(ciprofloxacin injection)

Prescribing Information
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1 INDICATIONS AND USAGE

1 INDICATIONS AND USAGE

1.1 Skin and Skin Structure Infections

Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.

1.2 Bone and Joint Infections

Ciprofloxacin Injection is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.

1.3 Complicated Intra-Abdominal Infections

Ciprofloxacin Injection is indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

1.4 Nosocomial Pneumonia

Ciprofloxacin Injection is indicated in adult patients for treatment of nosocomial pneumonia caused by Haemophilus influenzae or Klebsiella pneumoniae.

1.5 Empirical Therapy for Febrile Neutropenic Patients

Ciprofloxacin Injection is indicated in adult patients for the treatment of febrile neutropenia in combination with piperacillin sodium [see Clinical Studies (14.1)].

1.6 Inhalational Anthrax (Post-Exposure)

Ciprofloxacin Injection is indicated in adults and pediatric patients from birth to 17 years of age for treatment of inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.1 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001 [see Clinical Studies (14.3)].

1.7 Plague

Ciprofloxacin Injection is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies of ciprofloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only [see Clinical Studies (14.4)].

1.8 Chronic Bacterial Prostatitis

Ciprofloxacin Injection is indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.

1.9 Lower Respiratory Tract Infections

Ciprofloxacin Injection is indicated in adult patients for treatment of lower respiratory tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae. Ciprofloxacin Injection is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumonia.

Ciprofloxacin Injection is indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by Moraxella catarrhalis.

Because fluoroquinolones, including Ciprofloxacin Injection, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.16)] and for some patients AECB is self-limiting, reserve Ciprofloxacin Injection for treatment of AECB in patients who have no alternative treatment options.

1.10 Urinary Tract Infections

Urinary Tract Infection in Adults

Ciprofloxacin Injection is indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.

Complicated Urinary Tract Infections and Pyelonephritis in Pediatric Patients Ciprofloxacin Injection is indicated in pediatric patients one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to Escherichia coli [see Use in Specific Populations (8.4)].

Although effective in clinical trials, Ciprofloxacin Injection is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues. Ciprofloxacin Injection, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals [see Warnings and Precautions (5.13), Adverse Reactions (6.1), Use in Specific Populations (8.4), and Nonclinical Toxicology (13.2)].

1.11 Acute Sinusitis

Ciprofloxacin Injection is indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.

Because fluoroquinolones, including Ciprofloxacin Injection, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.16)] and for some patients acute sinusitis is self-limiting, reserve Ciprofloxacin for treatment of acute sinusitis in patients who have no alternative treatment options.

1.12 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Injection and other antibacterial drugs, Ciprofloxacin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by 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 Injection 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.

Medication Guide

MEDICATION GUIDE

This Medication Guide has been approved by the U.S. Food and Drug Administration.

MEDICATION GUIDE
CIPROFLOXACIN (sip-row-FLOX-a-sin) INJECTION, USP
(in 5% Dextrose Injection)
(ciprofloxacin)
for intravenous infusion
Read this Medication Guide before you start taking ciprofloxacin and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about ciprofloxacin?

Ciprofloxacin, a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death.
If you get any of the following serious side effects while you take ciprofloxacin, you should stop taking ciprofloxacin immediately and get medical help right away.
1. Tendon rupture or swelling of the tendon (tendinitis).
  • Tendon problems can happen in people of all ages who take ciprofloxacin.Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include:
    • pain
    • swelling
    • tears and swelling of the tendons including the back of the ankle (Achilles), shoulder, hand, thumb, or other tendon sites.
  • The risk of getting tendon problems while you take ciprofloxacin is higher if you:
    • are over 60 years of age
    • are taking steroids (corticosteroids)
    • have had a kidney, heart or lung transplant.
  • Tendon problems can happen in people who do not have the above risk factors when they take ciprofloxacin.
  • Other reasons that can increase your risk of tendon problems can include:
    • physical activity or exercise
    • kidney failure
    • tendon problems in the past, such as in people with rheumatoid arthritis (RA).
  • Stop taking ciprofloxacin immediately and get medical help right away at the first sign of tendon pain, swelling or inflammation. The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons.
  • Tendon rupture can happen while you are taking or after you have finished taking ciprofloxacin. Tendon ruptures can happen within hours or days of taking ciprofloxacin and have happened up to several months after people have finished taking their fluoroquinolone.
  • Stop taking ciprofloxacin immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
    • hear or feel a snap or pop in a tendon area
    • bruising right after an injury in a tendon area
    • unable to move the affected area or bear weightThe tendon problems may be permanent.

2. Changes in sensation and possible nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including ciprofloxacin. Stop taking ciprofloxacin immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:
  • pain
  • burning
  • tingling
  • numbness
  • weaknessCiprofloxacin may need to be stopped to prevent permanent nerve damage.

