DOLOPHINE PRESCRIBING INFORMATION PDF

Substances Authority for information on how to prevent and detect abuse or diversion of this product. Interactions with other CNS Depressants. Medscape – Detoxification, pain-specific dosing for Methadose, Dolophine opioids; Substantial interpatient variability, see prescribing information for guidance. Find patient medical information for Dolophine Oral on WebMD including its uses , side effects and safety, interactions, pictures, warnings and user ratings.

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Send the page ” ” to a friend, relative, colleague or yourself. We do not record any personal information entered above. Methadone is associated with an increased risk for QT prolongation and torsade de pointes TdP. Although the risk of QT prolongation appears to be dose-relatedwith most incidences of QT prolongation and torsade de pointes occurring in patients receiving large doses for pain management i.

A public health advisory was issued concerning cardiac-related deaths, which have been reported during initiation of methadone treatment as well as during conversion to methadone from other opiates. Extreme caution is recommended during initiation of treatment, conversion from one opiate to another, and dose titrations.

An understanding of methadone pharmacokinetic parameters is critical. In addition to slowing the rate of cardiac repolarization thus lengthening the QT interval, methadone may produce cholinergic side effects by stimulating medullary vagal nuclei causing bradycardia and induce the release of histamine causing peripheral vasodilation. Use methadone with extreme caution, if at all, in patients whose ability to maintain blood pressure has already been compromised by hypovolemia or administration of certain CNS depressant medications such as phenothiazines or general anesthetics.

Monitor patients for hypotension at the initiation of therapy and during dose titration. These effects can cause problems in patients with cardiac disease e. Methadone should be used cautiously in patients with cardiac arrhythmias, hypokalemia, hypomagnesemia, hypotension, hypovolemia, or orthostatic hypotension.

Opiate agonists can induce vasovagal syncope or orthostatic hypotension. Use methadone with caution in patients with cardiac disease or other conditions that may increase the risk of QT prolongation including heart failure, bradycardia, myocardial infarction, hypertension, coronary artery disease, hypocalcemia, or in patients receiving medications known to cause electrolyte imbalances.

Females, elderly patients, patients with diabetes mellitus, thyroid disease, malnutrition, a history of alcohol abuse, or hepatic impairment may also be at increased risk for QT prolongation. A clinical guideline for cardiac safety with methadone treatment recommends that prescribers: Drugs known to prolong the QT interval, potentiate hypokalemia, or reduce methadone elimination should be coadministered with a careful assessment of risks versus benefits.

Methadone is an opioid agonist and therefore has abuse potential and risk of fatal overdose from respiratory failure. Addiction may occur in patients who obtain methadone illicitly or in those appropriately prescribed the drug. The risk of addiction in any individual is unknown. However, patients with mental illness e. Assess patients for risks of addiction, abuse, or misuse before drug initiation, and monitor patients who receive opioids routinely for development of these behaviors or conditions.

A potential risk of abuse should not preclude appropriate pain management in any patient, but requires more intensive counseling and monitoring. Abuse and addiction are separate and distinct from physical dependence and tolerance; patients with addiction may presribing exhibit tolerance and symptoms of physical dependence. The misuse of methadone by crushing, chewing, snorting, or injecting the dissolved product can result in overdose and death. To discourage abuse, the smallest appropriate quantity of methadone should be dispensed, and proper disposal instructions for unused drug should be given to patients.

Additionally, avoid coadministration with other CNS depressants when possible as this significantly increases the risk for respiratory depression, low blood pressure, doloophine death.

Methadone Dolophine, Methadose – Treatment – Hepatitis C Online

Reserve concomitant use of these drugs for patients in whom alternative treatment options are inadequate. If concurrent use is necessary, use the lowest effective doses and minimum treatment durations possible and monitor patients closely 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. Careful monitoring is also required with concomitant use of drugs that may inhibit or induce the metabolism of methadone; an increase in methadone concentrations could cause potentially fatal respiratory depression.

