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Methadon HCl Sandoz Uses

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Methadon HCl Sandoz is used to treat moderate to severe pain when around-the-clock pain relief is needed for a long period of time. Methadon HCl Sandoz should not be used to treat pain that you only have once in a while or 'as needed'. Methadon HCl Sandoz is also used together with medical supervision and counseling to treat opioid addiction eg, heroin or other morphine-like drugs. Methadon HCl Sandoz is an opioid narcotic analgesic pain medicine. It acts on the central nervous system CNS to relieve pain. Methadon HCl Sandoz is indicated for the: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations Of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids, reserve Methadon HCl Sandoz for use in patients for whom alternative analgesic treatment options e. Methadon HCl Sandoz is not indicated as an as-needed prn analgesic. Detoxification treatment of opioid addiction heroin or other morphine-like drugs. Maintenance treatment of opioid addiction heroin or other morphine-like drugs , in conjunction with appropriate social and medical services. Conditions For Distribution And Use Of Methadon HCl Sandoz Products For The Treatment Of Opioid Addiction Code of Federal Regulations, Title 42, Sec 8 Methadon HCl Sandoz products when used 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 agreement with the program sponsor certified by the Substance Abuse and Mental Health Services Administration and approved by the designated state authority. 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. During an emergency period of no longer than 3 days while definitive care for the addiction is being sought in an appropriately licensed facility pursuant to 21CFR Use Methadon HCl Sandoz concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions. Take Methadon HCl Sandoz concentrate by mouth with or without food. Methadon HCl Sandoz concentrate is for oral use only and must not be injected or snorted. Methadon HCl Sandoz concentrate must be administered under close medical supervision. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. Methadon HCl Sandoz concentrate must be mixed with water or other liquid before you use it. Do not suddenly stop taking Methadon HCl Sandoz concentrate. You may have an increased risk of withdrawal symptoms eg, nausea, vomiting, diarrhea, anxiety, shivering. If you need to stop Methadon HCl Sandoz concentrate, your doctor will gradually lower your dose. Methadon HCl Sandoz concentrate works best if it is taken at the same time s each day. Do not miss any doses. If you miss a dose of Methadon HCl Sandoz concentrate, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than your prescribed dose in 24 hours. Ask your health care provider any questions you may have about how to use Methadon HCl Sandoz concentrate. A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of morphine. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Methadon HCl Sandoz is also used as part of the treatment of dependence on opioid drugs, although prolonged use of Methadon HCl Sandoz itself may result in dependence. From Martindale, The Extra Pharmacopoeia, 30th ed, p A high degree of opioid tolerance does not eliminate the possibility of Methadon HCl Sandoz overdose, iatrogenic or otherwise. Deaths have been reported during conversion to Methadon HCl Sandoz from chronic, high-dose treatment with other opioid agonists and during initiation of Methadon HCl Sandoz treatment of addiction in subjects previously abusing high doses of other opioid agonists. There is high interpatient variability in absorption, metabolism, and relative analgesic potency. Population-based equianalgesic conversion ratios between Methadon HCl Sandoz and other opioids are not accurate when applied to individuals. The duration of analgesic action of Methadon HCl Sandoz is 4 to 8 hours based on single-dose studies but the plasma elimination half-life is 8 to 59 hours. With repeated dosing, Methadon HCl Sandoz is retained in the liver and then slowly released, prolonging the duration of potential toxicity. Steady-state plasma concentrations, and full analgesic effects, are not attained until 3 to 5 days after initiation of dosing. Methadon HCl Sandoz has a narrow therapeutic index, especially when combined with other drugs. Methadon HCl Sandoz is administered at a frequency of every 8 to 12 hours. To maintain adequate analgesia, more frequent administration may be required. Monitor patients closely for signs of respiratory and central nervous system depression. Deaths have occurred in opioid-tolerant patients during conversion