CIPROFLOXACIN  - ciprofloxacin hydrochloride tablet 
Pack Pharmaceuticals, LLC

----------

Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg

WARNING:

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 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).


DESCRIPTION


17 18 3 3 2
Chemical Structure

17 18 3 3
Chemical Structure

CLINICAL PHARMACOLOGY

Absorption:




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


max
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
a 0-12h
b 0-12h
c 0-8h

Distribution:





Metabolism:


CONTRAINDICATIONS ; WARNINGS; PRECAUTIONS: Drug Interactions

Excretion:



Drug-drug Interactions:


PRECAUTIONS



CONTRAINDICATIONS.

WARNINGS: PRECAUTIONS

Special Populations:


max PRECAUTIONS: Geriatric Use

DOSAGE AND ADMINISTRATION


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 Iwoffii                   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

Haemophilus influenzae Haemophilus parainfluenzae Neisseria gonorrhoeae a
 MIC (μg/mL) Interpretation
   ≤ 1
   Susceptible   (S)    
     2
   Intermediate  (I)    
   ≥ 4
   Resistant       (R)    

a

Haemophilus influenzae Haemophilus parainfluenzae b
MIC (μg/mL) Interpretation
         ≤ 1    
   Susceptible  (S)    

b Haemophilus influenzae Haemophilus parainfluenzae Haemophilus 1



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

c



Organism   MIC (μg/mL)
   E. faecalis
   ATCC 29212    
   0.25   – 2
   E. coli
   ATCC 25922    
   0.004 – 0.015
   H. influenzaea    ATCC 49247    
   0.004 – 0.03
   P. aeruginosa
   ATCC 27853    
   0.25  – 1.0
   S. aureus
   ATCC 29213    
   0.12   – 0.5
   C. jejunib
   ATCC 33560    
   0.06 – 0.25 and 0.03 – 0.12    
   N. gonorrhoeaec    
   ATCC 49226    
   0.001– 0.008

a H. influenzae Haemophilus 1
b C. jejuni 2
c N. gonorrhoeae 2 3

Diffusion Techniques:


3



Enterobacteriaceae Enterococcus faecalis Staphylococcus Streptococcus pneumoniae Streptococcus pyogenes Pseudomonas aeruginosa a
Zone Diameter (mm) Interpretation
≥ 21
   Susceptible   (S)    
16 – 20
   Intermediate  (I)    
≤ 15
   Resistant       (R)    

a 2

Haemophilus influenzae Haemophilus parainfluenzae b

Zone Diameter (mm) Interpretation
        ≥ 21
   Susceptible  (S)    

b Haemophilus influenzae Haemophilus parainfluenzae Haemophilus 3



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

c




Organism Zone Diameter (mm)
   E. coli
   ATCC 25922    
30-40
   H. influenzaea
   ATCC 49247    
34-42
   N. gonorrhoeaeb
   ATCC 49226    
48-58
   P. aeruginosa
   ATCC 27853    
25-33
   S. aureus
   ATCC 25923    
22-30

a H. influenzae Haemophilus 3
b N. gonorrhoeae

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

CONTRAINDICATIONS




PRECAUTIONS: Drug Interactions .

WARNINGS

Tendinopathy and Tendon Rupture:

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.

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:




 

 

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).

Pseudomembranous Colitis:

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.

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:


 

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

2 4



2

Pregnancy


Teratogenic Effects


Pregnancy Category C:

8

9 In utero

10 in utero

8,9 WARNINGS

2 2 WARNINGS

Nursing Mothers:


Pediatric Use:


ANIMAL PHARMACOLOGY

Inhalational Anthrax (Post-Exposure)


DOSAGE AND ADMINISTRATION INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION

Complicated Urinary Tract Infection and Pyelonephritis

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.)

Cystic Fibrosis


Geriatric Use:


BOXED WARNING, WARNINGS, ADVERSE REACTIONS/Post-Marketing Adverse Event Reports).

