Ciprofloxacin description, usages, side effects, indications, overdosage, supplying and lots more!

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Ciprofloxacin

RedPharm Drug Inc.

Ciproflaxin Tablets


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

WARNING


Fluoroquinolones, including ciprofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (See WARNINGS).

Fluoroquinolones, including ciprofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis (see WARNINGS).


CIPROFLOXACIN DESCRIPTION


1718332Ciprofloxacin

171833Ciprofloxacin

CLINICAL PHARMACOLOGY

Absorption



Dose
      (mg)      		Maximum
      Serum Concentration     
(mcg/mL)		 Area
      Under Curve (AUC)     
(mcg•hr/mL)
250
500
750
1000
 1.2
2.4
4.3
5.4
 4.8
11.6
20.2
30.8



max
Steady-state Pharmacokinetic Parameters
Following Multiple Oral and I.V. Doses
aAUC 0-12h
bAUC 24h=AUC0-12h x 2
cAUC 24h=AUC0-8h x 3
Parameters
 500 mg
 q12h, P.O.
400 mg
 q12h, I.V.
750 mg
 q12h, P.O.
400 mg
 q8h, I.V.

      AUC (mcg•hr/mL)      
Cmax (mcg/mL)
      13.7a     
2.97

      12.7a     
4.56

     31.6b     
3.59

     32.9c     
4.07

Distribution




Metabolism


CONTRAINDICATIONS ; WARNINGS; PRECAUTIONS : Drug Interactions

Excretion







Drug-drug Interactions


PRECAUTIONS



CONTRAINDICATIONS WARNINGS: PRECAUTIONS

Special Populations


max PRECAUTIONS: Geriatric Use

DOSAGE AND ADMINISTRATION



maxmaxmax

MICROBIOLOGY


in vitro In vitro

in vitro.

in vitro INDICATIONS AND USAGE

Aerobic gram-positive microorganisms

Enterococcus faecalis
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus saprophyticus
Streptococcus pneumoniae
Streptococcus pyogenes

Aerobic gram-negative microorganisms

Campylobacter jejuni                               Proteus mirabilis
Citrobacter diversus                                 Proteus vulgaris
Citrobacter freundii                                  Providencia rettgeri
Enterobacter cloacae                               Providencia stuartii
Escherichia coli                                        Pseudomonas aeruginosa
Haemophilus influenzae                           Salmonella typhi
Haemophilus parainfluenzae                   Serratia marcescens
Klebsiella pneumoniae                             Shigella boydii
Moraxella catarrhalis                              Shigella dysenteriae
Morganella morganii                               Shigella flexneri
Neisseria gonorrhoeae                            Shigella sonnei

Bacillus anthracis in vitro INDICATIONS AND USAGE INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION

in vitro but their clinical significance is unknown.

in vitro

Aerobic gram-positive microorganisms

Staphylococcus haemolyticus
Staphylococcus hominis
Streptococcus pneumoniae

Aerobic gram-negative microorganisms

Acinetobacter Iwoffi                         Pasteurella multocida
Aeromonas hydrophila                     Salmonella enteritidis
Edwardsiella tarda                          Vibrio cholerae
Enterobacter aerogenes                  Vibrio parahaemolyticus
Klebsiella oxytoca                           Vibrio vulnificus
Legionella pneumophila                  Yersinia enterocolitica


Burkholderia cepacia Stenotrophomonas maltophilia Bacteroides fragilis Clostridium difficile.

