{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "methadone",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "( 2.5 ) Do not rapidly reduce or abruptly discontinue Methadone Hydrochloride Oral Solution in a physically dependent patient because rapid reduction or abrupt discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide.( 2.6 , 5.17 ) Initiation of Detoxification and Maintenance Treatment A single dose of 20 to 30 mg may be sufficient to suppress withdrawal syndrome.",
        "source": "US FDA label for methadone (Methadone Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/methadone.json",
        "verbatim": true
      },
      {
        "text": "Example conversion from a single opioid to Methadone Hydrochloride Oral Solution: Step 1 : Sum the total daily dose of the opioid (in this case, Morphine Extended Release Tablets 50 mg twice daily) 50 mg Morphine Extended Release Tablets 2 times daily = 100 mg total daily dose of Morphine Step 2 : Calculate the approximate equivalent dose of Methadone Hydrochloride Oral Solution based on the total daily dose of Morphine using 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 methadone (Methadone Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/methadone.json",
        "verbatim": true
      },
      {
        "text": "Round down, if necessary, to the appropriate methadone tablets strengths available. 15 mg daily / 2 = 7.5 mg Methadone Hydrochloride Oral Solution every 12 hours Then 7.5 mg is rounded down to 5 mg Methadone Hydrochloride Oral Solution every 12 hours Close observation and frequent titration are warranted until pain management is stable on the new opioid .",
        "source": "US FDA label for methadone (Methadone Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/methadone.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety, effectiveness, and pharmacokinetics of methadone in pediatric patients below the age of 18 years have not been established.",
        "source": "US FDA label for methadone (Methadone Hydrochloride), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/methadone.json",
        "verbatim": true
      },
      {
        "text": "Consider recommending or prescribing an opioid reversal agent (e.g., naloxone, nalmefene) based on the patient’s risk factors for overdose( 2.3 , 5.1 , 5.2 , 5.3 ) Management of Pain: Methadone Hydrochloride Oral Solution should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks.",
        "source": "US FDA label for methadone (Methadone Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/methadone.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Start these patients on lower doses and titrate slowly while carefully monitoring for signs of respiratory and central nervous system depression. 8.7 Renal Impairment Methadone pharmacokinetics have not been extensively evaluated in patients with renal insufficiency.",
        "source": "US FDA label for methadone (Methadone Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/methadone.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function. 8.6 Hepatic Impairment Methadone pharmacokinetics have not been extensively evaluated in patients with hepatic insufficiency.",
        "source": "US FDA label for methadone (Methadone Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/methadone.json",
        "verbatim": true
      },
      {
        "text": "Methadone is metabolized by hepatic pathways; therefore, patients with liver impairment may be at risk of increased systemic exposure to methadone after multiple dosing.",
        "source": "US FDA label for methadone (Methadone Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/methadone.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary The majority of available data from clinical trials, observational studies, case series, and case reports on methadone use in pregnancy do not indicate an increased risk of major malformations specifically due to methadone.",
        "source": "US FDA label for methadone (Methadone Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/methadone.json",
        "verbatim": true
      },
      {
        "text": "Pregnant women involved in methadone maintenance programs have been reported to have improved prenatal care leading to reduced incidence of obstetric and fetal complications and neonatal morbidity and mortality when compared to women using illicit drugs.",
        "source": "US FDA label for methadone (Methadone Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/methadone.json",
        "verbatim": true
      },
      {
        "text": "Several factors, including maternal use of illicit drugs, nutrition, infection and psychosocial circumstances, complicate the interpretation of investigations of the children of women who take methadone during pregnancy.",
        "source": "US FDA label for methadone (Methadone Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/methadone.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Infertility The effect of Methadone Hydrochloride Oral Solution on fertility is unknown.",
        "source": "US FDA label for methadone (Methadone Hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/methadone.json",
        "verbatim": true
      },
      {
        "text": "Use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential.",
        "source": "US FDA label for methadone (Methadone Hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/methadone.json",
        "verbatim": true
      },
      {
        "text": "It is not known whether these effects on fertility are reversible [ see Adverse Reactions ( 6 ), Clinical Pharmacology ( 12.2 ), Nonclinical Pharmacology ( 13.1 ) ].",
        "source": "US FDA label for methadone (Methadone Hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/methadone.json",
        "verbatim": true
      }
    ]
  }
}