Fosfomycin

DRUG INFORMATION

  ADULT
    - 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
    - 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
    - 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

  CHILD
    - 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
    - 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
    - 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

  RENAL IMPAIRMENT
    - 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
    - ( 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
    - 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

  HEPATIC IMPAIRMENT
    - 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

  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 'pregnancy', retrieved
      2026-08-29
    - Fosfomycin crosses the placental barrier.
      Source: US FDA label for fosfomycin (Contepo), section 'pregnancy', retrieved
      2026-08-29
    - 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

  BREASTFEEDING
    - 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
    - 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
    - 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