Methadone
Generic name: methadone (oral/injection) [ METH-a-done ]
Brand names: Dolophine, Methadose, Methadose Sugar-Free, Diskets
Dosage forms: injectable solution, intravenous solution, oral concentrate, oral solution, oral tablet, oral tablet, dispersible.
Drug class: Opioids
What is methadone?
Methadone is a long-acting opioid medication that is used to reduce withdrawal symptoms in people addicted to heroin or other narcotic drugs, and it can also be used as a pain reliever.
Methadone for Opioid Use Disorder (OUD) helps to reduce withdrawal symptoms and drug cravings without causing the "high" associated with drug addiction. Methadone is a highly regulated medication (Schedule 2 Controlled Substances Act) and, when used for OUD, it is only available through approved opioid treatment programs (OTP) that involve regular monitoring, counseling, and drug testing to make sure that patients are making progress in their recovery.
Methadone is used for severe and persistent pain that can not be treated effectively with other pain medications, including immediate-release opioids.
Methadone works by activating the opioid receptors in the brain and nervous system. It is usually taken orally as a liquid or tablet.
What is methadone FDA-approved for?
Management of severe, persistent pain
- For patients who require an opioid analgesic
- For those for whom alternative treatment options are inadequate, including immediate-release opioids
- Limitations of use (for pain).
- Due to the risks of addiction, abuse, misuse, overdose, and death, methadone should be reserved for patients in whom:
- Alternative treatment options are ineffective
- Alternative treatment options are not tolerated
- Alternative treatment options are otherwise inadequate to provide sufficient pain management
- Not indicated for as-needed (PRN) analgesic use
- Due to the risks of addiction, abuse, misuse, overdose, and death, methadone should be reserved for patients in whom:
Detoxification treatment of opioid addiction
- For dependence on heroin or other morphine-like drugs
Maintenance treatment of opioid addiction
- For dependence on heroin or other morphine-like drugs
- To be used in conjunction with appropriate medical and social services
- FDA limitations for opioid addiction treatment in detoxification or maintenance programs:
- Use is subject to the federal conditions for distribution and administration under 42 CFR 8.12
Boxed Warning
Methadone has a boxed warning for serious and life-threatening harm. A boxed warning is the strongest safety-related warning issued by the FDA.
Addiction, misuse, and overdose
Methadone is an opioid. It can be addictive and can be misused or abused. This can lead to overdose or death. Your healthcare provider should check your risk before prescribing it and monitor you regularly while you take it.
Dangerously slow or stopped breathing
Methadone can cause breathing problems that may be severe or fatal, especially when you first start taking it or when your dose is increased. Taking the right dose exactly as prescribed is very important.
Accidental use
Taking even one dose by accident, especially by a child, can cause a fatal overdose.
Mixing with certain medicines or alcohol
Taking methadone with benzodiazepines, alcohol, or other drugs that make you sleepy or slow your breathing can cause extreme drowsiness, breathing problems, coma, or death. These combinations should only be used when other treatment options are not good enough.
Pregnancy and newborn withdrawal
If methadone is used during pregnancy, the baby may be born with opioid withdrawal symptoms called
Neonatal Opioid Withdrawal Syndrome (NOWS). This condition can be serious or life-threatening if it is not recognized and treated. Patients should be told about this risk so the baby can be monitored and treated if needed.
Opioid REMS Patient education
Healthcare providers are strongly encouraged to complete a Risk Evaluation and Mitigation Strategy (REMS) compliant education program. Healthcare providers are encouraged to educate patients and caregivers about the serious risks of methadone, how to use it safely, and the importance of reading the Medication Guide every time it is prescribed.
Heart rhythm problems
Methadone can cause serious changes in heart rhythm, including a dangerous condition that can be life-threatening. The risk may be higher in people with certain heart problems, people taking higher doses, or people taking other medicines that affect the heart. Careful monitoring may be needed, especially when starting treatment or changing the dose.
Drug interactions
Many medicines can change how methadone works in your body. Some can raise methadone levels and increase the risk of severe sleepiness, breathing problems, or death. Stopping certain medicines can also raise methadone levels. Your healthcare provider should monitor you closely and may need to adjust your dose if your other medicines change.
Use for opioid addiction treatment
When methadone is used to treat opioid addiction, it must be given under strict federal treatment rules. These rules include limits on when doses can be taken without supervision.
Important information
- Get emergency help or call 911 right away if you take too many methadone hydrochloride tablets (overdose). When you first start taking methadone hydrochloride tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose, a medicine for the emergency treatment of an opioid overdose.
- Taking methadone hydrochloride tablets with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
- Methadone-associated hypoglycemia (low blood sugar levels) has been reported in patients using this medicine, some resulting in hospitalization. In many cases, patients had predisposing risk factors such as diabetes.
- Never give anyone else your methadone hydrochloride tablets. They could die from taking it. Selling or giving away methadone hydrochloride tablets is against the law.
- Store methadone hydrochloride tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
Before taking this medicine
You should not use this medicine if you are allergic to it, or if you have:
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severe asthma or breathing problems; or
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a blockage in your stomach or intestines.
This medicine 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 ever had:
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heart problems, long QT syndrome (in you or a family member);
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breathing problems, sleep apnea;
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a head injury, brain tumor, or seizures;
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drug or alcohol addiction, or mental illness;
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liver or kidney disease;
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urination problems; or
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problems with your gallbladder, pancreas, or thyroid.
Tell your healthcare provider if you notice your pain getting worse. If your pain gets worse after you take methadone hydrochloride tablets, do not take more methadone hydrochloride tablets without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking methadone hydrochloride tablets.