3. Central Nervous System (CNS) effects. Mental health problems and seizures have been reported in people who take fluoroquinolone antibacterial medicines, including ciprofloxacin. Tell your healthcare provider if you have a history of seizures before you start taking ciprofloxacin. CNS side effects may happen as soon as after taking the first dose of ciprofloxacin. Stop taking ciprofloxacin immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
  • seizures
  • hear voices, see things, or sense things that are not there (hallucinations)
  • feel restless or agitated
  • tremors
  • feel anxious or nervous
  • confusion
  • depression
  • reduced awareness of surroundings
  • trouble sleeping
  • nightmares
  • feel lightheaded or dizzy
  • feel more suspicious (paranoia)
  • suicidal thoughts or acts
  • headaches that will not go away, with or without blurred vision
  • memory problems
  • false or strange thoughts or beliefs (delusions)The CNS changes may be permanent.

4. Worsening of myasthenia gravis (a problem that causes muscle weakness). Fluoroquinolones like ciprofloxacin may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Tell your healthcare provider if you have a history of myasthenia gravis before you start taking ciprofloxacin. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
What is ciprofloxacin?
Ciprofloxacin is a fluoroquinolone antibacterial medicine used in adults age 18 years and older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:
  • urinary tract infection
  • chronic prostate infection
  • lower respiratory tract infection
  • sinus infection
  • skin infection
  • bone and joint infection
  • nosocomial pneumonia
  • intra-abdominal infection, complicated
  • infectious diarrhea
  • typhoid (enteric) fever
  • cervical and urethral gonorrhea, uncomplicated
  • people with a low white blood cell count and a fever
  • inhalational anthrax
  • plague
  • Studies of ciprofloxacin for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people.
  • Ciprofloxacin should not be used in patients with acute exacerbation of chronic bronchitis, acute uncomplicated cystitis, and sinus infections, if there are other treatment options available.
  • Ciprofloxacin should not be used as the first choice of antibacterial medicine to treat lower respiratory tract infections caused by a certain type of bacterial called Streptococcus pneumoniae.
  • Ciprofloxacin Injection, USP is also used in children younger than 18 years of age to treat complicated urinary tract and kidney infections or who may have breathed in anthrax germs, have plague or have been exposed to plague germs.
  • Children younger than 18 years of age have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking ciprofloxacin. Ciprofloxacin should not be used as the first choice of antibacterial medicine in children under 18 years of age.
Who should not take ciprofloxacin?
Do not take ciprofloxacin if you:
  • have ever had a severe allergic reaction to an antibacterial medicine known as a fluoroquinolone, or are allergic to ciprofloxacin hydrochloride or any of the ingredients in ciprofloxacin. See the end of this Medication Guide for a complete list of ingredients in ciprofloxacin.
  • also take a medicine called tizanidine (Zanaflex®).
Ask your healthcare provider if you are not sure.
What should I tell my healthcare provider before taking ciprofloxacin?
Before you take ciprofloxacin, tell your healthcare provider about all your medical conditions, including if you:
  • have tendon problems; ciprofloxacin should not be used in patients who have a history of tendon problems.
  • have a disease that causes muscle weakness (myasthenia gravis); ciprofloxacin should not be used in patients who have a known history of myasthenia gravis
  • have liver problems
  • have central nervous system problems (such as epilepsy).
  • have nerve problems. Ciprofloxacin should not be used in patients who have a history of a nerve problem called peripheral neuropathy
  • have or anyone in your family has an irregular heartbeat, or heart attack, especially a condition called “QT prolongation”.
  • have low blood potassium (hypokalemia) or low magnesium (hypomagnesemia).
  • have or have had seizures.
  • have kidney problems. You may need a lower dose of ciprofloxacin if your kidneys do not work well.
  • have diabetes or problems with low blood sugar (hypoglycemia).
  • have joint problems including rheumatoid arthritis (RA)
  • have trouble swallowing pills.
  • are pregnant or plan to become pregnant. It is not known if ciprofloxacin will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Ciprofloxacin passes into your breast milk.
    • You should not breastfeed during treatment with ciprofloxacin and for 2 days after taking your last dose of ciprofloxacin. You may pump your breast milk and throw it away during treatment with ciprofloxacin and for 2 days after taking your last dose of ciprofloxacin.
    • If you are taking ciprofloxacin for inhalation anthrax, you and your healthcare provider should decide whether you can continue breastfeeding while taking ciprofloxacin.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • Ciprofloxacin and other medicines can affect each other causing side effects.
  • Especially tell your healthcare provider if you take:
    • a steroid medicine.
    • an anti-psychotic medicine.
    • a tricyclic antidepressant.
    • a water pill (diuretic).
    • theophylline (such as Theo-24®, Elixophyllin®, Theochron®, Uniphyl®, Theolair®).
    • a medicine to control your heart rate or rhythm (antiarrhythmics).
    • an oral anti-diabetes medicine.
    • phenytoin (Fosphenytoin Sodium®, Cerebyx®, Dilantin-125®, Dilantin®, Extended Phenytoin Sodium®, Prompt Phenytoin Sodium®, Phenytek®).
    • cyclosporine (Gengraf®, Neoral®, Sandimmune®, Sangcya®).
    • a blood thinner (such as warfarin, Coumadin®, Jantoven®).
    • methotrexate (Trexall®).
    • ropinirole (Requip®).
    • clozapine (Clozaril®, Fazaclo® ODT®).
    • a Non-Steroidal Anti-Inflammatory Drug (NSAID). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take ciprofloxacin or other fluoroquinolones may increase your risk of central nervous system effects and seizures.
    • sildenafil (Viagra®, Revatio®).
    • duloxetine.
    • products that contain caffeine.
    • probenecid (Probalan®, Col-probenecid®).
Ask your healthcare provider for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take ciprofloxacin?
Taking all of your ciprofloxacin doses will help lower the chance that the bacteria will become resistant to ciprofloxacin. If you become resistant to ciprofloxacin, ciprofloxacin and other antibacterial medicines may not work for you in the future.
  • If you take too much ciprofloxacin, call your healthcare provider or get medical help right away.

