Approval Date:2006Year style=”font-family:Arial”>8Month2828day
Revision Date:2010Year10Month11Day 2015Year6month8day2015year11month30day 2017AugustMonth16day
Ciprofloxacin Hydrochloride Tablets Instructions =”font-family:Arial”>
Please read the instructions carefully and use under the direction of your physician
Strictly prohibited for food and feed processing
Warning: serious adverse reactions, including tendonitis and tendon rupture, peripheral neuropathy, central nervous system reactions, and severe myasthenia gravis system reactions and exacerbation of myasthenia gravis
Fluoroquinolones (including ciprofloxacin hydrochloride) are associated with both disabling and potentially irreversible serious adverse reactions (see [Caution]-1. Disabling and potentially irreversible serious adverse reactions), which include.
Tendonitis versus tendon rupture (see [Precautions]-2.)
Tendonitis and Tendon Rupture)
Peripheral neuropathy (see [caution]-3.
Peripheral neuropathy)
Central nervous system reactions (see [Note]-4.)
Central Nervous System Reactions)
Patients experiencing any of these serious adverse reactions should discontinue ciprofloxacin hydrochloride immediately and avoid fluoroquinolones (including ciprofloxacin hydrochloride, see [Precautions]-1. Disabling and Potentially Irreversible Serious Adverse Reactions). Fluoroquinolones (including ciprofloxacin hydrochloride) may exacerbate symptoms of myasthenia gravis in patients with myasthenia gravis. Ciprofloxacin hydrochloride should be avoided in patients with a history of myasthenia gravis (see [PRECAUTIONS]-5. Exacerbation of myasthenia gravis).
Because of the association of fluoroquinolones (including ciprofloxacin hydrochloride) with serious adverse reactions (see [Precautions]-1 to 15), ciprofloxacin hydrochloride is used to treat patients for whom no alternative treatment options are available for the following indications.
Acute exacerbation of chronic bronchitis ( See [Indications]-10. Lower respiratory tract infection)
Acute uncomplicated cystitis (see [Indications]-11. Urinary tract infections)
Acute sinusitis (see [Indications]-12. >
[Drug Name]
Generic Name: Ciprofloxacin Hydrochloride Tablets
English Name:Ciprofloxacin Hydrochloride Tablets
Hanyu Pinyin:Yansuan Huanbingshaxing Pian
[Ingredients]The main ingredient of this product is ciprofloxacin hydrochloride.
Chemical name:1-Cyclopropyl-6-Fluoro-1,4-dihydrodihydro family:Arial”>-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride monohydrate
Things.
Chemical structure formula:
Molecular Formula:C17H18FN3O3-HCl-H2O
molecular weight:385.82
[Properties]This product is a film-coated tablet, which appears white to slightly yellow after removing the coating.
[Indications]
To reduce the emergence of resistant organisms and to maintain the efficacy of this product with other antibacterial drugs, this product should only be used for the treatment or prevention of confirmed or highly suspected infections with sensitive organisms. Once culture and drug sensitivity test results are available, a switch or adjustment in antibiotic regimen should be considered. If these data are not available, then appropriate antibiotic therapy should be selected empirically based on local epidemiologic and drug sensitivity data.
If anaerobic infection is suspected, then reasonable treatment should be given. Prior to treatment, appropriate bacterial culture and drug sensitivity testing should be performed to isolate and identify the microorganisms causing the infection and to determine their susceptibility to ciprofloxacin. Treatment with this product may be administered until the results of these tests are known; once the results are obtained, appropriate treatment should be continued.
Similar to other drugs, some strains of Pseudomonas aeruginosa can rapidly develop resistance during ciprofloxacin therapy. Periodic bacterial culture and sensitivity testing during treatment can provide information not only on the efficacy of antibiotic therapy but also on possible bacterial resistance.
1.Skin and skin soft tissue infections
This product is indicated for the treatment of adult patients with Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Mycobacterium oddum, Proteus vulgaris, Providinella spp, Morgenella mori, Floindel’s Citrobacter, Pseudomonas aeruginosa, methicillin-sensitive Staphylococcus aureus, methicillin-sensitive Staphylococcus epidermidis, or Streptococcus pyogenes. em>streptococcus pyogenes-induced skin and soft tissue skin infections.
2.Bone and joint infections
This product is indicated for the treatment of bone and joint infections caused by Enterobacter cloacae, Sarcoidium mucilaginous, or Pseudomonas aeruginosa in adult patients.
3.Complicated intra-abdominal infections
This product is indicated for the treatment of complicated intra-abdominal infections in adult patients with Escherichia coli, Pseudomonas aeruginosa, Chlamydomonas oddis, Klebsiella pneumoniae, or Complicated intra-abdominal infections caused by Pseudomonas fragilis (in combination with metronidazole).
4.Infectious diarrhea
This product is indicated for the treatment of diarrhea caused by Escherichia coli (enterotoxic isolate), C campylobacter jejuni, Shigella baumannii in adult patients for whom antibiotic therapy is indicated. span>*, Shigella dysenteriae, Shigella fowleri, or Shigella sonneicaused infectious diarrhea.
*Although treatment of such microbial infections in this organ system can be clinically significant, its effectiveness is only in less than10 patients.
5.Typhoid fever (enteric fever)
This product is indicated for the treatment of typhoid fever (enteric fever) caused by Salmonella typhi in adult patients. The effectiveness of ciprofloxacin in eradicating chronic typhoid fever carrier status has not been demonstrated.
6.Non-complicated cervical and urethral gonorrhea
This product is indicated for the treatment of uncomplicated cervical and urethral gonorrhea in adults caused by Neisseria gonorrhoeae in adult patients (see [Precautions]-15.Interference with timely diagnosis of syphilis).
7.Inhalation anthrax (post-exposure)
This product is indicated for the treatment of adults and children from birth to17year-old pediatric patients with inhalational anthrax (post-exposure), thereby reducing the incidence or slowing disease progression after exposure to nebulized Bacillus anthracis.
Ciprofloxacin serum concentrations in the organism may be used as a surrogate endpoint to predict clinical benefit and as an initial basis for approval of this indication. In200110years span style=”font-family:equine”>Supportive clinical information on ciprofloxacin for post-exposure prophylaxis of anthrax was obtained during the anthrax bioterrorist attack in October(see [clinical trial]-1.Inhalational Anthrax in Adults and Children).
8.Plague
This product is indicated for the treatment of plague caused by Yersinia pestis, including pneumonic and septicemic plague, and may also be used in adults and children from birth to. family:Arial”>17year-old pediatric patients. For feasibility reasons, efficacy studies could not be conducted against ciprofloxacin in humans with plague. Therefore, this indication is based on only one efficacy study performed in animals (see [clinical trial]-2.Plague).