CLINICAL PHARMACOLOGY DOSAGE AND ADMINISTRATION

ADVERSE REACTIONS

Adverse Reactions in Adult Patients:
































Adverse Reactions 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
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%)





Post-Marketing Adverse Event Reports:




PRECAUTIONS

INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION .

Adverse Laboratory Changes:










OVERDOSAGE






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
   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

Conversion of I.V. to Oral Dosing in Adults:

CLINICAL PHARMACOLOGY
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

Adults with Impaired Renal Function:



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)



Weight (kg) x (140 - age)







DOSAGE AND ADMINISTRATION - PEDIATRICS


ADVERSE REACTIONS CLINICAL STUDIES


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

2

HOW SUPPLIED

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.

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

Store below 30°C (86°F).

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

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

ANIMAL PHARMACOLOGY


WARNINGS

2 2





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 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%)

INHALATIONAL ANTHRAX IN ADULTS AND PEDIATRICS – ADDITIONAL INFORMATION


DOSAGE AND ADMINISTRATION PRECAUTIONS, Pediatric Use 5

50 5 50 B. anthracis max 6 7

B. anthracis

REFERENCES:



  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 21 CFR 314.510 (Subpart H – Accelerated Approval of New Drugs for Life-Threatening Illnesses).
  6. Kelly DJ, et al. Serum concentrations of penicillin, doxycycline, and ciprofloxacin during prolonged therapy in rhesus monkeys. J Infect Dis 1992; 166:1184-7.
  7. Friedlander AM, et al. Postexposure prophylaxis against experimental inhalational anthrax. J Infect Dis 1993; 167:1239-42.
  8. Friedman J, Polifka J. Teratogenic effects of drugs: a resource for clinicians (TERIS). Baltimore, Maryland: Johns Hopkins University Press, 2000:149-195.
  9. 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.
  10. 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.

Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg

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.

What is the most important information I should know about Ciprofloxacin Tablets USP ?

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)


What is Ciprofloxacin Tablets USP?

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 antibiotic medicine in children under 18 years of age.

Ciprofloxacin Tablets USP should not be used in children under 18 years old, except to treat specific serious infections, such as complicated urinary tract infections and to prevent anthrax disease after breathing the anthrax bacteria germ (inhalational exposure). It is not known if Ciprofloxacin Extended Release Tablets are safe and work in children under 18 years of age.

Sometimes infections are caused by viruses rather than by bacteria. Examples include viral infections in the sinuses and lungs, such as the common cold or flu. Antibiotics, including Ciprofloxacin Tablets USP, do not kill viruses.

Call your healthcare provider if you think your condition is not getting better while you are taking Ciprofloxacin Tablets USP.

Who should not take Ciprofloxacin Tablets USP?

Do not take Ciprofloxacin Tablets USP if you:

What should I tell my healthcare provider before taking Ciprofloxacin Tablets USP?

See “What is the most important information I should know about Ciprofloxacin Tablets USP?”

Tell your healthcare provider about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal and dietary supplements. Ciprofloxacin Tablets USP and other medicines can affect each other causing side effects. Especially tell your healthcare provider if you take:

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 USP?

If you have been prescribed Ciprofloxacin Tablets USP after being exposed to anthrax:

What should I avoid while taking Ciprofloxacin Tablets USP?

What are the possible side effects of Ciprofloxacin Tablets USP?


Other serious side effects of Ciprofloxacin Tablets USP include:

These are not all the possible side effects of Ciprofloxacin Tablets USP. 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 USP?

Keep Ciprofloxacin Tablets USP and all medicines out of the reach of children.

General Information about Ciprofloxacin Tablets USP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Ciprofloxacin Tablets USP for a condition for which it is not prescribed. Do not give Ciprofloxacin Tablets USP to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Ciprofloxacin Tablets USP. If you would like more information about CIPRO, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Ciprofloxacin Tablets USP that is written for healthcare professionals.

