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methadone

Pronunciation

Generic Name: methadone (METH a done)
Brand Name: Dolophine, Methadose, Methadose Sugar-Free, Diskets

What is methadone?

Methadone is an opioid medication. An opioid is sometimes called a narcotic. Methadone also reduces withdrawal symptoms in people addicted to heroin or other narcotic drugs without causing the "high" associated with the drug addiction.

Methadone is used as a pain reliever and as part of drug addiction detoxification and maintenance programs.

Methadone is available only from a certified pharmacy.

Methadone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about methadone?

You should not use methadone if you have severe asthma or breathing problems, or a bowel obstruction called paralytic ileus.

Methadone can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Methadone may also be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medicine in a place where others cannot get to it.

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MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Methadone may cause a life-threatening heart rhythm disorder. Call your doctor at once if you have a headache with chest pain and severe dizziness, and fast or pounding heartbeats.

Methadone is available only from a certified pharmacy.

What should I discuss with my healthcare provider before using methadone?

You should not use methadone if you are allergic to it, or if you have:

  • severe asthma or breathing problems; or

  • a bowel obstruction called paralytic ileus.

Methadone may cause a life-threatening heart rhythm disorder. Your heart function may need to be checked during treatment.

To make sure methadone is safe for you, tell your doctor if you have:

  • heart disease, or heart rhythm disorder;

  • personal or family history of long QT syndrome;

  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

  • any type of breathing problem or lung disease;

  • a history of head injury, brain tumor, or seizures;

  • a history of drug abuse, alcohol addiction, or mental illness;

  • liver or kidney disease;

  • urination problems; or

  • problems with your gallbladder, pancreas, or thyroid.

It is not known whether methadone will harm an unborn baby. Methadone may cause breathing problems, behavior changes, or addiction and withdrawal symptoms in your newborn if you use the medication during pregnancy. Tell your doctor if you are pregnant.

Methadone can pass into breast milk and may cause breathing problems or addiction and withdrawal symptoms in a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use methadone?

Follow all directions on your prescription label. Methadone can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use methadone in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Methadone may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away methadone is against the law.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Dissolve the dispersible tablet in at least 4 ounces of water, orange juice, or other citrus-flavored non-alcoholic beverage. Allow the tablet to disperse in the liquid. The tablet will not dissolve completely. Drink this mixture right away. To get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Never use methadone tablets or liquid to make a mixture for injecting the drug into your vein. This practice has resulted in death with the misuse of methadone and similar prescription drugs.

When methadone is used as part of a treatment program for drug addiction or detoxification, your doctor may recommend that methadone be given to you by a family member or other caregiver. This is to make sure you are using the medicine as it was prescribed as part of your treatment.

Additional forms of counseling and/or monitoring may be recommended during treatment with methadone.

You should not stop using methadone suddenly. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat. Keep the medication in a place where others cannot get to it.

Keep track of how much of this medicine has been used. Methadone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

Do not keep leftover methadone pills or liquid. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused pills or liquid medicine down the toilet.

What happens if I miss a dose?

If you take methadone for pain: Take the missed dose as soon as you remember, then take your next dose 8 to 12 hours later. Skip the missed dose if it is almost time for your next scheduled dose.

If you take methadone for drug addiction: Take your missed dose the next day at the regular time. If you miss your doses for longer than 3 days in a row, call your doctor for instructions. You may need to restart methadone at a lower dose.

Do not use extra medicine to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A methadone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

What should I avoid while using methadone?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with methadone. Check your food and medicine labels to be sure these products do not contain alcohol.

Methadone may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Grapefruit and grapefruit juice may interact with methadone and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Methadone side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Even if you have used other narcotic medicines, you may still have serious side effects from methadone.

Call your doctor at once if you have:

  • weak or shallow breathing;

  • severe constipation;

  • a light-headed feeling, like you might pass out; or

  • symptoms of a life-threatening heart rhythm disorder--a headache with chest pain and severe dizziness, and fast or pounding heartbeats.