9.Chronic bacterial prostatitis
This product is indicated for the treatment of chronic bacterial prostatitis caused by Escherichia coli or Chlamydomonas oxytoca in adult patients.
10.Lower respiratory tract infection
This product is indicated for the treatment of lower respiratory tract infections in adult patients caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Mycobacterium oddum, Pseudomonas aeruginosa, Hemophilus influenzae, Hemophilus parainfluenzae, or Streptococcus pneumoniae causing lower respiratory tract infections.
This is not the drug of choice for suspected or confirmed Streptococcus pneumoniae secondary pneumonia.
This product is also indicated for the treatment of acute exacerbations of chronic bronchitis caused by M. mucosus (Acute Exacerbations of Chronic Bronchitis,AECB).
Because fluoroquinolones (including ciprofloxacin hydrochloride) are associated with serious adverse reactions and for some patients (see [Precautions]-1 to 15),AECBis self-limiting and is used to treat patients with AECB who have no alternative treatment options.
11.Urinary tract infection
Urinary tract infections in adults
This product is indicated for the treatment of urinary tract infections in adult patients caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Sarcoidium mucilaginous, Chimera Proteus mirabilis, Providens aeruginosa, Morgenella morganii, Alterative Citrobacter, Froindel’s Citrobacter, Pseudomonas aeruginosa, methicillin-sensitive Staphylococcus epidermidis, Retrogenic Staphylococcus or Enterococcus faecalis causing urinary tract infections.
Acute uncomplicated cystitis
This product is indicated for the treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus putrefaciens in adult female patients.
As fluoroquinolones (including ciprofloxacin hydrochloride) are associated with serious adverse reactions (see [Precautions]-1 to 15), and for some patients, acute uncomplicated cystitis is self-limiting. This product is used to treat patients with acute uncomplicated cystitis for whom no alternative treatment options are available.
12.Acute sinusitis
This product is indicated for the treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Katamora in adult patients.
As fluoroquinolones (including ciprofloxacin hydrochloride) are associated with serious adverse reactions (see [Precautions] “font-family:Arial”>-1 to 15), and for some patients, sinusitis is self-limiting and this product is used to treat no alternative treatment options for patients with acute sinusitis.
[Specifications]According toCC sub>17H18FN3O3Account 0.25g
This product is used for the above infectious diseases (see[Indications]) for the treatment of infectious diseases, the generic dosage is shown in the dosing guidelines below, but must be finalized by the clinician in conjunction with the severity of the disease.
1.Dosing and Administration Methods
1)in patients with normal renal function The dose of
(1)Adult dosage
The severity and nature of the infection, the susceptibility of the causative microorganism and the integrity of the patient’s host defense mechanisms, and the status of hepatic and renal function must be considered when determining the dose and duration of dosing for any given patient.
Table1: Adult Dose Guidelines
InfectionDoseFrequencyUsual duration of medication1Skin and skin soft tissue0.5~0.75g pereveryhour7to14daysBones and Joints0.5~0.75 g per12hourly4to8weeksComplicated intra-abdominal20.5 g per12once an hour7to14 dayInfectious diarrhea0.5 g per 12hourly5to7daysTyphoid Fever0.5 g pereveryhour10daysuncomplicated urethral and cervical gonococcal infection 0.25 g Single doseSingle doseInhalation Anthrax (post-exposure)30.5 g per12once an hour60daysPlague30.5~0.75 g every12once an hour14daysChronic bacterial prostatitis0.5 g every12hours28dayLower respiratory tract infection0.5~ 0.75 g every12hours7to14daysUrinary tract infection0.25~0.5 g per12once an hour7to14dayAcute uncomplicated cystitis0.25 g every12hours3dayAcute sinusitis0.5 g pereveryhour10days
Note:1 Except for inhalational anthrax (post-exposure), ciprofloxacin should be continued after signs and symptoms of infection have resolved at least2days.
2 in combination with metronidazole.
3 Start dosing as soon as possible after suspected or confirmed exposure.
(2) In adults Conversion of intravenous infusion to oral therapy
Patients initially receiving intravenous drip therapy with ciprofloxacin may be converted to this product if clinically indicated and at the discretion of the physician (Table 2) ) (see [Pharmacokinetics]).
Table2: Equivalence Curve Area Under the Curve (Area Under the Curve, AUC) dosing regimen
Oral dose of this productEquivalent Ciprofloxacin Injection Dose0.25 gtablet every12hours0.2 gadministered intravenously every12hourly0.5 gtablets every12hours0.4 gadministered intravenously every12hours Once0.75 gtablet per12hourly0.4 gadministered intravenously every8hours(3)Children’s dosage
It should be given as shown in Table3.
Table3: Children’s Dose Guidelines
InfectionDoseFrequencyTotal medication timeInhalation anthrax
(after exposure)115 mg/kg(maximum0.5 g per dose)every12once an hour60daysPlague1, 215 mg/kg(maximum0.5g per dose)every8to to span>12hourly10~ 21daysNote:1 Initiate dosing as soon as possible after suspected or confirmed exposure.
2 Start dosing as soon as possible after suspected or confirmed exposure to Yersinia pestisis initiated as soon as possible after suspected or confirmed exposure to Yersinia pestis.
2) Dose adjustment in patients with renal impairment
Ciprofloxacin is primarily cleared by renal excretion, but is also cleared by the biliary system in the liver as well as the intestinal metabolic fraction. In patients with impaired renal function, the other metabolic pathways described above may compensate for reduced renal excretion. However, dose adjustment is recommended in patients with impaired renal function, especially in patients with severe renal insufficiency. Table4 provides dosing guidelines in patients with impaired renal function.
Table4: Renal Function Recommended starting and maintenance doses in adult patients with impaired
Creatinine clearance (mL/min)Dose> 50 See Common Dosage. 30~50 0.25~0.5 g per12 “font-family:equinox”>once an hour5~29 0.25~0.5 g per18hourlyPatients on hemodialysis or peritoneal dialysis 0.25~0.5 g perevery24 hours (after dialysis)When only the serum creatinine concentration is known, creatinine clearance can be estimated using the following equation:
Male-Creatinine clearance (mL/min)=Weight (kg)×(140-age)72×Serum creatinine (mg/dL)female – 0.85 × value obtained from male calculation.
Serum creatinine levels represent a stable state of renal function.
In patients with severe infection and severe renal impairment, 0.75 g may be given at the above dosing interval “font-family:equine”>unit dose. The patient should be monitored closely.
Children with moderate to severe renal insufficiency were excluded from clinical trials in complicated urinary tract infections and pyelonephritis. Dosing for pediatric patients with moderate to severe renal insufficiency (creatinine clearance 50mL/min/1.73m2) has not been obtained. information for the adjustment.
