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Basic Drug Info
Drug Name:Ciprofloxacin
Manufacturer:Hospira, Inc.
Other Info:

Ciprofloxacin Injection, USP should be administered by intravenous infusion as described in the Dosage Guidelines table. Information related to dosing ciprofloxacin in pediatric patients for the treatment of complicated urinary tract infections and pyelonephritis is approved for Bayer Pharmaceutical Corporation’s ciprofloxacin drug products.

An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed.

(See ADVERSE REACTIONS.) Due to Bayer’s marketing exclusivity rights, this drug product, produced by Hospira, Inc., is not labeled for pediatric use, except for inhalational anthrax (post-exposure).PEDIATRIC - DOSAGE GUIDELINES Infection Route ofAdministration Dose (mg/kg)Frequency Total Duration InhalationalAnthrax(Post-Exposure)*Intravenous10 mg/kg(maximum 400 mgper dose)Every 12 hours60 days Oral15 mg/kg(maximum 500 mgper dose)Every 12 hours *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.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX ? ADDITIONAL INFORMATION.

Ciprofloxacin Injection, USP should be administered by intravenous infusion over a period of 60 minutes.

Preparation of Ciprofloxacin Injection, USP for AdministrationVials (Injection Concentrate): THIS PREPARATION MUST BE DILUTED BEFORE USE.

The intravenous dose should be prepared by aseptically withdrawing the concentrate from the vial of Ciprofloxacin Injection, USP.

This should be diluted with a suitable intravenous solution to a final concentration of 1 to 2 mg/mL.

(See COMPATIBILITY AND STABILITY.) The resulting solution should be infused over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place.If the Y-type or “piggyback” method of administration is used, it is advisable to discontinue temporarily the administration of any other solutions during the infusion of Ciprofloxacin Injection, USP.

If the concomitant use of Ciprofloxacin Injection, USP and another drug is necessary each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.COMPATIBILITY AND STABILITYCiprofloxacin Injection 1% (10 mg/mL), when diluted with the following intravenous solutions to concentrations of 0.5 to 2 mg/mL, is stable for up to 14 days at refrigerated or room temperature storage.0.9% Sodium Chloride Injection, USP5% Dextrose Injection, USPSterile Water for Injection10% Dextrose for Injection5% Dextrose and 0.225% Sodium Chloride for Injection5% Dextrose and 0.45% Sodium Chloride for InjectionLactated Ringer’s for Injection



Clinical Trials:


Indications and Usage

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.

Please see DOSAGE AND ADMINISTRATION for specific recommendations.Adult Patients: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.NOTE: Although effective in clinical trials, 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. (See CLINICAL STUDIES.)Pediatric Patients (1 to 17 years of age):Information related to the treatment of pediatric patients for complicated urinary tract infections and pyelonephritis is approved for Bayer Pharmaceutical Corporation’s ciprofloxacin drug products.

Ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues.

(See WARNINGS, PRECAUTIONS: Pediatric Use, and ADVERSE REACTIONS.) Ciprofloxacin, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals.

(See ANIMAL PHARMACOLOGY.)Due to Bayer’s marketing exclusivity rights, this drug product, produced by Hospira, Inc., is not labeled for pediatric use, except for inhalational anthrax (post-exposure).Adult and Pediatric Patients:Inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.Ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.4 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001.

(See also, INHALATIONAL ANTHRAX ? ADDITIONAL INFORMATION.)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, USP may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.As with other drugs, some strains 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.To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Injection, USP and other antibacterial drugs, Ciprofloxacin Injection, USP 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.
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Urinary tract infection -- Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA.

BACTEREMIA -- The presence of viable bacteria circulating in the blood. Fever, chills, tachycardia, and tachypnea are common acute manifestations of bacteremia. The majority of cases are seen in already hospitalized patients, most of whom have underlying diseases or procedures which render their bloodstreams susceptible to invasion.

Klebsiella pneumonia --

respiratory infection -- Invasion of the host RESPIRATORY SYSTEM by microorganisms, usually leading to pathological processes or diseases.

CHRONIC BRONCHITIS -- condition characterized by persistent coughing, increased secretion from the bronchial mucosa, obstruction of the respiratory passages, scanty or profuse expectoration, and necrosis and fibrosis of the respiratory tract.