For more information 1-(866)-562-4597

What are the ingredients in Ciprofloxacin Tablets USP?

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:
Unique Pharmaceutical Laboratories
(A Div. of J. B. Chemicals & Pharmaceuticals Ltd)
Mumbai 400 030, India

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg (100 Tablet Bottle)

Rx only       100 Tablets

Pack Pharmaceuticals, LLC

NDC 16571-411-10

Ciprofloxacin Tablets USP 250 mg*

Attention: Dispense with a Medication Guide

* Each tablet contains:
Ciprofloxacin Hydrochloride USP equivalent to 250 mg of ciprofloxacin.

Dosage:See accompanying package insert for complete information on dosage and administration

Recommedned Storage:Store below 86°F (30°C)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 250 mg (100 Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg (100 Tablet Bottle)

Rx only       100 Tablets

Pack Pharmaceuticals, LLC

NDC 16571-412-10

Ciprofloxacin Tablets USP 500 mg*

Attention: Dispense with a Medication Guide

* Each tablet contains:
Ciprofloxacin Hydrochloride USP equivalent to 500 mg of ciprofloxacin.

Dosage:See accompanying package insert for complete information on dosage and administration

Recommedned Storage:Store below 86°F (30°C)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 500 mg (100 Tablet Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 750 mg (50 Tablet Bottle)

Rx only       50 Tablets

Pack Pharmaceuticals, LLC

NDC 16571-413-05

Ciprofloxacin Tablets USP 750 mg*

Attention: Dispense with a Medication Guide

* Each tablet contains:
Ciprofloxacin Hydrochloride USP equivalent to 750 mg of ciprofloxacin.

Dosage:See accompanying package insert for complete information on dosage and administration

Recommedned Storage:Store below 86°F (30°C)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 750 mg (50 Tablet Bottle)

CIPROFLOXACIN 
ciprofloxacin   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16571-411
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ciprofloxacin hydrochloride (ciprofloxacin) ciprofloxacin 250 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
CELLULOSE, MICROCRYSTALLINE  
SILICON DIOXIDE  
CROSPOVIDONE  
MAGNESIUM STEARATE  
HYPROMELLOSE  
TITANIUM DIOXIDE  
POLYETHYLENE GLYCOL  
WATER  
Product Characteristics
Color white (white to slightly yellowish) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code P;250
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 16571-411-10 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076639 09/10/2004

CIPROFLOXACIN 
ciprofloxacin   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16571-412
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ciprofloxacin hydrochloride (ciprofloxacin) ciprofloxacin 500 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
CELLULOSE, MICROCRYSTALLINE  
SILICON DIOXIDE  
CROSPOVIDONE  
MAGNESIUM STEARATE  
HYPROMELLOSE  
TITANIUM DIOXIDE  
POLYETHYLENE GLYCOL  
WATER  
Product Characteristics
Color white (white to slightly yellowish) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code P;500
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 16571-412-10 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076639 09/10/2004

CIPROFLOXACIN 
ciprofloxacin   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16571-413
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ciprofloxacin hydrochloride (ciprofloxacin) ciprofloxacin 750 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
CELLULOSE, MICROCRYSTALLINE  
SILICON DIOXIDE  
CROSPOVIDONE  
MAGNESIUM STEARATE  
HYPROMELLOSE  
TITANIUM DIOXIDE  
POLYETHYLENE GLYCOL  
WATER  
Product Characteristics
Color white (white to slightly yellowish) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code P;750
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 16571-413-05 50 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076639 09/10/2004

Labeler - Pack Pharmaceuticals, LLC (614823875)
Registrant - Unique Pharmaceutical Laboratories (917165052)
Establishment
Name Address ID/FEI Operations
Unique Pharmaceutical Laboratories 650434645 manufacture, analysis
Revised: 12/2009 Pack Pharmaceuticals, LLC