2.Important dosing instructions
1)Polyvalent cations
should be used after taking magnesium/aluminum acid inhibitors, polymeric phosphate binders (e.g. Sevelamer, Lanthanum carbonate) or aluminum thioglycollate,Videx® (Didanosine) Chewable Tablets/Buffered tablets or powder for oral use in children, other highly buffered medications, or other preparations containing calcium, iron, or zinc before taking at least. family:Arial”>2hours before or6hours after taking this product. Take this product at the hour.
2) Dairy products
Avoid concomitant administration of this product with dairy products (e.g., milk or yogurt) or high-calcium beverages as it will likely result in decreased absorption of ciprofloxacin; however, this product may be ingested in combination with meals containing these foods.
3) Water intake in patients taking this product
Patients should drink plenty of water to prevent the formation of highly concentrated urine. There have been reports of quinolones triggering crystalluria.
[Adverse effects]
1. The following serious and otherwise important adverse drug reactions are discussed more specifically in other sections of the labeling
1) Disabling and potentially irreversible serious adverse reactions (see [Precautions]-1. Disabling and Potentially Irreversible Serious Adverse Reactions) Disabling and Potentially Irreversible Serious Adverse Reactions) /span>
2) Tendonitis and tendon rupture (see [Precautions]-2.Tendonitis and Tendon Rupture)
3) peripheral neuropathy (see [Caution]) =”font-family:Arial”>-3.Peripheral Neuropathy)
4)Central nervous system reactions (see [Precautions]-4.Central Nervous System Reactions)
5)Exacerbation of myasthenia gravis (see [Caution]-5.Exacerbation of myasthenia gravis)
6)Other serious or even fatal adverse reactions (see [Precautions]-6.Other Serious or Even Fatal Adverse Reactions)
7)Hypersensitivity reactions (see [Precautions]-7.Hypersensitivity reactions)
8)Hepatotoxicity (see [Precautions]-8.Hepatotoxicity)
9) Serious adverse reactions to theophylline concomitant administration (see [Precautions]-9.Serious Adverse Reactions in Concomitant Administration of Theophylline)
10) Clostridium difficile-associated diarrhea (see [Precautions]-10.Clostridium difficile-associated diarrhea)
11)QT Interval extension (see [Note]-11.QTInterval extension)
12)photoallergy/Phototoxicity (see [Precautions]-12.photosensitivity/phototoxicity)
13)Production of drug-resistant bacteria (see [Precautions]-13.Production of drug-resistant bacteria)
2.Clinical trial experience
Adverse reaction rates observed in clinical trials for one drug are not directly comparable to those observed in clinical trials for another drug and do not reflect the rates observed in practice because of differences in implementation across clinical trials.
Adult patients
in clinical studies of oral and parenteral application of ciprofloxacin,49,038 = “font-family:equine”> patients received multiple courses of therapy.
In clinical trials of ciprofloxacin in all dosage forms, all doses, all courses of therapy, and all indications, the most frequently reported adverse reaction was nausea (2.5%) ), diarrhea (1.6%), abnormal liver function tests (1.3%), vomiting (1%) and rash (1%).
table5: deficiencies1% of ciprofloxacin patients with clinically significant adverse reactions
System Organ ClassificationAdverse effectsSystemic DiseasesHeadache
Abdominal pain/discomfort
painHeart organ diseaseSwoon
Angina pectoris
Myocardial infarction
Cardiac arrest
Tachycardia
Low blood pressureCentral Nervous System DisordersMania
Dizziness
Insomnia
Nightmares
Hallucinations
Paranoia
Psychosis (toxic)
Manic reaction
Irritability
Tremors
Ataxia
Seizures (including status epilepticus)
Generalized weakness
Anorexia
Phobia
Depersonalization
Depression (may lead to self-harming behaviors such as suicidal ideation/attempt and attempted suicide or suicide completion)
Feeling abnormal
Gait abnormalities
MigraineGastrointestinal DisordersIntestinal perforation
Gastrointestinal bleeding
Cholestatic jaundice
Hepatitis
PancreatitisDiseases of the blood and lymphatic systemStasisMetabolic and Nutritional DisordersHyperglycemia
HypoglycemiaMusculoskeletal DisordersJoint pain
Joint stiffness
Muscle weaknessRenal, urinary and reproductive disorders Interstitial nephritis
Renal FailureRespiratory DiseaseHard to breathe
Laryngeal edema
Hemoptysis
BronchospasmDermal and subcutaneous tissue disorders hypersensitivity reactions, including life-threatening anaphylaxis
Polycythemia vera/History span style=”font-family:Arial”>-About syndrome (Stevens-Johnsonsyndrome)
Exfoliative dermatitis
Toxic epidermal necrolysis
pruritus
Hives
Photosensitivity/Phototoxic reaction
Flushing
Fever
Angioedema
Nodular erythema
SweatingSpecial Sensory OrgansBlurred vision
Visual disturbances (color vision and flash sensation)
Decreased visual acuity
Double vision
Tinnitus
Hearing loss
Abnormal TasteIn patients with respiratory tract infections participating in A study designed to compare ciprofloxacin tablets (0.5 g twice daily) with cefuroxime () in patients with respiratory infections (250 mg to 500 mg twice daily) and clarithromycin (500 mgtwice daily) in a randomized, double-blind controlled clinical trial, the ciprofloxacin group had comparable CNS adverse event profiles to the control drug group.
3.Post-marketing experience
The following adverse reactions have been reported in the global launch experience for all fluoroquinolones, including ciprofloxacin hydrochloride. Because these adverse reactions were spontaneously reported from an undeterminable number of people, it is not possible to fully estimate the incidence or determine a causal relationship with drug exposure on this basis (Table 6).
