Westminster Pharmaceuticals, LLC
Ciprofloxacin hydrochloride
GenericID: 69367038501
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TL;DR — Quick Summary
Key facts from the full medication guide below
🩺What it's for
Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: Skin and Skin Structure Infections (1.1) Bone and Joint Infections (1.2) Complicated Intra-Abdominal Infections (1.3) Infectious Diarrhea (1.4) Typhoid Fever (Enteric Fever) (1.5) Uncomplicated Cervical and Urethral Gonorrhea (1.6) Inhalational Anthrax post-exposure in adult and…
💊How to take it
Ciprofloxacin Tablets should be administered orally as described in the appropriate Dosage Guidelines tables.
ℹ️Common side effects
Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion).
⚠️Serious risks
Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1)] including: Tendinitis and tendon rupture [see Warnings and Precautions (5.2)] Peripheral neuropathy [see Warnings and Precautions (5.3)] Central nervous system effects [see Warnings and Precautions (5.4)] Discontinue ciprofloxacin immediately and avoid the use of fluoroquinolones, including…
📋Interactions & cautions
Ciprofloxacin is an inhibitor of human cytochrome P450 1A2 (CYP1A2) mediated metabolism. Co-administration of ciprofloxacin with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the co-administered drug.
📦Storage & missed dose
Ciprofloxacin Tablets USP, are available as 250 mg, 500 mg and 750 mg tablets for oral administration.
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Ciprofloxacin hydrochloride (Ciprofloxacin hydrochloride) Prices
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Dosage and Administration, Important Administration Instructions (2.1) 11/2021
Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: Skin and Skin Structure Infections (1.1) Bone and Joint Infections (1.2) Complicated Intra-Abdominal Infections (1.3) Infectious Diarrhea (1.4) Typhoid Fever (Enteric Fever) (1.5) Uncomplicated Cervical and Urethral Gonorrhea (1.6) Inhalational Anthrax post-exposure in adult and pediatric patients (1.7) Plague in adult and pediatric patients (1.8) Chronic Bacterial Prostatitis (1.9) Lower Respiratory Tract Infections (1.10) Acute Exacerbation of Chronic Bronchitis Urinary Tract Infections (1.11) Urinary Tract Infections (UTI) Acute Uncomplicated Cystitis Complicated UTI and Pyelonephritis in Pediatric Patients Acute Sinusitis (1.12) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs, ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.13)
Ciprofloxacin tablets are indicated in adult patients for treatment of 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.
Ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.
Ciprofloxacin tablets are indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.
Ciprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydiiAlthough treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients., Shigella dysenteriae, Shigella flexneri or Shigella sonnei when antibacterial therapy is indicated.
Ciprofloxacin tablets are indicated in adult patients for treatment of typhoid fever (enteric fever) caused by Salmonella typhi. The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.
Ciprofloxacin tablets are indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae [see Warnings and Precautions (5.17)].
Ciprofloxacin tablets are indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure) to reduse the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.1 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioerror attacks of October 2001 [see Clinical Studies (14.2)].
Ciprofloxacin tablets are indicated for treatment of plague, including pheumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies of ciprofloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only [see Clinical Studies (14.3)].
Ciprofloxacin tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.
Ciprofloxacin tablets are indicated in adult patients for treatment of lower respiratory tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus infuenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae. Ciprofloxacin is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae. Ciprofloxacin tablets are indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by Moraxella catarrhalis. Because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.16)] and for some patients AECB is sefl-limiting, reserve ciprofloxacin tablets for treatment of AECB in patients who have no alternative treatment options.
Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 Rev. R0424
Ciprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis. Because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.16)] and for some patients acute sinusitis is self-limiting, reserve ciprofloxacin tablets for treatment of acute sinusitis in patients who have no alternative treatment options.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs, ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with ciprofloxacin may be initiated before results of these tests are known; once results become available appropriate therapy should be continued. As with other drugs, some isolates of Pseadumonas aeruginosa may develop resistance failry rapidly during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.
Ciprofloxacin Tablets should be administered orally as described in the appropriate Dosage Guidelines tables. Infection Dose Frequency Duration Skin and Skin Structure 500 mg to 750 mg every 12 hours 7 to 14 days Bone and Joint 500 mg to 750 mg every 12 hours 4 to 8 weeks Complicated Intra-Abdominal 500 mg every 12 hours 7 to 14 days Infectious Diarrhea 500 mg every 12 hours 5 to 7 days Typhoid Fever 500 mg every 12 hours 10 days Uncomplicated Gonorrhea 250 mg single dose single dose Inhalational anthrax (post-exposure) 500 mg every 12 hours 60 days Plague 500 mg to 750 mg every 12 hours 14 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract 500 mg to 750 mg every 12 hours 7 to 14 days Urinary Tract 250 mg to 500 mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days Acute Sinusitis 500 mg every 12 hours 10 days Adults with creatinine clearance 30-50 mL/min 250-500 mg q 12 h (2.3) Adults with creatinine clearance 5 29 mL/min 250 500 mg q 18 h (2.3) Patients on hemodialysis or peritoneal dialysis 250 500 mg q 24 h (after dialysis) (2.3) Pediatric Oral Dosage Guidelines Infection Dose Frequency Duration Complicated UTI and Pyelonephritis (1 to 17 years of age) 10 to 20 mg/kg (maximum 750 mg per dose) Every 12 hours 10 to 21 days Inhalational Anthrax (Post-Exposure) 15 mg/kg (maximum 500 mg per dose) Every 12 hours 60 days Plague 15 mg/kg (maximum 500 mg per dose) Every 8 to 12 hours 14 days
The determination of dosage and duration for any particular patient must be take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient's host-defense mechanisms, and the status of renal and hepatic function. Ciprofloxacin Tablets may be administered to adult patients when clinically indicated at the discretion of the physician. Table 1: Adult Dosage Guidelines Infection Dose Frequency Usual DurationsGenerally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). Skin and Skin Structure 500 mg to 750 mg every 12 hours 7 to 14 days Bone and Joint 500 mg to 750 mg every 12 hours 4 to 8 weeks Complicated Intra-AbdominalUsed in conjunction with metronidazole. 500 mg every 12 hours 7 to 14 days Infectios Diarrhea 500 mg every 12 hours 5 to 7 days Typhoid Fever 500 mg every 12 hours 10 days Uncomplicated Urethral and Cervical Gonococcal Infections 250 mg single dose single dose Inhalational anthrax (post-exposure)Begin drug administration as soon as possible after suspected or confirmed exposure. 500 mg every 12 hours 60 days Plague 500 mg to 750 mg every 12 hours 14 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract Infections 500 mg to 750 mg every 12 hours 7 to 14 days Urinary Tract Infections 250 mg to 500 mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days Acute Sinusitis 500 mg every 12 hours 10 days
Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin should be administered as described in Table 3. Table 3: Pediatric Dosage Guidelines Infection Dose Frequency Total Duration Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) 10mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg) Every 12 hours 10 to 21 daysThe total duration of therapy for cUTI and pyelonephritis in the clinical trail was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). Inhalational Anthrax (Post-Exposure)Begin drug administration as soon as possible after suspected or confirmed exposure. 15 mg/kg maximum 500 mg per dose) Every 12 hours 60 days Plague , Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis. 15 mg/kg (maximum 500 mg per dose) Every 8 to 12 hours 14 days
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4. Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal Function Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 to 50 250 to 500 mg every 12 hours 5 to 29 250 to 500 mg every 18 hours Patients on hemodialysis or Peritoneal dialysis 250 to 500 mg every 24 hours (after dialysis) When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance: Men - Creatinine clearance (mL/min) = Weight (kg (140 age) 72 serum creatinine (mg/dL) Women - 0.85 the value calculated for men. The serum creatinine should represent a steady state of renal function. In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored. Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).