to Methadon HCl Sandoz. Conversion ratios in many commonly used equianalgesic dosing tables are based on single-dose comparisons in patients not tolerant to the effects of opioid and do not apply in the setting of conversion of opioid tolerant patients to Methadon HCl Sandoz for chronic use. In the case of a single-dose administration, the onset, duration, and potency of analgesic action of Methadon HCl Sandoz are comparable to those of morphine. Incomplete cross tolerance can result in greater than expected toxicity. In addition, with repeated dosing, the potency of Methadon HCl Sandoz increases due to systemic accumulation. The conversion ratio between Methadon HCl Sandoz and other opioids varies dramatically depending on baseline opioid morphine equivalent use as shown in the table below. The dose conversion scheme below Table 1 is derived from various consensus guidelines for converting chronic pain patients to Methadon HCl Sandoz from morphine. Consult published conversion guidelines to determine the equivalent morphine dose for patients converting from other opioids. Equianalgesic Methadon HCl Sandoz dosing varies not only between patients, but also within the same patient, depending on baseline morphine or other opioid dose. Table 1 has been included in order to illustrate this concept and to provide a recommendation for a starting point for opioid conversion. Continually re-evaluate patients receiving Methadon HCl Sandoz to assess the maintenance of pain control and the relative incidence of adverse reactions. During chronic therapy, especially for non-cancer-related pain or pain associated with other terminal illnesses , periodically reassess the continued need for the use of opioid analgesics. If the level of pain increases, attempt to identify the source of increased pain, while adjusting the Methadon HCl Sandoz dose to decrease the level of pain. Because steady-state plasma concentrations are approximated within 24 to 36 hours, Methadon HCl Sandoz dosage adjustments may be done every 1 to 2 days. Patients who experience breakthrough pain may require dosage adjustment or rescue medication with a small dose of an immediate-release medication. If signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions. The endpoint of titration is achievement of adequate pain relief, balanced against tolerability of opioid adverse reactions. If a patient develops intolerable opioid related adverse reactions, the Methadon HCl Sandoz dose, or dosing interval, may need to be adjusted. Discontinuation of Methadon HCl Sandoz for Pain When a patient no longer requires therapy with Methadon HCl Sandoz for pain, use a gradual downward titration, of the dose every two to four days, to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue Methadon HCl Sandoz. An initial single dose of 20 to 30 mg of Methadon HCl Sandoz 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 Methadon HCl Sandoz if withdrawal symptoms have not been suppressed or if symptoms reappear. The total daily dose of Methadon HCl Sandoz 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 Methadon HCl Sandoz 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. 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 Methadon HCl Sandoz. Decrease the dose of Methadon HCl Sandoz on a daily basis or at 2-day intervals, keeping the amount of Methadon HCl Sandoz sufficient to keep withdrawal symptoms at a tolerable level. Ambulatory patients may need a slower schedule. Titration and Maintenance Treatment of Opioid Dependence Detoxification 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 Methadon HCl Sandoz. Apprise patients of the high risk of relapse to illicit drug use associated with discontinuation of Methadon HCl Sandoz maintenance treatment. Opioid withdrawal symptoms have been associated with an increased risk of relapse to illicit drug use in susceptible patients. Such patients should be administered analgesics, including opioids, in doses that would otherwise be indicated for non-Methadon HCl Sandoz-treated patients with similar painful conditions. Methadon HCl Sandoz should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Methadon HCl Sandoz may be targeted for theft and diversion by criminals. Keep tightly closed. Dispense in a tight, light-resistant container. Distributed by: Mallinckrodt, Inc. Coadministration of Methadon HCl Sandoz with CYP inducers of these enzymes may result in a more rapid metabolism and potential for decreased effects of Methadon HCl Sandoz, whereas administration with CYP inhibitors may reduce metabolism and potentiate methadones effects. Therefore, drugs administered concomitantly with Methadon HCl Sandoz should be evaluated