hydration during therapy.
  • Serious and sometimes fatal hypoglycemia reported with fluoroquinolone use; hyperglycemia also reported; monitor patients closely for signs/symptoms of abnormal glucose levels.
  • Moderate-to-severe phototoxicity reactions reported; avoid excessive sunlight and take precautions to limit exposure; discontinue use if phototoxicity occurs.
  • Use with caution in patients with history of seizures taking concurrent therapy that lowers seizure threshold; risk increases rarely when administered concomitantly with NSAIDs.
  • Acute onset of retinal detachment increased 4.5-fold with oral fluoroquinolones in a single case-controlled study - JAMA 2012;307(13):1414-1419; another study disputes these findings (relative risk, 1.29) - JAMA 2013;310(20):2184-2190.
    • Serious and fatal reactions have reported in patients receiving concurrent administration of ciprofloxacin and theophylline; if concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate.
  • Clostridium difficile-associated diarrhea (CDAD) has been reported; if CDAD suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued; appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
  • Prescribing antibiotics in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria.

Pregnancy and Lactation

  • Use in pregnancy, though generally contraindicated for all quinolones, is allowed for life-threatening situations; limited data from use of ciprofloxacin in pregnancy show no higher rate of birth defects than background.
  • Use ciprofloxacin during pregnancy with caution if benefits outweigh risks.
  • Animal studies show risk and human studies not available or neither animal nor human studies done.
  • Ciprofloxacin enters breast milk; use of ciprofloxacin while breastfeeding is not recommended (American Academy of Pediatrics Committee states that drug is compatible with nursing).