Table6: Post-marketing Reported adverse drug reactions
System Organ ClassificationAdverse effectsHeart Organ Disease QTExtend
Tip-twist ventricular tachycardia
Vasculitis and ventricular arrhythmiasCentral Nervous System DisordersTension hyperactivity
Muscle weakness
Exacerbation of myasthenia gravis
Peripheral neuropathy
Polyneuropathy
TwitchingOcular organ diseaseNystagmusGastrointestinal DisordersPseudomembranous colitisDiseases of the blood and lymphatic systemComplete thrombocytopenia (life-threatening or causing death)
HyperhemoglobinemiaDiseases of the hepatobiliary systemLiver failure (including deaths)Infectious and Infectious Diseases Candidiasis (oral, gastrointestinal, vaginal)All kinds of checksProlonged or shortened prothrombin time
Elevated cholesterol (serum)
Elevated potassium (serum)Musculoskeletal DisordersMyalgia
Myoclonus
Tendonitis
Tendon ruptureMental illnessExcitement
Misawareness
DeliriumDermal and subcutaneous tissue disordersAcute Generalized Exanthematous PustulosisAcute Generalized Exanthematous Pustulosis, AGEP))
Fixed rash
Seropathy-like reactionSpecial Sensory OrgansLoss of sense of smell
Sensory hypersensitivity
Decreased sensation
Loss of taste4.Adverse laboratory changes
Changes in laboratory parameters during the use of ciprofloxacin are shown below:
1) Liver: alanine aminotransferase/Glutamyl Transaminase (Alanine Transaminase, Alanine AminotransferaseALT/ Serum Glutamic Pyruvic Transaminase,SGPT), Menthyltransferase/Glutamate Transaminase (Aspartate Transaminase,AST/ Serum Glutamic Oxaloacetic Transaminase “font-family:equivocal”>, SGOT), alkaline phosphatase, lactate dehydrogenase (Lactate Dehydrogenase, LDH), and elevated serum bilirubin levels.
2) Hematology: eosinophilia, leukopenia, decreased platelet count, elevated platelet count, and complete thrombocytopenia.
3) Renal: Elevated serum creatinine, blood urea nitrogen levels, crystalluria, tubuluria, and hematuria have been reported.
4) Other changes include: serumγ -elevated glutamyl transferase levels, elevated serum amylase levels, decreased blood glucose levels, elevated uric acid levels, decreased hemoglobin levels, anemia, bleeding tendencies, elevated blood mononuclear cell counts, and leukocytosis.
[Contraindicated]
Contraindicated in patients with a history of hypersensitivity to ciprofloxacin, any quinolone antimicrobial, or any of the formulation ingredients (see [Precautions]-7.hypersensitivity reactions).
Contraindicated in children, adolescents (except for inhalational anthrax (post-exposure) and plague). Because there is no current experience with the safety of the drug in these patients and based on animal studies, it cannot be completely ruled out that this drug causes articular cartilage damage in immature organs.
Contraindicated in pregnant and lactating women.
Concomitant use with tizanidine is prohibited (see [Drug Interactions]).
[Precautions]
1. Disabling and potentially irreversible serious adverse reactions, including tendonitis with tendon rupture, peripheral neuropathy, central nervous system reactions
Fluoroquinolones, including ciprofloxacin hydrochloride, are associated with disabling and potentially irreversible serious adverse reactions that can occur simultaneously in different body systems in the same patient. Common adverse reactions include tendonitis, tendon rupture, arthralgia, muscle pain, peripheral neuropathy, and central nervous system reactions (hallucinations, anxiety, depression, insomnia, severe headache, and confusion). These reactions may occur within hours to weeks after the start of administration of this product. These adverse reactions have occurred in patients of any age or in patients without prior risk factors (see [Precautions]-2.Tendonitis and tendon rupture, 3.Peripheral neuropathy,4.Central nervous system reactions).
The product should be discontinued immediately at the first sign or symptom of any serious adverse reaction. In addition, avoid fluoroquinolones (including ciprofloxacin hydrochloride) in patients who experience any of these adverse reactions associated with fluoroquinolones.
2.Tendonitis and tendon rupture
Fluoroquinolones (including ciprofloxacin hydrochloride) may increase the risk of tendonitis and tendon rupture in patients of all ages (see [Cautions]-1.
disabling and potentially irreversible serious adverse reactions, [adverse reactions]-3.Post-marketing experience). This adverse reaction most commonly involves the Achilles tendon, and tendinopathy with tendon rupture has also been reported in the piriformis group (shoulder), hand, biceps, thumb, and other tendon sites. Tendonitis or tendon rupture may occur within hours or days after administration of the drug or within a few months after the patient completes treatment with a fluoroquinolone. Bilateral tendonitis with tendon rupture may occur.
Older patients aged 60 years and older, patients taking corticosteroids, and patients with kidney transplant, heart transplant, or lung transplant develop fluoroquinolone-associated tendon There is an increased risk of fluoroquinolone-associated tendonitis and tendon rupture. Other independent risk factors that increase the risk of tendon rupture include: strenuous physical activity, renal failure, and previous tendon disease such as rheumatoid arthritis. In addition, tendonitis and tendon rupture have been reported in patients treated with fluoroquinolones who do not have these risk factors. If a patient develops tendon pain, swelling, inflammation, or rupture, the product should be discontinued. Patients with a history of tendon site disease or prior tendonitis or tendon rupture should avoid fluoroquinolones (including ciprofloxacin hydrochloride, see [Precautions]-1. disabling and potentially irreversible serious adverse reactions, [adverse reactions]-2.Clinical trial (3.Post-marketing experience).
3.Peripheral neuropathy
Fluoroquinolones (including ciprofloxacin hydrochloride) are associated with an increased risk of peripheral neuropathy. In patients treated with fluoroquinolones (including ciprofloxacin hydrochloride), there have been reports of sensory or sensorimotor axonal polyneuropathy involving small axons and/ or large axons, which can lead to abnormal sensation, hyperalgesia, dullness and weakness. These symptoms may occur shortly after initiation of this product and may be irreversible in some patients (see [Precautions]-1. Disabling and potentially irreversible serious adverse reactions, [Adverse reactions]-2. Clinical trial experience,3.Post-market experience).
If patients experience symptoms of peripheral neuropathy, including pain, burning, tingling sensation, numbness and// or weakness or other sensory changes including light touch, pain, warmth, position and vibration sensation and/ or motor ability, should Discontinue the product immediately so as to minimize the possibility of irreversible lesions. Fluoroquinolones (including ciprofloxacin hydrochloride, see [Adverse Reactions]-2.clinical trial experience,3.post-marketing experience) .
4. Central nervous system response
Fluoroquinolones (including ciprofloxacin hydrochloride) are associated with an increased risk of central nervous system reactions associated with increased risk of CNS reactions, including convulsions, increased intracranial pressure (including pseudotumors) and toxic psychosis.
This product may also cause other central nervous system (CNS) reactions, including: neuroticism, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and attempts that can progress to suicidal ideation/ and psychiatric reactions to self-harming behaviors (e.g., suicide attempts or suicides). These reactions may occur after the initial dose and patients treated with this product are advised to discontinue immediately and notify their healthcare provider immediately if they experience any of these adverse reactions and are given appropriate care. Similar to other fluoroquinolones, it is known that this product may induce seizures or lower the seizure threshold. As with all fluoroquinolones, in patients with known or suspected CNS disease that can induce seizures or lower seizure thresholds (e.g., severe cerebral atherosclerosis, previous history of convulsions, decreased cerebral blood flow, structural changes in the brain, or stroke) or in the presence of other risk factors that can induce seizures or lower seizure thresholds (e.g., specific drug therapy, renal dysfunction) This product must be used with caution. Given the potential for these central nervous system side effects, use this product only if the benefits of treatment outweigh the risks. Cases of persistent status epilepticus have been reported. In the event of seizures, discontinue this product (see [Adverse Reactions]-2.). clinical trial experience, [drug interactions]).