Susceptibility Tests


Dilution Techniques
 
1

Enterobacteriaceae,Enterococcus faecalis,Staphylococcus Streptococcus pneumoniae, Streptococcus pyogenes,Pseudomonas aeruginosaa
      MIC (mcg/mL)            Interpretation     
≤ 1
2
≥ 4
 Susceptible  (S)
Intermediate (I)
Resistant      (R)
a

Haemophilus influenzae Haemophilus parainfluenzaeb 
      MIC (mcg/mL)            Interpretation     
≤ 1
Susceptible  (S)

b Haemophilus influenzae Haemophilus parainfluenzae Haemophilus 1



Neisseria gonorrhoeaec
      MIC (mcg/mL)            Interpretation     
≤ 0.06
0.12 – 0.5
≥ 1
 Susceptible  (S)
Intermediate (I)
Resistant      (R)
c




  Organism              MIC (mcg/mL)     
a This quality control range is applicable to only H. influenzae ATCC 49247 tested by a broth microdilution procedure using Haemophilus Test Medium (HTM)1.
b C. jejuni ATCC 33560 tested by broth microdilution procedure using cation adjusted Mueller Hinton broth with 2.5 to 5%  lysed horse blood in a microaerophilic environment at 36 to 37oC for 48 hours and for 42oC at 24 hours2, respectively.
c N. gonorrhoeae ATCC 49226 tested by agar dilution procedure using GC agar and 1% defined growth supplement in a 5% CO2 environment at 35 to 37oC for 20 to 24 hours3.
 E. faecalis
 E. coli
 H. influenzae a
 P. aeruginosa
 S. aureus
 C. jejuni b
 N. gonorrhoeae c
ATCC 29212
ATCC 25922
ATCC 49247
ATCC 27853
ATCC 29213
ATCC 33560
ATCC 49226
             0.25   – 2
            0.004 – 0.015
            0.004 – 0.03
            0.25   – 1
            0.12   – 0.5
            0.06 – 0.25 and 0.03 – 0.12
            0.001 – 0.008


Diffusion Techniques 

3




EnterobacteriaceaeEnterococcus faecalisStaphylococcusStreptococcus pneumoniaeStreptococcus pyogenesPseudomonas aeruginosaa
      Zone Diameter (mm)               Interpretation        
≥ 21
16 – 20
≤ 15
 Susceptible  (S)
Intermediate (I)
Resistant      (R)
a 2

Haemophilus influenzae Haemophilus parainfluenzaeb:
      Zone Diameter (mm)               Interpretation        
≥ 21
Susceptible  (S)
b Haemophilus influenzae Haemophilus parainfluenzae Haemophilus 3



Neisseria gonorrhoeaec
      Zone Diameter (mm)               Interpretation        
≥ 41
28 – 40
≤ 27
 Susceptible  (S)
Intermediate (I)
Resistant      (R)
c




  Organism              Zone Diameter (mm)     
a These quality control limits are applicable to only H. influenzae ATCC 49247 testing using
  Haemophilus Test Medium (HTM)3.
b These quality control limits are applicable only to tests conducted with N. gonorrhoeae
  ATCC 49226 performed by disk diffusion using GC agar base and 1% defined growth supplement.
 E. coli
 H. influenzae a
 N. gonorrhoeae b
 P. aeruginosa
 S. aureus
ATCC 25922
ATCC 49247
ATCC 49226
ATCC 27853
ATCC 25923
 30 – 40
34 – 42
48 – 58
25 – 33
22 – 30

CIPROFLOXACIN INDICATIONS AND USAGE


DOSAGE AND ADMINISTRATION

Adult Patients


Urinary Tract Infections Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus epidermidis, Staphylococcus saprophyticus, Enterococcus faecalis.

Acute Uncomplicated Cystitis in females Escherichia coli Staphylococcus saprophyticus.

Chronic Bacterial Prostatitis Escherichia coli Proteus mirabilis.

Lower Respiratory Tract Infections Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pneumoniae. Moraxella catarrhalis

Streptococcus pneumoniae.

Acute Sinusitis Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis.

Skin and Skin Structure Infections Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes.

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

Complicated Intra-Abdominal Infections Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, Bacteroides fragilis.

Infectious Diarrhea Escherichia coli Campylobacter jejuni, Shigella boydii†, Shigella dysenteriae, Shigella flexneri Shigella sonnei†

Typhoid Fever (Enteric Fever) Salmonella typhi.



