{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "moxifloxacin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "( 2.2 ) 2.1 Dosage in Adult Patients The dose of moxifloxacin injection is 400 mg intravenously once every 24 hours.",
        "source": "US FDA label for moxifloxacin (Moxifloxacin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/moxifloxacin.json",
        "verbatim": true
      },
      {
        "text": "Type of Infection Dose Every 24 hours Duration (days) Community Acquired Pneumonia ( 1.1 ) 400 mg 7 to 14 Uncomplicated Skin and Skin Structure Infections (SSSI) ( 1.2 ) 400 mg 7 Complicated SSSI ( 1.3 ) 400 mg 7 to 21 Complicated Intra-Abdominal Infections ( 1.4 ) 400 mg 5 to 14 Acute Bacterial Sinusitis ( 1.5 ) 400 mg 10 Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.6 ) 400 mg 5 No dosage adjustment in patients with renal or hepatic impairment.",
        "source": "US FDA label for moxifloxacin (Moxifloxacin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/moxifloxacin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness in pediatric patients and adolescents less than 18 years of age have not been established. Moxifloxacin causes arthropathy in juvenile animals [see Boxed Warning , Warnings and Precautions (5.11) , and Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for moxifloxacin (Moxifloxacin), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/moxifloxacin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Therefore, moxifloxacin should be avoided in patients taking drugs that can result in prolongation of the QT interval (for example, Class IA or Class III antiarrhythmics) or in patients with risk factors for torsades de pointes (for example, known QT prolongation, uncorrected hypokalemia) [see Warnings and Precautions (5.6) , Drug Interactions (7.4) , and Clinical Pharmacology (12.3)] .",
        "source": "US FDA label for moxifloxacin (Moxifloxacin), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/moxifloxacin.json",
        "verbatim": true
      },
      {
        "text": "No dosage adjustment is necessary in patients with renal impairment, including those patients requiring hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD) [see Dosage and Administration (2) , and Clinical Pharmacology (12.3) ] . 8.7 Hepatic Impairment No dosage adjustment is recommended for mild, moderate, or severe hepatic insufficiency (Child-Pugh Classes A, B, or C).",
        "source": "US FDA label for moxifloxacin (Moxifloxacin), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/moxifloxacin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Type of Infection Dose Every 24 hours Duration (days) Community Acquired Pneumonia ( 1.1 ) 400 mg 7 to 14 Uncomplicated Skin and Skin Structure Infections (SSSI) ( 1.2 ) 400 mg 7 Complicated SSSI ( 1.3 ) 400 mg 7 to 21 Complicated Intra-Abdominal Infections ( 1.4 ) 400 mg 5 to 14 Acute Bacterial Sinusitis ( 1.5 ) 400 mg 10 Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.6 ) 400 mg 5 No dosage adjustment in patients with renal or hepatic impairment.",
        "source": "US FDA label for moxifloxacin (Moxifloxacin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/moxifloxacin.json",
        "verbatim": true
      },
      {
        "text": "No dosage adjustment is necessary in patients with renal impairment, including those patients requiring hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD) [see Dosage and Administration (2) , and Clinical Pharmacology (12.3) ] . 8.7 Hepatic Impairment No dosage adjustment is recommended for mild, moderate, or severe hepatic insufficiency (Child-Pugh Classes A, B, or C).",
        "source": "US FDA label for moxifloxacin (Moxifloxacin), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/moxifloxacin.json",
        "verbatim": true
      },
      {
        "text": "However, due to metabolic disturbances associated with hepatic insufficiency, which may lead to QT prolongation, moxifloxacin should be used with caution in these patients [see Warnings and Precautions (5.6) , and Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for moxifloxacin (Moxifloxacin), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/moxifloxacin.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Because no adequate or well-controlled studies have been conducted in pregnant women, moxifloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.",
        "source": "US FDA label for moxifloxacin (Moxifloxacin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/moxifloxacin.json",
        "verbatim": true
      },
      {
        "text": "Moxifloxacin was not teratogenic when administered to pregnant rats during organogenesis at oral doses as high as 500 mg/kg/day or 0.24 times the maximum recommended human dose based on systemic exposure (AUC), but decreased fetal body weights and slightly delayed fetal skeletal development (indicative of fetotoxicity) were observed.",
        "source": "US FDA label for moxifloxacin (Moxifloxacin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/moxifloxacin.json",
        "verbatim": true
      },
      {
        "text": "Intravenous administration of 80 mg/kg/day (approximately 2 times the maximum recommended human dose based on body surface area) to pregnant rats resulted in maternal toxicity and a marginal effect on fetal and placental weights and the appearance of the placenta.",
        "source": "US FDA label for moxifloxacin (Moxifloxacin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/moxifloxacin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Moxifloxacin is excreted in the breast milk of rats.",
        "source": "US FDA label for moxifloxacin (Moxifloxacin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/moxifloxacin.json",
        "verbatim": true
      },
      {
        "text": "Moxifloxacin may also be excreted in human milk.",
        "source": "US FDA label for moxifloxacin (Moxifloxacin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/moxifloxacin.json",
        "verbatim": true
      },
      {
        "text": "Because of the potential for serious adverse reactions in infants who are nursing from mothers taking moxifloxacin, 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 moxifloxacin (Moxifloxacin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/moxifloxacin.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "pregnancy": {
      "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'."
    }
  }
}