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

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Ciprofloxacin

Aurolife Pharma LLC


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


1718332

Ciprofloxacin

171833

Ciprofloxacin

CLINICAL PHARMACOLOGY

Absorption




      (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

Renal Impairment
DOSAGE AND ADMINISTRATION

Hepatic Impairment



Pediatrics
maxmaxmax

MICROBIOLOGY

Mechanism of Action

The bactericidal action of ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV (both type II topoisomerases), which are required for bacterial DNA replication, transcription, repair, and recombination.

Mechanism of Resistance

The mechanism of action of fluoroquinolones, including ciprofloxacin, is different from that of penicillins, cephalosporins, aminoglycosides, macrolides, and tetracyclines; therefore, microorganisms resistant to these classes of drugs may be susceptible to ciprofloxacin. Resistance to fluoroquinolones occurs primarily by either mutations in the DNA gyrases, decreased outer membrane permeability, or drug efflux. In vitro resistance to ciprofloxacin develops slowly by multiple step mutations. Resistance to ciprofloxacin due to spontaneous mutations occurs at a general frequency of between < 10-9 to 1x10-6.

Cross Resistance

There is no known cross-resistance between ciprofloxacin and other classes of antimicrobials.

Ciprofloxacin has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section of the package insert for ciprofloxacin tablets.

Gram-positive bacteria


Enterococcus faecalis
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus saprophyticus
Streptococcus pneumoniae

Streptococcus pyogenes

Gram-negative bacteria 

Campylobacter jejuni
Citrobacter diversus
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Haemophilus influenzae
Haemophilus parainfluenzae
Klebsiella pneumoniae
Moraxella catarrhalis
Morganella morganii
Neisseria gonorrhoeae


Proteus mirabilis Proteus vulgaris
Providencia rettgeri
Providencia stuartii
Pseudomonas aeruginosa
Salmonella typhi
Serratia marcescens
Shigella boydii
Shigella dysenteriae
Shigella flexneri
Shigella sonnei


Ciprofloxacin has been shown to be active against Bacillus anthracis both in vitro and by use of serum levels as a surrogate marker (see INDICATIONS AND USAGE and INHALATIONAL ANTHRAX– ADDITIONAL INFORMATION).


in vitro but their clinical significance is unknown.in vitro <has not been

Gram-positive bacteria
Staphylococcus haemolyticus
Staphylococcus hominis
 
Gram-negative bacteria

Acinetobacter Iwoffi
Aeromonas hydrophila
Edwardsiella tarda
Enterobacter aerogenes
Klebsiella oxytoca
Legionella pneumophila


Pasteurella multocida
Salmonella enteritidis
Vibrio cholerae

Vibrio parahaemolyticus
Vibrio vulnificus

Yersinia enterocolitica

Susceptibility Tests


in vitro

Dilution Techniques


1

·           Diffusion Techniques


2

Table 1: Susceptibility Test Interpretive Criteria for Ciprofloxacin


 
MIC (mcg/mL)
Zone Diameter (mm)
Species
S
I
R
S
I
R
Enterobacteriacae
≤1
2
≥4
≥21
16-20
≤15
Enterococcus faecalis
≤1
2
≥4
≥21
16-20
≤15
Staphylococcus species
≤1
2
≥4
≥21
16-20
≤15
Pseudomonas aeruginosa
≤1
2
≥4
≥21
16-20
≤15
Haemophilus influenzaea
≤1
 
 
≥21
 
 
Haemophilus parainfluenzaea
≤1
 
 
≥21
 
 
Streptococcus pneumoniae
≤1
2
≥4
≥21
16-20
≤15
Streptococcus pyogenes
≤1
2
≥4
≥21
16-20
≤15
Neisseria gonorrhoeaeb
≤0.06
0.12 - 0.5
≥1
≥41
28-40
≤27
S=Susceptible, I=Intermediate, and R=Resistant.
a The current absence of data on resistant strains precludes defining any results other than “Susceptible” . Strains yielding MIC results suggestive of a “nonsusceptible” category should be submitted to a reference laboratory for further testing.
b This interpretive standard is applicable only to agar dilution test with GC agar base and 1% defined growth supplement.



