Ciprofloxacin Tablets 500 mg | ciprofloxacin

20:19 EDT 25th October 2014 | BioPortfolio
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Fluoroquinolones, including CIPROFLOXACIN TABLETS USP, 250 mg, 500 mg and 750 mg, areassociated with an increased risk of tendinitis and tendon rupture in all ages. This risk is furtherincreased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, andin patients with kidney, heart or lung transplants (See WARNINGS).

IMAGE ciprofloxacin-str1.jpgIMAGE ciprofloxacin-str2.jpg

Dose (mg)
Maximum
Serum Concentrations
(μg/mL)
Area
Under Curve
(AUC)
(μg•hr/mL)
     250
     500
     750
     1000
                1.2
                2.4
                4.3
                5.4
         4.8
         11.6
         20.2
         30.8
Steady-state Pharmacokinetic Parameters
Following Multiple Oral and I.V. Doses
    Parameters

AUC (μg•hr/mL)
Cmax (μg/mL)
   500 mg
  q12h, P.O. 
      13.7a
       2.97
    400 mg
  q12h, I.V. 
      12.7a
       4.56
    750 mg
  q12h, P.O. 
      31.6b
       3.59
    400 mg
    q8h, I.V. 
      32.9c
       4.07
 MIC (μg/mL) Interpretation
   ≤ 1
   Susceptible   (S)    
     2
   Intermediate  (I)    
   ≥ 4
   Resistant       (R)    
MIC (μg/mL) Interpretation
         ≤ 1    
   Susceptible  (S)    
MIC (μg/mL) Interpretation
≤ 0.06
   Susceptible    (S)    
0.12 – 0.5
   Intermediate  (I)    
≥ 1
   Resistant       (R)    
Organism   MIC (μg/mL)
   E. faecalis
   ATCC 29212    
   0.25   – 2
   E. coli
   ATCC 25922    
   0.004 – 0.015
   H. influenzae a    ATCC 49247    
   0.004 – 0.03
   P. aeruginosa
   ATCC 27853    
   0.25  – 1.0
   S. aureus
   ATCC 29213    
   0.12   – 0.5
   C. jejuni b
   ATCC 33560    
   0.06 – 0.25 and 0.03 – 0.12    
   N. gonorrhoeae c    
   ATCC 49226    
   0.001– 0.008
Zone Diameter (mm) Interpretation
≥ 21
   Susceptible   (S)    
16 – 20
   Intermediate  (I)    
≤ 15
   Resistant       (R)    
Zone Diameter (mm) Interpretation
        ≥ 21
   Susceptible  (S)    
Zone Diameter (mm) Interpretation
≥41
   Susceptible   (S)    
28 – 40
   Intermediate  (I)    
≤ 27
   Resistant       (R)
Organism Zone Diameter (mm)
   E. coli
   ATCC 25922    
30-40
   H. influenzae a
   ATCC 49247    
34-42
   N. gonorrhoeae b
   ATCC 49226    
48-58
   P. aeruginosa
   ATCC 27853    
25-33
   S. aureus
   ATCC 25923    
22-30

Fluoroquinolones, including Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.

 

 

The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted (See PRECAUTIONS: Information for Patients and ADVERSE REACTIONS ).

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

 

Ciprofloxacin is indicated for the treatment of complicated urinary tract infections and pyelonephritis due to Escherichia coli. Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to the controls, including events related to joints and/or surrounding tissues. The rates of these events in pediatric patients with complicated urinary tract infection and pyelonephritis within six weeks of follow-up were 9.3% (31/335) versus 6% (21/349) for control agents. The rates of these events occurring at any time up to the one year follow-up were 13.7% (46/335) and 9.5% (33/349), respectively. The rate of all adverse events regardless of drug relationship at six weeks was 41% (138/335) in the ciprofloxacin arm compared to 31% (109/349) in the control arm. (See ADVERSE REACTIONS and CLINICAL STUDIES .)

