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Serious and Otherwise Important Adverse Reactions
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
- Tendon Effects [see WARNINGS AND PRECAUTIONS]
- Exacerbation of Myasthenia Gravis [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
- Other Serious and Sometimes Fatal Reactions [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Central Nervous System Effects [see WARNINGS AND PRECAUTIONS]
- Clostridium difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
- Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS]
- Prolongation of the QT Interval [see WARNINGS AND PRECAUTIONS]
- Musculoskeletal Disorders in Pediatric Patients [see WARNINGS AND PRECAUTIONS]
- Blood Glucose Disturbances [see WARNINGS AND PRECAUTIONS ]
- Photosensitivity/Phototoxicity [see WARNINGS AND PRECAUTIONS ]
- Development of Drug Resistant Bacteria [see WARNINGS AND PRECAUTIONS]
- Hypotension has been associated with rapid or bolus intravenous infusion of LEVAQUIN® . LEVAQUIN® should be infused slowly over 60 to 90 minutes, depending on dosage [see DOSAGE AND ADMINISTRATION].
- Crystalluria and cylindruria have been reported with quinolones, including LEVAQUIN® . Therefore, adequate hydration of patients receiving LEVAQUIN® should be maintained to prevent the formation of a highly concentrated urine [see DOSAGE AND ADMINISTRATION].
Clinical Trial Experience
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 data described below reflect exposure to LEVAQUIN® in 7537 patients in 29 pooled Phase 3 clinical trials. The population studied had a mean age of 50 years (approximately 74% of the population was < 65 years of age), 50% were male, 71% were Caucasian, 19% were Black. Patients were treated with LEVAQUIN® for a wide variety of infectious diseases [see INDICATIONS AND USAGE]. Patients received LEVAQUIN® doses of 750 mg once daily, 250 mg once daily, or 500 mg once or twice daily. Treatment duration was usually 3–14 days, and the mean number of days on therapy was 10 days.
The overall incidence, type and distribution of adverse reactions was similar in patients receiving LEVAQUIN® doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of LEVAQUIN® due to adverse drug reactions occurred in 4.3% of patients overall, 3.8% of patients treated with the 250 mg and 500 mg doses and 5.4% of patients treated with the 750 mg dose. The most common adverse drug reactions leading to discontinuation with the 250 and 500 mg doses were gastrointestinal (1.4%), primarily nausea (0.6%); vomiting (0.4%); dizziness (0.3%); and headache (0.2%). The most common adverse drug reactions leading to discontinuation with the 750 mg dose were gastrointestinal (1.2%), primarily nausea (0.6%), vomiting (0.5%); dizziness (0.3%); and headache (0.3%).
Adverse reactions occurring in ≥ 1% of LEVAQUIN® -treated patients and less common adverse reactions, occurring in 0.1 to < 1% of LEVAQUIN® -treated patients, are shown in Table 6 and Table 7, respectively. The most common adverse drug reactions ( ≥ 3%) are nausea, headache, diarrhea, insomnia, constipation, and dizziness.