for interaction potential; clinicians are advised to evaluate individual response to drug therapy. Examples of such agents are naloxone, naltrexone, pentazocine, nalbuphine, butorphanol, and buprenorphine. Methadon HCl Sandoz M-maintained patients beginning treatment with these antiretroviral drugs should be monitored for evidence of withdrawal effects and Methadon HCl Sandoz dose should be adjusted accordingly. Didanosine and Stavudine - Experimental evidence demonstrated that Methadon HCl Sandoz decreased the AUC and peak levels for didanosine and stavudine, with a more significant decrease for didanosine. Methadon HCl Sandoz M disposition was not substantially altered. Zidovudine - Experimental evidence demonstrated that Methadon HCl Sandoz increased the area under the concentration-time curve AUC of zidovudine which could result in toxic effects. The following drug interactions were reported following coadministration of Methadon HCl Sandoz with inducers of cytochrome P enzymes: Rifampin - In patients well-stabilized on Methadon HCl Sandoz, concomitant administration of rifampin resulted in a marked reduction in serum Methadon HCl Sandoz levels and a concurrent appearance of withdrawal symptoms. Phenytoin - In a pharmacokinetic study with patients on Methadon HCl Sandoz maintenance therapy, phenytoin administration mg b. Upon discontinuation of phenytoin, the incidence of withdrawal symptoms decreased and Methadon HCl Sandoz exposure increased to a level comparable to that prior to phenytoin administration. The expected clinical results would be increased or prolonged opioid effects. Some selective serotonin reuptake inhibitors SSRIs e. Frequent monitoring for adverse events and toxicity related to Methadon HCl Sandoz is recommended during coadministration. Dose reduction of Methadon HCl Sandoz may be needed. Others Monoamine Oxidase MAO Inhibitors - Therapeutic doses of meperidine have precipitated severe reactions in patients concurrently receiving monoamine oxidase inhibitors or those who have received such agents within 14 days. Similar reactions thus far have not been reported with Methadon HCl Sandoz. However, if the use of Methadon HCl Sandoz is necessary in such patients, a sensitivity test should be performed in which repeated small, incremental doses of Methadon HCl Sandoz are administered over the course of several hours while the patients condition and vital signs are under careful observation. Desipramine - Blood levels of desipramine have increased with concurrent Methadon HCl Sandoz administration. Potentially Arrhythmogenic Agents Extreme caution is necessary when any drug known to have the potential to prolong the QT interval is prescribed in conjunction with Methadon HCl Sandoz. Pharmacodynamic interactions may occur with concomitant use of Methadon HCl Sandoz and potentially arrhythmogenic agents such as class I and III antiarrhythmics, some neuroleptics and tricyclic antidepressants, and calcium channel blockers. Caution should also be exercised when prescribing Methadon HCl Sandoz concomitantly with drugs capable of inducing electrolyte disturbances hypomagnesemia, hypokalemia that may prolong the QT interval. These drugs include diuretics, laxatives, and, in rare cases, mineralocorticoid hormones. Interactions with Alcohol and Drugs of Abuse Methadon HCl Sandoz M may be expected to have additive effects when used in conjunction with alcohol, other opioids or CNS depressants, or with illicit drugs that cause central nervous system depression. Deaths have been reported when Methadon HCl Sandoz has been abused in conjunction with benzodiazepines. Anxiety - Since Methadon HCl Sandoz as used by tolerant patients at a constant maintenance dosage does not act as a tranquilizer, patients who are maintained on this drug will react to life problems and stresses with the same symptoms of anxiety as do other individuals. The physician should not confuse such symptoms with those of narcotic abstinence and should not attempt to treat anxiety by increasing the dose of Methadon HCl Sandoz. The action of Methadon HCl Sandoz in maintenance treatment is limited to the control of narcotic withdrawal symptoms and is ineffective for relief of general anxiety. Acute Pain - Maintenance patients on a stable dose of Methadon HCl Sandoz who experience physical trauma, postoperative pain or other acute pain cannot be expected to derive analgesia from their existing dose of Methadon HCl Sandoz. Presentation of these symptoms have been associated with an increased risk of susceptible patients to relapse to illicit drug use and should be considered when assessing the risks and benefit of Methadon HCl Sandoz use. Tolerance and Physical Dependence Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia in the absence of disease progression or other external factors. Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. If Methadon HCl Sandoz is abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur. The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other 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. In general, chronically administered Methadon HCl Sandoz should not be abruptly discontinued. Special-Risk Patients Methadon HCl Sandoz M should be given with caution and the initial dose reduced in certain patients, such as the elderly and debilitated and those with severe impairment of hepatic or renal function, hypothyroidism, Addisons disease, prostatic hypertrophy, or urethral stricture. The usual precautions appropriate to the use of parenteral opioids should be observed and the possibility of respiratory depression should always be kept in mind. Heroin Withdrawal During the induction phase of Methadon HCl Sandoz maintenance treatment, patients are being withdrawn from heroin and may therefore show typical withdrawal symptoms, which should be differentiated from Methadon HCl Sandoz-induced side effects. They may exhibit some or all of the following signs and symptoms associated with acute withdrawal from heroin or other opiates: lacrimation, rhinorrhea, sneezing, yawning, excessive perspiration, goose-flesh, fever, chilliness 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. The major hazards of Methadon HCl Sandoz are respiratory depression and, to a lesser degree, systemic hypotension. Respiratory arrest, shock, cardiac arrest, and death have occurred. The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients and in those who are not suffering severe pain. In such individuals, lower doses are advisable. However, constipation and sweating often persist. Schedule II opioid substances, which also include hydromorphone, morphine, oxycodone, and oxymorphone, have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Methadon HCl Sandoz, like morphine and other opioids used for analgesia, has the potential for being abused and is subject to criminal diversion. Abuse of Methadon HCl Sandoz poses a risk of overdose and death. This risk is increased with concurrent abuse of Methadon HCl Sandoz with alcohol and other substances. In addition, parenteral drug abuse is commonly associated with transmission of infectious disease such as hepatitis and HIV. Since Methadon HCl Sandoz may be diverted for non-medical use, careful record keeping of ordering and dispensing information, including quantity, frequency, and renewal requests is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. Methadon HCl Sandoz, when used for the treatment of opioid addiction in detoxification or maintenance programs, may be dispensed only by opioid treatment programs certified by the Substance Abuse and Mental Health Services Administration and agencies, practitioners or institutions by formal agreement with the program sponsor. Infants born to mothers physically dependent on opioids may also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms. Taking Methadon HCl Sandoz improperly will increase your risk of serious side effects or death. Even if you have used other narcotic medications, you may still have serious side effects from Methadon HCl Sandoz. Follow all dosing instructions carefully. Like other narcotic medicines, Methadon HCl Sandoz can slow your breathing, even long after the pain-relieving effects of the medication wear off. Death may occur if breathing becomes too weak. Never use more Methadon HCl Sandoz than your doctor has prescribed. Call your doctor if you think the medicine is not working. Do not stop using Methadon HCl Sandoz suddenly, or you could have unpleasant withdrawal symptoms. Call your doctor if you miss doses or forget to take this medication for longer than 3 days in a row. Do not drink alcohol. Methadon HCl Sandoz can increase the effects of alcohol, which could be dangerous. Check your food and medicine labels to be sure these products do not contain alcohol. This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Methadon HCl Sandoz will affect you. Methadon HCl Sandoz Uses. Side effects. An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician. There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it. List of Methadon HCl Sandoz substitutes brand and generic names. Methadon-neuraxpharm Germany. See substitutes for Methadon HCl Sandoz. Your name:. Contact Privacy Policy. This site does not supply any medicines. It contains prices for information purposes only.

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