{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "levofloxacin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Avoid rapid or bolus IV (2.5) Dilute single-dose vials to 5 mg/mL prior to IV infusion (2.6) Do not mix with other medications in vial or IV line (2.6) 2.1 Dosage in Adult Patients with Normal Renal Function The usual dose of levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1.",
        "source": "This line points to a numbered table that this card does not show - read that table in the label before you dose. US FDA label for levofloxacin (Levofloxacin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/levofloxacin.json",
        "verbatim": true
      },
      {
        "text": "Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens [see Indications and Usage (1) ] . † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.",
        "source": "This line points to a numbered table that this card does not show - read that table in the label before you dose. US FDA label for levofloxacin (Levofloxacin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/levofloxacin.json",
        "verbatim": true
      },
      {
        "text": "Levofloxacin injection is supplied in single-dose vials containing a concentrated levofloxacin solution with the equivalent of 500 mg (20 mL vial) and 750 mg (30 mL vial) of levofloxacin in Water for Injection, USP.",
        "source": "US FDA label for levofloxacin (Levofloxacin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/levofloxacin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Quinolones, including levofloxacin, cause arthropathy and osteochondrosis in juvenile animals of several species. [see Warnings and Precautions (5.12) and Animal Toxicology and/or Pharmacology (13.2) ]. Pharmacokinetics following intravenous administration The pharmacokinetics of levofloxacin following a single intravenous dose were investigated in pediatric patients ranging in age from six months to 16 years.",
        "source": "US FDA label for levofloxacin (Levofloxacin), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/levofloxacin.json",
        "verbatim": true
      },
      {
        "text": "Children 6 months to 5 years of age received levofloxacin 10 mg/kg twice a day and children greater than 5 years of age received 10 mg/kg once a day (maximum 500 mg per day) for approximately 10 days.",
        "source": "US FDA label for levofloxacin (Levofloxacin), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/levofloxacin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "These recommendations apply to patients with creatinine clearance ≥ 50 mL/min.",
        "source": "US FDA label for levofloxacin (Levofloxacin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/levofloxacin.json",
        "verbatim": true
      },
      {
        "text": "For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3) ] .",
        "source": "US FDA label for levofloxacin (Levofloxacin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/levofloxacin.json",
        "verbatim": true
      },
      {
        "text": "Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens [see Indications and Usage (1) ] . † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.",
        "source": "This line points to a numbered table that this card does not show - read that table in the label before you dose. US FDA label for levofloxacin (Levofloxacin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/levofloxacin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Neither hemodialysis nor continuous ambulatory peritoneal dialysis (CAPD) is effective in removal of levofloxacin from the body, indicating that supplemental doses of levofloxacin are not required following hemodialysis or CAPD [see Dosage and Administration (2.3) ]. 8.7 Hepatic Impairment Pharmacokinetic studies in hepatically impaired patients have not been conducted.",
        "source": "US FDA label for levofloxacin (Levofloxacin), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/levofloxacin.json",
        "verbatim": true
      },
      {
        "text": "Due to the limited extent of levofloxacin metabolism, the pharmacokinetics of levofloxacin are not expected to be affected by hepatic impairment.",
        "source": "US FDA label for levofloxacin (Levofloxacin), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/levofloxacin.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Levofloxacin was not teratogenic in rats at oral doses as high as 810 mg/kg/day which corresponds to 9.4 times the highest recommended human dose based upon relative body surface area, or at intravenous doses as high as 160 mg/kg/day corresponding to 1.9 times the highest recommended human dose based upon relative body surface area.",
        "source": "US FDA label for levofloxacin (Levofloxacin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/levofloxacin.json",
        "verbatim": true
      },
      {
        "text": "The oral dose of 810 mg/kg/day to rats caused decreased fetal body weight and increased fetal mortality.",
        "source": "US FDA label for levofloxacin (Levofloxacin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/levofloxacin.json",
        "verbatim": true
      },
      {
        "text": "No teratogenicity was observed when rabbits were dosed orally as high as 50 mg/kg/day which corresponds to 1.1 times the highest recommended human dose based upon relative body surface area, or when dosed intravenously as high as 25 mg/kg/day, corresponding to 0.5 times the highest recommended human dose based upon relative body surface area.",
        "source": "US FDA label for levofloxacin (Levofloxacin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/levofloxacin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Based on data on other fluoroquinolones and very limited data on levofloxacin, it can be presumed that levofloxacin will be excreted in human milk.",
        "source": "US FDA label for levofloxacin (Levofloxacin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/levofloxacin.json",
        "verbatim": true
      },
      {
        "text": "Because of the potential for serious adverse reactions from levofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.",
        "source": "US FDA label for levofloxacin (Levofloxacin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/levofloxacin.json",
        "verbatim": true
      },
      {
        "text": "Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 8.3 Nursing Mothers Based on data on other fluoroquinolones and very limited data on levofloxacin, it can be presumed that levofloxacin will be excreted in human milk.",
        "source": "US FDA label for levofloxacin (Levofloxacin), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/levofloxacin.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "lactation": {
      "level": "caution",
      "line": "The label allows it only when the benefit is judged to outweigh the risk. Read the quote below.",
      "set_by": "Set from the label's own words, not from a reading of them: 'should be used during pregnancy only if'."
    }
  }
}