Table 6: Common ( ≥ 1%) Adverse Reactions Reported in Clinical
Trials with LEVAQUIN®
|System/Organ Class||Adverse Reaction||%
|Infections and Infestations||moniliasis||1|
|Psychiatric Disorders||insomnia* [see WARNINGS AND PRECAUTIONS]||4|
|Nervous System Disorders||headache||6|
|dizziness [see WARNINGS AND PRECAUTIONS]||3|
|Respiratory, Thoracic and Mediastinal Disorders||dyspnea [see WARNINGS AND PRECAUTIONS]||1|
|Skin and Subcutaneous Tissue Disorders||rash [see WARNINGS AND PRECAUTIONS]||2|
|Reproductive System and Breast Disorders||vaginitis||1†|
|General Disorders and Administration Site Conditions||edema||1|
|injection site reaction||1|
† N=3758 (women)
Table 7: Less Common (0.1 to 1%) Adverse
Reactions Reported in Clinical Trials with LEVAQUIN® (N=7537)
|System/Organ Class||Adverse Reaction|
|Infections and Infestations||genital moniliasis|
|Blood and Lymphatic System Disorders||anemia thrombocytopenia granulocytopenia [see WARNINGS AND PRECAUTIONS]|
|Immune System Disorders||allergic reaction [see WARNINGS AND PRECAUTIONS]|
|Metabolism and Nutrition Disorders||hyperglycemia hypoglycemia [see WARNINGS AND PRECAUTIONS] hyperkalemia|
|Psychiatric Disorders||anxiety agitation confusion depression hallucination nightmare* [see WARNINGS AND PRECAUTIONS] sleep disorder* anorexia abnormal dreaming*|
|Nervous System Disorders||tremor convulsions [see WARNINGS AND PRECAUTIONS] paresthesia [see WARNINGS AND PRECAUTIONS] vertigo hypertonia hyperkinesias abnormal gait somnolence* syncope|
|Respiratory, Thoracic and Mediastinal Disorders||epistaxis|
|Cardiac Disorders||cardiac arrest palpitation ventricular tachycardia ventricular arrhythmia|
|Gastrointestinal Disorders||gastritis stomatitis pancreatitis esophagitis gastroenteritis glossitis pseudomembranous/ C. difficile colitis [see WARNINGS AND PRECAUTIONS]|
|Hepatobiliary Disorders||abnormal hepatic function increased hepatic enzymes increased alkaline phosphatase|
|Skin and Subcutaneous Tissue Disorders||urticaria [see WARNINGS AND PRECAUTIONS]|
|Musculoskeletal and Connective Tissue Disorders||arthralgia tendinitis [see WARNINGS AND PRECAUTIONS] myalgia skeletal pain|
|Renal and Urinary Disorders||abnormal renal function acute renal failure [see WARNINGS AND PRECAUTIONS]|
|* N = 7274|
In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with quinolones, including LEVAQUIN® . The relationship of the drugs to these events is not presently established.
Table 8 lists adverse reactions that have been identified during post-approval use of LEVAQUIN® . Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.
Table 8: Postmarketing Reports Of Adverse
|System/Organ Class||Adverse Reaction|
|Blood and Lymphatic System Disorders||pancytopenia aplastic anemia leukopenia hemolytic anemia [seeWARNINGS AND PRECAUTIONS] eosinophilia|
|Immune System Disorders||hypersensitivity reactions, sometimes fatal including: anaphylactic/anaphylactoid reactions anaphylactic shock angioneurotic edema serum sickness [see WARNINGS AND PRECAUTIONS]|
|Psychiatric Disorders||psychosis paranoia isolated reports of suicide attempt and suicidal ideation [see WARNINGS AND PRECAUTIONS]|
|System/Organ Class||Adverse Reaction|
|Nervous System Disorders||exacerbation of myasthenia gravis [see WARNINGS AND PRECAUTIONS] anosmia ageusia parosmia dysgeusia peripheral neuropathy [see WARNINGS AND PRECAUTIONS] isolated reports of encephalopathy abnormal electroencephalogram (EEG) dysphonia pseudotumor cerebri [see WARNINGS AND PRECAUTIONS]|
|Eye Disorders||vision disturbance, including diplopia visual acuity reduced vision blurred scotoma|
|Ear and Labyrinth Disorders||hypoacusis tinnitus|
|Cardiac Disorders||isolated reports of torsade de pointes electrocardiogram QT prolonged [see WARNINGS AND PRECAUTIONS] tachycardia|
|Respiratory, Thoracic and Mediastinal Disorders||isolated reports of allergic pneumonitis [see WARNINGS AND PRECAUTIONS]|
|Hepatobiliary Disorders||hepatic failure (including fatal cases) hepatitis jaundice [see WARNINGS AND PRECAUTIONS]|
|Skin and Subcutaneous Tissue Disorders||bullous eruptions to include: Stevens-Johnson Syndrome toxic epidermal necrolysis erythema multiforme [seeWARNINGS AND PRECAUTIONS)] photosensitivity/phototoxicity reaction [see WARNINGS AND PRECAUTIONS] leukocytoclastic vasculitis|
|Musculoskeletal and Connective Tissue Disorders||tendon rupture [see WARNINGS AND PRECAUTIONS] muscle injury, including rupture rhabdomyolysis|
|Renal and Urinary Disorders||interstitial nephritis [see WARNINGS AND PRECAUTIONS]|
|General Disorders and Administration Site Conditions||multi-organ failure pyrexia|
|Investigations||prothrombin time prolonged international normalized ratio prolonged muscle enzymes increased|
Read the Levaquin (levofloxacin) Side Effects Center for a complete guide to possible side effects »
Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
LEVAQUIN® Tablets and Oral Solution
While the chelation by divalent cations is less marked than with other fluoroquinolones, concurrent administration of LEVAQUIN® Tablets and Oral Solution with antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc may interfere with the gastrointestinal absorption of levofloxacin, resulting in systemic levels considerably lower than desired. Tablets with antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine may substantially interfere with the gastrointestinal absorption of levofloxacin, resulting in systemic levels considerably lower than desired. These agents should be taken at least two hours before or two hours after oral LEVAQUIN® administration.