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
1/36 (2.8%)
0/41
≥ 2 years < 6 years
5/124 (4%)
3/118 (2.5%)
≥ 6 years < 12 years
18/143 (12.6%)
12/153 (7.8%)
≥ 12 years to 17 years
7/32 (21.9%)
6/37 (16.2 %)
All Patients (within 1 year)
46/335 (13.7%)
33/349 (9.5%)
95% Confidence Interval*
(-0.6%, + 9.1%)
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
   250 mg    
q 12 h
   3 Days
   Mild/Moderate
   250 mg    
q 12 h
   7 to 14 Days
   Severe/Complicated
   500 mg    
q 12 h
   7 to 14 Days
   Chronic Bacterial Prostatits    
   Mild/Moderate
   500 mg    
q 12 h
   28 Days
   Lower Respiratory Tract
   Mild/Moderate
   500 mg    
q 12 h
   7 to 14 days
   Severe/Complicated
   750 mg    
q 12 h
   7 to 14 days
   Acute Sinusitis
   Mild/Moderate
   500 mg    
q 12 h
   10 days
   Skin and Skin Structure
   Mild/Moderate
   500 mg    
q 12 h
   7 to 14 Days
   Severe/Complicated
   750 mg    
q 12 h
   7 to 14 Days
   Bone and Joint
   Mild/Moderate
   500 mg    
q 12 h
   ≥4 to 6 weeks
   Severe/Complicated
   750 mg    
q 12 h
   ≥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
Equivalent AUC Dosing Regimens
Cipro Oral Dosage Equivalent Cipro I.V. Dosage
250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
Creatinine Clearance (mL/min) Dose
> 50
   See Usual Dosage.
30-50
   250-500 mg q 12 h
5-29
250-500 mg q 18 h

   Patients on hemodialysis   
   or Peritoneal dialysis    

   250-500 mg q 24 h   
   (after dialysis)
PEDIATRIC DOSAGE GUIDELINES
Infection Route of
Administration
Dose
(mg/kg)
Frequency Total
Duration
* 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.5 For a discussion of ciprofloxacin serum concentrations in various
   human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION .
  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

Ciprofloxacin Tablets are available as round biconvex white to slightly yellowish film coated tablets containing 250 mg of ciprofloxacin. The 250 mg tablet is embossed with the word "P" on one side and "250" on reverse side. The 500 mg and 750 mg tablet are available as capsule shaped, white to slightly yellowish film coated tablets with the word "P" embossed on one side and "500" or "750" on reverse side, respectively.

Store below 30°C (86°F).

Manufactured by:Unique Pharmaceutical LaboratoriesNeelam Centre, Hind Cycle Road Worli, Mumbai 400 025, India

Distributed by:PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089 USA

Strength NDC Code Tablet Identification
Bottles of 50: 250 mg
500 mg
750 mg
NDC 16571-411-05
NDC 16571-412-05
NDC 16571-413-05
P 250
P 500
P 750
Bottles of 100: 250 mg
500 mg
750 mg
NDC 16571-411-10
NDC 16571-412-10
NDC 16571-413-10
P 250
P 500
P 750
Bottles of 500: 250 mg
500 mg
750 mg
NDC 16571-411-50
NDC 16571-412-50
NDC 16571-413-50
P 250
P 500
P 750
Clinical Success and Bacteriologic Eradication at Test of Cure (5 to 9 Days Post-Therapy)
Ciprofloxacin Comparator
* 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.
   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%)

Read the Medication Guide that comes with Ciprofloxacin Tablets USP before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Ciprofloxacin Tablets USP belongs to a class of antibiotics called fluoroquinolones. Ciprofloxacin Tablets USP can cause side effects that may be serious or even cause death. If you get any of the following serious side effects, get medical help right away. Talk with your healthcare provider about whether you should continue to take Ciprofloxacin Tablets USP.

Tendon rupture or swelling of the tendon (tendinitis)

Ciprofloxacin Tablets USP is a fluoroquinolone antibiotic medicine used to treat certain infections caused by certain germs called bacteria.

Children less than 18 years of age have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking Ciprofloxacin Tablets USP. Ciprofloxacin Tablets USP should not be used as the first choice of a

Manufacturer

Preferred Pharmaceuticals, Inc

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