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Generic name: Methadone hydrochloride Dosage Methadone tablets strengths tablet Drug class: Narcotic analgesics. Medically reviewed by Drugs. Last updated on Sep 1, 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. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.
Healthcare providers are strongly encouraged to. 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. 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 Methadone tablets strengths receiving doses commonly used for maintenance treatment of opioid addiction. 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 concomitant use of Methadone hydrochloride tablets with all cytochrome P 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 P 3A4 2B6, 2C19, or 2C9 inducers may also result in an increase in Methadone plasma concentration. Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs Methadone tablets strengths subject to the conditions for distribution and use required under 42 CFR 8.
Code of Federal Regulations, Title 42, Sec 8 : Methadone products when Methadone tablets strengths for the treatment of opioid addiction in detoxification or maintenance programs, shall be dispensed only by opioid treatment programs and agencies, practitioners or institutions by formal Methadone tablets strengths with the program sponsor certified by the Substance Abuse and Mental Health Services Administration and approved by the deated state authority.
Certified treatment programs shall dispense and use Methadone in oral form only and according to the treatment requirements stipulated in the Federal Opioid Treatment Standards 42 CFR 8. See below for important regulatory exceptions to the general requirement for certification to provide opioid agonist treatment.
Failure to abide by the requirements in these regulations may result in criminal prosecution, seizure of the drug supply, revocation of the program approval, and injunction precluding operation of the program. Methadone hydrochloride tablets should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Consider the following important factors that differentiate Methadone from other opioid analgesics:. Conversion from Other Oral Opioids to Methadone Hydrochloride Tablets : Discontinue all other around-the-clock opioid drugs when Methadone hydrochloride tablets therapy is initiated.
Deaths have occurred in opioid-tolerant patients during conversion to Methadone. The potency of Methadone relative to other opioid analgesics is nonlinear and increases with increasing dose. Table 1 provides an estimated conversion factor for use when converting patients from another opioid to Methadone. Because of the high inter-patient variability in absorption, metabolism, and relative potency, it is critical to avoid overestimating the Methadone dose which can lead to fatal respiratory depression.
Always round the dose down, if necessary, to the appropriate Methadone hydrochloride tablets strength s available. Sum the total daily dose of the opioid in this case, Morphine Extended Release Tablets 50 mg twice daily. Calculate the approximate equivalent dose of Methadone hydrochloride tablets based on the total daily dose of Morphine using Table 1. Calculate the approximate starting dose of Methadone hydrochloride tablets to be given every 12 hours.
Round down, if necessary, to the appropriate Methadone hydrochloride tablets strengths available. Close observation and frequent titration are warranted until pain management is Methadone tablets strengths on the new opioid. Conversion from Parenteral Methadone to Methadone Hydrochloride Tablets : Use a conversion ratio of mg for parenteral to oral Methadone e. Individually titrate Methadone hydrochloride tablets to a dose that provides adequate analgesia and minimizes adverse reactions. During chronic therapy, periodically reassess the continued need for the use of opioid analgesics.
Patients who experience breakthrough pain may require a dose increase of Methadone hydrochloride tablets, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the Methadone hydrochloride tablets dosage. Because of individual variability in the pharmacokinetic profile i.
However, because of this high variability, some patients may require substantially longer periods between Methadone tablets strengths increases up to 12 days. Monitor patients closely for the development of potentially life-threatening adverse reactions e. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions. Do not abruptly discontinue Methadone hydrochloride tablets in patients who may be physically dependent on opioids.
Rapid discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse.
Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances. Methadone tablets strengths a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient taking Methadone hydrochloride tablets, there are a variety of factors that should be considered, including the dose of Methadone hydrochloride tablets the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.
It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule Methadone tablets strengths follow-up plan so that patient and provider goals and expectations are clear and realistic. When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation Methadone tablets strengths treatment of the substance use disorder. Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder.
Complex patients with co-morbid pain and substance use disorders may benefit from referral to a specialist. There are no standard opioid tapering schedules that are suitable for all patients. Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually.
For patients on Methadone hydrochloride tablets who are physically opioid-dependent, initiate the taper by a small enough increment e. Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper. It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper. Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge. Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other s and symptoms also may develop, including irritability, anxiety, backache, t pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the dose, and then proceed with a slower taper. In addition, monitor patients for any changes in mood, emergence of suicidal thoughts, or use of other substances.
For detoxification and maintenance of opioid dependence Methadone should be administered in accordance with the treatment standards cited in 42 CFR Section 8. Administer the initial Methadone dose under supervision, when there are no s of sedation Methadone tablets strengths intoxication, and the patient shows symptoms of withdrawal. An initial single dose of 20 to 30 mg of Methadone hydrochloride tablets will often be sufficient to suppress withdrawal symptoms. The initial dose should not exceed 30 mg.
