Ciprofloxacin Tablet

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1. 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:
2. Tendinitis and tendon rupture [see Warnings and Precautions ( 5.2)]
3. Peripheral neuropathy [see Warnings and Precautions ( 5.3)]
4. Central nervous system effects [see Warnings and Precautions ( 5.4)]
5. Discontinue ciprofloxacin immediately and avoid the use of fluoroquinolones, including ciprofloxacin, in patients who experience any of these serious adverse reactions [see Warnings and Precautions ( 5.1)] . Fluoroquinolones, including ciprofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis [see Warnings and Precautions ( 5.5)] .
6. Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1– 5.16)] , reserve ciprofloxacin for use in patients who have no alternative treatment options for the following indications:
7. Acute exacerbation of chronic bronchitis [see Indications and Usage ( 1.10)]
8. Acute uncomplicated cystitis [see Indications and Usage ( 1.11)]
9. Acute sinusitis [see Indications and Usage ( 1.12)]

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 ciprofloxacin. 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 ciprofloxacin immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including ciprofloxacin, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

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:

1. Fever, rash, or severe dermatologic reactions (for example, toxic epidermal necrolysis, Stevens-Johnson syndrome);
2. Vasculitis; arthralgia; myalgia; serum sickness;
3. Allergic pneumonitis;
4. Interstitial nephritis; acute renal insufficiency or failure;
5. Hepatitis; jaundice; acute hepatic necrosis or failure;
6. 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 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 of 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)].

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:

1. Disabling and Potentially Irreversible Serious Adverse Reactions [see Warnings and Precautions ( 5.1)]
2. Tendinitis and Tendon Rupture [see Warnings and Precautions ( 5.2)]
3. Peripheral Neuropathy [see Warnings and Precautions ( 5.3)]
4. Central Nervous System Effects [see Warnings and Precautions ( 5.4)] Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.5)]
5. Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions ( 5.6)]
6. Hypersensitivity Reactions [see Warnings and Precautions ( 5.7)]
7. Hepatotoxicity [see Warnings and Precautions ( 5.8)]
8. Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions ( 5.9)]
9. Serious Adverse Reactions with Concomitant Theophylline [see Warnings and Precautions ( 5.10)]
10. Clostridioides difficile-Associated Diarrhea [see Warnings and Precautions ( 5.11)]
11. Prolongation of the QT Interval [see Warnings and Precautions ( 5.12)]
12. Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions ( 5.13)]
13. Photosensitivity/Phototoxicity [see Warnings and Precautions ( 5.14)]
14. Development of Drug Resistant Bacteria [see Warnings and Precautions ( 5.15)]

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Ciprofloxacin tablets should be administered orally as described in the appropriate Dosage Guidelines tables.

The determination of dosage and duration for any particular patient must 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 indicted at the discretions of the physician.

Table 1: Adult Dosage Guidelines

¹Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).

²Used in conjunction with metronidazole.

³Begin drug administration as soon as possible after suspected or confirmed exposure.

Conversion of IV to Oral Dosing in Adults

Patients whose therapy is started with Ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology ( 12.3)].

Table 2: Equivalent AUC Dosing Regimens

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 tablets should be administered as described in Table 3.

Table 3: Pediatric Dosage Guidelines

^1.The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).

^2.Begin drug administration as soon as possible after suspected or confirmed exposure.

^3.Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis.

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

When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance:

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/1.73m ²).

1. Ciprofloxacin Tablets, USP 500 mg, white, oval shaped tablets, plain on one side, and “Y102” with no breakline on the other side.

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