There are no data concerning an interaction of intravenous fluoroquinolones with oral antacids, sucralfate, multivitamins, didanosine, or metal cations. However, no fluoroquinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see DOSAGE AND ADMINISTRATION].
No significant effect of LEVAQUIN® on the peak plasma concentrations, AUC, and other disposition parameters for R- and S- warfarin was detected in a clinical study involving healthy volunteers. Similarly, no apparent effect of warfarin on levofloxacin absorption and disposition was observed. However, there have been reports during the postmarketing experience in patients that LEVAQUIN® enhances the effects of warfarin. Elevations of the prothrombin time in the setting of concurrent warfarin and LEVAQUIN® use have been associated with episodes of bleeding. Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if LEVAQUIN® is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding [see ADVERSE REACTIONS; PATIENT INFORMATION].
Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered [see WARNINGS AND PRECAUTIONS; ADVERSE REACTIONS , PATIENT INFORMATION].
Non-Steroidal Anti-Inflammatory Drugs
The concomitant administration of a non-steroidal anti-inflammatory drug with a fluoroquinolone, including LEVAQUIN® , may increase the risk of CNS stimulation and convulsive seizures [see WARNINGS AND PRECAUTIONS].
No significant effect of LEVAQUIN® on the plasma concentrations, AUC, and other disposition parameters for theophylline was detected in a clinical study involving healthy volunteers. Similarly, no apparent effect of theophylline on levofloxacin absorption and disposition was observed. However, concomitant administration of other fluoroquinolones with theophylline has resulted in prolonged elimination half-life, elevated serum theophylline levels, and a subsequent increase in the risk of theophylline-related adverse reactions in the patient population. Therefore, theophylline levels should be closely monitored and appropriate dosage adjustments made when LEVAQUIN® is co-administered. Adverse reactions, including seizures, may occur with or without an elevation in serum theophylline levels [see WARNINGS AND PRECAUTIONS].
No significant effect of LEVAQUIN® on the peak plasma concentrations, AUC, and other disposition parameters for cyclosporine was detected in a clinical study involving healthy volunteers. However, elevated serum levels of cyclosporine have been reported in the patient population when co-administered with some other fluoroquinolones. Levofloxacin Cmax and ke were slightly lower while Tmax and t½ were slightly longer in the presence of cyclosporine than those observed in other studies without concomitant medication. The differences, however, are not considered to be clinically significant. Therefore, no dosage adjustment is required for LEVAQUIN® or cyclosporine when administered concomitantly.
No significant effect of LEVAQUIN® on the peak plasma concentrations, AUC, and other disposition parameters for digoxin was detected in a clinical study involving healthy volunteers. Levofloxacin absorption and disposition kinetics were similar in the presence or absence of digoxin. Therefore, no dosage adjustment for LEVAQUIN® or digoxin is required when administered concomitantly.
Probenecid and Cimetidine
No significant effect of probenecid or cimetidine on the Cmax of levofloxacin was observed in a clinical study involving healthy volunteers. The AUC and t½ of levofloxacin were higher while CL/F and CLR were lower during concomitant treatment of LEVAQUIN® with probenecid or cimetidine compared to LEVAQUIN® alone. However, these changes do not warrant dosage adjustment for LEVAQUIN® when probenecid or cimetidine is co-administered.
Interactions with Laboratory or Diagnostic Testing
Some fluoroquinolones, including LEVAQUIN® , may produce false-positive urine screening results for opiates using commercially available immunoassay kits. Confirmation of positive opiate screens by more specific methods may be necessary.
Last reviewed on RxList: 5/10/2012
This monograph has been modified to include the generic and brand name in many instances.
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