5.Exacerbation of myasthenia gravis
Fluoroquinolones (including ciprofloxacin hydrochloride) have neuromuscular blocking activity and therefore may exacerbate muscle weakness in patients with myasthenia gravis. Patients with myasthenia gravis treated with fluoroquinolones have experienced post-marketing serious adverse effects, including death and the need for assisted breathing. Patients with a history of myasthenia gravis should avoid this product (see [Adverse Reactions]-3.Post-market experience).
6.Other serious or even fatal adverse reactions
Other serious adverse events and even fatal adverse reactions have been reported in patients treated with quinolones, including ciprofloxacin hydrochloride, partly as a result of hypersensitivity reactions and partly of unknown etiology. These adverse events may be severe and are usually seen after multiple doses. Clinical manifestations include one or more of the following:
1) Fever, rash, or severe skin reactions (e.g., toxic epidermal necrolysis relaxans, Stevens-Johnson syndrome);
2) vasculitis, arthralgia, myalgia, serum sickness;
3) allergic pneumonia;
4) interstitial nephritis, acute renal insufficiency or renal failure;
5) hepatitis, jaundice, acute hepatic necrosis or liver failure;
6) anemia, including hemolytic and aplastic anemia, thrombocytopenia, including thrombotic thrombocytopenic purpura, leukopenia, granulocyte deficiency, pancytopenia, and/ or other hematologic abnormalities.
Once rash, jaundice, or any other sign of hypersensitivity reaction occurs, the product should be discontinued immediately and supportive measures taken (see [Adverse Reactions]). “font-family:Arial”>-2.Experience with clinical trials,3.Post-market experience).
7.Hypersensitivity reactions
Severe episodic fatal hypersensitivity (allergic) reactions have been reported in patients treated with quinolones, including ciprofloxacin hydrochloride, with some cases occurring after the first dose. Adverse reactions may be accompanied by cardiovascular collapse, loss of consciousness, tingling sensation, pharyngeal or facial edema, dyspnea, urticaria, and pruritus. Only a few patients have a history of hypersensitivity reactions. Once indicated, severe hypersensitivity reactions require immediate emergency treatment with epinephrine and other resuscitative measures, including oxygen therapy, intravenous fluids, intravenous administration of antiblockers, corticosteroids, elevated amines, and airway management, such as intubation (see [Adverse Reactions]-2.Clinical trial experience).
8.Hepatotoxicity
Severe hepatotoxic reactions have been reported in patients treated with ciprofloxacin, including events of hepatic necrosis, fatal liver failure, and even death. Acute liver injury has a rapid onset (range1 to 39days) and is often associated with hypersensitivity reactions. This liver injury may be hepatocellular, cholestatic, or mixed. The majority of patients who die are 55years old and older. Treatment should be discontinued as soon as signs and symptoms of hepatitis (e.g., anorexia, jaundice, yellow urine, pruritus, and abdominal tenderness) appear.
Patients treated with ciprofloxacin, especially those with prior hepatic impairment, may experience transient elevations in transaminases, alkaline phosphatase, or cholestatic jaundice (see [Adverse Reactions]) -3.Post-marketing experience, 4.Adverse laboratory changes).
9.Serious adverse reactions to theophylline concomitant administration
Serious and lethal adverse reactions have been reported in patients receiving ciprofloxacin and theophylline combination therapy.
These reactions have included cardiac arrest, seizures, persistent epilepsy, and respiratory failure. Nausea, vomiting, tremor, irritability, or palpitations have also occurred.
Although similar serious adverse reactions have been reported in patients treated with theophylline only, the possibility that ciprofloxacin promotes these adverse reactions cannot be ruled out. If combination use cannot be avoided, serum levels of theophylline must be monitored and dose adjusted as appropriate (see [Drug Interactions]).
10.Clostridium difficile-associated diarrhea
Almost all antibiotics (including ciprofloxacin hydrochloride) have been associated with Clostridium difficile-associated diarrhea during use (Clostridium Difficile Associated Diarrhea, CDAD) have been reported, which can range in severity from mild diarrhea to fatal colitis. Antibiotic therapy can alter the normal flora in the colon, leading to overgrowth of Clostridium difficile.
Clostridium difficile can produce toxinsAandB, which can causeCDAD. Virulence-producing strains of Clostridium difficile can lead to increased morbidity and mortality, and antibiotics are difficult to treat such infections, potentially requiring colectomy. All patients who develop diarrhea after antibiotic therapy must be consideredCDAD. Had antibiotic therapy after 2months ofCDAD have been reported, so a careful history is needed.
If the diagnosis is suspected or confirmedCDAD, it may require discontinuation of antibiotics that have no direct activity against Clostridium difficile. Depending on clinical indications, appropriate rehydration and maintenance of electrolyte balance, protein supplementation, administration of antibiotic therapy against Clostridium difficile, and surgical evaluation may be indicated (see [Adverse Reactions]-2.Clinical Trial Experience).
11. Prolonged QTinterval
Some fluoroquinolones (including ciprofloxacin hydrochloride) may cause QT on the ECGinterval prolongation and arrhythmias. Tip-twisting ventricular tachycardia has been reported in patients treated with fluoroquinolones (including ciprofloxacin hydrochloride) during postmarketing surveillance.
Patients with prolonged QT intervals, patients with QTinterval prolongation or risk factors for the development of tip-twist ventricular tachycardia (e.g., congenitalQT family:equivocal”>prolonged, uncorrected electrolyte disturbances such as hypokalemia, hypomagnesemia and cardiac disorders such as heart failure, myocardial infarction, bradycardia) and patients takingIA family:isoline”>class antiarrhythmic drugs (quinidine, procainamide) or IIIclass antiarrhythmic drugs (amiodarone, sotalol), tricyclic Antidepressants, macrolides, and antipsychotics are contraindicated in patients. Elderly patients may have a higher sensitivity to drug-related effects acting in the QTinterval (see [Adverse Reactions]-3.Postmarketing Experience, [Geriatric Use]).
12.Photosensitivity/Phototoxicity
Moderate to severe photosensitivity after exposure to sunlight or UV light during treatment with quinolones, including ciprofloxacin hydrochloridephototoxic reactions, the latter manifesting as light-exposed areas (usually the face, neck”V”shaped areas, forearm extensor surfaces, back of hands) sun reactions are exacerbated (e.g., burning sensation, erythema, exudation, blistering, blistering, edema). Therefore, overexposure to the above mentioned light sources needs to be avoided. Discontinue the product if phototoxicity occurs (see [Adverse Reactions]-2.clinical trial experience).