Uncomplicated cervical and urethral gonorrhea Neisseria gonorrhoeae.

Pediatric patients (1 to 17 years of age)

Complicated Urinary Tract Infections and Pyelonephritis Escherichia coli.

WARNINGS, PRECAUTIONS, Pediatric Use, ADVERSE REACTIONS CLINICAL STUDIES ANIMAL PHARMACOLOGY

Adult and Pediatric Patients


Inhalational anthrax Bacillus anthracis.

5 INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).

†

Pseudomonas aeruginosa

CIPROFLOXACIN CONTRAINDICATIONS




PRECAUTIONS: Drug Interactions .

WARNINGS

Tendinopathy and Tendon Rupture


Exacerbation of Myasthenia Gravis


PRECAUTIONS: Information for Patients ADVERSE REACTIONS: Post-Marketing Adverse Event Reports.

Pregnant Women


THE SAFETY AND EFFECTIVENESS OF CIPROFLOXACIN IN PREGNANT AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED. PRECAUTIONS: Pregnancy, Nursing Mothers

Pediatrics


INDICATIONS AND USAGE ADVERSE REACTIONS

ANIMAL PHARMACOLOGY

Cytochrome P450 (CYP450)


Central Nervous System Disorders


PRECAUTIONS: General, Information for Patients, Drug Interactions ADVERSE REACTIONS

Theophylline


SERIOUS AND FATAL REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AND THEOPHYLLINE.

Hypersensitivity Reactions





  • 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.
PRECAUTIONS: Information for Patients ADVERSE REACTIONS

Pseudomembranous Colitis


Clostridium difficile C. difficile.

C. difficile C. difficile

C. difficile C. difficile

Peripheral neuropathy


Syphilis


PRECAUTIONS

General


ANIMAL PHARMACOLOGY

Central Nervous System


WARNINGS, Information for Patients, Drug Interactions

Renal Impairment


DOSAGE AND ADMINISTRATION

Photosensitivity/Phototoxicity


ADVERSE REACTIONS/Post-Marketing Adverse Events



Information for Patients


  • to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue ciprofloxacin treatment. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
  • that fluoroquinolones like ciprofloxacin may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Patients should call their healthcare provider right away if they have any worsening muscle weakness or breathing problems.
  • that antibacterial drugs including ciprofloxacin tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ciprofloxacin tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ciprofloxacin tablets or other antibacterial drugs in the future.
  • that ciprofloxacin may be taken with or without meals and to drink fluids liberally. As with other quinolones, concurrent administration of ciprofloxacin with magnesium/aluminum antacids, or sucralfate, didanosine chewable/buffered tablets or pediatric powder, other highly buffered drugs, or with other products containing calcium, iron or zinc should be avoided. Ciprofloxacin may be taken two hours before or six hours after taking these products. Ciprofloxacin should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone since absorption of ciprofloxacin may be significantly reduced; however, ciprofloxacin may be taken with a meal that contains these products.
  • that ciprofloxacin may be associated with hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash or other allergic reaction.
  • that photosensitivity/phototoxicity has been reported in patients receiving quinolones. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking quinolones. If patients need to be outdoors while using quinolones, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. If a sunburn-like reaction or skin eruption occurs, patients should contact their physician.
  • that peripheral neuropathies have been associated with ciprofloxacin use. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, they should discontinue treatment and contact their physicians.                       
  • that ciprofloxacin may cause dizziness and lightheadedness; therefore, patients should know how they react to this drug before they operate an automobile or machinery or engage in activities requiring mental alertness or coordination.
  • that ciprofloxacin increases the effects of tizanidine. Patients should not use ciprofloxacin if they are already taking tizanidine.
  • that ciprofloxacin may increase the effects of theophylline and caffeine. There is a possibility of caffeine accumulation when products containing caffeine are consumed while taking quinolones.
  • that convulsions have been reported in patients receiving quinolones, including ciprofloxacin, and to notify their physician before taking this drug if there is a history of this condition.
  • that ciprofloxacin has been associated with an increased rate of adverse events involving joints and surrounding tissue structures (like tendons) in pediatric patients (less than 18 years of age). Parents should inform their child’s physician if the child has a history of joint-related problems before taking this drug. Parents of pediatric patients should also notify their child’s physician of any joint-related problems that occur during or following ciprofloxacin therapy. (See WARNINGS, PRECAUTIONS, Pediatric Use and ADVERSE REACTIONS .)
  • that diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Drug Interactions