·         Quality Control

Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures.1,2 For dilution technique, standard ciprofloxacin powder should provide the MIC values according to criteria outlined in Table 2. For diffusion technique, the 5-mcg ciprofloxacin disk should provide the zone diameters outlined in Table 2.

Table 2: Quality Control for Susceptibility Testing of Ciprofloxacin

Strains
MIC Range (mcg/mL)
Zone Diameter (mm)
Enterococcus faecalis ATCC 29212
0.25–2
-
Escherichia coli ATCC 25922
0.004–0.015
30–40
Haemophilus influenzae ATCC 49247
0.004–0.03
34–42
Pseudomonas aeruginosa ATCC 27853
0.25–1
25–33
Staphylococcus aureus ATCC 29213
0.12–0.5
-
Staphylococcus aureus ATCC 25923
-
22–30
Neisseria gonorrhoeae ATCC 49226a
0.001–0.008
48–58
C. jejuni ATCC 33560 b
0.06–0.25 and 0.03–0.12
-
a 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 37°C for 20 to 24 hours3.
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 37°C for 48 hours and for 42°C at 24 hours,2 respectively.

CIPROFLOXACIN INDICATIONS AND USAGE


DOSAGE AND ADMINISTRATION

Adult Patients

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

Acute Uncomplicated Cystitis in females caused by Escherichia coli or 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

*Ciprofloxacin is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.

Acute Sinusitis caused by Haemophilus influenzae, penicillin-susceptible Streptococcus pneumoniae, or Moraxella catarrhalis.

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

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

Complicated Intra-Abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

Infectious Diarrhea caused by Escherichia coli (enterotoxigenic strains), Campylobacter jejuni, Shigella boydii , Shigella dysenteriae, Shigella flexneri or Shigella sonnei when antibacterial therapy is indicated.         

Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.


Typhoid Fever (Enteric Fever) Salmonella typhi.


Uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae.

Pediatric patients (1 to 17 years of age)

Complicated Urinary Tract Infections and Pyelonephritis due to Escherichia coli.

NOTE: 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 controls, including events related to joints and/or surrounding tissues. (See WARNINGS , PRECAUTIONS, Pediatric Use, ADVERSE REACTIONS and CLINICAL STUDIES .) Ciprofloxacin, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals. (See ANIMAL PHARMACOLOGY .)  

Adult and Pediatric Patients


Inhalational anthrax Bacillus anthracis.

5 INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).


Pseudomonas aeruginosa

CIPROFLOXACIN CONTRAINDICATIONS



DESCRIPTION

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

Hypersensitivity Reactions


Other Serious and Sometimes Fatal Reactions










PRECAUTIONS Information for Patients ADVERSE REACTIONS

Theophylline


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

Central Nervous System Effects


Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis have been reported in patients receiving fluoroquinolones, including ciprofloxacin. Ciprofloxacin may also cause central nervous system (CNS) events including: dizziness, confusion, tremors, hallucinations, depression, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving ciprofloxacin, the drug should be discontinued and appropriate measures instituted. As with all fluoroquinolones, ciprofloxacin should be used with caution in patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction). (See PRECAUTIONS: General, Information for Patients, Drug Interactions and ADVERSE REACTIONS).

Clostridium Difficile-Associated Diarrhea


Clostridium difficile C. difficile.

C. difficile C. difficile

C. difficile C. difficile

Peripheral neuropathy

Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including ciprofloxacin. Ciprofloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness, or is found to have deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength in order to prevent the development of an irreversible condition.

Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals


Ciprofloxacin should be used in pediatric patients (less than 18 years of age) only for infections listed in the INDICATIONS AND USAGE section. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS .)

In pre-clinical studies, oral administration of ciprofloxacin caused lameness in immature dogs. Histopathological examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage. Related quinolone-class drugs also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species. (See ANIMAL PHARMACOLOGY .)

Prolongation of the QT Interval


Some fluoroquinalones, including ciprofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. Rare cases of torsade de pointes have been spontaneously reported during postmarketing surveillance in patients receiving fluoroquinalones, including ciprofloxacin. Ciprofloxacin should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval (See PRECAUTIONS, Drug Interactionsand Geriatric Use ).

