Ciprofloxacin (injection)

Ciprofloxacin (injection)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Black Box Warning

WARNING: See full prescribing information for complete Boxed Warning. * Fluoroquinolones, including Ciprofloxacin Injection, USP, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Fluoroquinolones, including Ciprofloxacin Injection, USP, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid Ciprofloxacin Injection, USP in patients with known history of myasthenia gravis.

Overview

Ciprofloxacin (injection) is an antibiotic that is FDA approved for the treatment of urinary tract infections, lower respiratory infections,nosocomial pneumonia, skin infections, acute sinusitis,intra-abdominal infections and chronic bacterial prostatitis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include rash,diarrhea,nausea, vomiting and headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Ciprofloxacin Injection, USP is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below when the intravenous administration offers a route of administration advantageous to the patient.

Urinary Tract Infections caused by Escherichia coli (including cases with secondary bacteremia), Klebsiella pneumoniae subspecies pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.

Lower Respiratory Infections caused by Escherichia coli, Klebsiella pneumoniae subspecies pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or penicillin-susceptible Streptococcus pneumoniae.

• Also, Moraxella catarrhalis for the treatment of acute exacerbations of chronic bronchitis.

• Ciprofloxacin is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.

Nosocomial Pneumonia caused by Haemophilus influenzae or Klebsiella pneumoniae.

Skin and Skin Structure Infections caused by Escherichia coli, Klebsiella pneumoniae subspecies 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.

Bone and Joint Infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.

Complicated Intra-Abdominal Infections (used in conjunction with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

Acute Sinusitis caused by Haemophilus influenzae, penicillin-susceptible Streptococcus pneumoniae, or Moraxella catarrhalis.

Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis.

Empirical Therapy for Febrile Neutropenic Patients in combination with piperacillin sodium.

Inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ciprofloxacin (injection) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ciprofloxacin (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Ciprofloxacin (injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ciprofloxacin (injection) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ciprofloxacin (injection) in pediatric patients.

Contraindications

• Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antimicrobial agents, or any of the product components.

• Concomitant administration with tizanidine is contraindicated.

Warnings

WARNING: See full prescribing information for complete Boxed Warning. * Fluoroquinolones, including Ciprofloxacin Injection, USP, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Fluoroquinolones, including Ciprofloxacin Injection, USP, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid Ciprofloxacin Injection, USP in patients with known history of myasthenia gravis.

Tendinopathy and Tendon Rupture

• Fluoroquinolones, including Ciprofloxacin injection, USP are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, 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. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Ciprofloxacin Injection, USP should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.

Exacerbation of Myasthenia Gravis

• Fluoroquinolones, including Ciprofloxacin Injection, USP, have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid Ciprofloxacin Injection, USP in patients with known history of myasthenia gravis.

Pregnant Women

• THE SAFETY AND EFFECTIVENESS OF CIPROFLOXACIN IN PREGNANT AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED.

Hypersensitivity Reactions

• Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy. Some reactions were accompanied by cardiovascular collapse, 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, as clinically indicated.

• Other Serious and Sometimes Fatal Reactions

• Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely 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.

• The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted.

Theophylline

• SERIOUS AND FATAL REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING CONCURRENT ADMINISTRATION OF INTRAVENOUS CIPROFLOXACIN AND THEOPHYLLINE. These reactions have included cardiac arrest, seizure, status epilepticus, and respiratory failure. Although similar serious adverse events 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, serum levels of theophylline should be monitored and dosage adjustments made as appropriate.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Ciprofloxacin (injection) in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Ciprofloxacin (injection) in the drug label.

Drug Interactions

Tizanidine

• In a pharmacokinetic study, systemic exposure of tizanidine (4 mg single dose) was significantly increased (Cmax 7-fold, AUC 10-fold) when the drug was given concomitantly with ciprofloxacin (500 mg bid for 3 days). The hypotensive and sedative effects of tizanidine were also potentiated. Concomitant administration of tizanidine and ciprofloxacin is contraindicated.

Theophylline

• As with some other quinolones, concurrent administration of ciprofloxacin with theophylline may lead to elevated serum concentrations of theophylline and prolongation of its elimination half-life. This may result in increased risk of theophylline-related adverse reactions.If concomitant use cannot be avoided, serum levels of theophylline should be monitored and dosage adjustments made as appropriate.

Other Xanthine Derivatives

• Some quinolones, including ciprofloxacin, have also been shown to interfere with the metabolism of caffeine. This may lead to reduced clearance of caffeine and prolongation of its serum half-life. On concurrent administration of ciprofloxacin and caffeine or pentoxifylline containing products, elevated serum concentrations of these xanthine derivatives were reported.