The potential risk of serious adverse effects with concomitant use of methadone and other CNS depressants should not preclude the appropriate treatment of opioid addiction with methadone, but requires more intensive counseling and monitoring. Methadone may significantly decrease respiratory drive and cause hypoventilation.

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Respiratory depression, if left untreated, may cause respiratory arrest and death. Symptoms of respiratory depression include a reduced urge to breathe, a decreased respiratory rate, or deep breaths separated by long pauses a “sighing” breathing pattern.

Serious or fatal respiratory depression can occur at any time during the use of methadone; however, the risk is greatest during the first 24 to 72 hours after therapy initiation or dose titration.

It is important to note respiratory depressant effects occur later and persist longer than peak analgesic effects. Extreme caution is recommended during initiation of therapy, conversion from 1 opioid to another, and dose titrations; dose overestimation may lead to fatal overdose.

Only healthcare professionals who are knowledgeable about methadone pharmacokinetics and pharmacodynamics should prescribe the drug, particularly during conversions to methadone from other opioids and in the use of methadone for chronic pain. Methadone should be reserved for patients in whom alternative treatment options e.

Do not use as a “prn” or “as needed” analgesic, for acute pain, or if the pain is mild or not expected to persist for an extended period of time. In patients with pulmonary disease such as chronic obstructive pulmonary disease COPDcor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, respiratory insufficiency, upper airway obstruction, or preexisting respiratory depression, it is recommended that non-opioid analgesics be considered as alternatives to methadone, as even usual therapeutic doses may decrease respiratory drive and cause apnea in these patient populations.

Extreme caution should also be used in patients with chronic asthma, kyphoscoliosis a type of scoliosishypoxemia, or paralysis of the phrenic nerve. Patients with cachexia, debilitation, severe obesity, or sleep apnea are at an increased risk for doloophine development of respiratory depression associated perscribing methadone; monitor these patients closely. Respiratory depression may persist for a significant period of time after discontinuation of methadone and patients require close monitoring until their respiratory rate has stabilized.

Management of respiratory depression should include observation, necessary supportive measures, and careful use of an opioid antagonist e. There are no adequate and well-controlled studies with methadone in pregnant women. Use methadone for severe pain during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Medical withdrawal of pregnant, opioid-dependent women from methadone is not recommended.

When methadone is used during pregnancy as part of a supervised, therapeutic regimen, it is unlikely to pose substantial teratogenic risk. Pregnant women in methadone maintenance programs may have reduced incidence of obstetric and fetal complications and neonatal morbidity and mortality when compared to women using illicit drugs.

Untreated opioid addiction in pregnancy is associated with adverse obstetrical outcomes and risk of continued or relapsing illicit opioid use. Consider these risks in pregnant women treated with methadone for maintenance treatment of opioid addiction. No increased risk of miscarriage in dolohine second trimester or premature delivery in the third trimester was noted by a retrospective review of data from opioid-dependent women.

Benefits of methadone therapy during pregnancy include assisting women staying free of heroin or other opioids, increasing prenatal care, lessening the possibility of fetal death, and reducing the risk of HIV and hepatitis infection. Infants born to narcotic-addicted women treated with methadone during pregnancy have dolophije found to have decreased fetal growth with reduced birth weight, length, or head circumference.

The growth deficit does not appear to persist into later childhood. Children born to mothers who received methadone during pregnancy demonstrate mild but persistent performance deficits on psychometric and behavioral tests and may have an increased risk of visual development anomalies.

Administration of methadone to pregnant animals during organogenesis through lactation resulted in decreased litter size, increased pup mortality, decreased pup body weights, developmental delays, and long-term neurochemical changes in the brain which correlate with altered behavioral responses at exposures comparable to and less than the human daily dose of mg.

Methadone clearance may be increased during pregnancy. The methadone dose or interval may need to be increased as the pregnancy progresses due to changes in plasma volume and renal blood flow; due to an increased metabolism of methadone during pregnancy, close monitoring of pregnant women is recommended.

