{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "enoxaparin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "( 2 ) 2.1 Pretreatment Evaluation Evaluate all patients for a bleeding disorder before starting Enoxaparin Sodium Injection treatment, unless treatment is urgently needed. 2.2 Adult Dosage Abdominal Surgery The recommended dose of Enoxaparin Sodium Injection is 40 mg by subcutaneous injection once a day (with the initial dose given 2 hours prior to surgery) in patients undergoing abdominal surgery who are at risk for thromboembolic complications.",
        "source": "US FDA label for enoxaparin (Enoxaparin Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/enoxaparin.json",
        "verbatim": true
      },
      {
        "text": "Hip or Knee Replacement Surgery The recommended dose of Enoxaparin Sodium Injection is 30 mg every 12 hours administered by subcutaneous injection in patients undergoing hip or knee replacement surgery.",
        "source": "US FDA label for enoxaparin (Enoxaparin Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/enoxaparin.json",
        "verbatim": true
      },
      {
        "text": "A dose of Enoxaparin Sodium Injection of 40 mg once a day subcutaneously may be considered for hip replacement surgery for up to 3 weeks.",
        "source": "US FDA label for enoxaparin (Enoxaparin Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/enoxaparin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness of Enoxaparin Sodium Injection in pediatric patients have not been established. Enoxaparin Sodium Injection is not approved for use in neonates or infants. Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and low birth weight infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative.",
        "source": "US FDA label for enoxaparin (Enoxaparin Sodium), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/enoxaparin.json",
        "verbatim": true
      },
      {
        "text": "See full prescribing information for dosing and administration information. ( 2 ) 2.1 Pretreatment Evaluation Evaluate all patients for a bleeding disorder before starting Enoxaparin Sodium Injection treatment, unless treatment is urgently needed.",
        "source": "US FDA label for enoxaparin (Enoxaparin Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/enoxaparin.json",
        "verbatim": true
      },
      {
        "text": "In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L).",
        "source": "US FDA label for enoxaparin (Enoxaparin Sodium), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/enoxaparin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "If the last Enoxaparin Sodium Injection subcutaneous administration was given more than 8 hours before balloon inflation, administer an intravenous bolus of 0.3 mg/kg of Enoxaparin Sodium Injection [ see Warnings and Precautions ( 5.2 ) ].",
        "source": "US FDA label for enoxaparin (Enoxaparin Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/enoxaparin.json",
        "verbatim": true
      },
      {
        "text": "In patients with renal impairment anti-Factor Xa levels may be used to monitor the anticoagulant effects of Enoxaparin Sodium Injection.",
        "source": "US FDA label for enoxaparin (Enoxaparin Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/enoxaparin.json",
        "verbatim": true
      },
      {
        "text": "• Severe Renal Impairment: Adjust dose for patients with creatinine clearance <30 mL/min.",
        "source": "US FDA label for enoxaparin (Enoxaparin Sodium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/enoxaparin.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 enoxaparin (Enoxaparin Sodium), retrieved 2026-08-29",
        "cached_file": "labels/enoxaparin.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Placental transfer of enoxaparin was observed in the animal studies.",
        "source": "US FDA label for enoxaparin (Enoxaparin Sodium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/enoxaparin.json",
        "verbatim": true
      },
      {
        "text": "Human data from a retrospective cohort study, which included 693 live births, suggest that enoxaparin does not increase the risk of major developmental abnormalities ( see Data ).",
        "source": "US FDA label for enoxaparin (Enoxaparin Sodium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/enoxaparin.json",
        "verbatim": true
      },
      {
        "text": "Based on animal data, Enoxaparin Sodium Injection is not predicted to increase the risk of major developmental abnormalities ( see Data ).",
        "source": "US FDA label for enoxaparin (Enoxaparin Sodium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/enoxaparin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. 8.2 Lactation Risk Summary It is unknown whether Enoxaparin Sodium Injection is excreted in human milk.",
        "source": "US FDA label for enoxaparin (Enoxaparin Sodium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/enoxaparin.json",
        "verbatim": true
      },
      {
        "text": "There is no information available on the effect of enoxaparin or its metabolites on the breastfed child, or on the milk production.",
        "source": "US FDA label for enoxaparin (Enoxaparin Sodium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/enoxaparin.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Enoxaparin Sodium Injection and any potential adverse effects on the breastfed child from Enoxaparin Sodium Injection or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness of Enoxaparin Sodium Injection in pediatric patients have not been established.",
        "source": "US FDA label for enoxaparin (Enoxaparin Sodium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/enoxaparin.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'."
    }
  }
}