DOLOPHINE PRESCRIBING INFORMATION PDF

For maintenance treatment of opioid addiction heroin or other morphine-like drugs , in conjunction with appropriate social and medical services. Adult: See full labeling. Particular vigilance is necessary during treatment initiation, during conversion from one opioid to another, and during dose titration. Peak respiratory depressant effects typically occur later, and persist longer than peak analgesic effects.

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Divide the total daily methadone dose derived from the table above to reflect the intended dosing schedule i. Always round the dose down, if necessary, to the appropriate Dolophine Tablets strength s available. Round down, if necessary, to the appropriate Dolophine Tablets strengths available.

Conversion from Parenteral Methadone to Dolophine Tablets: Use a conversion ratio of mg for parenteral to oral methadone e. Titration and Maintenance of Therapy for Pain Individually titrate Dolophine Tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving Dolophine Tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see Warnings and Precautions 5.

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 Dolophine 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 Dolophine 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 dose 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. 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. It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and 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 and 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. Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually. For patients on Dolophine 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. 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 signs and symptoms also may develop, including irritability, anxiety, backache, joint 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 previous 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. A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic [see Warnings and Precautions 5.

Administer the initial methadone dose under supervision, when there are no signs of sedation or intoxication, and the patient shows symptoms of withdrawal. An initial single dose of 20 to 30 mg of Dolophine 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 Dolophine Tablets if withdrawal symptoms have not been suppressed or if symptoms reappear.

The total daily dose of Dolophine 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 previous 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 signs 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 supervised 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 Dolophine Tablets. Decrease the dose of Dolophine Tablets on a daily basis or at 2-day intervals, keeping the amount of Dolophine Tablets sufficient to keep withdrawal symptoms at a tolerable level.

Ambulatory patients may need a slower schedule. Titration and Maintenance Treatment of Opioid Dependence Titrate patients in maintenance treatment to a dose that prevents opioid withdrawal symptoms for 24 hours, reduces drug hunger or craving, and blocks or attenuates the euphoric effects of self-administered opioids, ensuring that the patient is tolerant to the sedative effects of methadone.

During prolonged administration of methadone, monitor patients for persistent constipation and manage accordingly. Medically Supervised Withdrawal after a Period of Maintenance Treatment for Opioid Addiction 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 in susceptible patients. Considerations for Management of Acute Pain during Methadone Maintenance Treatment 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. Dosage Adjustment during Pregnancy Methadone clearance may be increased during pregnancy. Methadone should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations 8. As an opioid, Dolophine Tablets expose users to the risks of addiction, abuse, and misuse.

As long-acting opioids such as Dolophine Tablets have pharmacological effects over an extended period of time, there is a greater risk for overdose and death [see Drug Abuse and Dependence 9 ]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Dolophine Tablets.

Addiction can 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 of Dolophine Tablets for the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as Dolophine Tablets, but use in such patients necessitates intensive counseling about the risks and proper use of Dolophine Tablets along with the intensive monitoring for signs of addiction, abuse, and misuse.

Abuse or misuse of Dolophine Tablets by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the methadone and can result in overdose and death [see Overdosage 10 ]. Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Consider these risks when prescribing or dispensing Dolophine Tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see Patient Counseling Information 17 ].

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. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. The FDA Blueprint can be found at www. Life-Threatening Respiratory Depression 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 CO2 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 Dolophine Tablets, the risk is greatest during the initiation of therapy or following a dosage increase.

The peak respiratory depressant effect of methadone occurs later, and persists longer than the peak analgesic effect, especially during the initial dosing period. Monitor patients closely for respiratory depression, when initiating therapy with Dolophine Tablets and following dose increases.

To reduce the risk of respiratory depression, proper dosing and titration of Dolophine Tablets are essential [see Dosage and Administration 2.

Overestimating the Dolophine Tablets dosage when converting patients from another opioid product can result in fatal overdose with the first dose.

Accidental ingestion of even one dose of Dolophine Tablets, especially by children, can result in respiratory depression and death due to an overdose of methadone. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper [see Dosage and Administration 2.

Life-Threatening QT Prolongation Cases of QT interval prolongation and serious arrhythmia torsades de pointes have been observed 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. However, the evidence strongly suggests that methadone possesses the potential for adverse cardiac conduction effects in some patients.

The effects of methadone on the QT interval have been confirmed in in vivo laboratory studies, and methadone has been shown to inhibit cardiac potassium channels in in vitro studies. Closely monitor patients with risk factors for development of prolonged QT interval e. QT prolongation has also been reported in patients with no prior cardiac history who have received high doses of methadone.

Evaluate patients developing QT prolongation while on methadone treatment for the presence of modifiable risk factors, such as concomitant medications with cardiac effects, drugs that might cause electrolyte abnormalities, and drugs that might act as inhibitors of methadone metabolism. Only initiate Dolophine Tablets therapy for pain in patients for whom the anticipated benefit outweighs the risk of QT prolongation and development of dysrhythmias that have been reported with high doses of methadone.

The use of methadone in patients already known to have a prolonged QT interval has not been systematically studied. Neonatal Opioid Withdrawal Syndrome Neonatal opioid withdrawal syndrome NOWS is an expected and treatable outcome of prolonged use of opioids during pregnancy, whether that use is medically-authorized or illicit. Unlike opioid withdrawal syndrome in adults, NOWS may be life-threatening if not recognized and treated in the neonate.

Advise the patient of the risk of NOWS so that appropriate planning for management of the neonate can occur. Healthcare professionals should observe newborns for signs of NOWS and manage accordingly [see Specific Populations 8. NOWS can result from in utero exposure to opioids regardless of the source. Therefore, prescribers should discuss the importance and benefits of management of opioid addiction throughout pregnancy.

For Patients Being Treated for Pain: Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [see Drug Interactions 7 ].

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Sasar Start these patients on lower doses and titrate slowly while carefully monitoring for signs of respiratory and CNS depression. Infants born to narcotic-addicted women treated with methadone during pregnancy have been found to have decreased fetal growth with reduced birth weight, length, or head circumference. Monitor patients for symptoms of opioid-induced endocrinopathy. Whenever possible, pain management should be colophine with health care providers before any surgery or dental work takes place. Methadone should be reserved for patients in whom alternative treatment options e. Local tissue reactions may occur with SC use. It is important to note respiratory depressant effects occur later and persist longer than peak analgesic effects.

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Dolophine Side Effects

Note: This document contains side effect information about methadone. Some of the dosage forms listed on this page may not apply to the brand name Dolophine. For the Consumer Applies to methadone : oral solution, oral tablet, oral tablet for suspension Other dosage forms: Warning 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. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of methadone hydrochloride tablets.

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