Cytochrome P450 (CYP450) Drug Interactions


Ciprofloxacin is an inhibitor of the hepatic CYP1A2 enzyme pathway. Coadministration of ciprofloxacin and other drugs primarily metabolized by CYP1A2 (for example, theophylline, methylxanthines, tizanidine) results in increased plasma concentrations of the coadministered drug and could lead to clinically significant pharmacodynamic side effects of the coadministered drug (see PRECAUTIONS, Drug Interactions).

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, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) 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

Tizanidine

In a pharmacokinetic study, systemic exposure of tizanidine (4 mg single dose) was significantly increased (Cmax 7-fold, AUC 10-fold) when the drug was given concomitantly with ciprofloxacin (500 mg bid for 3 days). The hypotensive and sedative effects of tizanidine were also potentiated. Concomitant administration of tizanidine and ciprofloxacin is contraindicated (see   CONTRAINDICATIONS ).

Theophylline

As with some other quinolones, concurrent administration of ciprofloxacin with theophylline may lead to elevated serum concentrations of theophylline and prolongation of its elimination half-life. This may result in increased risk of theophylline-related adverse reactions. (See WARNINGS .) If concomitant use cannot be avoided, serum levels of theophylline should be monitored and dosage adjustments made as appropriate.

Other Xanthine Derivatives

Some quinolones, including ciprofloxacin, have also been shown to interfere with the metabolism of caffeine. This may lead to reduced clearance of caffeine and a prolongation of its serum half-life. On concurrent administration of ciprofloxacin and caffeine or pentoxifylline containing products, elevated serum concentrations of these xanthine derivatives were reported.

Chelation Complex Foundation

Concurrent administration of a quinolone, including ciprofloxacin, with multivalent cation-containing products such as magnesium/aluminum antacids, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate), sucralfate, didanosine chewable/buffered tablets or pediatric powder, other highly buffered drugs, or products containing calcium, iron, or zinc may substantially decrease its absorption, resulting in serum and urine levels considerably lower than desired. (See DOSAGE AND ADMINISTRATION for concurrent administration of these agents with ciprofloxacin.)

Histamine H2-receptor antagonists appear to have no significant effect on the bioavailability of ciprofloxacin.

Omeprazole

Concomitant administration of a single tablet dose of 500 mg ciprofloxacin and once-daily administration of 20 mg omeprazole pretreatment for 4 days resulted in a 16% reduction of mean Cmax and mean AUC of ciprofloxacin.

Phenytoin

Altered serum levels of phenytoin (increased and decreased) have been reported in patients receiving concomitant ciprofloxacin.

Glyburide

The concomitant administration of ciprofloxacin with the sulfonylurea glyburide has, on rare occasions, resulted in severe hypoglycemia.

Metronidazole

The serum concentrations of ciprofloxacin and metronidazole were not altered when these two drugs were given concomitantly.

Cyclosporine

Some quinolones, including ciprofloxacin, have been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

Oral Anti-coagulants

Simultaneous administration of ciprofloxacin with an oral anticoagulant may augment the effect of the anticoagulant. The risk may vary with the underlying infections, age and general status of the patient so that the contribution of ciprofloxacin to the increase in INR (international normalized ratio) is difficult to assess. Prothromin time and INR should be monitored frequently during and shortly after co-administration of ciprofloxacin with an oral anticoagulant (for example, warfarin).

Probenecid

Probenecid interferes with renal tubular secretion of ciprofloxacin and produces an increase in the level of ciprofloxacin in the serum. This should be considered if patients are receiving both drugs concomi­tantly.

Methotrexate

Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin potentially leading to increased plasma levels of methotrexate. This might increase the risk of methotrexate associated toxic reactions. Therefore, patients under methotrexate therapy should be carefully monitored when concomitant ciprofloxacin therapy is indicated.

Metoclopramide

Metoclopramide significantly accelerates the absorption of oral ciprofloxacin resulting in shorter time to reach maximum plasma concentrations. No significant effect was observed on the bioavailability of ciprofloxacin.

Duloxetine

In clinical studies it was demonstrated that concomitant use of duloxetine with strong inhibitors of the CYP450 1A2 isozyme such as fluvoxamine, may result in a 5-fold increase in mean AUC and a 2.5-fold increase in mean Cmax of duloxetine. Although no clinical data are available on a possible interaction with ciprofloxacin, similar effects can be expected upon concomitant administration.