max

WARNINGS



DOSAGE AND ADMINISTRATION

2















Carcinogenesis, Mutagenesis, Impairment of Fertility


in vitro


E. coli

79

Saccharomyces cerevisiae
Saccharomyces cerevisiae


in vivo





2

24



2

Pregnancy

Teratogenic Effects. Pregnancy Category C


8

9 In utero

10in utero

8,9 WARNINGS

22 WARNINGS

Nursing Mothers


Pediatric Use


ANIMAL PHARMACOLOGY

Inhalational Anthrax (Post-Exposure)


DOSAGE AND ADMINISTRATION INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION

Complicated Urinary Tract Infection and Pyelonephritis


Escherichia coli. ADVERSE REACTIONS CLINICAL STUDIES

Cystic Fibrosis




Geriatric Use


Boxed Warning, WARNINGS, ADVERSE REACTIONS/Post-Marketing Adverse Event Reports).

CLINICAL PHARMACOLOGY DOSAGE AND ADMINISTRATION

CIPROFLOXACIN ADVERSE REACTIONS

Side Effects in Adult Patients








BODY AS A WHOLE:

CARDIOVASCULAR:

CENTRAL NERVOUS SYSTEM:

GASTROINTESTINAL:

HEMIC/LYMPHATIC:

METABOLIC/NUTRITIONAL:

MUSCULOSKELETAL:

RENAL/UROGENITAL:

RESPIRATORY:

SKIN/HYPERSENSITIVITY:

SPECIAL SENSES:



Side Effects in Pediatric Patients







Findings Involving Joint or Peri-articular Tissues as Assessed by the IPSC
Ciprofloxacin Comparator
* The study was designed to demonstrate that the arthropathy rate for the ciprofloxacin group did not exceed that of the control group by more than + 6%. At both the 6 week and 1 year evaluations, the 95% confidence interval indicated that it could not be concluded that ciprofloxacin group had findings comparable to the control group.
All Patients
(within 6 weeks)
 31/335 (9.3%)
 21/349 (6%)
95% Confidence Interval*
(-0.8%, +7.2%)
Age Group
≥ 12 months < 24 months
≥ 2 years < 6 years
≥ 6 years < 12 years
≥ 12 years to 17 years
1/36 (2.8%)
5/124 (4%)
18/143 (12.6%)
7/32 (21.9%)
 0/41
3/118 (2.5%)
12/153 (7.8%)
6/37 (16.2 %)
All Patients (within 1 year)
46/335 (13.7%)
 33/349 (9.5%)
95% Confidence Interval*
(-0.6%, + 9.1%)



In this trial, the overall incidence rates of adverse events regardless of relationship to study drug and within 6 weeks of treatment initiation were 41% (138/335) in the ciprofloxacin group versus 31% (109/349) in the comparator group. The most frequent events were gastrointestinal: 15% (50/335) of ciprofloxacin patients compared to 9% (31/349) of comparator patients. Serious adverse events were seen in 7.5% (25/335) of ciprofloxacin-treated patients compared to 5.7% (20/349) of control patients. Discontinuation of drug due to an adverse event was observed in 3% (10/335) of ciprofloxacin-treated patients versus 1.4% (5/349) of comparator patients. Other adverse events that occurred in at least 1% of ciprofloxacin patients were diarrhea 4.8%, vomiting 4.8%, abdominal pain 3.3%, accidental injury 3%, rhinitis 3%, dyspepsia 2.7%, nausea 2.7%, fever 2.1%, asthma 1.8% and rash 1.8%.