Pregnancy
Talk to your doctor before using opioid medicine if you are pregnant or planning a pregnancy. If you use opioid medicine during pregnancy, your baby could be born with life-threatening withdrawal symptoms, called neonatal opioid withdrawal syndrome (NOWS), which is treatable, and your baby may need medical treatment for several weeks.
Breastfeeding
Ask a doctor before using opioid medicine if you are breastfeeding. This medicine passes into breast milk and may harm your baby. Tell your doctor immediately if you notice increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness in the nursing baby. Talk to your baby's doctor when you decide to wean your baby. It is important to wean your baby gradually so that your baby does not develop withdrawal symptoms when he or she stops receiving methadone in breastmilk.
How should I use methadone?
Use this medicine exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.
Never share opioid medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.
Methadone instructions:
- Methadone oral is taken by mouth. The injection is given as an intravenous, intramuscular or subcutaneous injection.
- Measure liquid medicine with the supplied measuring device (not a kitchen spoon).
- Dissolve the dispersible tablet in water, orange juice, or other citrus-flavored non-alcoholic beverage. Stir and drink this mixture right away.
- Take this medicine regularly with or without food
- Never crush a pill to inhale the powder or inject it into your vein. This could result in death.
- You should not stop using this medicine suddenly. Ask your doctor before stopping the medicine.
Do not keep leftover medicine. Just one dose can cause death in someone using it accidentally or improperly. Ask your pharmacist about a drug take-back program, or flush the unused medicine down the toilet.
Keep an opioid overdose rescue medicine on hand
Talk to your doctor about opioid overdose rescue medicine: Patients and caregivers should learn about medicines that can reverse an opioid overdose, such as naloxone or nalmefene.
Keep overdose rescue medicine available: It is important to have access to one of these medicines, especially if you have a higher risk of overdose. This includes people who take other medicines that can cause drowsiness, have a history of opioid use disorder, or have had an opioid overdose before. It is also important if there are children or others in the home who could accidentally use the medicine.
Pain treatment should still be considered: Having risk factors for overdose does not mean pain should go untreated. Your doctor can help manage your pain while also taking steps to reduce risk.
Know how to get it: Ask your doctor or pharmacist about ways to get an overdose rescue medicine. It may be available by prescription, over the counter, or through a community program.
These medicines are not all the same: Overdose rescue medicines can differ in how they are given, how strong they are, who can use them, and how long they last. Your doctor or pharmacist should help you choose the right one and explain how to use it.
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.
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 your dosing schedule at a lower dose.
Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or a person using opioid medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.
Your doctor may recommend that you get naloxone or nalmefene (medicines used to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone or nalmefene if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.
Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.
There are important differences among the opioid overdose reversal agents, such as route of administration, product strength, approved patient age range, and pharmacokinetics. Be familiar with these differences, as outlined in the approved labeling for those products, prior to recommending or prescribing such an agent.
What should I avoid while using methadone?
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
Grapefruit may interact with this medicine and cause side effects. Avoid consuming grapefruit products.
There are many dangerous drug interactions with methadone. Tell your prescribing doctor about all medications that you take. See “What other drugs will affect methadone?” section below.
Methadone side effects
Get emergency medical help if you have signs of an allergic reaction to methadone: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Serious methadone side effects.
Call your doctor at once if you have:
- weak or shallow breathing, breathing that stops during sleep;
- severe constipation;
- seizures
- withdrawal symptoms
- a light-headed feeling, like you might pass out;
- fast or pounding heartbeats, fluttering in your chest, shortness of breath;
- low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
- serotonin syndrome - agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea.
Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.
Common methadone side effects may include:
- dizziness, drowsiness;
- nausea, vomiting;
- increased sweating; or
- pain, redness, or swelling where the medicine was injected.
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 the FDA at 1-800-FDA-1088.
Related/similar drugs
What other drugs will affect methadone?
You may have a fatal methadone overdose if you start or stop using certain other medicines. Tell your doctor about all your medications.
Many other drugs can be dangerous when used with opioid medicine. Tell your doctor if you also use:
- medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;
- other opioid medicines;
- a benzodiazepine sedative like Valium, Klonopin, or Xanax;
- sleep medicine, muscle relaxers, or other drugs that make you drowsy; or
- drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.
This list is not complete. Many drugs may affect methadone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
Storage
Store at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.
Popular FAQ
What drugs cause pinpoint pupils?
Pinpoint pupils, medically termed miosis, refer to abnormally small, constricted pupils that do not dilate appropriately in low light. This symptom can be caused by opioids, clonidine, buspirone, metoclopramide, and other medications.
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Any drug that is classified as an "opioid" can cause constipation, which can be a serious side effect if not addressed. Examples of commonly prescribed opioids that may cause this side effect include morphine, tramadol, fentanyl, methadone, hydrocodone, codeine and oxycodone.
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How long opioid withdrawal lasts depends on the opioid you have been taking and whether it is a short-acting or long acting opioid.
If you have been using a short-acting opioid, acute opioid withdrawal lasts 4 to 10 days, with withdrawal symptoms starting 8 to 24 hours after last use.
If you have been using a long-acting opioid, acute opioid withdrawal lasts 10 to 20 days, with withdrawal symptoms starting 12 to 48 hours after last use. Continue reading
How can I get emergency methadone?
If you are experiencing a medical emergency due to an opioid withdrawal, you should call 911 right away. You may need to be transported to a hospital for treatment. If appropriate, emergency methadone can be administered as determined by a healthcare provider for acute withdrawal. Continue reading
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use methadone only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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