Levofloxacin (Page 6 of 16)

6.3 Post-Marketing Experience

Table 6 lists adverse reactions that have been identified during post-approval use of levofloxacin. 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 6: Post-Marketing Reports of Adverse Drug Reactions
System/Organ Class Adverse Reaction
Blood and Lymphatic System Disorders

pancytopenia

aplastic anemia

leukopenia

hemolytic anemia

[see Warnings and Precautions (5.4)]

Immune System Disorders

hypersensitivity reactions, sometimes fatal including: anaphylactic/anaphylactoid reactions

anaphylactic shock

angioneurotic edema

serum sickness

[see Warnings and Precautions (5.3, 5.4)]
Psychiatric Disorders

psychosis

paranoia

isolated reports of suicide attempt and suicidal ideation

[see Warnings and Precautions (5.6)]
Nervous System Disorders

exacerbation of myasthenia gravis [see Warnings and Precautions (5.2)]

anosmia

ageusia

parosmia

dysgeusia

peripheral neuropathy [see Warnings and Precautions (5.8)]

isolated reports of encephalopathy

abnormal electroencephalogram (EEG)

dysphonia

pseudotumor cerebri [see Warnings and Precautions (5.6)]

Eye Disorders

vision disturbance, including diplopia

visual acuity reduced

vision blurred

Ear and Labyrinth Disorders

hypoacusis

Cardiac Disorders

isolated reports of Torsades de pointes

electrocardiogram QT prolonged

[see Warnings and Precautions (5.9)]

Vascular Disorders vasodilatation
Respiratory, Thoracic and Mediastinal Disorders isolated reports of allergic pneumonitis [see Warnings and Precautions (5.4)]
Hepatobiliary Disorders

hepatic failure (including fatal cases)

hepatitis

jaundice

[see Warnings and Precautions (5.4, 5.5)]
Skin and Subcutaneous Tissue Disorders

bullous eruptions to include:

Stevens-Johnson Syndrome

toxic epidermal necrolysis

erythema multiforme

[see Warnings and Precautions (5.4)]

photosensitivity/phototoxicity reaction [see Warnings and Precautions (5.12)]

Musculoskeletal and Connective Tissue Disorders

tendon rupture [see Warnings and Precautions (5.1)]

muscle injury, including rupture

Renal and Urinary Disorders interstitial nephritis [see Warnings and Precautions (5.4)]
General Disorders and Administration Site Conditions

multi-organ failure

Investigations

prothrombin time prolonged

international normalized ratio prolonged

7 DRUG INTERACTIONS

7.1 Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

While the chelation by divalent cations is less marked than with other fluoroquinolones, concurrent administration of levofloxacin tablets 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 2 hours before or 2 hours after oral levofloxacin tablet administration.

7.2 Warfarin

No significant effect of levofloxacin 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 post-marketing experience in patients that levofloxacin enhances the effects of warfarin. Elevations of the prothrombin time in the setting of concurrent warfarin and levofloxacin use have been associated with episodes of bleeding. Prothrombin time, International Normalized Ratio (INR) or other suitable anticoagulation tests should be closely monitored if levofloxacin is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding [see Adverse Reactions (6.3) and Patient Counseling Information (17.4)].

7.3 Antidiabetic Agents

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 coadministered [see Warnings and Precautions (5.11), Adverse Reactions (6.2) and Patient Counseling Information (17.4)].

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