Methadone is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Common side effects may include:

  • dizziness, drowsiness;

  • nausea, vomiting; or

  • increased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Methadone dosing information

Usual Adult Dose for Pain:

Individualize dose; dosing recommendations should only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient; this drug has a narrow therapeutic index, especially when combined with other drugs; monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy.

Parenteral:
Initiation in Opioid Non-Tolerant Patients:
Initial dose: 2.5 mg to 10 mg IV every 8 to 12 hours
Maintenance dose: Slowly titrate to effect; more frequent administration may be required to maintain adequate analgesia during initiation, however, extreme caution is necessary to avoid overdosing.

Comments:
-May be administered IV, IM or subcutaneously, although the absorption of IM or subcutaneous injections has not been well studied and appears to be unpredictable; local tissue reactions may occur.
-Oral methadone is not indicated as an as-needed analgesic; due to increased risk of overdose and death with this long-acting opioid, its use is limited to chronic pain management.

CONVERSION: Switching a patient from another chronically administered opioid to methadone requires caution due to the uncertainty of dose conversion ratios and incomplete cross-tolerance; deaths have occurred in opioid tolerant patients during conversion. When prescribing this drug for pain, might be best to consider all patients opioid naive; limit dose adjustments to once a week to allow steady state levels to develop.

From ORAL Methadone to PARENTERAL Methadone:
-Start with a 2:1 ratio of oral to parenteral (e.g., oral methadone 10 mg to parenteral methadone 5 mg)

From Other Chronic Opioids to PARENTERAL Methadone:
-Individualize dose taking into account the patient's prior opioid exposure, general medical condition, concomitant medications, and anticipated breakthrough medication use.
-Manufacturer's product information may be consulted for tables that aid in converting chronic pain patients from oral morphine doses to oral and parenteral methadone doses.

Uses: For the treatment of moderate to severe pain not responsive to non-narcotic analgesics.

Usual Adult Dose for Opiate Withdrawal:

For detoxification and maintenance of opioid dependence, the drug should be administered in accordance with the treatment standards cited in 42 CFR (Code of Feral Regulations) Section 8.12, including limitations on unsupervised administration.

Oral:
Day 1: Administer initial dose under supervision when symptoms of withdrawal are present.
-Initial dose: 20 to 30 mg orally; an additional 5 to 10 mg may be given orally after 2 to 4 hours if withdrawal symptoms have not been suppressed or if symptoms reappear.
-Maximum initial dose: 30 mg
-Maximum day 1 dose: 40 mg
-Adjust dose over the first week based on control of withdrawal symptoms at 2 to 4 hours after dosing; titrate carefully as methadone levels will accumulate over the first several days of dosing.

Short-term Detoxification:
-For a brief course of stabilization followed by a period of medically supervised withdrawal, titrate to a total daily dose around 40 mg per day in divided doses; after 2 to 3 days, gradually decrease the dose at 2-day intervals maintaining sufficient dose to keep withdrawal symptoms at a tolerable level.

Titration and Maintenance of Opioid Dependence Detoxification:
-Titrate to a dose that prevents opioid withdrawal, reduces drug hunger or cravings, and blocks or attenuates the euphoric effects of self-administered opioids while ensuring the patients is tolerant to the sedative effects.
-Target range: 80 to 120 mg orally per day is a range that is commonly associated with therapeutic effectiveness.
-Cessation of therapy: There is considerable variability in the rate at which patients taper off; abrupt discontinuation is not advised. Dose reductions should generally be in increments of less than 10% every 10 to 14 days.

Parenteral:
-Injectable methadone products may be used in the temporary treatment of opioid dependence in patients unable to take oral medication.
-The patient's oral dose should be converted to the parenteral dose based on a 2:1 ratio (e.g., oral methadone 10 mg = parenteral methadone 5 mg)
-Injectable products are not approved for the outpatient treatment of opioid dependence.