To make same-day dosing adjustments, have the patient wait 2 to 4 hours for further evaluation, when peak levels have been reached. Provide an additional 5 to 10 mg of Methadone hydrochloride tablets if withdrawal symptoms have not been suppressed or if symptoms reappear.
The total daily dose of Methadone hydrochloride tablets on the first day of treatment should not ordinarily exceed 40 mg. Adjust the dose over the first week of treatment based on control of withdrawal symptoms at the time of expected peak activity e. When adjusting the dose, keep in mind that Methadone levels will accumulate over the first several days of dosing; deaths have occurred in early treatment due to the cumulative effects. Use lower initial doses for patients whose tolerance is expected to be low at treatment entry.
Any patient who has not taken opioids for more than 5 days may no longer be tolerant. Do not determine initial doses based on treatment episodes or dollars spent per day on illicit drug use. During the induction phase of Methadone maintenance treatment, patients are being withdrawn from opioids and may have opioid withdrawal symptoms. Monitor patients for s and symptoms of opioid withdrawal including: lacrimation, rhinorrhea, sneezing, yawning, excessive perspiration, goose-flesh, fever, chilling alternating with flushing, restlessness, irritability, weakness, anxiety, depression, dilated pupils, tremors, tachycardia, abdominal cramps, body aches, involuntary twitching and kicking movements, anorexia, nausea, vomiting, diarrhea, intestinal spasms, and weight loss and consider dose adjustment as indicated.
Short-term Detoxification. For a brief course of stabilization followed by a period of medically Methadone tablets strengths withdrawal, titrate the patient to a total daily dose of about 40 mg in divided doses to achieve an adequate stabilizing level. After 2 to 3 days of stabilization, gradually decrease the dose of Methadone hydrochloride tablets. Decrease the dose of Methadone hydrochloride tablets on a daily basis or at 2-day intervals, keeping the amount of Methadone hydrochloride tablets sufficient to keep withdrawal symptoms at a tolerable level.
Ambulatory patients may need a slower schedule. Titrate patients in maintenance treatment to a dose that prevents opioid withdrawal symptoms for 24 hours, reduces Methadone tablets strengths hunger or craving, and blocks or attenuates the euphoric effects of self-administered opioids, ensuring that Methadone tablets strengths patient is tolerant to the sedative effects of Methadone. During prolonged administration of Methadone, monitor patients for persistent constipation and manage accordingly.
There is considerable variability in the appropriate rate of Methadone taper in patients choosing medically supervised withdrawal from Methadone treatment.
Apprise patients of the high risk of relapse to illicit drug use associated with discontinuation of Methadone maintenance treatment. Opioid withdrawal symptoms have been associated with an increased risk of relapse to illicit drug use insusceptible patients. Patients in Methadone maintenance treatment for opioid dependence who experience physical trauma, postoperative pain or other acute pain cannot be expected to derive analgesia from their existing dose of Methadone.
Such patients should be administered analgesics, including opioids, in doses that would otherwise be indicated for non-Methadone-treated patients with similar painful conditions. Methadone clearance may be increased during pregnancy. Methadone hydrochloride tablets contain Methadone, a Schedule II controlled substance. As an opioid, Methadone hydrochloride tablets exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Methadone hydrochloride tablets.
Addiction Methadone tablets strengths occur at recommended doses and if the drug is misused or abused. Risks are increased in patients with a personal or family history of substance abuse including drug or alcohol addiction or abuse or mental illness e. The potential for these risks should not, however, prevent the prescribing Methadone tablets strengths Methadone hydrochloride tablets for the proper management of pain in any given patient.
Patients at increased risk may be Methadone tablets strengths opioids such as Methadone hydrochloride tablets, but use in such patients necessitates intensive counseling about the risks and proper use of Methadone hydrochloride tablets along with the intensive monitoring for s of addiction, abuse, and misuse.
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing Methadone hydrochloride tablets. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. Healthcare providers are strongly encouraged to do all of the following:. The FDA Blueprint can be found at www. Serious, life-threatening, or fatal respiratory depression has been reported with the use of Methadone, even when used as recommended.
The peak respiratory depressant effect of Methadone occurs later, and persists longer than the peak analgesic effect. Respiratory depression from opioid use, if not immediately recognized and treated, may lead to respiratory arrest and death. Carbon dioxide CO 2 retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.
While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Methadone hydrochloride tablets, the risk is greatest during the initiation of therapy or following a dosage increase.Methadone tablets strengths
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