The suitable dosage for each patient should be prescribed by a doctor.
IV: IV infusion over a period of approximately 60 min.

The infusion solution can be infused either directly or after mixing with other infusion solutions.

Adults

The determination of dosage 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.

ADULT DOSAGE GUIDELINES
Urinary Tract: Mild/Moderate; 200 mg q12h 7-14 Days
Severe/Complicated; 400 mg q12h 7-14 Days

Lower Respiratory Tract: Mild/Moderate; 400 mg q12h 7-14 Days
Severe/Complicated; 400 mg q8h 7-14 Days

Nosocomial Pneumonia: Mild/Moderate/Severe; 400 mg q8h 10-14 Days

Skin and Skin Structure: Mild/Moderate; 400 mg q12h 7-14 Days
Severe/Complicated; 400 mg q8h 7-14 Days

Bone and Joint: Mild/Moderate; 400 mg q12h ≥ 4-6 Weeks
Severe/Complicated; 400 mg q8h ≥ 4-6 Weeks

Intra-Abdominal*: Complicated; 400 mg q12h 7-14 Days
*used in conjunction with metronidazole.

Acute Sinusitis: Mild/Moderate; 400 mg q12h 10 Days

Chronic Bacterial Prostatitis: Mild/Moderate; 400 mg q12h 28 Days

Empirical Therapy in Febrile Neutropenic Patients: Severe; Ciprofloxacin 400 mg q8h 7-14 Days + Piperacillin
Ciprofloxacin 50 mg/kg Not to exceed 24 g/day q4h 7-14 Days + Piperacillin

Inhalational anthrax (post-exposure)** 400 mg q12h 60 Days
** Drug administration should begin as soon as possible after suspected or confirmed exposure.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.

For a discussion of ciprofloxacin serum concentrations in various human populations, see Medication Safety Issues - Inhalational Anthrax - Additional Information.

Total duration of ciprofloxacin administration (I.V. or oral) for inhalational anthrax (post-exposure) is 60 days.

Conversion of I.V. to Oral Dosing in Adults: CIPRO Tablets and CIPRO Oral Suspension for oral administration are available. Parenteral therapy may be switched to oral CIPRO when the condition warrants, at the discretion of the physician. (See table below for the equivalent dosing regimens.)

Equivalent AUC Dosing Regimens
CIPRO Oral Dosage Equivalent CIPRO I.V. Dosage
250 mg Tablet q 12 h 200 mg I.V. q 12 h
500 mg Tablet q 12 h 400 mg I.V. q 12 h
750 mg Tablet q 12 h 400 mg I.V. q 8 h

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Children Dosage:

Pediatrics

Ciprofloxacin iv should be administered as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed.
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

PEDIATRIC DOSAGE GUIDELINES
Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)
IV; 6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10-21 days*
PO; 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours 10-21 days*
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).

Inhalational Anthrax (Post-Exposure)**
IV; 10 mg/kg (maximum 400 mg per dose) Every 12 hours 60 days
PO; 15 mg/kg (maximum 500 mg per dose) Every 12 hours 60 days
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores.
This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.

For a discussion of ciprofloxacin serum concentrations in various human populations, see Medication Safety Issues - Inhalational Anthrax - Additional Information.

Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis.

No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).

The bactericidal action of ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination. The mechanism of action of fluoroquinolones, including ciprofloxacin, is different from that of penicillins, cephalosporins, aminoglycosides, macrolides, and tetracyclines; therefore, microorganisms resistant to these classes of drugs may be susceptible to ciprofloxacin and other quinolones. There is no known cross-resistance between ciprofloxacin and other classes of antimicrobials. In vitro resistance to ciprofloxacin develops slowly by multiple step mutations.

Warnings
Tendinopathy and Tendon Rupture
Fluoroquinolones, including ciprofloxacin, 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 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.

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

Pediatrics
Ciprofloxacin should be used in pediatric patients (less than 18 years of age) only for infections listed in the INDICATIONS AND USAGE section. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed.

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.

Cytochrome P450 (CYP450)
Ciprofloxacin is an inhibitor of the hepatic CYP1A2 enzyme pathway. Coadministration of ciprofloxacin and other drugs primarily metabolized by CYP1A2 (e.g. theophylline, methylxanthines, tizanidine) results in increased plasma concentrations of the coadministered drug and could lead to clinically significant pharmacodynamic side effects of the coadministered drug.

