Brand Name, Dosage Format and Strength
500 mg/100 mL Solution for Infusion
STATEMENT ON USAGE FOR HIGH RISK GROUPS
Pregnancy [see Warnings]: Pregnancy Category C. Levofloxacin was not teratogenic in rats at oral doses as high as 810 mg/kg/day [(about 9.4 times the highest recommended human dose based upon relative body surface area (BSA)], or at IV doses as high as 160 mg/kg/day (about 1.9 times the highest recommended human dose based upon relative BSA). The oral dose of 810 mg/kg/day to rats caused decreased fetal body weight and increased fetal mortality. No teratogenicity was observed when rabbits were dosed orally as high as 50 mg/kg/day which (about 1.1 times the highest recommended human dose upon relative BSA), or when dosed IV as high as 25 mg/kg/day, (about 0.5 times the highest recommended human dose based upon relative BSA).
There have been no adequate and well-controlled studies in pregnant women. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Levofloxacin has not been measured in human milk. However, based on the ofloxacin data, it can be presumed that levofloxacin will be excreted in human milk. Therefore, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother as well as the possible serious adverse effects to the infant.
Children: Levofloxacin is indicated in children ≥ 6 mos of age only for the prevention of inhalational anthrax (post-exposure). An increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendonopathy, and gait abnormality) compared to controls has been observed in pediatric patients receiving levofloxacin.
Oral and IV administration of levofloxacin in immature rats and dogs increased the incidence and severity of osteochondrosis. Histopathological examination of the weight-bearing joints of immature dogs dosed with levofloxacin revealed persistent lesions of the cartilage. Other quinolones also produce similar erosions in the weight-bearing joints and other signs of arthropathy in immature animals of various species.
Elderly: There have been post-marketing reports of severe, and sometimes fatal cases of hepatotoxicity associated with levofloxacin therapy, particularly in patients 65 yrs or older.
Elderly patients are at increased risk of developing severe tendon disorders including tendon rupture or to drug-associated effects on QT interval when being treated with a quinolone including levofloxacin [see Warnings and Precautions].
No dosage adjustment is necessary for elderly patients with normal renal function. However, since levofloxacin is substantially excreted by the kidneys and some elderly patients experience age-related reduction in renal function, care should be taken in dose selection and renal function monitoring is recommended.
Renal Impairment: Since clearanceof levofloxacin is substantially reduced and plasma elimination t1/2 is substantially prolonged in patients with renal impairment (CLCR <50 mL/min), adjustment of the dosage regimen in such patients is necessary to avoid drug accumulation [see Dosage and Administration].
Hepatic Impairment: PK studies in patients with liver impairment have not been conducted. Due to the limited extent of levofloxacin metabolism, the PK of levofloxacin are not expected to be affected by hepatic impairment.
Gender Differences: There are no significant differences in levofloxacin PK between male and female subjects when subjects’ differences in CLCR are taken into consideration. Dose adjustment based on gender alone is not necessary.
Race: Race does not affect the apparent total body clearance and apparent volume of distribution of levofloxacin.
Last Update: Jul 29, 2011