13.Production of drug-resistant bacteria
In the absence of a confirmed or highly suspected bacterial infection or evidence of prophylactic indications, administration of this treatment or prophylaxis is of little benefit to the patient and may increase the risk of development of drug-resistant organisms.
14.with cytochromeP450 1A2potential risk in concomitant use of drugs metabolized by
This product is a hepaticCYP1A2enzyme pathway inhibitors. The combination of this product with other drugs that are primarily metabolized via CYP1A2 (e.g., theophylline, methylxanthine, caffeine, tizanidine, ropinirole, clozapine, olanzapine ) in combination can lead to increased plasma concentrations of the combination drug and cause clinically significant adverse pharmacodynamic effects (see [Drug Interactions], [Pharmacokinetics]).
15.Interference with timely diagnosis of syphilis
Ciprofloxacin has not been shown to be effective in the treatment of syphilis. Short-term treatment of gonorrhea with high-dose antibiotics may mask or delay the symptoms of latent syphilis. All patients with gonorrhea must undergo serologic testing for syphilis at the time of diagnosis. A follow-up syphilis serology should be performed 3months after receiving this product.
16. Crystalluria
Ciprofloxacin crystals are rare in the urine of human subjects, but are more common in the urine of experimental animals and are usually alkaline (see [Pharmacology and Toxicology]-2.Toxicological studies-4)Other toxicity). Because human urine is usually acidic, crystalluria associated with this product is relatively rare in the population. Patients receiving this product should avoid alkaline urine. Patients should drink plenty of water to prevent the formation of highly concentrated urine (see [Dosage and Administration]-2.Important dosing instructions).
17.Renal injury
Ciprofloxacin is primarily cleared by the kidneys, but is also cleared by the biliary system in the liver and by the intestinal metabolic fraction. In patients with impaired renal function, the other metabolic pathways described above may compensate for reduced renal excretion. However, dose adjustment is recommended in patients with impaired renal function, especially in patients with severe renal insufficiency (see [Dosage]-1.dose and dosing method-2)Dose adjustment in patients with renal impairment, strong>[pharmacokinetics]).
18.Liver injury
Significant changes in the pharmacokinetics of ciprofloxacin have not been observed in preliminary studies in patients with stable chronic cirrhosis who participated. The pharmacokinetic profile of ciprofloxacin in patients with acute hepatic insufficiency has not been studied.
[For pregnant and lactating women]
1.Pregnant women
PregnancyCClass
Adequate controlled studies have not been conducted in pregnant women. The use of this product in women during pregnancy is contraindicated unless the potential benefits to the fetus and the pregnant woman from its use outweigh the potential risks. For Teratogen Information System () Teratogen Information System, TERIS), an expert review of data on the use of ciprofloxacin in pregnancy concluded that the use of therapeutic doses during pregnancy is unlikely to produce a significant teratogenic risk (quantity and quality of data== = “font-family:equine”>moderate); however, the data are insufficient to demonstrate no teratogenic risk.
A controlled, prospective, observational study followed 200women exposed to fluoroquinolones during pregnancy (52.5%exposed to ciprofloxacin,68%exposure in the first trimester of gestation). Intrauterine exposure to fluoroquinolones during embryogenesis does not increase the risk of serious malformations. The reported rates of severe congenital malformations in fluoroquinolones and controls were 2.2% and , respectively. family:Arial”>2.6% (the base incidence of severe malformations is 1 to 5%). The incidence of spontaneous abortion, preterm birth, and low birth weight did not differ between the two groups, and no clinically significant musculoskeletal by age 1 years were observed in children exposed to ciprofloxacin. function disorder by age 1.
Another prospective follow-up study reported549fluoroquinolone exposed pregnant women (93% were exposed in the first trimester of pregnancy). A total of70 cases of ciprofloxacin exposure were seen, all in the first trimester of pregnancy. The overall incidence of malformations in live births of infants exposed to ciprofloxacin and fluoroquinolones was within the background incidence range. No specific pattern of distribution was seen for congenital malformations. The study did not suggest that any significant adverse effects were due to intrauterine exposure to ciprofloxacin.
There was no difference in the incidence of preterm delivery, spontaneous abortion, or low birth weight among women exposed to ciprofloxacin during pregnancy. However, in these small postmarketing epidemiologic studies, most of the experience was from only short-term exposures, first trimester exposures, and was insufficient to assess the risk of less common defects or to draw reliable and definitive conclusions regarding the safety of ciprofloxacin in pregnant women and developing fetuses.
Reproduction studies were conducted in rats and mice at a maximum oral dose of 100 mg/kg (based on body surface area, which is 0.6 and of the maximum human daily dose, respectively) style=”font-family:Arial”>0.3fold), the results did not show that ciprofloxacin caused harm to the fetuses. Rabbits were given oral doses of ciprofloxacin30 and 100 mg/kg (approximately 0.4 of the maximum recommended therapeutic dose, based on body surface area “>and1.3fold), gastrointestinal toxicity occurred, resulting in maternal weight loss and an increased incidence of miscarriage, but no teratogenicity was observed at any dose level. The maximum intravenous infusion dose of 20 mg/kg (based on body surface area, approximately 0.3fold) after which no maternal toxicity occurred and no embryotoxicity or teratogenicity was observed.
2.Lactation use
Ciprofloxacin is excreted through human milk. The amount of ciprofloxacin absorbed by the nursing infant is unknown. Because serious adverse reactions (including joint damage) may occur in infants breastfed by mothers receiving this product, the decision to stop breastfeeding or discontinue the drug must be based on the importance of the drug to the mother.
[Pediatric Dosage]
1.Inhalation anthrax (post-exposure)
This product is indicated for use from birth to 17 years of age for inhalational anthrax (post-exposure ) pediatric patients. Risk-Benefit assessment indicates that pediatric patients may receive ciprofloxacin administration (see [Dosage]-1.Dose and Method of Administration-1 ) Dose in patients with normal renal function-(3)Children’s dosage, [clinical trial]-1.Inhalation Anthrax in Adults and Children).
2.Plague
This product is indicated from birth to17 years of age in children with distemper, including those due to Yersinia distemper
pneumonic and septicemic plague, and also to prevent plague. For feasibility reasons, it has not been possible to conduct efficacy studies with ciprofloxacin in plague-stricken humans. Therefore, this indication was approved based on efficacy studies performed in animals. Risk-Benefit assessment indicates that pediatric patients can receive this product for administration (see [Indications]-8.Plague, [Dosage]-1.Dosage and Administration-1) Dose in patients with normal renal function-(3)Children’s dosage, [clinical trial]-2.Plague).