Tablets: 250 mg, 500 mg and 750 mg (3)
Ciprofloxacin tablets 250 mg are available as white to off-white, round, film coated, debossed "E442" on one side and plain on the other side. Ciprofloxacin tablets 500 mg are available as white to off-white, capsule-shaped, film-coated, debossed "E451" on one side and plain on the other side. Ciprofloxacin tablets 750 mg are available as white to off-white, capsule-shaped, film-coated, debossed "E470" on one side and plain on the other side.
Known hypersensitivity to ciprofloxacin or other quinolones (4.1, 5.6, 5.7) Concomitant administration with tizanidine (4.2)
Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components [see Warnings and Precautions (5.7)].
Concomitant administration with tizanidine is contraindicated [see Drug Interactions (7)].
Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions (for example, anaphylactic reactions) may occur after the first or subsequent doses of ciprofloxacin. Discontinue ciprofloxacin at the first sign of skin rash, jaundice or any sign of hypersensitivity. (4.1, 5.6, 5.7) Hepatotoxicity: Discontinue immediately if signs and symptoms of hepatitis occur. (5.8) Clostridioides difficile-associated diarrhea: Evaluate if colitis occurs. (5.11) QT Prolongation: Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval. (5.12, 7, 8.5)
Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting ciprofloxican. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see Warnings and Precautions (5.2, 5.3, 5.4)]. Discontinue ciprofloxican immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including ciprofloxican, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
Fluoroquinolones, including ciprofloxacin, have been associated with an increased risk of tendinitis and tendon rupture in all ages see Warnings and Precautions (5.1) and Adverse Reactions (6.2)]. This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur, within hours or days of starting ciprofloxican, or as long as several months after completion of fluoroquinolone therapy. Tendinitis and tendon rupture can occur bilaterally. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previoustendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroqhinolones who do not have the above risk factors. Discontinue ciprofloxican immediately if the patient experiences pain, swelling, imflammation or rupture of a tendon. Avoid fluoroquinolones, including ciprofloxican, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture [see Adverse Reactions (6.2)].
Fluoroquinolones, including ciprofloxican, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in parenthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including ciprofloxican. Symptoms may occur soon after initiation of ciprofloxican and may be irreversible in some patients [see Warnings and Precautions (5.1) and Adverse Reactions (6.1, 6.2)]. Discontinue ciprofloxican immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness, or other alterations in sensations including light touch, pain, temperature, position sense and vibratory sensation, and/or motor strength in order to minimize the development of an irreversible condition. Avoid fluoroquinolones, including ciprofloxacin, in patients who have previously experienced peripheral neuropathy [see Adverse Reactions (6.1, 6.2)].
Fluoroquinolones, including ciprofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Postmarking serious adverse reactions, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis [see Adverse Reactions (6.2)].
Other serious and sometimes fatal adverse reactions, some due to hypersensitivity, and some due to uncertain etiology, have been reported in patients receiving therapy with quinolones, including ciprofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following: Fever, rash, or severe dermatologic reactions (for example, toxic epidermal necrolysis, Stevens-Johnson syndrome); Vasculitis; arthralgia; myalgia; serum sickness; Allergic pneumonitis; Interstitial nephritis; acute renal insufficiency or failure; Hepatitis; jaundice; acute hepatic necrosis or failure; Anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities. Discontinue ciprofloxacin immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted [see Adverse Reactions (6.1, 6.2)].
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving fluoroquinolone therapy, including ciprofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, including intubation, as indicated [see Adverse Reactions (6.1)].
Cases of severe hepatotoxicity, including hepatic necrosis, life-threatening hepatic failure, and fatal events, have been reported with ciprofloxacin. Acute liver injury is rapid in onset (range 1 39 days), and is often associated with hypersensitivity. The pattern of injury can be hepatocellular, cholestatic, or mixed. Most patients with fatal outcomes were older than 55 years old. In the event of any signs and symptoms of hepatitis (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), discontinue treatment immediately. There can be a temporary increase in transaminases, alkaline phosphatase, or cholestatic jaundice, especially in patients with previous liver damage, who are treated with ciprofloxacin [see Adverse Reactions (6.2, 6.3)].
Epidermiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in eldery patients. The cause for the increased risk has not been identified. In patients with a known aortic aneurysm or patients who are at greater risk for aortic aneurysms, reverse ciprofloxacin for use only when there are no alternative antibacterial treatments available.
Serious and fatal reactions have been reported in patients receiving concurrent administration of ciprofloxacin and theophylline. These reactions have included cardiac arrest, seizure, status epilepticus, and respiratory failure. Instances od nausea, vomiting, tremor, irritability, or palpitation have also occurred. Although similar serious adverse reactions have been reported in patients receiving theophylline alone, the possibility that these reactions may be potentiated by ciprofloxacin cannot be eliminated. If concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate [see Drug Interactions (7)].