NSAIDs

Non-steroidal anti-inflammatory drugs (but not acetyl salicylic acid) in combination of very high doses of quinolones have been shown to provoke convulsions in pre-clinical studies.

Ropinirole

In a study conducted in 12 patients with Parkinson’s disease who were administered 6 mg ropinirole once daily with 500 mg ciprofloxacin twice-daily, the mean Cmax and mean AUC of ropinirole were increase by 60% and 84%, respectively. Monitoring for ropinirole-related side effects and appropriate dose adjustment of ropinirole is recommended during and shortly after co-administration with ciprofloxacin (see WARNINGS , Cytochrome P450).

Lidocaine

In a study conducted in 9 healthy volunteers, concomitant use of 1.5 mg/kg IV lidocaine with 500 mg ciprofloxacin twice daily, resulted in an increase of lidocaine Cmax and AUC by 12% and 26%, respectively. Although lidocaine treatment was well tolerated at this elevated exposure, a possible interaction with ciprofloxacin and an increase in side effects related to lidocaine may occur upon concomitant administration.

Clozapine

Following concomitant administration of 250 mg ciprofloxacin with 304 mg clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively. Careful monitoring of clozapine associated adverse effects and appropriate adjustment of clozapine dosage during and shortly after co-administration with ciprofloxacin are advised (see WARNINGS ).

Sildenafil

Following concomitant administration of a single oral dose of 50 mg sildenafil with 500 mg ciprofloxacin to healthy subjects, the mean Cmax and mean AUC of sildenafil were both increased approximately two-fold. Therefore, sildenafil should be used with caution when co-administered with ciprofloxacin.

Class IA or III Antiarrhythmics

Precaution should be taken when using ciprofloxacin concomitantly with class IA or III antiarrhythmics as ciprofloxacin may have an additive effect on the QT interval (see WARNINGS AND PRECAUTIONS , Geriatric Use).

 

Carcinogenesis, Mutagenesis, Impairment of Fertility


in vitro


E. coli

79

Saccharomyces cerevisiae
Saccharomyces cerevisiae


in vivo





2

23



2

Pregnancy

Teratogenic Effects. Pregnancy Category C


7

8 In utero

9in utero

7,8 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

WARNINGS

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


Adults







ADULT DOSAGE GUIDELINES
Infection Severity      Dose       Frequency    Usual Durations† 
   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

*  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 .


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



ADVERSE REACTIONS  CLINICAL STUDIES





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




Bacillus anthracis4 INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION .

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

NOTE: 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 controls, including events related to joints and/or surrounding tissues. 

Ciprofloxacin, administered I.V. and/or orally, was compared to a cephalosporin for treatment of complicated urinary tract infections (cUTI) and pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4 years). The trial was conducted in the U.S., Canada, Argentina, Peru, Costa Rica, Mexico, South Africa, and Germany. The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with a range of 1 to 88 days). The primary objective of the study was to assess musculoskeletal and neurological safety. 

Patients were evaluated for clinical success and bacteriological eradication of the baseline organism(s) with no new infection or superinfection at 5 to 9 days post-therapy (Test of Cure or TOC). The Per Protocol population had a causative organism(s) with protocol specified colony count(s) at baseline, no protocol violation, and no premature discontinuation or loss to follow-up (among other criteria).  

The clinical success and bacteriologic eradication rates in the Per Protocol population were similar between ciprofloxacin and the comparator group as shown below. 

Post-Therapy)
 
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%)

*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.

INHALATIONAL ANTHRAX IN ADULTS AND PEDIATRICS – ADDITIONAL INFORMATION


Additional Information

DOSAGE AND ADMINISTRATION PRECAUTIONS, Pediatric Use 4

50550B. anthracis max56

B. anthracis

REFERENCES


Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically;
Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard,











Aurobindo Pharma LLC



Aurobindo Pharma USA, Inc.


Revised: 01/2012

MEDICATION GUIDE



Ciprofloxacin Tablets, USP

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


Ciprofloxacin tablets belong to a class of antibiotics called fluoroquinalones. Ciprofloxacin tablets 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 heathcare provider about whether you should continue to take ciprofloxacin tablets.