Methadone is not recommended for analgesia during labor and obstetric informmation due to its long duration of action and potential for respiratory depression in the newborn.

Women maintained on methadone require appropriate obstetric pain management, as methadone maintenance does not provide analgesia.

Prolonged maternal use of opioids, such as methadone, during pregnancy may result in neonatal opioid withdrawal dolphine NOWS. This syndrome can be life-threatening. Severe symptoms may require pharmacologic therapy managed by clinicians familiar with neonatal opioid withdrawal. Monitor the neonate for withdrawal symptoms including irritability, hyperactivity, abnormal sleep pattern, high-pitched crying, tremor, vomiting, diarrhea, and failure to gain weight. Onset, duration, and severity of opioid withdrawal may vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination by the newborn.

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All forms of methadone have the potential for overdose or poisoning. Methadone is a long-acting opioid that should only be used as an analgesic in patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment.

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When used for analgesia, methadone should be reserved for use in patients for whom alternative treatment options e. Due to the risk of respiratory depression, use methadone with caution in opioid-naive patients. Patients tolerant to other opioids may be incompletely tolerant to methadone; use caution when converting patients from other opioids to methadone.

Special care should be taken to keep it out of the reach of patients for whom it was not prescribed, particularly pediatric patients, as accidental exposure may cause fatal overdose. Methadone therapy requires an experienced clinician skilled in the use of potent opioids for chronic pain or opioid addiction.

Outpatient maintenance and outpatient detoxification treatment may be provided only by Opioid Treatment Programs OTPs certified by the U. If clinically indicated, patients may be enrolled directly into a maintenance program without first attempting detoxification since the purpose of the maintenance program is to provide a stable dose of methadone as a substitute for illicit opiate use.

Maintenance should be continued as long as desired by the patient and as long as continued benefit is derived from treatment. During chronic administration of methadone, monitor patients for persistent constipation and maintain an effective bowel regimen. Maintenance treatments are effective in retaining patients in treatment and suppressing opiate use, with or without structured psychosocial services. An exception may be made for the maintenance treatment of a patient with concurrent opioid addiction who is hospitalized for conditions other than opioid addiction and who requires temporary maintenance during the critical period of their stay, or of a patient whose enrollment has been verified in a program which has been certified for maintenance treatment with methadone.

A phenylheptylamine synthetic opiate agonist; is structurally unrelated to morphine Used in medically supervised opiate withdrawal and maintenance programs; effective for the relief of severe or chronic pain For the treatment of opiate dependence, prescriber must register and comply with the Narcotic Addict Treatment Act NATA [21USC g ].

Medical withdrawal from methadone should be done in decrements as tolerated by the patient on a daily basis or at 2-day intervals. The dose should be sufficient to keep withdrawal symptoms at a tolerable level. In ambulatory patients, a somewhat slower schedule may be required. Patients should be allowed to discontinue withdrawal at anytime, for any reason, without feelings of guilt. They should then be placed into a methadone maintenance program at an appropriate dose. Any decrease in methadone dosage could precipitate a relapse to drug use.

Methadone use is preferable to the use of illegal street drugs. Medical withdrawal of methadone maintenance is generally not recommended during pregnancy.

If required, methadone withdrawal is done in decrements of 2 to 2. This should be done in conjunction with an obstetrician who can monitor the effects on the fetus. Additional doses of 5 to 10 mg of methadone PO may be given 2 to 4 hours after the initial dose if withdrawal symptoms have not been suppressed or if symptoms reappear.

The total daily oral dose on Day 1 should not ordinarily exceed 40 mg. Dosage adjustments on subsequent days should be based on withdrawal symptom control at the time of expected peak methadone activity 2 to 4 hours after dosing.

Due to the extended half-life of methadone, it may take up to 5 days to achieve a steady-state dose that controls symptoms of opiate withdrawal.

Prior to achieving steady state, adequate total daily doses may not hold patients for a full 24 hours. Deaths have occurred in early treatment due to the cumulative effects of methadone. The stabilizing dose is continued for 2 to 3 days.

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