Clostridioides difficile (C. difficile)-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ciprofloxacin, 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 isolates of C. difficile cause increased morbidity and morality, 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 antibacterial 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 antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and institute surgical evaluation as clinically indicated [see Adverse Reactions (6.1)].
Some fluoroquinolones, including ciprofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and cases of arrhythmia. Cases of torsade de pointes have been reported during postmarketing surveillance in patients receiving fluoroquinolones, including ciprofloxacin. Avoid ciprofloxacin in patients with known prolongation of the QT interval, risk factors for QT prolongation or torsade de pointes (for example, congenital long QT syndrome, uncorrected electrolyte imbalance, such as hypokalemia or hypomagnesemia and cardiac disease, such as heart failure, myocardial infarction, or bradycardia), and patients receiving Class IA antiarrhythmic agents (quinidine, procainamide), or Class III antiarrhythmic agents (amiodarone, sotalol), tricyclic antidepressants, macrolides, and antipsychotics. Elderly patients may also be more susceptible to drug-associated effects on the QT interval [see Adverse Reactions (6.2), Use in Specific Populations (8.5)].
DCiprofloxacin is indicated in pediatric patients (less than 18 years of age) only for cUTI, prevention of inhalational anthrax (post exposure), and plague [see Indications and Usage (1.7, 1.8, 1.11)]. An increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues, has been observed [see Adverse Reactions (6.1)]. 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 Use in Specific Populations (8.4) and Nonclinical Toxicology (13.2)].
Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (for example, burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, "V" area of the neck, exteensor surfaces of the forearms, dorsa of the hands), can be associated with the use of quinolones including ciprofloxacin after sun or UV light exposure. Therefore, avoid excessive exposure to these sources of light. Discontinue ciprofloxacin if phototoxicity occurs [see Adverse Reactions (6.1)].
Prescribing ciprofloxacin tablets in the absense of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Ciprofloxacin is an inhibitor of the hepatic CY1A2 enzyme pathway. Co-administration of ciprofloxacin and other drugs primarily metabolized by CYP1A2 (for example, theophylline, methylxanthines, caffeine, tizanidine, ropinirole, clozapine, olanzapine and zolpidem), results in increased plasma concentrations of the co-administered drug and could lead to clinically significant pharmacodynamic adverse reactions of the co-administered drug [see Drug Interactions (7) and Clinical Pharmacology (12.3)].
Ciprofloxacin has not been shown to be effective in the treatment of syphilis. Antimicrobial agents used in high dose for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. Perform a serologic test for syphilis in all patients with gonorrhea at the time of diagnosis. Perform follow-up serologic test for syphilis three months after ciprofloxacin treatment.
Crystals of ciprofloxacin have been observed rarely in the urine of human subjects but more frequently in the urine of laboratory animals, which is usually alkaline [see Nonclinical Toxicology (13.2)]. Crystalluria related to ciprofloxacin has been reported only rarely in humans because human urine is usually acidic. Avoid alkalinity of the urine in patients receiving ciprofloxacin. Hydrate patients well to prevent the formation of highly concentrated urine [see Dosage and Administration (2.4)].
Fluoroquinolones, including ciprofloxacin, have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (for example, glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. Severe cases of hypoglycemia resulting in coma or death have been reported. If a hypoglycemic reaction occurs in a patient being treated with ciprofloxacin, discontinue ciprofloxacin and initiate appropriate therapy immediately [see Adverse Reactions (6.1), Drug Interactions (7)].
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: Disabling and Potentially Irreversible Serious Adverse Reactions [see Warnings and Precautions (5.1)] Tendinitis and Tendon Rupture [see Warnings and Precautions (5.2)] Peripheral Neuropathy [see Warnings and Precautions (5.3)] Central Nervous System Effects [see Warnings and Precautions (5.4)] Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.5)] Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions (5.6)] Hypersensitivity Reactions [see Warnings and Precautions (5.7)] Hepatotoxicity [see Warnings and Precautions (5.8)] Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions (5.9)] Serious Adverse Reactions with Concomitant Theophylline [see Warnings and Precautions (5.10)] Clostridioides difficile-Associated Diarrhea [see Warnings and Precautions (5.11)] Prolongation of the QT Interval [see Warnings and Precautions (5.12)] Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions (5.13)] Photosensitivity/Phototoxicity [see Warnings and Precautions (5.14)] Development of Drug Resistant Bacteria [see Warnings and Precautions (5.15)] The most common adverse reactions 1% were nausea, diarrhea, liver function tests abnormal, vomiting, and rash. (6) To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following adverse reactions have been reported from worldwide marketing experience with fluoroquinolones, including ciprofloxacin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure (Table 7). Table 7: Postmarketing Reports of Adverse Reactions System Organ Class Adverse Reactions Cardiovascular QT prolongation Torsade de Pointes Vasculitis and ventricular arrhythmia Central Nervous System Hypertonia Myasthenia Exacerbation of myasthenia gravis Peripheral neuropathy Polyneuropathy Twitching Eye Disorders Nystagmus Gastrointestinal Pseudomembranous colitis Hemic/Lymphatic Pancytopenia (life threatening or fatal outcome) Methemoglobinemia Hepatobiliary Hepatic failure (including fatal cases) Infections and Infestations Candidiasis (oral, gastrointestinal, vaginal) Investigations Prothrombin time prolongation or decrease Cholesterol elevation (serum) Potassium elevation (serum) Musculoskeletal Myalgia Myoclonus Tendinitis Tendon rupture Psychiatric Disorders Agitation Confusion Delirium Skin/Hypersensitivity Acute generalized exanthematous pustulosis (AGEP) Fixed eruption Serum sickness-like reaction Special Senses Anosmia Hyperesthesia Hypesthesia Taste loss
Changes in laboratory parameters while on ciprofloxacin are listed below: Hepatic Elevations of ALT (SGPT), AST (SGOT), alkaline phosphatase, LDH, serum bilirubin. Hematologic Eosinophilia, leukopenia, decreased blood platelets, elevated blood platelets, pancytopenia. Renal Elevations of serum creatinine, BUN, crystalluria, cylindruria, and hematuria have been reported. Other changes occurring were: elevation of serum gammaglutamyl transferase, elevation of serum amylase, resuction in blood glucose, elevated uric acid, decrease in hemoglobin, anemia, bleeding diathesis, increase in blood monocytes, and leukocytosis.
