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Methadone Diskets Side Effects

Generic name: methadone

Medically reviewed by Drugs.com. Last updated on Mar 19, 2024.

Note: This document provides detailed information about Methadone Diskets Side Effects associated with methadone. Some dosage forms listed on this page may not apply specifically to the brand name Methadone Diskets.

Applies to methadone: oral solution, oral tablet, oral tablet for suspension.

Other dosage forms:

Important warnings This medicine can cause some serious health issues

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.

Oral route (tablet; solution)

ing: Addiction, Abuse And Misuse; Life-Threatening Respiratory Depression; Accidental Ingestion; Life-Threatening QT Prolongation; Neonatal Opioid Withdrawal Syndrome; Interactions With Drugs Affecting Cytochrome P450 Isoenzymes; Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants; And Treatment For Opioid Addiction

Addiction, Abuse, and Misuse

Methadone hydrochloride tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.

Assess each patient’s risk prior to prescribing methadone hydrochloride tablets, and monitor all patients regularly for the development of these behaviors and conditions.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of methadone hydrochloride tablets.

The peak respiratory depressant effect of methadone occurs later, and persists longer than the peak analgesic effect, especially during the initial dosing period or following a dose increase.

Monitor for respiratory depression, especially during initiation of methadone hydrochloride tablets or following a dose increase.

Proper dosing and titration are essential and methadone hydrochloride should only be prescribed by healthcare professionals who are knowledgeable in the use of methadone for toxification and maintenance treatment of opioid addiction.

Accidental Ingestion

Accidental ingestion of even one dose of methadone hydrochloride tablets, especially by children, can result in a fatal overdose of methadone.Life-Threatening QT Prolongation: QT interval prolongation and serious arrhythmia (torsades de pointes) have occurred during treatment with methadone.

Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction.

Closely monitor patients with risk factors for development of prolonged QT interval, a history of cardiac conduction abnormalities, and those taking medications affecting cardiac conduction for changes in cardiac rhythm during initiation and titration of methadone hydrochloride tablets

Neonatal Opioid Withdrawal Syndrome

Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of use of methadone hydrochloride tablets during pregnancy.

NOWS may be life-threatening if not recognized and treated in the neonate.

The balance between the risks of NOWS and the benefits of maternal methadone hydrochloride use may differ based on the risks associated with the mother’s underlying condition, pain, or addiction.

Advise the patient of the risk of NOWS so that appropriate planning for management of the neonate can occur.Cytochrome P450 Interaction. The concomitant use of methadone hydrochloride tablets with all cytochrome P450 3A4, 2B6, 2C19, 2C9 or 2D6 inhibitors may result in an increase in methadone plasma concentrations, which could cause potentially fatal respiratory depression.

In addition, discontinuation of concomitantly used cytochrome P450 3A4, 2B6, 2C19, or 2C9 inducers may also result in an increase in methadone plasma concentration.

Follow patients closely for respiratory depression and sedation, and consider dosage reduction with any changes of concomitant medications that can result in an increase in methadone levels.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.Reserve concomitant prescribing of methadone and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.Limit dosages and durations to the minimum required.Follow patients for signs and symptoms of respiratory depression and sedation.

If the patient is visibly sedated, evaluate the cause of sedation, and consider delaying or omitting the daily methadone dose.Conditions For Distribution And Use Of Methadone Products For The Treatment Of Opioid Addiction:For detoxification and maintenance of opioid dependence, methadone should be administered in accordance with the treatment standards cited in 42 CFR Section 8, including limitations on unsupervised administration.

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 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 narcotics, 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 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.

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. 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.

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.

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.

Serious side effects of Methadone Diskets

Along with its needed effects, methadone (the active ingredient contained in Methadone Diskets) 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 while taking methadone:

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
  • cough
  • coughing that sometimes produces a pink frothy sputum
  • darkening of the skin
  • decreased urine output
  • 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 sweating
  • increased thirst
  • irregular heartbeat
  • irregular, fast or slow, or shallow breathing
  • loss of appetite
  • mental depression
  • 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
  • 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 while taking methadone:

Symptoms of overdose

Other side effects of Methadone Diskets

Some side effects of methadone 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

For healthcare professionals

Applies to methadone: compounding powder, injectable solution, intravenous solution, oral concentrate, oral solution, oral tablet, oral tablet dispersible.

General adverse events

The major adverse reaction of this drug is respiratory depression; to a lesser degree, systemic hypotension, respiratory arrest, shock, cardiac arrest, and death have occurred. The most commonly observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating.[Ref]

Cardiovascular

Cases of QT interval prolongation and Torsades de pointes have occurred during treatment; these cases appear to be more commonly associated with higher dose treatment (greater than 200 mg per day). There have been some cases in patients receiving lower doses and in these cases contributing factors such as concomitant medications and/or clinical conditions were present. In vivo studies have confirmed this drug effects the QT interval and in vitro studies have shown it inhibits cardiac potassium channels.[Ref]

Gastrointestinal

Constipation often persists during chronic administration; nausea, and vomiting appear to be more frequent after oral administration.[Ref]

Other

Hypersensitivity

Anaphylaxis has been reported with ingredients contained in methadone products.[Ref]

Psychiatric

Endocrine

Hypogonadism, decreased serum testosterone, and reproductive effects are thought to be related to chronic opioid use.[Ref]

Genitourinary

Respiratory

Renal

Hematologic

Reversible thrombocytopenia has been described in opioid addicts with chronic hepatitis.[Ref]

Nervous system

Metabolic

Ocular

Dermatologic

Sweating often persists during chronic administration.[Ref]

Hepatic

Local

See also:

References

1. (2002) "Product Information. Dolophine (methadone)." Lilly, Eli and Company

2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

3. (2007) "Product Information. Diskets (methadone)." Cebert Pharmaceuticals Inc

4. Cerner Multum, Inc. "Australian Product Information."

5. (2021) "Product Information. Methadose (methadone)." Mallinckrodt Medical Inc

Frequently asked questions

Further information

Methadone Diskets side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.