In addition to the events reported in pediatric patients in clinical trials, it should be expected that events reported in adults during clinical trials or post-marketing experience may also occur in pediatric patients.

Post-Marketing Adverse Event Reports




PRECAUTIONS

INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION .

Adverse Laboratory Changes











OVERDOSAGE






CIPROFLOXACIN DOSAGE AND ADMINISTRATION

ADULTS







ADULT DOSAGE GUIDELINES
Infection Severity      Dose       Frequency    Usual Durations† 
*  used in conjunction with metronidazole
†   Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** 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.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION .
   Urinary Tract
   Acute Uncomplicated 
   Mild/Moderate 
   Severe/Complicated
250 mg
250 mg
500 mg
 q 12 h
q 12 h
q 12 h
     3 Days 
    7 to 14 Days
    7 to 14 Days
   Chronic Bacterial Prostatitis    
    Mild/Moderate
500 mg
 q 12 h
     28 Days
   Lower Respiratory Tract    
    Mild/Moderate 
   Severe/Complicated
500 mg
750 mg
 q 12 h
q 12 h
     7 to 14 days 
    7 to 14 days
   Acute Sinusitis    
    Mild/Moderate
500 mg
 q 12 h
     10 days
   Skin and Skin Structure    
    Mild/Moderate 
   Severe/Complicated
500 mg
750 mg
 q 12 h
q 12 h
     7 to 14 Days 
    7 to 14 Days
   Bone and Joint    
    Mild/Moderate 
   Severe/Complicated
500 mg
750 mg
 q 12 h
q 12 h
     ≥ 4 to 6 weeks
    ≥ 4 to 6 weeks
   Intra-Abdominal*    
    Complicated
500 mg
 q 12 h
     7 to 14 Days
   Infectious Diarrhea    
    Mild/Moderate/Severe
500 mg
 q 12 h
     5 to 7 Days
   Typhoid Fever    
    Mild/Moderate
500 mg
 q 12 h
     10 Days
   Urethral and Cervical 
   Gonococcal Infections    
    Uncomplicated
250 mg
 single dose
     single dose
   Inhalational anthrax    
   (post-exposure)**   
  
500 mg
 q 12 h
     60 Days


Conversion of I.V. to Oral Dosing in Adults

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

Adults with Impaired Renal Function

RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
           Creatinine Clearance (mL/min)          Dose
> 50
30 – 50
5 – 29
Patients on hemodialysis or
Peritoneal dialysis
    See Usual Dosage.   
            250 – 500 mg q 12 h          
   250 – 500 mg q 18 h   
   250 – 500 mg q 24 h   
   (after dialysis)   



Weight (kg) x (140 - age)






PEDIATRICS

Ciprofloxacin tablets should be administered orally 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. (See ADVERSE REACTIONS and CLINICAL STUDIES .)




* 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).

** 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.5For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION .

PEDIATRIC DOSAGE GUIDELINES
Infection
 Route of
Administration
 Dose
(mg/kg)
 Frequency
 Total
Duration
Complicated
Urinary Tract
or
Pyelonephritis
 Intravenous
 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*
(patients from 1 to 17 years of age)
 Oral
 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
Inhalational
Anthrax
(Post-
Exposure)**
 Intravenous
 10 mg/kg
(maximum 400 mg per
dose)
 Every 12
hours
 60 days
Oral
 15 mg/kg
(maximum 500 mg per dose)
 Every 12 hours

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).