Ciprofloxacin is an inhibitor of human cytochrome P450 1A2 (CYP1A2) mediated metabolism. Co-administration of ciprofloxacin with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the co-administered drug. Table 8: Drugs That are Affected by and Affecting Ciprofloxacin Drugs That are Affected by Ciprofloxacin Drug(s) Recommendation Comments Tizanidine Contraindicated Concomitant administration of tizanidine and ciprofloxacin is contraindicated due to the potentiation of hypotensive and sedative effects of tizanidine [see Contraindications (4.2)] Theophylline Avoid Use (Plasma Exposure Likely to be Increased and Prolonged) Concurrent administration of ciprofloxacin with theophylline may result in increased risk of a patienyt developing central nervous system (CNS) or other adverse reactions. If concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate [see Warnings and Precautions (5.10)]. Drugs Known to Prolong QT Interval Avoid Use Ciprofloxacin may further prolong the QT interval in patients receiving drugs known to prolong the QT interval (for example, class IA or III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) [see Warnings and Precautions (5.12) and Use in Specific Populations (8.5)]. Oral antidiabetic drugs Use with caution Glucose-lowering effect potentiated Hypoglycemia sometimes severe has been reported when ciprofloxacin and oral antidiabetic agents, mainly sulfonylureas (for example, glyburide, glimepiride), were co-administered, presumably by intensifying the action of the oral antidiabetic agent. Fatalities have been reported. Monitor blood glucose when ciprofloxacin is co-administered with oral antidiabetic drugs [see Adverse Reactions (6.1)]. Phenytoin Use with caution Altered serum levels of phenytoin (increased and decreased) To avoid the loss of seizure control associated with decreased phenytoin levels and to prevent phenytoin overdose-related adverse reactions upon ciprofloxacin discontinuation in patients receiving both agents, monitor phenytoin therapy, including phenytoin serum concentration during and shortly after co-adminstration of ciprofloxacin with phenytoin. Cyclosporine Use with caution (transient elevations in serum creatinine) Monitor renal function (in particular serum creatinine) when ciprofloxacin is co-administered with cyclosporine. Anti-coagulant drugs Use with caution (Increase in anticoagulant effect) The risk may vary with the underlying infection, 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. Monitor prothrombin time and INR frequently during and shortly after co-administration of ciprofloxacin with an oral anti-coagulant (for example, warfarin). Methotrexate Use with caution Inhibition of methotrexate renal tubular transport potentially leading to increased methotrexate plasma levels Potential increase in the risk of methotrexate associated toxic reactions. Therefore, carefully monitor patients under methotrexate therapy when concomitant ciprofloxacin therapy is indicated. Ropinirole Use with caution Monitoring for ropinirole-related adverse reactions and appropriate dose adjustment of ropinirole is recommended during and shortly after co-administration with ciprofloxacin [see Warnings and Precautions (5.16)]. Clozapine Use with caution Careful monitoring of clozapine associated adverse reactions and appropriate adjustment of clozapine dosage during and shortly after co-administration with ciprofloxacin are advised. NSAIDs Use with caution 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 and in postmarketing. Sildenafil Use with caution Two-fold increase in exposure Monitor for sildenafil toxicity [see Clinical Pharmacology (12.3)]. Duloxetine Avoid Use Five-fold increase in duloxetine exposure If unavoidable, monitor for duloxetine toxicity Caffeine/Xanthine Derivatives Use with caution Reduced clearance resulting in elevated levels and prolongation of serum half-life Ciprofloxacin inhibits the formation of paraxanthine after caffeine administration (or pentoxifylline containing products). Monitor for xanthine toxicity and adjust doses as necessary. Zolpidem Avoid Use Co-administration with ciprofloxacin may increase blood levels of zolpidem, concurrent use is not recommended Drug(s) Affecting Pharmacokinetics of Ciprofloxacin Antacids, Sucralfate, Multivitamins and Other Products Containing Multivalent Cations (magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate); sucralfate; Videx (didanosine) chewable/buffered tablets or pediatric powder; other highly buffered drugs; or products containing calcium, iron, or zinc and dairy products) Ciprofloxacin should be taked at least two hours before or six hours after Multivalent cation-containing products administration [see Dosage and Administration (2.4)]. Decrease ciprofloxacin absorption, resulting in lower serum and urine levels Probenecid Use with caution (interferes with renal tubular secretion of ciprofloxacin and increases ciprofloxacin serum levels) Potentiation of ciprofloxacin toxicity may occur. Interacting Drug Interaction Theophylline Serious and fatal reactions. Avoid concomitant use. Monitor serum level (7) Warfarin Anticoagulant effect enhanced. Monitor prothrombin time, INR, and bleeding (7) Antidiabetic agents Hypoglycemia including fatal outcomes have been reported. Monitor blood glucose (7) Phenytoin Monitor phenytoin level (7) Methotrexate Monitor for methotrexate toxicity (7) Cyclosporine May increase serum creatinine. Monitor serum creatinine (7) Multivalent cation-containing products including antacids, metal cations or didanosine Decreased ciprofloxacin absorption. Take ciprofloxacin 2 hours before or 6 hours after administration of multivalent cation containing drugs (7)
Lactation: Breastfeeding is not recommended during treatment, but a lactating woman may pump and discard breastmilk during treatment and an additional 2 days after the last dose. In patients treated for inhalational anthrax (post exposure), consider the risks and benefits of continuing breastfeeding. (8.2) See full prescribing information for use in pediatric and geriatric patients (8.4, 8.5)
Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls. Quinolones, including ciprofloxacin, cause arthropathy (arthralgia, arthritis), in juvenile animals [see Warnings and Precautions (5.13) and Nonclinical Toxicology (13.2)].
Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as ciprofloxacin. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing ciprofloxacin to elderly patients especially those on corticosteroids. Patients should be informed of this potential adverse reaction and advised to discontinue ciprofloxacin and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur [see Boxed Warning, Warnings and Precautions (5.2), and Adverse Reactions (6.2)]. Epidemiologic studies report an increased rate of aortic aneurysm and disection within two months following use of fluoroquinolones, particularly in elderly patients [see Warnings and Precautions (5.9)]. In a retrospective analysis of 23 multiple-dose controlled clinical trials of ciprofloxacin encompassing over 3500 ciprofloxacin treated patients, 25% of patients were greater than or equal to 65 years of age and 10% were greater than or equal to 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals on any drug therapy cannot be ruled out. Ciprofloxacin is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. No alteration of dosage is necessary for patients greater than 65 years of age with normalrenal function. However, since some older individuals experience reduced renal function by virtue of their advanced age, care should be taken in dose selection for elderly patients, and renal function monitoring may be useful in these patients [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)]. In general, elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using ciprofloxacin with concomitant drugs that can result in prolongation of the QT interval (for example, class IA or class III antiarrhythmics) or in patients with risk factors for torsade de pointes (for example, known QT prolongation, uncorrected hypokalemia) [see Warnings and Precautions (5.12)].
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].
In preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in ciprofloxacin pharmacokinetics have been observed. The pharmacokinetics of ciprofloxacin in patients with acute hepatic insufficiency, have not been studied.
In the event of acute overdosage, reversible renal toxicity has been reported in some cases. Empty the stomach by induing vomiting or by gastric lavage. Observe the patient carefully and give supportive treatment, including monitoring of renal function, urinary pH and acidify, if required, to prevent crystalluria and administration of magnesium, aluminum, or calcium containing antacids which can reduce the absorption of ciprofloxacin. Adequate hydration must be maintained. Only a small amount of ciprofloxacin (less than 10%) is removed from the body after hemodialysis or peritoneal dialysis.
Ciprofloxacin Tablets, USP are synthetic antimicrobial agents for oral administration.Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3 HCl H2O and its chemical structure is as follows: Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its molecular weight is 331.4. It is faintly yellowish to light yellow crystalline substance and its chemical structure is as follows: Ciprofloxacin Tablets, USP are film coated and available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin tablets are white to slightly yellowish. The inactive ingredients are colloidal silicon dioxide, pregelatinized starch (corn), magnesium stearate, sodium starch glycolate (potato). The 500 mg and 750 mg contains polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), titanium dioxide and talc. The 250 mg contains titanium dioxide, hypromellose, polyethylene glycol, and polysorbate.
Ciprofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology (12.4)].
Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below: Salmonella/Microsone Test (Negative) E. coli DNA Repair Assay (Negative) Mouse Lymphoma Cell Forward Mutation Assay (Positive) Chinese Hamster V79 Cell HGPRT Test (Negative) Syrian Hamster Embryo Cell Transformation Assay (Negative) Saccharomyces cerevisiae Point Mutation Assay (Negative) Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative) Rat Hepatocyte DNA Repair Assay (Positive) Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems gave negative results: Rat Hepatocyte DNA Repair Assay Micronucleus Test (Mice) Dominant Lethal Test (Mice) Long-term carcinogenicity studies in rats and mice resulted in no carcinogenic or tumorigenic effects due to ciprofloxacin at daily oral dose levels up to 250 mg/kg and 750 mg/kg to rats and mice, respectively (approximately 1.7- and 2.5- times the highest recommended therapeutic dose based upon body surface area, respectively). esults from photo co-carcinogenicity testing indicate that ciprofloxacin does not reduce the time to appearance of UV- induced skin tumors as compared to vehicle control. Hairless (Skh-1) mice were exposed to UVA light for 3.5 hours five times every two weeks for up to 78 weeks while concurrently being dministered ciprofloxacin. The time to development of the first skin tumors was 50 weeks in mice treated concomitantly with UVA and ciprofloxacin (mouse dose approximately equal to maximum recommended human dose based upon body surface area), as opposed to 34 weeks when animals were treated with both UVA and vehicle. The times to development of skin tumors ranged from 16 weeks to 32 weeks in mice treated concomitantly with UVA and other quinolones.5 In this model, mice treated with ciprofloxacin alone did not develop skin or systemic tumors. There are no data from similar models using pigmented mice and/or fully haired mice. The clinical significance of these findings to humans is unknown. Fertility studies performed in male and female rats at oral doses of ciprofloxacin up to 100 mg/kg (approximately 0.6 times the highest recommended therapeutic oral dose based upon body surface area) revealed no evidence of impairment. Male rats received oral ciprofloxacin for 10 weeks prior to mating and females were dosed for 3 weeks prior to mating through Gestation Day 7.
Ciprofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested [see Warnings and Precautions (5.13)]. Damage of weight bearing joints was observed in juvenile dogs and rats. In young beagles, 100 mg/kg ciprofloxacin, given daily for 4 weeks, caused degenerative articular changes of the knee joint. At 30 mg/kg, the effect on the joint was minimal. In a subsequent study in young beagle dogs, oral ciprofloxacin doses of 30 mg/kg and 90 mg/kg ciprofloxacin (approximately 1.3-times and 3.5-times the pediatric dose based upon comparative plasma AUCs) given daily for 2 weeks caused articular changes which were still observed by histopathology after a treatment-free period of 5 months. At 10 mg/kg (approximately 0.6-times the pediatric dose based upon comparative plasma AUCs), no effects on joints were observed. This dose was also not associated with arthrotoxicity after an additional treatment-free period of 5 months. In another study, removal of weight bearing from the joint reduced the lesions but did not totally prevent them. Crystalluria, sometimes associated with secondary nephropathy, occurs in laboratory animals dosed with ciprofloxacin. This is primarily related to the reduced solubility of ciprofloxacin under alkaline conditions, which predominate in the urine of test animals; in man, crystalluria is rare since human urine is typically acidic. In rhesus monkeys, crystalluria without nephropathy was noted after single oral doses as low as 5 mg/kg. (approximately 0.07-times the highest recommended therapeutic dose based upon body surface area). After 6 months of intravenous dosing at 10 mg/kg/day, no nephropathological changes were noted; however, nephropathy was observed after dosing at 20 mg/kg/day for the same duration (approximately 0.2-times the highest recommended therapeutic dose based upon body surface area). In dogs, ciprofloxacin at 3 mg/kg and 10 mg/kg by rapid intravenous injection (15 sec.) produces pronounced hypotensive effects. These effects are considered to be related to histamine release, since they are partially antagonized by pyrilamine, an antihistamine. In rhesus monkeys, rapid intravenous injection also produces hypotension but the effect in this species is inconsistent and less pronounced. In mice, concomitant administration of nonsteroidal anti-inflammatory drugs such as phenylbutazone and indomethacin with quinolones has been reported to enhance the CNS stimulatory effect of quinolones. Ocular toxicity seen with some related drugs has not been observed in ciprofloxacin-treated animals.
