Generic Name: methadone (Oral route)
Use of methadone hydrochloride increases the risk of opioid addiction, abuse, or misuse, which may cause overdose and death. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing methadone and monitor for signs of these behaviors during treatment. Respiratory depression, including fatal cases, have been reported, particularly during therapy initiation and dose increases. QT interval prolongation and serious arrhythmias (eg, torsades de pointes) have occurred during treatment, generally with large, multiple daily doses, but also with commonly used doses for maintenance treatment of opioid addiction. 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 . Prolonged use during pregnancy may result in neonatal opioid withdrawal syndrome, which may be life-threatening if unnoticed and untreated. If prolonged use is required in a pregnant woman, advise mother of fetal risk and ensure treatment availability. Administer methadone according to treatment standards for detoxification and maintenance of opioid dependence .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)
Addiction, abuse, and misuse, leading to overdose and death has been reported. Before prescribing, assess the patient's risk and watch for signs of the development of these behaviors. Serious and fatal respiratory depression may occur. Monitor for respiratory depression, especially when beginning treatment or increasing dose. QT interval prolongation and serious arrhythmias, including torsades de pointes, have occurred during treatment, especially when patients are given large, multiple daily doses. Monitor patients with risk factors for development of prolonged QT interval. Accidental ingestion can result in a fatal overdose, especially in children. Life-threatening neonatal withdrawal syndrome is expected when methadone hydrochloride is used during pregnancy. If methadone hydrochloride must be used during pregnancy, advise the patient of the risk and ensure that treatment will be available to the infant. Concomitant use of cytochrome P450 inhibitors or discontinuation of cytochrome P450 inhibitors can cause a fatal methadone hydrochloride overdose; patients should be monitored for sedation and respiratory depression. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation. 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 .
Commonly used brand name(s)
In the U.S.
- Diskets Dispersible
- Methadone HCl Intensol
Available Dosage Forms:
- Tablet for Suspension
Therapeutic Class: Analgesic
Chemical Class: Opioid
Uses For Methadone HCl Intensol
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 is an opioid (narcotic) analgesic (pain medicine). It acts on the nervous system to relieve pain.
This medicine is available only with your doctor's prescription.
Before Using Methadone HCl Intensol
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:
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.
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.
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.
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.
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 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.
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.
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Chloral Hydrate
- Methylene Blue
- Morphine Sulfate Liposome
- Nitrous Oxide
- Opium Alkaloids
- Peginterferon Alfa-2b
- Sodium Oxybate
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- St John's Wort
- Tolonium Chloride
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.
- Peginterferon Alfa-2a
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 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:
- Alcohol abuse, or history of or
- Brain tumor or
- Breathing or lung problems (eg, chronic obstructive pulmonary disease [COPD], cor pulmonale, hypercapnia, hypoxia, apnea) or
- Depression, history of or
- Drug dependence, especially narcotic abuse or dependence, 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.
- 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), severe or
- Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.
Proper Use of methadone
This section provides information on the proper use of a number of products that contain methadone. It may not be specific to Methadone HCl Intensol. Please read with care.
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.
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.
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 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 pain:
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.
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.
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.
Precautions While Using Methadone HCl Intensol
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 within the past 14 days.
This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you 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 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 (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 this medicine 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 this medicine 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 this medicine. The results of some tests may be affected by this medicine.
This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, 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 neonatal withdrawal syndrome in your newborn child. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.
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.
Methadone HCl Intensol 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
- coughing that sometimes produces a pink frothy sputum
- decreased urine output
- difficult or troubled breathing
- difficult, fast, noisy breathing, sometimes with wheezing
- difficulty with swallowing
- dilated neck veins
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- extreme fatigue
- fast, slow, or irregular heartbeat
- hives, itching, or skin rash
- increased sweating
- increased thirst
- irregular heartbeat
- irregular, fast or slow, or shallow breathing
- loss of appetite
- muscle pain or cramps
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- 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
- swelling of the face, fingers, feet, or lower legs
- trouble sleeping
- trouble urinating
- 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
- blurred or loss of vision
- confusion about identity, place, and time
- 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
- 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
- stopping of menstrual bleeding
- tunnel vision
- weight changes
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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