{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "naltrexone",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "The recommended dose of naltrexone for extended-release injectable suspension is 380 mg delivered intramuscularly (deep) as a gluteal injection, every 4 weeks or once a month, alternating buttocks for each subsequent injection, using the carton components provided (2.1) .",
        "source": "US FDA label for naltrexone (Naltrexone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      },
      {
        "text": "The recommended dose of naltrexone for extended-release injectable suspension is 380 mg delivered intramuscularly (deep) as a gluteal injection every 4 weeks or once a month, alternating buttocks for each subsequent injection, using the carton components provided [see How Supplied/Storage and Handling ( 16 ) ] .",
        "source": "US FDA label for naltrexone (Naltrexone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      },
      {
        "text": "Naltrexone for extended-release injectable suspension must be prepared and administered by a healthcare provider (2.1 , 2.6) . Prior to initiating naltrexone for extended-release injectable suspension, an opioid-free duration of a minimum of 7–10 days is recommended for patients, to avoid precipitation of opioid withdrawal that may be severe enough to require hospitalization (2.1) .",
        "source": "US FDA label for naltrexone (Naltrexone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and efficacy of naltrexone for extended-release injectable suspension have not been established in the pediatric population. The pharmacokinetics of naltrexone for extended-release injectable suspension have not been evaluated in a pediatric population.",
        "source": "US FDA label for naltrexone (Naltrexone), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      },
      {
        "text": "Naltrexone for extended-release injectable suspension must be prepared and administered by a healthcare provider (2.1 , 2.6) . Prior to initiating naltrexone for extended-release injectable suspension, an opioid-free duration of a minimum of 7–10 days is recommended for patients, to avoid precipitation of opioid withdrawal that may be severe enough to require hospitalization (2.1) .",
        "source": "US FDA label for naltrexone (Naltrexone), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Caution is recommended in administering naltrexone for extended-release injectable suspension to patients with moderate to severe renal impairment (8.6) .",
        "source": "US FDA label for naltrexone (Naltrexone), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      },
      {
        "text": "Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function. 8.6 Renal Impairment Pharmacokinetics of naltrexone for extended-release injectable suspension are not altered in subjects with mild renal insufficiency (creatinine clearance of 50-80 mL/min).",
        "source": "US FDA label for naltrexone (Naltrexone), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      },
      {
        "text": "Dose adjustment is not required in patients with mild renal impairment.",
        "source": "US FDA label for naltrexone (Naltrexone), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Naltrexone for extended-release injectable suspension pharmacokinetics have not been evaluated in subjects with severe hepatic impairment (8.7) . 8.1 Pregnancy Risk Summary The available data from published case series with naltrexone for extended-release injectable suspension 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 naltrexone (Naltrexone), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      },
      {
        "text": "Because naltrexone and its primary metabolite are excreted primarily in the urine, caution is recommended in administering naltrexone for extended-release injectable suspension to patients with moderate to severe renal impairment [see Clinical Pharmacology ( 12.3 ) ] .",
        "source": "US FDA label for naltrexone (Naltrexone), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      },
      {
        "text": "Dose adjustment is not required in subjects with mild or moderate hepatic impairment.",
        "source": "US FDA label for naltrexone (Naltrexone), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary The available data from published case series with naltrexone for extended-release injectable suspension 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 naltrexone (Naltrexone), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      },
      {
        "text": "There are clinical considerations (see Clinical Considerations ).",
        "source": "US FDA label for naltrexone (Naltrexone), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      },
      {
        "text": "Reproduction and developmental animal studies have not been conducted for naltrexone for extended-release injectable suspension.",
        "source": "US FDA label for naltrexone (Naltrexone), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Daily oral administration of naltrexone to rats and rabbits during the period of organogenesis did not induce malformations at doses up to 200 mg/kg/day (175- and 14‑times the human exposure based on an AUC (0-28d) comparison, respectively). 8.2 Lactation Risk Summary Naltrexone and its major metabolite, 6β-naltrexol, are present in human milk.",
        "source": "US FDA label for naltrexone (Naltrexone), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      },
      {
        "text": "There are no data on the effects on the breastfed infant or the effects on milk production.",
        "source": "US FDA label for naltrexone (Naltrexone), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      },
      {
        "text": "The developmental health benefits of breastfeeding should be considered along with the mother’s clinical need for naltrexone and any potential adverse effects on the breastfed infant from naltrexone or the mother’s underlying maternal condition. 8.4 Pediatric Use The safety and efficacy of naltrexone for extended-release injectable suspension have not been established in the pediatric population.",
        "source": "US FDA label for naltrexone (Naltrexone), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/naltrexone.json",
        "verbatim": true
      }
    ]
  }
}