Pronunciation:

METH-a-done

Brand Names:

• Diskets Dispersible
• Dolophine
• Methadone HCl Intensol
• Methadose

Dosage Forms:

• Tablet for Suspension
• Solution
• Tablet

Warnings:

Warning: Life-Threatening Respiratory Depression, Life-Threatening QT Prolongation, Accidental Ingestion, Abuse Potential, Interactions With Drugs Affecting Cytochrome P450 Isoenzymes, and Treatment For Opioid AddictionLife-Threatening Respiratory Depression: Respiratory depression, including fatal cases, have been reported during initiation and conversion of patients of methadone, and even when the drug has been used as recommended and not miss used or abused. Proper dosing and titration and essential and methadone hydrochloride dispersible tablets should only be prescribed by healthcare professionals who are knowledgeable in the use of methadone for detoxification and maintenance treatment of opioid addiction. Monitor for respiratory depression, especially during initiation of methadone hydrochloride or following a dose increase. The peak respiratory depressant effect of methadone occurs later, and persists longer than the peak pharmacologic effect, especially during the initial dosing period.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 benzodiazepines or other CNS depressants for use in patients in methadone treatment for whom alternative treatment options are inadequate. 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.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 dispersible tablets.Accidental Ingestion: Accidental ingestion of even one dose of methadone hydrochloride dispersible tablets, especially by children, can result in a fatal overdose of methadone.Misuse, Abuse, and Diversion of Opioids: Methadone hydrochloride dispersible tablets contains methadone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit.Interactions with Drugs Affecting Cytochrome P450 Isoenzymes: The concomitant use of methadone hydrochloride dispersible 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.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 .

Warning: 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 AddictionAddiction, 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.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 InteractionThe 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 .

Warning: Life-Threatening Respiratory Depression, Life-Threatening QT Prolongation, Accidental Ingestion, Abuse Potential, Interactions With Drugs Affecting Cytochrome P450 Isoenzymes, and Treatment For Opioid AddictionLife-Threatening Respiratory Depression: Respiratory depression, including fatal cases, have been reported during initiation and conversion of patients of methadone, and even when the drug has been used as recommended and not miss used or abused. Proper dosing and titration and essential and methadone hydrochloride should only be prescribed by healthcare professionals who are knowledgeable in the use of methadone for detoxification and maintenance treatment of opioid addiction. Monitor for respiratory depression, especially during initiation of methadone hydrochloride or following a dose increase. The peak respiratory depressant effect of methadone occurs later, and persists longer than the peak pharmacologic effect, especially during the initial dosing period.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 benzodiazepines or other CNS depressants for use in patients in methadone treatment for whom alternative treatment options are inadequate. 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.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.Accidental Ingestion: Accidental ingestion of even one dose of methadone hydrochloride, especially by children, can result in a fatal overdose of methadone.Misuse, Abuse, and Diversion of Opioids: Methadone hydrochloride contains methadone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit.Interactions with Drugs Affecting Cytochrome P450 IsoenzymesThe concomitant use of methadone hydrochloride 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.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 .

Classifications:

Therapeutic—

Analgesic

Chemical—

Opioid

Uses of This Medicine:

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 addiction (eg, heroin or other morphine-like drugs).

Methadone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

Other 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 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
• Itraconazole
• Ketoconazole
• Levoketoconazole
• Mesoridazine
• Nalmefene
• Naltrexone
• Nelfinavir
• Pimozide
• 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.

• Abametapir
• Acepromazine
• Adagrasib
• Alfentanil
• Alfuzosin
• Almotriptan
• Alprazolam
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anagrelide
• Anileridine
• Apomorphine
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Armodafinil
• Arsenic Trioxide
• Artemether
• Asenapine
• Astemizole
• Azithromycin
• Baclofen
• Bedaquiline
• Benperidol
• Benzhydrocodone
• Benzphetamine
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Bupropion
• Buserelin
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Capecitabine
• Carbamazepine
• Carbinoxamine
• Cariprazine
• Carisoprodol
• Carphenazine
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chloroquine
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clofazimine
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Clothiapine
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Dabrafenib
• Dantrolene
• Daridorexant
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Delavirdine
• Desipramine
• Deslorelin
• Desmopressin
• Desvenlafaxine
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Duloxetine
• Ebastine
• Eletriptan
• Encorafenib
• Enflurane
• Entrectinib
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etrasimod
• Famotidine
• Fedratinib
• Felbamate
• Fenfluramine
• Fentanyl
• Fexinidazole
• Fingolimod
• Flecainide
• Flibanserin
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Formoterol
• Fosaprepitant
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Fostemsavir
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halazepam
• Halofantrine
• Haloperidol
• Halothane
• Hexobarbital
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxyamphetamine
• Hydroxychloroquine
• Hydroxytryptophan
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imatinib
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Iproniazid
• Isocarboxazid
• Isoflurane
• Ivabradine
• Ivacaftor
• Ivosidenib
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Lapatinib
• Lasmiditan
• Lefamulin
• Lemborexant
• Lenacapavir
• Lenvatinib
• Leuprolide
• Levocetirizine
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Lorazepam
• Lorcaserin
• Loxapine
• Lumacaftor
• Lumefantrine
• Lurasidone
• Macimorelin
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Mefloquine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Metaxalone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Metronidazole
• Mibefradil
• Midazolam
• Mifepristone
• Milnacipran
• Mirtazapine
• Mitotane
• Mizolastine
• Mobocertinib
• Moclobemide
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nafcillin
• Nalbuphine
• Naratriptan
• Nefazodone
• Netupitant
• Nialamide
• Nicomorphine
• Nilotinib
• Nirmatrelvir
• Nitrazepam
• Nitrous Oxide
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Oliceridine
• Omaveloxolone
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxazepam
• Oxcarbazepine
• Oxycodone
• Oxymorphone
• Ozanimod
• Pacritinib
• Palbociclib
• Paliperidone
• Palonosetron
• Panobinostat
• Papaveretum
• Papaverine
• Paregoric
• Paroxetine
• Pasireotide
• Pazopanib
• Peginterferon Alfa-2b
• Pentamidine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pipamperone
• Piperacetazine
• Pipotiazine
• Piritramide
• Pitolisant
• Ponesimod
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Probucol
• Procainamide
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propafenone
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ramelteon
• Ranitidine
• Ranolazine
• Relugolix
• Remifentanil
• Remimazolam
• Remoxipride
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Risperidone
• Ritonavir
• Rizatriptan
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Selegiline
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Sibutramine
• Siponimod
• Sodium Oxybate
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sparsentan
• St John's Wort
• Sufentanil
• Sulpiride
• Sunitinib
• Suvorexant
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Temazepam
• Tetrabenazine
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thiothixene
• Tianeptine
• Tilidine
• Tipranavir
• Tizanidine
• Tolonium Chloride
• Topiramate
• Toremifene
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Triclabendazole
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Triptorelin
• Tryptophan
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Verapamil
• Vilanterol
• Vilazodone
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Vortioxetine
• Zaleplon
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuclopenthixol
• Zuranolone

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.

• Abacavir
• Atazanavir
• Didanosine
• Etravirine
• Fosamprenavir
• Nevirapine
• 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 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 abuse, 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 dependence, especially narcotic abuse 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 of This Medicine:

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 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. Do not take more than your prescribed dose in 24 hours.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (liquid or tablets for suspension):
  • 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. Do not take more than your prescribed dose in 24 hours.
    • Children—Use and dose must be determined by your doctor.

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 addiction 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 narcotic 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 narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic 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 While Using This Medicine:

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.

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 of This Medicine:

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.