Cyclosporine

• Some quinolones, including ciprofloxacin, have been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

Phenytoin

• Altered serum levels of phenytoin (increased and decreased) have been reported in patients receiving concomitant ciprofloxacin. To avoid the loss of seizure control associated with decreased phenytoin levels, and to prevent phenytoin overdose-related undesirable effects when ciprofloxacin is discontinued in patients receiving both agents, monitoring of phenytoin therapy, including phenytoin serum concentration measurements, is recommended during and shortly after co-administration of CIPRO IV with phenytoin.

Oral Antidiabetic Agents

• Hypoglycemia 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 (see ADVERSE REACTIONS). The concomitant administration of ciprofloxacin with glyburide has, on rare occasions, resulted in severe hypoglycemia. Fatalities have been reported.

Metronidazole

• The serum concentrations of ciprofloxacin and metronidazole were not altered when these two drugs were given concomitantly.

Oral Anti-Coagulants

• Simultaneous administration of ciprofloxacin with an oral anticoagulant may augment the effect of the anticoagulant. 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. Prothrombin time and INR should be monitored frequently during and shortly after co-administration of ciprofloxacin with an oral anticoagulant (for example, warfarin)

Probenecid

• Probenecid interferes with renal tubular secretion of ciprofloxacin and produces an increase in the level of ciprofloxacin in the serum. This should be considered if patients are receiving both drugs concomitantly.

Methotrxate

• Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin potentially leading to increased plasma levels of methotrexate. This might increase the risk of methotrexate associated toxic reactions. Therefore, patients under methotrexate therapy should be carefully monitored when concomitant ciprofloxacin therapy is indicated.

Duloxetine

• In clinical studies it was demonstrated that concomitant use of duloxetine with strong inhibitors of the CYP450 1A2 isozyme such as fluvoxamine, may result in an a 5-fold increase of in mean AUC and a 2.5-fold increase in mean Cmax of duloxetine. Although no clinical data are available on a possible interaction with ciprofloxacin, similar effects can be expected upon concomitant administration.

NSAIDs

• 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.

Ropinirole

• In a study conducted in 12 patients with Parkinson’s disease who were administered 6 mg ropinirole once daily with 500 mg ciprofloxacin twice-daily, the mean Cmax and mean AUC of ropinirole were increased by 60% and 84%, respectively. Monitoring for ropinirole-related side effects and appropriate dose adjustment of ropinirole is recommended during and shortly after co-administration with ciprofloxacin.

Lidocaine

• In a study conducted in 9 healthy volunteers, concomitant use of 1.5 mg/kg IV lidocaine with 500 mg ciprofloxacin twice daily, resulted in an increase of lidocaine Cmax and AUC by 12% and 26%, respectively. Although lidocaine treatment was well tolerated at this elevated exposure, a possible interaction with ciprofloxacin and an increase in side effects related to lidocaine may occur upon concomitant administration.

Clozapine

• Following concomitant administration of 250 mg ciprofloxacin with 304 mg clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. Careful monitoring of clozapine associated adverse effects and and appropriate adjustment of clozapine dosage during and shortly after co-administration with ciprofloxacin are advised.

Sildenafil

• Following concomitant administration of a single oral dose of 50 mg sildenafil with 500 mg ciprofloxacin to healthy subjects, the mean Cmax and mean AUC of sildenafil were both increased approximately two-fold. Therefore, sildenafil should be used with caution when co-administered with ciprofloxacin.

Drugs known to prolong QT interval

• Precaution should be taken when using ciprofloxacin concomitantly with drugs known to prolong the QT interval (for example, class IA or III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) as ciprofloxacin may have an additive effect on the QT interval.

Piperacillin Sodium

• Following infusion of 400 mg IV ciprofloxacin every eight hours in combination with 50 mg/kg IV piperacillin sodium every four hours, mean serum ciprofloxacin concentrations were 3.02 mcg/mL 1/2 hour and 1.18 mcg/mL between 6-8 hours after the end of infusion.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ciprofloxacin (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ciprofloxacin (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ciprofloxacin (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Ciprofloxacin (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Ciprofloxacin (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Ciprofloxacin (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ciprofloxacin (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ciprofloxacin (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ciprofloxacin (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ciprofloxacin (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ciprofloxacin (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Intravenous

Monitoring

There is limited information regarding Monitoring of Ciprofloxacin (injection) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Ciprofloxacin (injection) in the drug label.

Overdosage

There is limited information regarding Ciprofloxacin (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Ciprofloxacin (injection) Pharmacology in the drug label.

Mechanism of Action

• The bactericidal action of ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II topoisomerases), which are required for bacterial DNA replication, transcription, repair, and recombination.

Structure

There is limited information regarding Ciprofloxacin (injection) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Ciprofloxacin (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Ciprofloxacin (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Ciprofloxacin (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Ciprofloxacin (injection) in the drug label.

How Supplied

Storage

There is limited information regarding Ciprofloxacin (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Ciprofloxacin (injection) in the drug label.

Precautions with Alcohol

• Alcohol-Ciprofloxacin (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• CIPROFLOXACIN®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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