[Geriatric use]
Older patients treated with fluoroquinolones (e.g., ciprofloxacin hydrochloride) are at increased risk for severe tendon disease, including tendon rupture. This risk is further increased in patients receiving glucocorticoid combination therapy. Tendonitis or tendon rupture can involve the Achilles tendon, hand, shoulder, or other tendon sites and can be seen during or after treatment; cases of these disorders have been reported several months after the end of fluoroquinolone therapy. Caution should be exercised when prescribing this product to elderly patients receiving glucocorticoid therapy. Patients should be informed of this potential adverse effect and advised to discontinue treatment with this product and contact their physician if they develop any symptoms of tendonitis or tendon rupture (see [Precautions]-2.Tendonitis and Tendon Rupture, [Adverse Reactions]-3.Post-marketing experience).
In a review of 23 multiple doses of ciprofloxacin in In a retrospective analysis of controlled clinical trials, a total of 3500plus patients were treated with ciprofloxacin, of whom25%of the patients were older than 65years old, 10%of patients reach 75 years of age. There were no overall differences in safety or efficacy between these subjects and younger subjects, and other reported clinical experiences have not revealed differences in response to the drug between older and younger patients, although the possibility of greater sensitivity to any drug in some older adults cannot be ruled out. Ciprofloxacin is known to be excreted primarily by the kidneys, and therefore there is an increased risk of adverse reactions in patients with impaired renal function. In patients older than 65 years with normal renal function, no dose adjustment is required. However, dosing should be carefully selected due to the development of decreased renal function in some older adults due to advanced age, and renal function monitoring is useful in these patients (see [Dosage and Administration]-1.) Dose and method of administration-2) Dose adjustment in patients with renal impairment, [pharmacokinetics]).
Often, older patients may be more sensitive to drug-related effects that act on QT The sensitivity of drug-related effects in the interval is higher. Therefore,
when concomitant use of this product with drugs that can cause QTinterval span>IAclass or IIIclass when the drug is prolonged (e.g. span>class antiarrhythmic drugs) or in patients with risk factors for tip-twist ventricular tachycardia (e.g.QTprolonged interval, uncorrected hypokalemia) must be used with caution (see [Precautions]-11. QTinterval prolongation).
[Drug Interactions]
Ciprofloxacin inhibits human cytochromeP450 1A2(CYP1A2)-mediated metabolism. Ciprofloxacin is associated with its
which is metabolized primarily by CYP1A2 Drug combinations can lead to elevated plasma concentrations of the combination drug and result in clinically significant adverse reactions to the combination drug.
Table7: Effects of Ciprofloxacin and drugs affecting Ciprofloxacin
Drugs affected by Ciprofloxacin-affected drugsMedicationsRecommendationsRemarksTizanidinedisabledCiprofloxacin enhances the hypotensive and sedative effects of tizanidine; therefore, concomitant use of tizanidine and ciprofloxacin is contraindicated (see [Contraindications]). TheophyllineAvoidance
(likely to increase and prolong plasma exposure)Concurrent use of ciprofloxacin with theophylline may result in patients at increased risk for central nervous system or other The risk of CNS or other adverse reactions is elevated. If concomitant use cannot be avoided, serum levels of theophylline must be monitored and the dose adjusted as appropriate (see [Precautions]-6.Serious adverse reactions in concomitant administration of theophylline). known to be able to extendQTinterval drugsAvoidis receiving the ability to extendQTinterval (e.g.IAclass or IIIclass antiarrhythmic drugs, tricyclic antidepressants, macrolide antibiotics , and antipsychotics) will further prolong the QTinterval in patients with [precautions]-11. QTInterval Prolongation, [Geriatric Use]). Oral hypoglycemic drugsCaution
Enhanced hypoglycemic effectThere have been cases where ciprofloxacin and oral hypoglycemic agents, mainly sulfonylureas (e.g., glibenclamide, Glimepiride), have been reported to exacerbate hypoglycemia when used concomitantly, presumably because the effects of oral hypoglycemic agents are enhanced. There have been reports of deaths. Blood glucose levels should be monitored when ciprofloxacin is used concomitantly with oral hypoglycemic agents (see [Adverse Reactions]-2.Clinical trial experience). PhenytoinCaution
Change in phenytoin serum levels (elevated and decreased)In order to avoid patients receiving both ciprofloxacin and phenytoin from experiencing a decrease in phenytoin due to discontinuation of Ciprofloxacin caused a decrease in phenytoin serum levels leading to uncontrolled seizures and to prevent adverse reactions associated with phenytoin overdose, it is recommended that patients treated with the combination of ciprofloxacin and phenytoin be monitored for phenytoin therapy, including monitoring phenytoin serum concentrations, during and shortly after the end of the combination therapy. CyclosporineCaution
(Transient elevation of serum creatinine)Renal function (especially serum creatinine) should be monitored when ciprofloxacin is used concomitantly with ciclosporin. AnticoagulantCaution
(Improved anticoagulation)This risk may vary depending on the type of underlying infection, age, and overall status of the patient, and therefore it is also It is difficult to assess the effect of ciprofloxacin on the International Normalized RatioInternational Normalized Ratio,INR) increased in the degree of impact. Prothrombin time and INR should be monitored frequently during and for a short period after the end of ciprofloxacin and oral anticoagulant (e.g., warfarin) coadministration. MethotrexateCaution
May inhibit renal tubular transport of methotrexate, resulting in elevated plasma levels of methotrexate. may increase the risk of methotrexate-related toxic reactions. Therefore, patients receiving methotrexate should be closely monitored if a combination of ciprofloxacin is required. RopiniroleCautionDuring and for a short time after co-administration with ciprofloxacin, monitoring for adverse reactions associated with ropinirole and adjusting the dose of ropinirole as appropriate is recommended (see [Precautions] style=”font-family:Arial”>-14.with cytochromeP450 1A2potential risk in concomitant use of drugs metabolized by ). ClozapineCautionClose monitoring of clozapine-related side effects and adjustment of clozapine dose as appropriate is recommended during and for a short time after the end of coadministration with ciprofloxacin. Non-steroidal anti-inflammatory drugsUse with cautionThe combination of NSAIDs (but not acetylsalicylic acid) and very high doses of quinolones can induce convulsions in preclinical studies and in postmarketing surveillance. SildenafilCaution
Double the exposureMonitor sildenafil toxicity (see [Pharmacokinetics]). DuloxetineAvoidance
Duloxetine exposure rises to five timesMonitor duloxetine toxicity if use cannot be avoidedCaffeine/Xanthine derivativesCaution
Decreased clearance leads to elevated levels and prolonged serum half-lifeCiprofloxacin after administration of caffeine (or preparations containing hexanone cocaine) Inhibit paraxanthine formation Monitor xanthine toxicity and adjust dose if necessary. Drugs affecting the pharmacokinetics of ciprofloxacin Acid suppressants, aluminum thioglycollate, multivitamin tablets and other preparations containing multivalent cations (containing magnesium/aluminum antacids, polymeric phosphate binders (e.g., sevelamer, lanthanum carbonate), aluminum thioglycollate,Videx®(didanosine) chewable tablets/buffered tablets or powder for oral use in children, other highly buffered medications, or other preparations containing calcium, iron, or zinc). at least until polyvalent cation-containing preparations are given2hours or after6hours of administration of ciprofloxacin (see [Dosage])reduced absorption of ciprofloxacin, resulting in decreased serum and urine levels PropofolCaution
(Interferes with renal tubular secretion of ciprofloxacin and causes elevated serum levels of ciprofloxacin)may enhance the toxicity of ciprofloxacin [Drug overdose]
In cases of acute drug overdose, reversible nephrotoxicity may occur in some patients. The stomach must be emptied by inducing vomiting or gastric lavage. Patients must be closely monitored and given supportive therapy if necessary, including monitoring of renal function, urinepH and acidity, if needed, to prevent crystalluria and taking magnesium, aluminum, or calcium-containing Acid suppressants, which reduce the absorption of ciprofloxacin. Adequate fluid replacement must be maintained. Only small amounts of ciprofloxacin (less than 10%) are cleared from the body after hemodialysis or peritoneal dialysis.