Ciprofloxacin administered intravenously and/or orally was compared to a cephalosporin for treatment of cUTI and pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 4 years). The trial was conducted in the US, 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. Table 12: Clinical Success and Bacteriologic Eradication at Test of Cure (5 to 9 Days 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% Cl [-1.3%, 7.3%] Bacteriologic Eradication by Patient at 5 to 9 Days Post-TreatmentPatients 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. 84.4% (178/211) 78.3% (181/231) 95% Cl [-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%)
The mean serum concentrations of ciprofloxacin associated with a statistically significant improvement in survival in the rhesus monkey model of inhalational anthrax are reached or exceeded in adult and pediatric patients receiving oral and intravenous regimens. Ciprofloxacin pharmacokinetics have been evaluated in various human populations. The mean peak serum concentration achieved at steady-state in human adults receiving 500 mg orally every 12 hours is 2.97 mcg/mL, and 4.56 mcg/mL following 400 mg intravenously every 12 hours. The mean trough serum concentration at steady-state for both of these regimens is 0.2 mcg/mL. In a study of 10 pediatric patients between 6 and 16 years of age, the mean peak plasma concentration achieved is 8.3 mcg/mL and trough concentrations range from 0.09 mcg/mL to 0.26 mcg/mL, following two 30-minute intravenous infusions of 10 mg/kg administered 12 hours apart. After the second intravenous infusion patients switched to 15 mg/kg orally every 12 hours achieve a mean peak concentration of 3.6 mcg/mL after the initial oral dose. Long-term safety data, including effects on cartilage, following the administration of ciprofloxacin to pediatric patients are limited. Ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication.1 A placebo-controlled animal study in rhesus monkeys exposed to an inhaled mean dose of 11 LD50 (~5.5 105 spores (range 5 30 LD50) of B. anthracis was conducted. The minimal inhibitory concentration (MIC) of ciprofloxacin for the anthrax strain used in this study was 0.08 mcg/mL. In the animals studied, mean serum concentrations of ciprofloxacin achieved at expected Tmax (1 hour post-dose) following oral dosing to steady-state ranged from 0.98 mcg/mL to 1.69 mcg/mL.6 Mortality due to anthrax for animals that received a 30-day regimen of oral ciprofloxacin beginning 24 hours post- exposure was significantly lower (1/9), compared to the placebo group (9/10) [p= 0,001]. The one ciprofloxacin -treated animal that died of anthrax did so following the 30-day drug administration period.7 More than 9300 persons were recommended to complete a minimum of 60 days of antibacterial prophylaxis against possible inhalational exposure to B. anthracis during 2001. Ciprofloxacin was recommended to most of those individuals for all or part of the prophylaxis regimen. Some persons were also given anthrax vaccine or were switched to alternative antibacterial drugs. No one who received ciprofloxacin or other therapies as prophylactic as all or part of their post-exposure prophylaxis regimen is unknown.
A placebo-controlled animal study in African green monkeys exposed to an inhaled mean dose of 110 LD50 (range 92 to 127 LD50) of Yersinia Pestis (CO92 strain) was conducted. The minimal inhibitory concentration (MIC) of ciprofloxacin for the Y. pestis strain used in this study was 0.015 mcg/mL. Mean peak serum concentrations of ciprofloxacin achieved at the end of a single 60 minute infusion were 3.49 mcg/mL 0.55 mcg/mL, 3.91 mcg/mL 0.58 mcg/mL and 4.03 mcg/mL 1.22 mcg/mL on Day 2, Day 6 and Day 10 of treatment in African green monkeys, respectively All trough concentrations (Day 2, Day 6 and Day 10) were <0.5 mcg /mL. Animals were randomized to receive either a 10-day regimen of intravenous ciprofloxacin 15 mg/kg, or placebo beginning when animals were found to be febrile (a body temperature greater than 1.5o C over baseline for two hours), or at 76 hours post-challenge, whichever occurred sooner. Mortality in the ciprofloxacin group was significantly lower (1/10) compared to the placebo group (2/2) [difference: 90.0%, 95% exact confidence interval: -99.8% to -5.8%]. The one ciprofloxacin-treated animal that died did not receive the proposed dose of ciprofloxacin due to a failure of the administration catheter. Circulating ciprofloxacin concentration was below 0.5 mcg/mL at all timepoints tested in this animal. It became culture negative on Day 2 of treatment, but had a resurgence of low grade bacteremia on Day 6 after treatment initiation. Terminal blood culture in this animal was negative.8
21 CFR 314.510 (Subpart H Accelerated Approval of New Drugs for Life-Threatening Illnesses). Friedman J, Polifka J. Teratogenic effects of drugs: a resource for clinicians (TERIS). Baltimore, Maryland: Johns Hopkins University Press, 2000:149-195. Loebstein R, Addis A, Ho E, et al. Pregnancy outcome following gestational exposure to fluoroquinolones: a multicenter prospective controlled study. Antimicrob Agents Chemother. 1998;42(6):1336-1339. Schaefer C, Amoura-Elefant E, Vial T, et al. Pregnancy outcome after prenatal quinolone exposure. Evaluation of a case registry of the European network of teratology information services (ENTIS). Eur J Obstet Gynecol Reprod Biol. 1996;69:83-89. 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 Avenie, Room 200, Rockville, MD 20852, USA. Kelly DJ, et al. Serum concentrations of penicillin, doxycycline, and ciprofloxacin during prolonged therapy in rhesus monkeys. J Infect Dis 1992; 166:1184-7. Friedlander AM, et al. Postexposure prophylaxis against experimental inhalational anthrax. J Infect Dis 1993; 167:1239-42. Anti-infective Drugs Advisory Committee Meeting, April 3, 2012 - The efficiency of Ciprofloxacin for treatment of Pneumonic Plague.
Ciprofloxacin Tablets USP, are available as 250 mg, 500 mg and 750 mg tablets for oral administration. Ciprofloxacin Tablets, USP, 250 mg are white to off-white, round, film-coated, debossed "E442" on one side and plain on the other side and are available as follows: NDC 69367-385-01 Bottles of 100 Ciprofloxacin Tablets, USP, 500 mg are white to off-white, capsule-shaped, film-coated, debossed "E451" on one side and plain on the other side and are available as follows: NDC 69367-386-01 Bottles of 100 NDC 69367-386-05 Bottles of 500 Ciprofloxacin Tablets, USP, 750 mg are white to off-white, capsule shaped, film-coated, debossed "E470" on one side and plain on the other side and are available as follows: NDC 69367-387-50 Bottles of 50
Store at 20 C to 25 C (68 to 77 F) [see USP Controlled Room Temperature].
