Methadone

DRUG INFORMATION

  ADULT
    - ( 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
    - 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
    - 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

  CHILD
    - 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
    - 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

  RENAL IMPAIRMENT
    - 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

  HEPATIC IMPAIRMENT
    - 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
    - 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

  PREGNANCY
    - 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
    - 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
    - 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

  BREASTFEEDING
    - 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
    - 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
    - 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