1. Tendon rupture or swelling of the tendon (tendinitis)
  • Tendon problems can happen in people of all ages who take ciprofloxacin tablets. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include:
    • Pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites.
  • The risk of getting tendon problems while you take ciprofloxacin tablets are higher if you: 
    • are over 60 years of age
    • are taking steroids (corticosteroids)
    • have had a kidney, heart or lung transplant.
  • Tendon problems can happen in people who do not have the above risk factors when they take ciprofloxacin tablets. Other reasons that can increase your risk of tendon problems 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

2.      Worsening of myasthenia gravis (a disease which causes muscle weakness).

Fluoroquinalones 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?








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, do not kill viruses.

Call your healthcare provider if you think your condition is not getting better while you are taking ciprofloxacin tablets.

Who should not take ciprofloxacin tablets?


Do not take ciprofloxacin tablets if you:

·      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?


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

  • have tendon problems
  • have a disease that causes muscle weakness (myasthenia gravis)
  • 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 breastfeeding or planning to breastfeed. 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,

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?


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

You may have serious seizure and breathing problems when you take theophylline with ciprofloxacin tablets. These problems may lead to death. Get emergency help right away if you have seizures or trouble breathing.

  • 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. 
















  • Serious allergic reactions 

Allergic reactions, including death, 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:









  • Skin rash

Skin rash may happen in people taking ciprofloxacin tablets even after only one dose. Stop taking ciprofloxacin tablets at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to ciprofloxacin tablets.



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

Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. Ciprofloxacin tablets may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this event are higher in people:

·      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) 

Pseudomembranous colitis can happen with most antibiotics, including ciprofloxacin tablets. Call your healthcare provider right away if you get watery diarrhea, diarrhea that doesnot go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic. 


  • 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:






Ciprofloxacin tablets may need to be stopped to prevent permanent nerve damage.  


  • Low blood sugar (hypoglycemia) 

People who take ciprofloxacin tablets and other fluoroquinolone medicines with the oral anti-diabetes medicine glyburide can get low blood sugar (hypoglycemia) which can sometimes be severe. Tell your healthcare provider if you get low blood sugar with ciprofloxacin tablets. Your antibiotic medicine may need to be changed. 


  • Sensitivity to sunlight (photosensitivity) 

“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:  









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 20° to 25°C (68° to 77°F); excursions permitted to 15°to 30°C (59° to 86°F).

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

General information about ciprofloxacin tablets

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

This Medication Guide summarizes the most important information about ciprofloxacin tablets. If you would like more information about ciprofloxacin tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ciprofloxacin tablets that is written for healthcare professionals. For more information call 1-866-850-2876.

What are the ingredients in ciprofloxacin tablets?











Aurobindo Pharma LLC



Aurobindo Pharma USA, Inc.


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 250 MG (1000 TABLETS BOTTLE)


NDC 13107-076-99
Ciprofloxacin Tablets USP
250 mg
PHARMACIST:     PLEASE    DISPENSE    WITH
MEDICATION GUIDE PROVIDED SEPARATELY
Rx only           1000 Tablets
AUROBINDO

Ciprofloxacin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 500 MG (1000 TABLETS BOTTLE)


NDC 13107-077-99
Ciprofloxacin Tablets USP
500 mg

PHARMACIST:     PLEASE    DISPENSE    WITH
MEDICATION GUIDE PROVIDED SEPARATELY
Rx only           1000 Tablets
AUROBINDO

Ciprofloxacin

Ciprofloxacin

Ciprofloxacin TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:13107-076
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN 250 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) 11 mm C;95 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13107-076-30 30 in 1 BOTTLE
2 NDC:13107-076-01 100 in 1 BOTTLE
3 NDC:13107-076-99 1000 in 1 BOTTLE

Marketing Information

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


Ciprofloxacin

Ciprofloxacin TABLET, FILM COATED

Product Information

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

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CIPROFLOXACIN HYDROCHLORIDE 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 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:13107-077-30 30 in 1 BOTTLE
2 NDC:13107-077-01 100 in 1 BOTTLE
3 NDC:13107-077-99 1000 in 1 BOTTLE

Marketing Information

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


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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