{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "diazepam",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "( 2.2 ) Initial Dose: VALTOCO 5 mg and 10 mg doses are administered as a single spray intranasally into one nostril.",
        "source": "US FDA label for diazepam (Valtoco), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/diazepam.json",
        "verbatim": true
      },
      {
        "text": "Administration of 15 mg and 20 mg doses requires two nasal spray devices, one spray into each nostril.",
        "source": "US FDA label for diazepam (Valtoco), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/diazepam.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 ) 2.1 Instructions Prior to Dosing Prior to treatment, healthcare professionals should instruct the individual administering VALTOCO on how to identify seizure clusters and use the product appropriately [see Dosage and Administration (2.3) and Patient Counseling Information (17) ]. 2.2 Dosing Information The recommended dose of VALTOCO nasal spray is 0.2 mg/kg to 0.5 mg/kg, depending on the patient's age and weight.",
        "source": "US FDA label for diazepam (Valtoco), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/diazepam.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Administer VALTOCO by the nasal route only. ( 2.3 ) Dosage is dependent on the patient's age and weight. ( 2.2 ) Initial Dose: VALTOCO 5 mg and 10 mg doses are administered as a single spray intranasally into one nostril. Administration of 15 mg and 20 mg doses requires two nasal spray devices, one spray into each nostril. ( 2.2 ) Second Dose: A second dose, when required, may be administered at least 4 hours after the initial dose.",
        "source": "US FDA label for diazepam (Valtoco), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/diazepam.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 diazepam (Valtoco), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/diazepam.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 ) 2.1 Instructions Prior to Dosing Prior to treatment, healthcare professionals should instruct the individual administering VALTOCO on how to identify seizure clusters and use the product appropriately [see Dosage and Administration (2.3) and Patient Counseling Information (17) ]. 2.2 Dosing Information The recommended dose of VALTOCO nasal spray is 0.2 mg/kg to 0.5 mg/kg, depending on the patient's age and weight.",
        "source": "US FDA label for diazepam (Valtoco), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/diazepam.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for diazepam (Valtoco), retrieved 2026-08-29",
        "cached_file": "labels/diazepam.json",
        "verbatim": false
      }
    ],
    "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 diazepam (Valtoco), retrieved 2026-08-29",
        "cached_file": "labels/diazepam.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as VALTOCO, during pregnancy.",
        "source": "US FDA label for diazepam (Valtoco), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/diazepam.json",
        "verbatim": true
      },
      {
        "text": "Healthcare providers are encouraged to recommend that pregnant women who are taking VALTOCO during pregnancy enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org.",
        "source": "US FDA label for diazepam (Valtoco), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/diazepam.json",
        "verbatim": true
      },
      {
        "text": "Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see Warnings and Precautions (5.7) and Clinical Considerations ] .",
        "source": "US FDA label for diazepam (Valtoco), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/diazepam.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "The window of vulnerability to these changes in rats (postnatal days 0-14) includes a period of brain development that takes place during the third trimester of pregnancy in humans. 8.2 Lactation Risk Summary Diazepam is excreted in human milk.",
        "source": "US FDA label for diazepam (Valtoco), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/diazepam.json",
        "verbatim": true
      },
      {
        "text": "There are reports of sedation, poor feeding, and poor weight gain in infants exposed to benzodiazepines through breast milk.",
        "source": "US FDA label for diazepam (Valtoco), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/diazepam.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VALTOCO nasal spray and any potential adverse effects on the breastfed infant from VALTOCO or from the underlying maternal condition.",
        "source": "US FDA label for diazepam (Valtoco), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/diazepam.json",
        "verbatim": true
      }
    ]
  }
}