Levofloxacin (Page 5 of 16)

5.10 Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals

Levofloxacin is indicated in pediatric patients (≥ 6 months of age) only for the prevention of inhalational anthrax (post-exposure) [see Indications and Usage (1.13)]. An increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendinopathy and gait abnormality) compared to controls has been observed in pediatric patients receiving levofloxacin [see Use in Specific Populations (8.4)].

In immature rats and dogs, the oral and intravenous administration of levofloxacin resulted in increased osteochondrosis. Histopathological examination of the weight bearing joints of immature dogs dosed with levofloxacin revealed persistent lesions of the cartilage. Other fluoroquinolones also produce similar erosions in the weight bearing joints and other signs of arthropathy in immature animals of various species [see Animal Toxicology and/or Pharmacology (13.2)].

5.11 Blood Glucose Disturbances

As with other fluoroquinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, have been reported with levofloxacin, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. If a hypoglycemic reaction occurs in a patient being treated with levofloxacin, levofloxacin should be discontinued and appropriate therapy should be initiated immediately [see Adverse Reactions (6.2), Drug Interactions (7.3) and Patient Counseling Information (17.4)].

5.12 Photosensitivity/Phototoxicity

Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of fluoroquinolones after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if photosensitivity/phototoxicity occurs [see Adverse Reactions (6.3) and Patient Counseling Information (17.3)].

5.13 Development of Drug Resistant Bacteria

Prescribing levofloxacin in the absence 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 [see Patient Counseling Information (17.1)].

6 ADVERSE REACTIONS

6.1 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:

Crystalluria and cylindruria have been reported with quinolones, including levofloxacin. Therefore, adequate hydration of patients receiving levofloxacin should be maintained to prevent the formation of a highly concentrated urine [see Dosage and Administration (2.5)].

6.2 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 levofloxacin in 7,537 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 levofloxacin for a wide variety of infectious diseases [see Indications and Usage (1)]. Patients received levofloxacin doses of 750 mg once daily, 250 mg once daily or 500 mg once or twice daily. Treatment duration was usually 3 to 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 levofloxacin doses of 750 mg once daily, 250 mg once daily and 500 mg once or twice daily. Discontinuation of levofloxacin 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 mg 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 levofloxacin-treated patients and less common adverse reactions, occurring in 0.1% to < 1% of levofloxacin-treated patients, are shown in Table 4 and Table 5, respectively. The most common adverse drug reactions (≥ 3%) are nausea, headache, diarrhea, insomnia, constipation and dizziness.

Table 4: Common (≥ 1%) Adverse Reactions Reported in Clinical Trials with Levofloxacin
*
N = 7,274
N = 3,758 (women)
System/Organ Class Adverse Reaction

%

(N = 7,537)
Infections and Infestations moniliasis 1
Psychiatric Disorders insomnia *[see Warnings and Precautions (5.6)] 4
Nervous System Disorders

headache

[see Warnings and Precautions (5.6)]

6

Respiratory, Thoracic and Mediastinal Disorders dyspnea [see Warnings and Precautions (5.3)] 1
Gastrointestinal Disorders

nausea

diarrhea

constipation

abdominal pain

vomiting

7

5

3

2

2

Skin and Subcutaneous Tissue Disorders rash [see Warnings and Precautions (5.3)] pruritus

2

Reproductive System and Breast Disorders vaginitis 1
General Disorders and Administration Site Conditions

edema

injection site reaction

1

1

Table 5: Less Common (0.1% to 1%) Adverse Reactions Reported in Clinical Trials with Levofloxacin (N = 7,537)
*
N = 7,274
System/Organ Class Adverse Reaction
Infections and Infestations genital moniliasis
Blood and Lymphatic System Disorders

anemia

thrombocytopenia

granulocytopenia

[see Warnings and Precautions (5.4)]
Immune System Disorders allergic reaction [see Warnings and Precautions (5.3, 5.4)]
Metabolism and Nutrition Disorders

hyperglycemia

hypoglycemia

[see Warnings and Precautions (5.11)]

Psychiatric Disorders

anxiety

agitation

confusion

depression

hallucination

nightmare *

[see Warnings and Precautions (5.6)]

sleep disorder *

anorexia

Nervous System Disorders

tremor

convulsions

[see Warnings and Precautions (5.6)]

paresthesia [see Warnings and Precautions (5.8)]

vertigo

hypertonia

hyperkinesias

abnormal gait

somnolence *

Respiratory, Thoracic and Mediastinal Disorders epistaxis
Cardiac Disorders

cardiac arrest

palpitation

ventricular tachycardia

Vascular Disorders phlebitis
Gastrointestinal Disorders

gastritis

stomatitis

pancreatitis

esophagitis

gastroenteritis

glossitis

C. difficile colitis [see Warnings and Precautions (5.7)]
Hepatobiliary Disorders

abnormal hepatic function

increased hepatic enzymes

Skin and Subcutaneous Tissue Disorders urticaria [see Warnings and Precautions (5.3)]
Musculoskeletal and Connective Tissue Disorders

arthralgia

tendinitis

[see Warnings and Precautions (5.1)]

myalgia

Renal and Urinary Disorders

abnormal renal function

[see Warnings and Precautions (5.4)]

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 levofloxacin. The relationship of the drugs to these events is not presently established.

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