Pneumonia -- Inflammation of any part, segment or lobe, of the lung parenchyma.

skin infection -- Skin diseases caused by bacteria, fungi, parasites, or viruses.

Arthropathy associated with infection --

Abdominal Infection --

SINUSITIS ACUTE --

Pyelonephritis -- Inflammation of the KIDNEY involving the renal parenchyma (the NEPHRONS); KIDNEY PELVIS; and KIDNEY CALICES. It is characterized by ABDOMINAL PAIN; FEVER; NAUSEA; VOMITING; and occasionally DIARRHEA.

Arthropathy -- condition in which there is a deviation from or interruption of the normal structure or function of the joints.

Pulmonary anthrax --

Disease Progression -- The worsening of a disease over time. This concept is most often used for chronic and incurable diseases where the stage of the disease is an important determinant of therapy and prognosis.

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

Communicable Diseases -- broad class of diseases whose causative agents may be passed between individuals in many different ways.

BACTERIAL RESISTANCE --

Contraindications
Ciprofloxacin is contraindicated in persons with 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. (See PRECAUTIONS: Drug Interactions.)
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

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

(See PRECAUTIONS: Pregnancy and Nursing Mothers.)Pediatrics: Ciprofloxacin should be used in pediatric patients (less than 18 years of age) only for inhalational anthrax (post-exposure).

Information related to an additional use of ciprofloxacin in the pediatric population is approved for Bayer Pharmaceutical Corporation's ciprofloxacin drug products.

An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed.

(See ADVERSE REACTIONS.) Due to Bayer's marketing exclusivity rights, this drug product, produced by Hospira Inc.

is not labeled for pediatric use, except for inhalational anthrax (post-exposure).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.

(See ANIMAL PHARMACOLOGY.)Cytochrome P450 (CYP450): Ciprofloxacin is an inhibitor of the hepatic CYP1A2 enzyme pathway.

Coadministration of ciprofloxacin and other drugs primarily metabolized by the 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).

(See PRECAUTIONS: General, Information for Patients, Drug Interactions and ADVERSE REACTIONS.)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.Severe hypersensitivity reactions characterized by rash, fever, eosinophilia, jaundice, and hepatic necrosis with fatal outcome have also been reported extremely rarely in patients receiving ciprofloxacin along with other drugs.

The possibility that these reactions were related to ciprofloxacin cannot be excluded. Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.Pseudomembranous Colitis: Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ciprofloxacin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia.

Studies indicate that a toxin produced by Clostridium difficile is one primary cause of “antibiotic-associated colitis.”After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated.

Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone.

In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C.

difficile colitis.

Drugs that inhibit peristalsis should be avoided.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.Tendon Effects: Ruptures of the shoulder, hand, Achilles tendon or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including ciprofloxacin.

Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant cortisteroids, especially the elderly.

Ciprofloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon.

Patients should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been excluded. Tendon rupture can occur during or after therapy with quinolones, including ciprofloxacin.
Branded Drugs
The following US Branded drugs contain Ciprofloxacin


CIPRO -- BAYER HEALTHCARE PHARMACEUTICALS INC

CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER -- BAYER HEALTHCARE PHARMACEUTICALS INC

CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- BAYER PHARMACEUTICALS CORP

CIPROFLOXACIN IN DEXTROSE 5% -- HIKMA FARMACEUTICA (PORTUGAL) SA

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER -- ACS DOBFAR INFO SA

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER -- BAXTER HEALTHCARE CORP

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER -- BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER -- CLARIS LIFESCIENCES LTD

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER -- HOSPIRA INC

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER -- TEVA PARENTERAL MEDICINES INC

CIPRO XR -- BAYER HEALTHCARE PHARMACEUTICALS INC

CIPROFLOXACIN EXTENDED RELEASE -- ANCHEN PHARMACEUTICALS INC

CIPROFLOXACIN EXTENDED RELEASE -- DR REDDYS LABORATORIES LTD

CIPROFLOXACIN EXTENDED RELEASE -- MYLAN PHARMACEUTICALS INC

CIPROFLOXACIN EXTENDED RELEASE -- SANDOZ INC

CIPRODEX -- ALCON INC


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