Ciproflaxin Tablets | Ciprofloxacin
Fluoroquinolones, including ciprofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis (see WARNINGS).
| 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 |
| 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 |
| MIC (mcg/mL) | Interpretation |
|---|---|
| ≤ 1 2 ≥ 4 |
Susceptible (S) Intermediate (I) Resistant (R) |
| MIC (mcg/mL) | Interpretation |
|---|---|
| ≤ 1 |
Susceptible (S) |
| MIC (mcg/mL) | Interpretation |
|---|---|
| ≤ 0.06 0.12 – 0.5 ≥ 1 |
Susceptible (S) Intermediate (I) Resistant (R) |
| 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 |
| Zone Diameter (mm) | Interpretation |
|---|---|
| ≥ 21 16 – 20 ≤ 15 |
Susceptible (S) Intermediate (I) Resistant (R) |
| Zone Diameter (mm) | Interpretation |
|---|---|
| ≥ 21 |
Susceptible (S) |
| Zone Diameter (mm) | Interpretation |
|---|---|
| ≥ 41 28 – 40 ≤ 27 |
Susceptible (S) Intermediate (I) Resistant (R) |
| 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 |
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.
| 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%) |
|
| 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 . |
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| 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 |
| 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 |
| 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) |
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 .)
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/1.73m).
|
* 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 . |
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|
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 |
|||
|
*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%) |
Revised: 03/2011
See the section “What are the possible side effects of ciprofloxacin tablets?” for more information about side effects.
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.
If you have been prescribed ciprofloxacin tablets after being exposed to anthrax:
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:
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:
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:
See “ What should I avoid while taking ciprofloxacin tablets? ”
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:
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.
Manufacturer
RedPharm Drug Inc.
Active Ingredients
Source
- U.S. National Library of Medicine
- DailyMed
- Last Updated: 4 May 2013
Drugs and Medications
Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets, 500 mg
Ciprofloxacin [Aurolife Pharma LLC]
Ciprofloxacin [Lake Erie Medical DBA Quality Care Products LLC]
Ciprofloxacin 500 mg
Cipro (ciprofloxacin hydrochloride, hydrocortisone and benzyl alcohol) Suspension
Ciprofloxacin hydrochloride [Rebel Distributors Corp]
CIPROFLOXACIN HYDROCHLORIDE OPHTHALMIC SOLUTION0.3% as baseSterile
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PubMed Articles
Pharmacokinetic interactions between ciprofloxacin and itraconazole in healthy male volunteers.
Objective. To investigate the pharmacokinetic interaction between ciprofloxacin and itraconazole in healthy male volunteers. Methods. Ten healthy male volunteers were assigned into a 2-sequence, 3-per...
In this contribution, bovine serum albumin stabilized gold nanoclusters as novel fluorescent probes were successfully utilized for the detection of ciprofloxacin for the first time. Our prepared gold...
Biodegradation of ciprofloxacin in water and soil and its effects on the microbial communities.
While antibiotics are frequently found in the environment, their biodegradability and ecotoxicological effects are not well understood. Ciprofloxacin inhibits active and growing microorganisms and the...
Using data from the Gonococcal Isolate Surveillance Project, we studied changes in ciprofloxacin resistance in Neisseria gonorrhoeae isolates in the United States during 2002-2007. Compared with preva...
The objective of this study was to determine the pharmacokinetics and dosage regimen of ciprofloxacin in Teddy goats. Ciprofloxacin was administered intramuscularly at 5 mg/kg body weight in each of e...