Comments:
-Use lower dose for patients whose tolerance is expected to be low at treatment entry.
-Patients who have not taken opioids for more than 5 days may no longer be tolerant; initial doses should not be based on previous treatment episodes.
-Patients receiving methadone maintenance for opioid dependence cannot be expected to derive analgesia from their methadone; if acute pain occurs and requires treatment, these patients may require higher and/or more frequent doses than non-tolerant patients due to the opioid tolerance induced by methadone.
-During pregnancy, an increase in dose or a decrease in dosing interval may be required due to altered kinetics.

Uses: For detoxification and maintenance treatment of opioid addiction in conjunction with appropriate social and medical services.

Usual Adult Dose for Chronic Pain:

Individualize dose; dosing recommendations should only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient; this drug has a narrow therapeutic index, especially when combined with other drugs; monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy.

As the First Opioid Analgesic:
Initial dose: 2.5 mg orally every 8 to 12 hours

Conversion from Other Oral Opioids:
-Upon initiation, discontinue all other around-the-clock opioid drugs.
-The following conversion factors can be used to convert from another oral opioid analgesic to methadone, however do not use these conversion factors to convert from methadone to another opioid as doing so will result in an overestimation of the opioid dose and may result in fatal respiratory depression.
-Conversion is based on oral morphine equivalents; to estimate a patient's 24-hour oral morphine requirement, use published potency tables.
-It is best to underestimate a patient's 24-hour oral morphine requirement and use rescue medication as the dose is titrated due to substantial inter-patient variability.
-Suggested Maximum Starting Dose: 20 mg per day (10 mg for the elderly or infirmed).

-For patients receiving a total daily baseline ORAL morphine equivalent dose less than 100 mg: estimate the daily oral methadone requirement at 20% to 30%.
-For patients receiving a total daily baseline ORAL morphine equivalent dose of 100 to 300 mg: estimate the daily oral methadone requirement at 10% to 20%.
-For patients receiving a total daily baseline ORAL morphine equivalent dose of 300 to 600 mg: estimate the daily oral methadone requirement at 8% to 12%.
-For patients receiving a total daily baseline ORAL morphine equivalent dose of 600 to 1000 mg: estimate the daily oral methadone requirement at 5% to 10%.
-For patients receiving a total daily baseline ORAL morphine equivalent dose greater than 1000 mg: estimate the daily oral methadone requirement at less than 5%.
-Divide the total daily methadone dose by the number of doses permitted based on dosing interval; always round down, if necessary.

Conversion from Parenteral Methadone to Oral Methadone:
-Use a conversion ratio of 2:1 for oral to parenteral (e.g., oral methadone 10 mg to parenteral methadone 5 mg)

TITRATION and MAINTENANCE:
-Titrate to a dose that provides adequate analgesia and minimizes adverse reactions; dose adjustments should be no sooner than every 1 to 2 days (manufacturer); preferably no more than once a week (Institute for Safe Medical Practices (ISMP)).
-Breakthrough Pain: If the level of pain increases after dose stabilization, attempt to identify the source before increasing dose; rescue medication with appropriate immediate-release analgesia may be helpful.

Comments:
-ISMP suggests when prescribing this drug for pain, consider all patients as opioid naive; consider limiting the starting dose to oral doses not exceeding 20 mg per day (10 mg for the elderly or infirmed) and limit dose adjustments to once a week to allow steady state levels to develop.
-Prescribe oral liquid doses in mg to avoid confusion.
-Dose conversion should be done carefully and with close monitoring due to large patient variability in regards to opioid analgesic response.
-This drug is not indicated as an as-needed analgesic.
-Upon cessation of therapy, gradually taper dose in physically dependent patient.

Use: For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for whom the use of alternative analgesic treatments are ineffective, not tolerated, or would otherwise be inadequate to provide sufficient pain management.

What other drugs will affect methadone?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking methadone with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with methadone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about methadone.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.04. Revision Date: 2015-03-11, 2:59:27 PM.

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