HOW SUPPLIED


Ciprofloxacin Tablets USP, 250 mg





Ciprofloxacin Tablets USP, 500 mg





Store at

ANIMAL PHARMACOLOGY


WARNINGS

22





CLINICAL STUDIES

Complicated Urinary Tract Infection and Pyelonephritis – Efficacy in Pediatric Patients









Clinical Success and Bacteriologic Eradication at Test of Cure (5 to 9 Days Posy- Therapy)
*Patients with baseline pathogen(s) eradicated and no new infections or superinfections/total number of patients. There were 5.5% (6/211) ciprofloxacin and 9.5% (22/231) comparator patients with superinfections or new infections.
 
 Ciprofloxacin
Comparator
Randomized Patients
337
 352
Per Protocol Patients
211
 231
Clinical Response at 5 to 9 Days
Post-Treatment
95.7% (202/211)
 92.6% (214/231)
 
 95% CI [-1.3%, 7.3%]
Bacteriologic Eradication by
Patient at 5 to 9 Days
Post-Treatment*
84.4% (178/211)
 78.3% (181/231)
 
 95% CI [-1.3%, 13.1%]
Bacteriologic Eradication of the
Baseline Pathogen at 5 to 9 Days
Post-Treatment
 
Escherichia coli
156/178 (88%)
 161/179 (90%)

 

INHALATIONAL ANTHRAX IN ADULTS AND PEDIATRICS – ADDITIONAL INFORMATION


DOSAGE AND ADMINISTRATION PRECAUTIONS, Pediatric Use 5

50550B. anthracis max67

B. anthracis

REFERENCES

  •  National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically-Fifth Edition. Approved Standard NCCLS Document M7-A5, Vol. 20, No. 2, NCCLS, Wayne, PA, January, 2000.
  • Clinical and Laboratory Standards Institute, Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline., CLSI Document M45-A, Vol. 26, No. 19, CLSI, Wayne, PA, 2006.
  • National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests-Seventh Edition. Approved Standard NCCLS Document M2-A7, Vol. 20, No. 1, NCCLS, Wayne, PA, January, 2000.
  • Report presented at the FDA’s Anti-Infective Drug and Dermatological Drug Product’s Advisory Committee meeting, March 31, 1993, Silver Spring, MD. Report available from FDA, CDER, Advisors and Consultants Staff, HFD-21, 1901 Chapman Avenue, Room 200, Rockville, MD 20852, USA.
  • 21 CFR 314.510 (Subpart H – Accelerated Approval of New Drugs for Life-Threatening Illnesses).
  • Kelly DJ, et al. Serum concentrations of penicillin, doxycycline, and ciprofloxacin during prolonged therapy in rhesus monkeys. J Infect Dis 1992; 166:1184-7.
  • Friedlander AM, et al. Postexposure prophylaxis against experimental inhalational anthrax. J Infect Dis 1993; 167:1239-42.
  • Friedman J, Polifka J. Teratogenic effects of drugs: a resource for clinicians (TERIS). Baltimore, Maryland: Johns Hopkins University Press, 2000:149-195.
  • Loebstein R, Addis A, Ho E, et al. Pregnancy outcome following gestational exposure to fluoroquinolones: a multicenter prospective controlled study. Antimicrob Agents Chemother. 1998;42(6):1336-1339.
  • Schaefer C, Amoura-Elefant E, Vial T, et al. Pregnancy outcome after prenatal quinolone exposure. Evaluation of a case registry of the European network of teratology information services (ENTIS). Eur J Obstet Gynecol Reprod Biol. 1996;69:83-89.

 



Aurolife Pharma LLC



Aurobindo Pharma USA, Inc.


