Description
Methadone is used to treat moderate to severe pain when around-the-clock pain relief is needed for a long period of time. This medicine should not be used to treat pain that you only have once in a while or "as needed". Methadone is also used together with medical supervision and counseling to treat opioid use disorder (eg, heroin or other morphine-like drugs).
Methadone belongs to the group of medicines called opioid analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.
The use of methadone to treat opioid use disorder in the US is only available through opioid treatment programs (methadone clinics).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet for Suspension
- Solution
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of methadone in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of methadone in the elderly. However, elderly patients are more likely to have age-related heart, kidney, liver, or lung problems, which may require caution and an adjustment in the dose for patients receiving methadone.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Fluconazole
- Isocarboxazid
- Itraconazole
- Ketoconazole
- Levoketoconazole
- Mesoridazine
- Naltrexone
- Phenelzine
- Piperaquine
- Posaconazole
- Rasagiline
- Safinamide
- Samidorphan
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abacavir
- Abametapir
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acepromazine
- Aclidinium
- Adagrasib
- Aldosterone
- Alfentanil
- Alfuzosin
- Almotriptan
- Alprazolam
- Amantadine
- Amiloride
- Amineptine
- Amiodarone
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anagrelide
- Anileridine
- Apalutamide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Arsenic Trioxide
- Artemether
- Asenapine
- Astemizole
- Atazanavir
- Atropine
- Avacopan
- Azithromycin
- Baclofen
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Etravirine
- Peginterferon Alfa-2a
- Stavudine
- Zidovudine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
- Grapefruit Juice
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Addison disease (adrenal gland problem) or
- Alcohol use disorder, or history of or
- Brain tumor or
- Breathing or lung problems (eg, COPD, hypercapnia, hypoxia, apnea, sleep apnea) or
- CNS depression, history of or
- Cor pulmonale (serious heart condition) or
- Drug use disorder or dependence, or history of or
- Gallbladder disease or
- Head injuries, history of or
- Heart disease (eg, cardiac hypertrophy) or
- Heart rhythm problems (eg, arrhythmia, long QT syndrome), or history of or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood) or
- Increased pressure in your head or
- Stomach or bowel problems or
- Weakened physical condition—Use with caution. May increase risk for more serious side effects.
- Diabetes or
- Hypotension (low blood pressure) or
- Pancreatitis (inflammation of the pancreas) or
- Seizures, history of—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Lung or breathing problems (eg, asthma, respiratory depression), severe or
- Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Swallow the tablet whole. Do not crush, break, chew, or dissolve it.
To use the dispersible tablet:
- Do not chew or swallow the tablet. You may break or cut the tablet in half.
- Dissolve the tablet in 120 mL (4 ounces) of water, orange juice, or other acidic fruit drinks before taking. If there are remaining pieces in the cup, add a small amount of liquid and drink the mixture.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For pain:
- For patients taking Dolophine® as the first pain medicine:
- Adults—At first, 2.5 milligrams (mg) every 8 to 12 hours. Your doctor may adjust your dose as needed. Do not take more than your prescribed dose in 24 hours.
- Children—Use and dose must be determined by your doctor.
- For patients switching from other opioids to Dolophine®:
- Adults—The dose must be determined by your doctor based on the previous dose of opioid medicine. The dose is given every 8 or 12 hours. Your doctor may adjust your dose as needed. Do not take more than your prescribed dose in 24 hours.
- Children—Use and dose must be determined by your doctor.
- For patients taking Dolophine® as the first pain medicine:
- For opioid use disorder:
- Adults—At first, 20 to 30 milligrams (mg) taken as a single dose per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day. Do not take more than your prescribed dose in 24 hours.
- Children—Use and dose must be determined by your doctor.
- For pain:
- For oral dosage form (liquid or tablets for suspension):
- For opioid use disorder:
- Adults—At first, 20 to 30 milligrams (mg) taken as a single dose per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day. Do not take more than your prescribed dose in 24 hours.
- Children—Use and dose must be determined by your doctor.
- For opioid use disorder:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you are taking this medicine for opioid use disorder and miss a dose, take your next dose the following day as scheduled.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Methadone can cause serious unwanted effects if taken by adults who are not used to strong opioid pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it. Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm
Precautions
It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
This medicine may be present in your breast milk and passed to your baby. Talk to your doctor if you plan to breastfeed.
This medicine may cause serious allergic reactions called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or opioids, medicine for anxiety or benzodiazepines, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
Using opioids for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary. Signs of an overdose include: change or loss of consciousness, cold, clammy skin, coughing that sometimes produces a pink frothy sputum, decreased awareness or responsiveness, extreme dizziness or weakness, increased sweating, irregular, fast, or slow, or shallow breathing, pale or blue lips, fingernails, or skin, sleepiness or unusual drowsiness, slow heartbeat, seizures, swelling in legs and ankles, or trouble breathing. Call your doctor right away if you notice these symptoms.
This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem including QT prolongation.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.
If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as stomach cramps, anxiety, fever, nausea, restlessness, runny nose, sweating, tremors, or trouble sleeping.
If you are pregnant and have been on a stable dose of methadone, do not stop taking it without talking to your doctor. Stopping it suddenly may cause withdrawal symptoms and lead to pregnancy complications.
This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
This medicine may cause hypoglycemia (low blood sugar). Check with your doctor right away if you have anxiety, blurred vision, chills, cold sweats, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Anxiety
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- bulging soft spot on the head of an infant
- change in the ability to see colors, especially blue or yellow
- changes in skin color
- chest discomfort or pain
- cold sweats
- coma
- confusion
- cool, pale skin
- cough
- coughing that sometimes produces a pink frothy sputum
- darkening of the skin
- decreased urine output
- depression
- diarrhea
- difficult, fast, noisy breathing
- difficulty with swallowing
- dilated neck veins
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- extreme fatigue
- fainting
- fast, slow, or irregular heartbeat
- headache
- hives, itching, or skin rash
- increased hunger
- increased sweating
- increased thirst
- irregular heartbeat
- irregular, fast or slow, or shallow breathing
- loss of appetite
- mental depression
- muscle pain or cramps
- nausea or vomiting
- nervousness
- nightmares
- numbness or tingling in the hands, feet, or lips
- pain
- pale or blue lips, fingernails, or skin
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- seizures
- shakiness
- slurred speech
- sweating
- swelling of the face, fingers, feet, or lower legs
- tenderness
- trouble breathing
- trouble sleeping
- trouble urinating
- unusual bleeding or bruising
- unusual tiredness or weakness
- weight gain
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Change in consciousness
- chest pain or discomfort
- cold, clammy skin
- constricted, pinpoint, or small pupils (black part of the eye)
- coughing that sometimes produces a pink frothy sputum
- decreased awareness or responsiveness
- increased sweating
- irregular, fast, or slow, or shallow breathing
- loss of consciousness
- no muscle tone or movement
- pale or blue lips, fingernails, or skin
- sleepiness or unusual drowsiness
- slow or irregular heartbeat
- swelling in the legs and ankles,
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Absent, missed, or irregular menstrual periods
- blurred or loss of vision
- confusion about identity, place, and time
- constipation
- decreased interest in sexual intercourse
- disturbed color perception
- double vision
- false or unusual sense of well-being
- halos around lights
- inability to have or keep an erection
- irritability
- lack or loss of strength
- loss in sexual ability, desire, drive, or performance
- night blindness
- overbright appearance of lights
- redness, swelling, or soreness of the tongue
- restlessness
- stopping of menstrual bleeding
- tunnel vision
- weight changes
- welts
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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