Advise the patient to read the FDA-approved patient labeling (Medication Guide)
Medication Guide Ciprofloxacin Tablets, USP for oral use (sih-proe-FLOX-ah-sin) Read this Medication Guide before you start taking ciprofloxacin tablets and each time you get a refill. There may be new information. This information 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? Ciprofloxacin tablets, a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death. If you get any of the following serious side effects while you take ciprofloxacin tablets, you should stop taking ciprofloxacin tablets immediately and get medical help right away. 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 swelling of the tendons including the back of the ankle (Achilles), shoulder, hand, thumb, or other tendon sites. The risk of getting tendon problems while you take ciprofloxacin tablets is higher if you: 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: are over 60 years of age are taking steroides (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). Stop taking ciprofloxacin tablets immediately and get medical help right away at the first sign of tendon pain, swelling or inflammation. 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. Tendon rupture can happen while you are taking or after you have finished taking ciprofloxacin tablets.Tendon ruptures can happen within hours or days of taking ciprofloxacin tablets and have happened up to several months after people have finished taking their fluoroquinolone. Stop taking ciprofloxacin tablets immediately and 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 The tendon problems may be permanent. 2. 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. Stop taking ciprofloxacin tablets immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet: pain burning tingling numbness weakness Ciprofloxacin tablets may need to be stopped to prevent permanent nerve damage. 3. Central Nervous System (CNS) effects. Mental health problems and seizures have been reported in people who take fluoroquinolone antibacterial medicines, including ciprofloxacin tablets. Tell your healthcare provider if you have a history of seizure before you start taking ciprofloxacin tablets. CNS side effects may happen as soon as after taking the first dose of ciprofloxacin tablets. Stop taking ciprofloxacin tablets immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior: seizures hear voices, see things, or sense things that are not there (hallucinations) feel restless or agitated tremors feel anxious or nervous confusion depression reduced awareness of surrounding trouble sleeping nightmares feel lightheaded or dizzy feel more suspicious (paranoia) suicidal thoughts or acts headaches that will not go away, with or without blurred vision memory problems false or strange thoughts or beliefs (delusions) The CNS changes may be permanent. 4. Worsening of myasthenia gravis (a problem that causes muscle weakness). Fluoroquinolones like ciprofloxacin tablets may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Tell your healthcare provider if you have a history of myasthenia gravis before you start taking ciprofloxacin tablets. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems. What are ciprofloxacin tablets? Ciprofloxacin tablets is a fluoroquinolone antibacterial medicine used in adults age 18 years and older to treat certain infections caused by certain germs called bacteria. These bacterial infections include: urinary tract infection chronic prostate infection lower respiratory tract infection sinus infection skin infection bone and joint infection nosocomial pneumonia intra-abdominal infection, complicated infectious diarrhea typhoid (enteric) fever cervical and urethral gonorrhea, uncomplicated people with a low white blood cell count and a fever inhalational anthrax plague Studies of ciprofloxacin tablets for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people. Ciprofloxacin tablets should not be used in people with acute exacerbation of chronic bronchitis, acute uncomplicated cystitis, and sinus infections, if there are other treatment options available. Ciprofloxacin tablets should not be used as the first choice of antibacterial medicine to treat lower respiratory tract infections caused by a certain type of bacterial called Streptococcus pneumoniae. Ciprofloxacin tablets are also used in children younger than 18 years of age to treat complicated urinary tract and kidney infections or who may have breathed in anthrax germs, have plague or have been exposed to plague germs. Children younger 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. Ciprofloxacin tablets should not be used as the first choice of antibacterial medicine in children under 18 years of age. Who should not take ciprofloxacin tablets? Do not take ciprofloxacin tablets if you: have ever had a severe allergic reaction to an antibacterial medicine known as a fluoroquinolon, or are allergic to ciprofloxacin hydrochloride or any of the ingredients in ciprofloxacin tablets. See the end of the Medication Guide for a complete list of ingredients in ciprofloxacin tablets. also take a medicine called tizanidine (Zanaflex ). Ask your healthcare provider if you are not sure. What should I tell my healthcare provider before taking ciprofloxacin tableta? Before you take ciprofloxacin tablets, tell your healthcare provider about all your medical conditions, including if you: have tendon problems. ciprofloxacin tablets should not be used in people who have a history of tendon problems. have a disease that causes muscle weakness (myasthenia gravis); ciprofloxacin tablets should not be used in people who have a known history of myasthenia gravis. have liver problems. have central nervous system problems (such as epilepsy). have nerve problems. Ciprofloxacin tablets should not be used in people who have a history of a nerve problem called peripheral neuropathy have or anyone in your family has an irregular heartbeat, or heart attack, especially a condition called "QT prolongation". have low blood potassium (hypokalemia) or low magnesium (hypomagnesemia). have or have had seizures. have kidney problems. You may need a lower dose of ciprofloxacin tablets if your kidneys do not work well. have diabetes or problems with low blood sugar (hypoglycemia). have joint problems including rheumatoid arthritis (RA). have trouble swallowing pills. are pregnant or plan to become pregnant. It is not known if ciprofloxacin tablets will harm your unborn baby. are breastfeeding or plan to breastfeed. Ciprofloxacin passes into breast milk. You should not breastfeed during treatment with ciprofloxacin tablets and for 2 days after taking your last dose of ciprofloxacin tablets. You may pump your breast milk and throw it away during treatment with ciprofloxacin tablets and for 2 days after taking your last dose of ciprofloxacin tablets. If you are taking ciprofloxacin for inhalation anthrax, you and your healthcare provider should decide whether you can continue breastfeeding while taking ciprofloxacin tablets. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ciprofloxacin tablets and other medicines can affect each other causing side effects. Especially tell your healthcare provider if you take: a steroid medicine. an anti-psychotic medicine. a tricyclic antidepressant. a water pill (diuretic). theophylline (such as Theo-24 , Elixophyllin , Theochron , Uniphyl , Theolair ). a medicine to control your heart rate or rhythm (antiarrhythmics). an oral anti-diabetes medicine. phenytoin (Fosphenytoin Sodium , Cerebyx , Dilantin-125 , Dilantin , Extended Phenytoin Sodium , Prompt Phenytoin Sodium , Phenytek ). cyclosporine (Gengraf , Neoral , Sandimmune , Sangcya ). a blood thinner (such as warfarin, Coumadin , Jantoven ). methotrexate (Trexall ). ropinirole (Requip ). clozapine (Clozaril , Fazaclo ODT ). a Non-Steroidal Anti-Inflammatory Drug (NSAID). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take ciprofloxacin tablets or other fluoroquinolones may increase your risk of central nervous system effects and seizures. sildenafil (Viagra , Revatio ). duloxetine. products that contain caffeine. probenecid (Probalan , Col-probenecid ). Certain medicines may keep ciprofloxacin tablets from working correctly. Take ciprofloxacin tablets either 2 hours before or 6 hours after taking these medicines, vitamins, or supplements: an antacid, multivitamin, or other medicine or supplements that has magnesium, calcium, aluminum, iron, or zinc. sucralfate (Carafate ). didanosine (Videx , Videx EC ). Ask your healthcare provider for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take ciprofloxacin tablets? Take ciprofloxacin tablets exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much ciprofloxacin to take and when to take it. 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 cannot swallow the tablet whole. Ciprofloxacin tablets can be taken with or without food. If you miss a dose of ciprofloxacin tablets and it is: 6 hours or more until your next scheduled dose, take your missed dose right away. Then take the next dose at your regular time. less than 6 hours until your next scheduled dose, do not take the missed dose. Take the next dose at your regular time. Do not take 2 doses of ciprofloxacin tablets at one time to make up for a missed dose. If you are not sure about when to take ciprofloxacin tablets after a missed dose, ask your doctor or pharmacist. 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 of ciprofloxacin tablets, or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless: you have tendon problems. See "What is the most important information I should know about ciprofloxacin tablets?" you have nerve problems. See "What is the most important information I should know about ciprofloxacin tablets?" you have central nervous system problems. See "What is the most important information I should know about ciprofloxacin tablets?" you have a serious allergic reaction. See "What are the possible side effects of ciprofloxacin tablets?" your healthcare provider tells you to stop taking ciprofloxacin tablets. Taking all of your ciprofloxacin tablets doses will help make sure that all of the bacteria are killed. Taking all of your ciprofloxacin tablets doses will help lower the chance that the bacteria will become resistant to ciprofloxacin tablets. If you become resistant to ciprofloxacin tablets, ciprofloxacin tablets and other antibacterial medicines may not work for you in the future. If you take too much ciprofloxacin call your healthcare provider or get medical help right away. 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 a severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while you take 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? Ciprofloxacin tablets may cause serious side effects, including: See "What is the most important information I should know about ciprofloxacin tablets?" Serious allergic reactions. Serious allergic reactions, including death, can happen in people taking fluoroquinolones, including ciprofloxacin tablets, even after only 1 dose. Stop taking ciprofloxacin tablets and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction: hives trouble breathing or swallowing swelling of the lips, tongue, face throat tightness, hoarseness rapid heartbeat faint skin rash Skin rash may happen in people taking ciprofloxacin tablets even after only 1 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. Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take ciprofloxacin tablets. Call your healthcare provider right away if you have unexplained symptoms such as: nausea or vomiting stomach pain fever weakness abdominal pain or tenderness itching unusual tiredness loss of appetite light colored bowel movements dark colored urine yellowing of the skin and whites of your eyes Stop taking ciprofloxacin tablets and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to ciprofloxacin tablets (a liver problem). Aortic aneurysm and dissection. Tell your healthcare provider if you have ever been told that you have an aortic aneurysm, a swelling of the large artery that carries blood from the heart to the body. Get emergency medical help right away if you have sudden chest, stomach, or back pain. Intestine infection (Clostridiodes difficile - associated diarrhea). Clostridiodes difficile-associated diarrhea (CDAD) can happen with many antibacterial medicines, including ciprofloxacin tablets. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. CDAD can happen 2 or more months after you have finished your antibacterial medicine. Serious heart rhythm changes (QT prolongation and torsade de pointes). Tell your healthcare provider right away if you have a change in your heartbeat (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) or low magnesium (hypomagnesemia). who take certain medicines to control heart rhythm (antiarrhythmics). Joint Problems. Increased chance of problems with joints and tissues around joints in children under 18 years old can happen. Tell your child's healthcare provider if your child has any joint problems during or after treatment with ciprofloxacin tablets. Sensitivity to sunlight (photosensitivity). See "What should I avoid while taking ciprofloxacin tablets?" Changes in blood sugar. People who take ciprofloxacin and other fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Follow your healthcare provider's instructions for how often to check your blood sugar. If you have diabetes and you get low blood sugar while taking ciprofloxacin, stop taking ciprofloxacin and call your healthcare provider right away. Your antibiotic medicine may need to be changed. The most common side effects of ciprofloxacin tablets include: nausea diarrhea changes in liver function tests vomiting rash Tell your healthcare provider about any side effect that bothers you, or that does not go away. These are not all the possible side effects of ciprofloxacin tablets. For more information, ask your healthcare provider or pharmacist. 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 ciprofloxacin tablets at room temperature (20 to 25 C or 68 F to 77 F). Keep ciprofloxacin tablets and all medicines out of the reach of children. General Information about the safe and effective use of 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. It 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. What are the ingredients in ciprofloxacin tablets? Active ingredient: Ciprofloxacin hydrochloride, USP Inactive ingredients: Colloidal silicon dioxide, pregelatinized starch (corn), magnesium stearate, sodium starch glycolate (potato). The 500 mg and 750 mg contains polyethylene glycol, polyvinyl alcohol (partially hydrolyzed), titanium dioxide and talc. The 250 mg contains titanium dioxide, hypromellose, polyethylene glycol, and polysorbate. For more information call Westminster Pharmaceuticals, LLC at 1-844-221-7294. This Medication Guide has been approved by the U.S. Food and Drug Administration. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Westminster Pharmaceuticals, LLC Manufactured by: Zhejiang Jingxin Pharmaceutical Co., Ltd. Zhejiang, 312500, China Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217 LB8073 R0424
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