Revised: 03/2011

MEDICATION GUIDE



Ciprofloxacin Tablets, USP

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




  • Tendon rupture or swelling of the tendon (tendinitis)
    • Tendons are tough cords of tissue that connect muscles to bones.
    • Pain, swelling, tears, and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites can happen in people of all ages who take fluoroquinolone antibiotics, including ciprofloxacin tablets. The risk of getting tendon problems is higher if you:
      • are over 60 years of age
      • are taking steroids (corticosteroids)
      • have had a kidney, heart, or lung transplant.
    • Swelling of the tendon (tendinitis) and tendon rupture (breakage) have also happened in patients who take fluoroquinolones who do not have the above risk factors.
    • Other reasons for tendon ruptures can include:
      • physical activity or exercise
      • kidney failure
      • tendon problems in the past, such as in people with rheumatoid arthritis (RA)
  • Call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop taking ciprofloxacin tablets until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons. Talk to your healthcare provider about the risk of tendon rupture with continued use of ciprofloxacin tablets. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.
  • Tendon rupture can happen while you are taking or after you have finished taking ciprofloxacin tablets. Tendon ruptures have happened up to several months after patients have finished taking their fluoroquinolone.
  • Get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
    • hear or feel a snap or pop in a tendon area
    • bruising right after an injury in a tendon area
    • unable to move the affected area or bear weight 
  • Worsening of myasthenia gravis (a disease which causes muscle weakness). Fluoroquinolones like ciprofloxacin tablets may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

See the section “What are the possible side effects of ciprofloxacin tablets?” for more information about side effects.

What are ciprofloxacin tablets?










Who should not take ciprofloxacin tablets?


  • have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or are allergic to any of the ingredients in ciprofloxacin tablets. Ask your healthcare provider if you are not sure. See the list of ingredients in ciprofloxacin tablets at the end of this Medication Guide.
  • also take a medicine called tizanidine. Serious side effects from tizanidine are likely to happen.

What should I tell my healthcare provider before taking ciprofloxacin tablets?


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

Tell your healthcare provider about all your medical conditions, including if you: 
  • have tendon problems
  • have central nervous system problems (such as epilepsy)
  • have nerve problems
  • have or anyone in your family has an irregular heartbeat, especially a condition called “QT prolongation”
  • have a history of seizures
  • have kidney problems. You may need a lower dose of ciprofloxacin tablets if your kidneys do not work well.
  • have rheumatoid arthritis (RA) or other history of joint problems
  • have trouble swallowing pills
  • are pregnant or planning to become pregnant. It is not known if ciprofloxacin tablets will harm your unborn child.
  • are breast-feeding or planning to breast-feed. Ciprofloxacin passes into breast milk. You and your healthcare provider should decide whether you will take ciprofloxacin tablets or breastfeed.


Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal and dietary supplements. Ciprofloxacin tablets and other medicines can affect each other causing side effects.  The risk of getting tendon problems is higher if you:


Ask your healthcare provider if you are not sure if any of your medicines are listed above.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take ciprofloxacin tablets?


  • Take ciprofloxacin tablets exactly as prescribed by your healthcare provider.
  • Take ciprofloxacin tablets in the morning and evening at about the same time each day. Swallow the tablet whole. Do not split, crush or chew the tablet. Tell your healthcare provider if you can not swallow the tablet whole.
  • Ciprofloxacin tablets can be taken with or without food.
  • Ciprofloxacin tablets should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone, but may be taken with a meal that contains these products.
  • Drink plenty of fluids while taking ciprofloxacin tablets.
  • Do not skip any doses, or stop taking ciprofloxacin tablets even if you begin to feel better, until you finish your prescribed treatment, unless:  



  • If you miss a dose of ciprofloxacin tablets, take them as soon as you remember. Do not take two doses at the same time, and do not take more than two doses in one day.
  • If you take too much, call your healthcare provider or get medical help immediately.


