methadone (Oral route)

Pronunciation

METH-a-done

Oral route(Tablet;Solution)

Assess each patient’s risk for opioid abuse or addiction prior to prescribing methadone and monitor for signs of misuse, abuse, and addiction during treatment. Respiratory depression, including fatal cases, have been reported during initiation and conversion of patients to methadone, even when the drug has been used as recommended. QT interval prolongation and serious arrhythmias (torsades de pointes) have been observed during treatment with methadone. Monitor for respiratory depression and QT prolongation during initiation of therapy and dose titration. Accidental ingestion, especially in children, can result in a fatal overdose of methadone .

Oral route(Tablet for Suspension)

Deaths due to too-rapid titration, drug interactions, or cardiac and respiratory side effects have occurred with methadone use for opioid dependence. Respiratory depression is the main hazard associated with methadone administration. QT interval prolongation and serious arrhythmias (torsades de pointes) have been observed during treatment with methadone. Only approved hospitals and pharmacies can dispense oral methadone for the treatment of narcotic addiction .

Commonly used brand name(s)

In the U.S.

  • Diskets Dispersible
  • Dolophine
  • Methadone HCl Intensol
  • Methadose

Available Dosage Forms:

  • Tablet for Suspension
  • Liquid
  • Solution
  • Tablet

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For methadone

Methadone is used to treat moderate to severe pain when around-the-clock pain relief is needed for a long period of time. methadone 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 addiction (e.g., heroin or other morphine-like drugs).

Slideshow: Are You at Risk of Prescription Drug Addiction?

Methadone is an opioid (narcotic) analgesic (pain medicine). It acts on the central nervous system (CNS) to relieve pain.

methadone is available only with your doctor's prescription.

Before Using methadone

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 methadone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to methadone 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.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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 methadone, 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 methadone 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.

  • Amifampridine
  • Cisapride
  • Dronedarone
  • Fluconazole
  • Itraconazole
  • Ketoconazole
  • Mesoridazine
  • Naltrexone
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Rasagiline
  • Selegiline
  • Sparfloxacin
  • Thioridazine
  • Ziprasidone

Using methadone 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.

  • Almotriptan
  • Amiodarone
  • Amitriptyline
  • Amoxapine
  • Amprenavir
  • Apomorphine
  • Arsenic Trioxide
  • Artemether
  • Asenapine
  • Astemizole
  • Azithromycin
  • Bedaquiline
  • Buprenorphine
  • Butorphanol
  • Carbamazepine
  • Carbinoxamine
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Desvenlafaxine
  • Dezocine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Droperidol
  • Duloxetine
  • Escitalopram
  • Eslicarbazepine Acetate
  • Fentanyl
  • Fingolimod
  • Flecainide
  • Fluoxetine
  • Fluphenazine
  • Formoterol
  • Fospropofol
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Hydrocodone
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Ivabradine
  • Lapatinib
  • Levofloxacin
  • Levomilnacipran
  • Lorcaserin
  • Lumefantrine
  • Meclizine
  • Mefloquine
  • Meptazinol
  • Mifepristone
  • Mitotane
  • Moxifloxacin
  • Nalbuphine
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Paliperidone
  • Pasireotide
  • Pazopanib
  • Pentazocine
  • Perflutren Lipid Microsphere
  • Perphenazine
  • Procainamide
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Salmeterol
  • Saquinavir
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • Sunitinib
  • Tapentadol
  • Telavancin
  • Telithromycin
  • Terfenadine
  • Tetrabenazine
  • Thiethylperazine
  • Thioridazine
  • Tizanidine
  • Toremifene
  • Tramadol
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Tryptophan
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Vilanterol
  • Vinflunine
  • Vortioxetine

Using methadone 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.

  • Abacavir
  • Atazanavir
  • Darunavir
  • Desipramine
  • Didanosine
  • Efavirenz
  • Etravirine
  • Fluvoxamine
  • Fosamprenavir
  • Lopinavir
  • Nelfinavir
  • Nevirapine
  • Peginterferon Alfa-2a
  • Perampanel
  • Rifampin
  • Rilpivirine
  • Risperidone
  • Ritonavir
  • Stavudine
  • St John's Wort
  • Telaprevir
  • Thiotepa
  • Tipranavir
  • Voriconazole
  • Zidovudine

Interactions with Food/Tobacco/Alcohol

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 methadone 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 methadone, 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 methadone. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse, or history of or
  • Depression, history of or
  • Drug dependence, especially narcotic abuse or dependence, history of—Use with caution. May increase risk for more serious side effects.
  • Asthma, acute or severe or
  • Paralytic ileus (intestinal blockage) or
  • Respiratory depression (hypoventilation or slow breathing)—Should not be used in patients with these conditions.
  • Brain tumor or
  • Head injuries or
  • Increased pressure in your head—Some of the side effects of methadone can cause serious problems in people who have these medical problems.
  • Breathing or lung problems (e.g., chronic obstructive pulmonary disease [COPD], cor pulmonale, hypercapnia, hypoxia, apnea) or
  • Gallbladder disease or
  • Heart rhythm problems (e.g., arrhythmia, QT prolongation) or
  • Hypotension (low blood pressure) or
  • Pancreatitis (inflammation of the pancreas) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Heart disease (cardiac hypertrophy) or
  • Heart rhythm problems, history of or
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood)—Use with caution. May increase risk for QT prolongation.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of methadone

Take methadone 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.

methadone comes with a Medication Guide. Read the information carefully and make sure you understand it before taking methadone. If you have any questions, talk to your doctor.

Dosing

The dose of methadone 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 methadone. 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 to 10 milligrams (mg) every 8 to 12 hours. Your doctor may adjust your dose as needed.
        • 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.
        • Children—Use and dose must be determined by your doctor.
    • For opioid addiction:
      • 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.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of methadone, 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.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Flush all leftover medicine down the toilet after you have finished your treatment. Also flush old medicine after the expiration date has passed. methadone is one of only a few medicines that should be disposed of this way.

Precautions While Using methadone

It is very important that your doctor check your progress while you are taking methadone. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused medicine in a safe and secure place. People who are addicted to drugs might want to steal methadone.

methadone will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using methadone.

methadone may be habit-forming (causing mental or physical dependence). 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 narcotics 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.

Do not use more of methadone or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include extreme dizziness or weakness, trouble breathing, slow heartbeat, seizures, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

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 such as 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 methadone regularly for several weeks or more, do not suddenly stop using it without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely, or to take another narcotic for a while, to lessen the chance of withdrawal side effects.

Before you have any medical tests, tell the medical doctor in charge that you are taking methadone. The results of some tests may be affected by methadone.

methadone may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to methadone before you drive, use machines, or do anything else that could be dangerous until you know how methadone affects you.

Using methadone while you are pregnant may cause neonatal withdrawal syndrome in your newborn child. Tell your doctor right away if your child has the following symptoms: abnormal sleep pattern, diarrhea, high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.

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 or vitamin supplements.

methadone 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
  • 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
  • confusion
  • convulsions
  • cough
  • coughing that sometimes produces a pink frothy sputum
  • decreased urine output
  • difficult or troubled breathing
  • difficult, fast, noisy breathing, sometimes with wheezing
  • difficulty 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
  • increased sweating
  • increased thirst
  • irregular heartbeat recurrent
  • irregular, fast or slow, or shallow breathing
  • itching
  • loss of appetite
  • muscle pain or cramps
  • nausea or vomiting
  • 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
  • skin rash
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • tenderness
  • trouble in urinating
  • trouble sleeping
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weight gain

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
  • anxiety
  • 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.

See also: Side effects (in more detail)

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