Central Nervous System Disorders
Convulsions, increased intracranial pressure and toxic psychosis have been reported in patients receiving quinolones, including ciprofloxacin. Ciprofloxacin may also cause central nervous system (CNS) events including: dizziness, confusion, tremors, hallucinations, depression, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving ciprofloxacin, the drug should be discontinued and appropriate measures instituted. As with all quinolones, ciprofloxacin should be used with caution in patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (e.g. severe cerebral arteriosclerosis, epilepsy), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g. certain drug therapy, renal dysfunction).

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.

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 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 (e.g., 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

Pseudomembranous Colitis
Clostridium 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 strains 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 antibiotic 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 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.

Peripheral Neuropathy
Rare 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 quinolones, including ciprofloxacin. Ciprofloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness, or is found to have deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength in order to prevent the development of an irreversible condition.

Precautions
General
INTRAVENOUS CIPROFLOXACIN SHOULD BE ADMINISTERED BY SLOW INFUSION OVER A PERIOD OF 60 MINUTES. Local I.V. site reactions have been reported with the intravenous administration of ciprofloxacin. These reactions are more frequent if infusion time is 30 minutes or less or if small veins of the hand are used.

Central Nervous System
Quinolones, including ciprofloxacin, may also cause central nervous system (CNS) events, including: nervousness, agitation, insomnia, anxiety, nightmares or paranoia.

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. Crystalluria related to ciprofloxacin has been reported only rarely in humans because human urine is usually acidic. Alkalinity of the urine should be avoided in patients receiving ciprofloxacin. Patients should be well hydrated to prevent the formation of highly concentrated urine.

Renal Impairment
Alteration of the dosage regimen is necessary for patients with impairment of renal function.

Photosensitivity/ Phototoxicity
Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (e.g., 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 after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if phototoxicity occurs .

As with any potent drug, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during prolonged therapy.

Prescribing Ciprofloxacin Injection 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.
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Ciprofloxacin has been assigned to pregnancy category C by the FDA. Animal studies failed to reveal embryotoxicity or teratogenicity, although maternal toxicity in some animal studies resulted in increased incidence of abortion. There are no controlled data in human pregnancy. However, ciprofloxacin has been shown to distribute into amniotic fluid. Concentrations reported were 57% (at 2 to 4 hours post dose) to 1000% (at 10 to 12 hours post dose) of that found in maternal serum. A review by the Teratogen Information System concluded that a substantial risk is unlikely;

however, there were insufficient data to state that there is no risk. Cartilage damage and arthropathies associated with ciprofloxacin have been reported in immature animals of various species, giving rise to concern over its possible toxic effects on human fetal bone formation. Because safer alternatives are generally available, some experts consider ciprofloxacin contraindicated during pregnancy, especially during the first trimester. The manufacturer recommends use of ciprofloxacin during pregnancy only when benefit outweighs risk.

Ciprofloxacin is excreted into human milk. Concentrations found in breast milk have ranged from 85% (at 24 hours post dose) to 214% (at 4 hours post dose) of maternal serum concentration. In one case report, a 2-month-old girl developed perforated pseudomembranous colitis following ingestion of ciprofloxacin via the mother's milk and subsequently required a bowel resection. In addition, quinolone-induced cartilage erosion and arthropathies that have been observed in juvenile animals render some concern over its possible toxic effects on the developing joints of nursing infants. Ciprofloxacin is considered compatible with breast-feeding by the American Academy of Pediatrics. Because of the potential for serious adverse effects in nursing infants, a decision should be made to discontinue nursing or discontinue administration of ciprofloxacin, taking into account the importance of the drug to the mother

Frequency not defined.

Diarrhea; dizziness; headache; loss of appetite; nausea; stomach upset; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; chest pain; dark urine or unusual change in the amount of urine; fainting; fever, chills, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; irregular heartbeat; loss of consciousness; moderate to severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion, depression, restlessness, sleeplessness); muscle pain or weakness; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness; shortness of breath or trouble breathing; stomach cramps or pain; suicidal thoughts or actions; tremors; unusual bruising or bleeding; unusual fatigue; vaginal yeast infection; vision changes; yellowing of the skin or eyes.