If you have been prescribed ciprofloxacin tablets after being exposed to anthrax:

  • Ciprofloxacin tablets have been approved to lessen the chance of getting anthrax disease or worsening of the disease after you are exposed to the anthrax bacteria germ.
  • Take ciprofloxacin tablets exactly as prescribed by your healthcare provider. Do not stop taking ciprofloxacin tablets without talking with your healthcare provider. If you stop taking ciprofloxacin tablets too soon, it may not keep you from getting the anthrax disease.
  • Side effects may happen while you are taking ciprofloxacin tablets. When taking your ciprofloxacin tablets to prevent anthrax infection, you and your healthcare provider should talk about whether the risks of stopping ciprofloxacin tablets too soon are more important than the risks of side effects with ciprofloxacin tablets.
  • If you are pregnant, or plan to become pregnant while taking ciprofloxacin tablets, you and your healthcare provider should decide whether the benefits of taking ciprofloxacin tablets for anthrax are more important than the risks.

What should I avoid while taking ciprofloxacin tablets?

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

What are the possible side effects of ciprofloxacin tablets?




  • Central Nervous System Effects

Seizures have been reported in people who take fluoroquinolone antibiotics including ciprofloxacin tablets. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking ciprofloxacin tablets will change your risk of having a seizure.

Central Nervous System (CNS) side effects may happen as soon as after taking the first dose of ciprofloxacin tablets. Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:

  • feel dizzy
  • seizures
  • hear voices, see things, or sense things that are not there (hallucinations)
  • feel restless
  • tremors
  • feel anxious or nervous
  • confusion
  • depression
  • trouble sleeping
  • nightmares
  • feel more suspicious (paranoia)
  • suicidal thoughts or acts

 

  • Serious allergic reactions

Allergic reactions can happen in people taking fluoroquinolones, including ciprofloxacin tablets, even after only one dose. Stop taking ciprofloxacin tablets and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:  

  • hives
  • trouble breathing or swallowing
  • swelling of the lips, tongue, face
  • throat tightness, hoarseness
  • rapid heartbeat
  • faint
  • yellowing of the skin or eyes. Stop taking ciprofloxacin tablets and tell your healthcare provider right away if you get yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to ciprofloxacin tablets (a liver problem).

 

  • Skin rash



  • Serious heart rhythm changes (QT prolongation and torsade de pointes)

  • who are elderly
  • with a family history of prolonged QT interval
  • with low blood potassium (hypokalemia)
  • who take certain medicines to control heart rhythm (antiarrhythmics)

  • Intestine infection (Pseudomembranous colitis)



  • Changes in sensation and possible nerve damage (Peripheral Neuropathy)

Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including ciprofloxacin tablets. Talk with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:

  • pain
  • burning
  • tingling
  • numbness
  • weakness




  • Low blood sugar (hypoglycemia)



  • Sensitivity to sunlight (photosensitivity)

See “ What should I avoid while taking ciprofloxacin tablets? ”

 

  • Joint Problems

Increased chance of problems with joints and tissues around joints in children under 18 years old. Tell your child’s healthcare provider if your child has any joint problems during or after treatment with ciprofloxacin tablets.

The most common side effects of ciprofloxacin tablets include:

  • nausea
  • headache
  • diarrhea
  • vomiting
  • vaginal yeast infection
  • changes in liver function tests
  • pain or discomfort in the abdomen

These are not all the possible side effects of ciprofloxacin tablets. Tell your healthcare provider about any side effect that bothers you, or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ciprofloxacin tablets?


Store at

Keep ciprofloxacin tablets and all medicines out of the reach of children.

General information about ciprofloxacin tablets




What are the ingredients in ciprofloxacin tablets?











Aurolife Pharma LLC



Aurobindo Pharma USA, Inc.


Ciprofloxacin

Ciprofloxacin

Ciprofloxacin TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:67296-0579(NDC:13107-077)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Ciprofloxacin CIPROFLOXACIN 500 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE K30
SILICON DIOXIDE
MAGNESIUM STEARATE
Hypromellose 2910 (5 Mpa.s)
polyethylene glycol 400
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white (white to off-white) 18 mm C;94 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67296-0579-2 10 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077859 2009-08-01


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