{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "vancomycin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "The supplied lyophilized powder must be reconstituted and subsequently diluted prior to intravenous use [see Dosage and Administration (2.5) ]. 2.2 Dosage in Adult Patients With Normal Renal Function The usual daily intravenous dose is 2 grams divided either as 500 mg every 6 hours or 1 g every 12 hours.",
        "source": "US FDA label for vancomycin (Vancomycin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vancomycin.json",
        "verbatim": true
      },
      {
        "text": "For functionally anephric patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentration.",
        "source": "US FDA label for vancomycin (Vancomycin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vancomycin.json",
        "verbatim": true
      },
      {
        "text": "A dose of 1.9 mg/kg/24 hr should be given after the initial dose of 15 mg/kg. 2.5 Preparation of Vancomycin Hydrochloride for Injection for Intravenous Administration and Storage Instructions Vancomycin Hydrochloride for Injection must be reconstituted and further diluted.",
        "source": "US FDA label for vancomycin (Vancomycin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vancomycin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Vancomycin Hydrochloride for Injection is indicated in pediatric patients (neonates and older). In pediatric patients, monitor vancomycin serum concentration and renal function when administering Vancomycin Hydrochloride for Injection [see Dosage and Administration (2.2 , 2.3) and Warnings and Precautions (5.2) ] . More severe infusion related reactions related to vancomycin administration may occur in pediatric patients.",
        "source": "US FDA label for vancomycin (Vancomycin Hydrochloride), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/vancomycin.json",
        "verbatim": true
      },
      {
        "text": "Other patient factors, such as age or obesity, may call for modification of the usual intravenous daily dose. 2.3 Dosage in Pediatric Patients With Normal Renal Function Pediatric Patients (Aged 1 month and older) The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours.",
        "source": "US FDA label for vancomycin (Vancomycin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vancomycin.json",
        "verbatim": true
      },
      {
        "text": "In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1 st week of life and every 8 hours thereafter up to the age of 1 month.",
        "source": "US FDA label for vancomycin (Vancomycin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vancomycin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Close monitoring of serum concentrations of vancomycin is recommended in these patients. 2.4 Dosage in Patients With Renal Impairment Dosage adjustment must be made in patients with renal impairment.",
        "source": "US FDA label for vancomycin (Vancomycin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vancomycin.json",
        "verbatim": true
      },
      {
        "text": "The initial dose should be no less than 15 mg/kg, in patients with any degree of renal impairment.",
        "source": "US FDA label for vancomycin (Vancomycin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/vancomycin.json",
        "verbatim": true
      },
      {
        "text": "The risk of AKI increases with higher vancomycin serum levels, prolonged exposure, concomitant administration of other nephrotoxic drugs, concomitant administration of piperacillin-tazobactam [see Drug Interactions (7.2) ] , volume depletion, pre-existing renal impairment and in critically ill patients and patients with co-morbid conditions that predispose to renal impairment.",
        "source": "US FDA label for vancomycin (Vancomycin Hydrochloride), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/vancomycin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for vancomycin (Vancomycin Hydrochloride), retrieved 2026-08-29",
        "cached_file": "labels/vancomycin.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary There are no available data on vancomycin use in pregnant women to inform a drug associated risk of major birth defects or miscarriage.",
        "source": "US FDA label for vancomycin (Vancomycin Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/vancomycin.json",
        "verbatim": true
      },
      {
        "text": "Available published data on vancomycin use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy related outcomes (see Data ) .",
        "source": "US FDA label for vancomycin (Vancomycin Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/vancomycin.json",
        "verbatim": true
      },
      {
        "text": "Vancomycin did not show adverse developmental effects when administered intravenously to pregnant rats and rabbits during organogenesis at doses less than or equal to the recommended maximum human dose based on body surface area (see Data ) .",
        "source": "US FDA label for vancomycin (Vancomycin Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/vancomycin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Maternal toxicity was observed in rats (at doses 120 mg/kg and above) and rabbits (at 80 mg/kg and above). 8.2 Lactation Risk Summary There are insufficient data to inform the levels of vancomycin in human milk.",
        "source": "US FDA label for vancomycin (Vancomycin Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/vancomycin.json",
        "verbatim": true
      },
      {
        "text": "There are no data on the effects of vancomycin on the breastfed infant or milk production.",
        "source": "US FDA label for vancomycin (Vancomycin Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/vancomycin.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for vancomycin and any potential adverse effects on the breastfed infant from vancomycin or from the underlying maternal condition. 8.4 Pediatric Use Vancomycin Hydrochloride for Injection is indicated in pediatric patients (neonates and older).",
        "source": "US FDA label for vancomycin (Vancomycin Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/vancomycin.json",
        "verbatim": true
      }
    ]
  }
}