{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "fosfomycin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "To prepare the infusion solution, first remove 80 mL from a 250 mL intravenous bag of Sterile Water for Injection, USP for infusion so that it contains approximately 170 mL.",
        "source": "US FDA label for fosfomycin (Contepo), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fosfomycin.json",
        "verbatim": true
      },
      {
        "text": "After dilution, CONTEPO solution for administration is stable for 16 hours at room temperature (20°C to 25°C) at a concentration of 15 mg/mL to 30 mg/mL in Sterile Water for Injection, USP. 2.5 Drug Incompatibility The compatibility of CONTEPO with other drugs and infusion solutions has not been established.",
        "source": "US FDA label for fosfomycin (Contepo), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fosfomycin.json",
        "verbatim": true
      },
      {
        "text": "Administer CONTEPO, 6 grams every 8 hours by intravenous (IV) infusion over 1 hour for up to 14 days, in patients 18 years of age or older with an estimated creatinine clearance (CLcr) greater than 50 mL/min. ( 2.1 ) The recommended dosage in patients 18 years of age and older with an estimated CLcr of 50 mL/min or less is presented in the table below. ( 2.2 ) a CLcr estimated using Cockcroft-Gault Equation.",
        "source": "US FDA label for fosfomycin (Contepo), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fosfomycin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness of CONTEPO in patients less than 18 years of age has not been established.",
        "source": "US FDA label for fosfomycin (Contepo), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/fosfomycin.json",
        "verbatim": true
      },
      {
        "text": "Administer CONTEPO, 6 grams every 8 hours by intravenous (IV) infusion over 1 hour for up to 14 days, in patients 18 years of age or older with an estimated creatinine clearance (CLcr) greater than 50 mL/min. ( 2.1 ) The recommended dosage in patients 18 years of age and older with an estimated CLcr of 50 mL/min or less is presented in the table below. ( 2.2 ) a CLcr estimated using Cockcroft-Gault Equation.",
        "source": "US FDA label for fosfomycin (Contepo), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fosfomycin.json",
        "verbatim": true
      },
      {
        "text": "Administer CONTEPO, 6 grams every 8 hours by intravenous (IV) infusion over 1 hour for up to 14 days, in patients 18 years of age or older with an estimated creatinine clearance (CLcr) greater than 50 mL/min.",
        "source": "US FDA label for fosfomycin (Contepo), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fosfomycin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Administer CONTEPO, 6 grams every 8 hours by intravenous (IV) infusion over 1 hour for up to 14 days, in patients 18 years of age or older with an estimated creatinine clearance (CLcr) greater than 50 mL/min.",
        "source": "US FDA label for fosfomycin (Contepo), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fosfomycin.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 ) 2.1 Recommended Dosage The recommended dosage of CONTEPO is 6 grams administered every 8 hours by intravenous (IV) infusion over 1 hour in patients 18 years of age or older with an estimated creatinine clearance (CLcr) greater than 50 mL/min.",
        "source": "US FDA label for fosfomycin (Contepo), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fosfomycin.json",
        "verbatim": true
      },
      {
        "text": "During treatment, different dosage recommendations may be required based on change in estimated CLcr [ see Dosage and Administration ( 2.2 ) ] . 2.2 Recommended Dosage in Patients (18 Years of Age and Older) with Renal Impairment The recommended dosage of CONTEPO in patients 18 years of age and older with an estimated CLcr of 50 mL/min or less is presented 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 fosfomycin (Contepo), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/fosfomycin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "In patients requiring hemodialysis, CONTEPO should be administered after hemodialysis on hemodialysis days [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 )] . 8.7 Hepatic Impairment Monitor patients with severe hepatic impairment closely for fluid overload and electrolyte abnormalities [see Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.3 )] .",
        "source": "US FDA label for fosfomycin (Contepo), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/fosfomycin.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Available data from observational studies and pharmacovigilance reports with fosfomycin use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.",
        "source": "US FDA label for fosfomycin (Contepo), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/fosfomycin.json",
        "verbatim": true
      },
      {
        "text": "Fosfomycin crosses the placental barrier.",
        "source": "US FDA label for fosfomycin (Contepo), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/fosfomycin.json",
        "verbatim": true
      },
      {
        "text": "There are no animal data that meet current standards for nonclinical developmental toxicity studies.",
        "source": "US FDA label for fosfomycin (Contepo), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/fosfomycin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Lactation: Breastfeeding not recommended during treatment and 24 hours after the last dose (8.2). 8.1 Pregnancy Risk Summary Available data from observational studies and pharmacovigilance reports with fosfomycin use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.",
        "source": "US FDA label for fosfomycin (Contepo), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/fosfomycin.json",
        "verbatim": true
      },
      {
        "text": "Survival and postnatal body growth also were normal in the second-generation offspring at all doses. 8.2 Lactation Risk Summary Fosfomycin is present in human milk.",
        "source": "US FDA label for fosfomycin (Contepo), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/fosfomycin.json",
        "verbatim": true
      },
      {
        "text": "There are no data on the effects of fosfomycin on the breastfed child or on milk production.",
        "source": "US FDA label for fosfomycin (Contepo), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/fosfomycin.json",
        "verbatim": true
      }
    ]
  }
}