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 causal relationship to drug exposure (Table 10).
|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|
|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 generalize 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, reduction 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 11: Drugs That are Affected by and Affecting Ciprofloxacin|
|Drugs That are Affected by Ciprofloxacin|
|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 patient 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 (5.9)].|
|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 (5.11) 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-administration 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 dose 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 taken 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.|
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