What should I avoid while taking ciprofloxacin?

  • Ciprofloxacin can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how ciprofloxacin affects you.
  • Avoid sunlamps, tanning beds, and try to limit your time in the sun. Ciprofloxacin can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get a severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while you take ciprofloxacin, call your healthcare provider right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

What are the possible side effects of ciprofloxacin?

Ciprofloxacin may cause serious side effects, including:
  • See “What is the most important information I should know about ciprofloxacin?”
  • Serious allergic reactions. Serious allergic reactions, including death, can happen in people taking fluoroquinolones, including ciprofloxacin, even after only 1 dose. Stop taking ciprofloxacin and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
    • hives
    • trouble breathing or swallowing
    • swelling of the lips, tongue, face
    • throat tightness, hoarseness
    • rapid heartbeat
    • faint
    • skin rash
    Skin rash may happen in people taking ciprofloxacin even after only 1 dose. Stop taking ciprofloxacin at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to ciprofloxacin.
  • Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take ciprofloxacin. Call your healthcare provider right away if you have unexplained symptoms such as:
    • nausea or vomiting
    • stomach pain
    • fever
    • weakness
    • abdominal pain or tenderness
    • itching
    • unusual tiredness
    • loss of appetite
    • light colored bowel movements
    • dark colored urine
    • yellowing of the skin and whites of your eyes
    Stop taking ciprofloxacin and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to ciprofloxacin (a liver problem).
  • Aortic aneurysm and dissection. Tell your healthcare provider if you have ever been told that you have an aortic aneurysm, a swelling of the large artery that carries blood from the heart to the body. Get emergency medical help right away if you have sudden chest, stomach, or back pain.
  • Intestine infection (Clostridioides difficile - associated diarrhea). Clostridioides difficile-associated diarrhea (CDAD) can happen with many antibacterial medicines, including ciprofloxacin. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. CDAD can happen 2 or more months after you have finished your antibacterial medicine.
  • Serious heart rhythm changes (QT prolongation and torsade de pointes). Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. Ciprofloxacin may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this event are higher in people:
    • who are elderly.
    • with a family history of prolonged QT interval.
    • with low blood potassium (hypokalemia) or low magnesium (hypomagnesemia).
    • who take certain medicines to control heart rhythm (antiarrhythmics).
  • Joint Problems. Increased chance of problems with joints and tissues around joints in children under 18 years old can happen. Tell your child's healthcare provider if your child has any joint problems during or after treatment with ciprofloxacin.
  • Sensitivity to sunlight (photosensitivity). See “What should I avoid while taking ciprofloxacin?”
  • Changes in blood sugar. People who take ciprofloxacin and other fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Follow your healthcare provider's instructions for how often to check your blood sugar. If you have diabetes and you get low blood sugar while taking ciprofloxacin, stop taking ciprofloxacin and call your healthcare provider right away. Your antibiotic medicine may need to be changed.
The most common side effects of ciprofloxacin include:
  • nausea
  • diarrhea
  • changes in liver function tests
  • vomiting
  • rash
Tell your healthcare provider about any side effect that bothers you, or that does not go away.
These are not all the possible side effects of ciprofloxacin. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Keep ciprofloxacin and all medicines out of the reach of children.
General Information about the safe and effective use of ciprofloxacin.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ciprofloxacin for a condition for which it is not prescribed. Do not give ciprofloxacin to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about ciprofloxacin. If you would like more information about ciprofloxacin, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ciprofloxacin that is written for healthcare professionals.
What are the ingredients in ciprofloxacin?
Ciprofloxacin Injection, USP (in 5% Dextrose Injection):
  • Active ingredient: ciprofloxacin
  • Inactive ingredients: dextrose monohydrate as a tonicity agent, hydrochloric acid for pH adjustment, lactic acid as a solubilizing agent.

Brands listed are the trademarks of their respective owners.
Hospira
Distributed by Hospira, Inc.,
Lake Forest, IL 60045 USA
Revised: August 2022

L54USCFX00

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