[Pharmacology and Toxicology]
1.Pharmacology and Toxicology
1) Mechanism of action:
Ciprofloxacin acts via topoisomeraseII(DNAdeconvolutive enzyme) and topoisomeraseIV (both type II topological
isomerase), thereby inhibiting bacterialDNA Replication, transcription, repair, or recombination for sterilization.
2) Resistance mechanisms:
The mechanism of action of fluoroquinolones, including ciprofloxacin, is different from that of penicillin, cephalosporins, aminoglycosides, macrolides, and tetracyclines; therefore, microorganisms that are resistant to other classes of drugs mentioned above may be ciprofloxacin sensitive. Bacterial resistance to fluoroquinolones is mainly achieved through DNAdecapping enzyme mutations, reduced outer membrane permeability, or active drug efflux. In vitro resistance to ciprofloxacin develops slowly through multi-step mutations. The incidence of ciprofloxacin resistance due to spontaneous mutations is typically<10-9toto =”font-family:Arial”>1×10-6.
3) Cross-resistance:
No known cross-resistance between ciprofloxacin and other classes of antibiotic drugs.
Ciprofloxacin has shown antibacterial activity against most isolates of the following bacteria in vitro and in patients with clinical infections (see[Indications]).
Gram-positive bacteria:
Bacillus anthracis
Enterococcus faecalis
Staphylococcus aureus (methicillin-sensitive isolates only)
Staphylococcus epidermidis (methicillin-sensitive isolates only)
Staphylococcus saprophyticus
Streptococcus pneumoniae
Streptococcus pyogenes
Gram-negative bacteria:
Campylobacter jejuni
Citrobacter heterotrophicus
Floindel’s Citrobacter
Enterobacter cloacae
Escherichia coli
Haemophilus influenzae
Haemophilus parainfluenzae
Klebsiella pneumoniae
Mucositis Moraxella
Moraxella mucosae
Neisseria gonorrhoeae
Neisseria oddisNeisseria gonorrhoeaeNeisseria gonorrhoeae
Amoeba vulgaris
Providinium rayonii
Providinia spp.
Pseudomonas aeruginosa
Salmonella typhimurium
Salmonella mucilaginosa
Shigella baumannii
Shigella dysenteriae
Shigella fowleri
Shigella sunglasses
Yersinia pestis
The following in vitro data are available, but their clinical significance is unclear. Ciprofloxacin is effective against at least 90% of the following bacteria
Minimum Inhibitory Concentrationin vitroMinimum Inhibitory Concentration,MIC) is not higher than the susceptibility threshold for ciprofloxacin (≤1 µg/mL). However, the effectiveness of ciprofloxacin for the treatment of these bacterial infections has not been established in adequate and well-controlled clinical trials.
Gram-positive bacteria:
Staphylococcus haemolyticus (methicillin-sensitive isolates only)
Human Staphylococcus (methicillin-sensitive isolates only)
Gram-negative bacteria:
Rucoidobacteria
Aerobacterium hydrophilum
Elderella slowly
Enterobacter aerogenes
Klebsiella prowazekii
Legionella pneumophila
Pasteurella haemorrhagica septica
Salmonella enterica
Vibrio cholerae
Vibrio parahaemolyticus
Vibrio traumaticus
Yersinia pestis
4) Drug sensitivity test:
When conditions permit, clinical microbiology laboratories should provide physicians with in vitro susceptibility monitoring results for antibiotic drugs used in hospitals in the form of periodic reports that describe the susceptibility characteristics of these hospital- and community-acquired pathogens. These reports will assist physicians in the rational use of antibiotic drugs to initiate therapy.
5) Dilution method:
Minimal inhibitory concentrations of antibiotics are determined using a quantitative method. TheseMIC allow estimation of bacterial susceptibility to antibiotics. It must be determined using standardized test methods (broth and / or agar) MIC. It should be judged based on the criteria listed in Table 8 of the MICvalues.
6) Diffusion method:
Quantitative methods that require measurement of inhibition ring diameter also provide reproducible valuation of bacterial susceptibility to antibiotics. The inhibition ring diameter provides a basis for estimating bacterial susceptibility to antibiotic compounds. A standard measurement method is also required to determine the diameter of the inhibition ring. Paper sheets impregnated with 5 µgciprofloxacin were used in this method to determine bacterial susceptibility to ciprofloxacin. Interpretation criteria for the paper diffusion method are provided in Table8.
Table8:Ciprofloxacin The drug sensitivity test interpretation criteria for
MIC(µg/mL)Inhibitory ring diameter (mm)bacteriaS S I R S I R Enterobacteriaceae≤1 2 ≥4 ≥21 16~20 ≤15 Enterococcus faecalis Enterococcus faecalis≤1 2 ≥4 ≥21 16~20 ≤15 Staphylococcus aureus≤1 2 ≥4 ≥21 16~20 ≤15 Epidermis Staphylococcus≤1 2 ≥4 ≥21 16~20 ≤15 Staphylococcus saprophyticus≤1 2 ≥4 ≥21 16~20 ≤15