United States - English - NLM (National Library of Medicine)

glenmark pharmaceuticals, inc., usa - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride tablets are indicated for the:   1. 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 [see warnings and precautions (5.1)], reserve methadone hydrochloride tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - methadone hydrochloride tablets are not indicated as an as-needed (prn) analgesic. 2. detoxification treatment of opioid addiction (heroin or other morphine-like drugs). 3. maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropria

United States - English - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride tablets usp are indicated for the: - management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. - 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. limitations of use methadone hydrochloride tablets usp are not for use: - as an as-needed (prn) analgesic - for pain that is mild or not expected to persist for an extended period of time - for acute pain - for postoperative pain conditions for distribution and use of methadone products for the treatment of opioid addiction code of federal regulations, title 42, sec 8 methadone 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 agre

United States - English - NLM (National Library of Medicine)

atlantic biologicals corp. - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - - for detoxification treatment of opioid addiction (heroin or other morphine-like drugs). - for maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.  methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 cfr, title 42, sec 8 (see dosage and administration ). methadone hydrochloride is contraindicated in patients with: - significant respiratory depression - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment - known or suspected gastrointestinal obstruction, including paralytic ileus - hypersensitivity (e.g., anaphylaxis) to methadone or any other ingredient in methadone hydrochloride oral concentrate   methadone hydrochloride oral concentrate contains methadone, a schedule ii opioid agonist. schedule ii opioid substances, which also include hydromor

Malta - English - Medicines Authority

alkaloid-int d.o.o. Šlandrova ulica 4, 1231 ljubljana-crnuce, slovenia - methadone hydrochloride - oral solution - methadone hydrochloride 1 mg/ml - other nervous system drugs

United States - English - NLM (National Library of Medicine)

precision dose, inc. - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride oral solution 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 [see warnings and precautions (5.2)] , reserve methadone hydrochloride oral solution for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - methadone hydrochloride oral solution 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. limitations of use: - methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 cfr 8.12 [see dosage and administration (2.1)] . methadone hydrochloride oral solution is contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.4)] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.9)] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings and precautions (5.14)] - hypersensitivity (e.g., anaphylaxis) to methadone [see adverse reactions (6)] risk summary: neonatal opioid withdrawal syndrome (nows) is an expected and treatable outcome of prolonged use of opioids during pregnancy [see warnings and precautions (5.6)] . 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. these risks should be considered in women treated with methadone hydrochloride oral solution for maintenance treatment of opioid addiction. for women treated with methadone hydrochloride oral solution for pain severe enough to require daily, around-the-clock, long-term opioid treatment, methadone hydrochloride oral solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. there are no adequate and well-controlled studies in pregnant women. in published animal reproduction studies, methadone administered subcutaneously during the early gestational period produced neural tube defects (i.e., exencephaly and cranioschisis) in the hamster at doses 2 times the human daily oral dose of 120 mg/day on a mg/m2 basis (hdd) and in mice at doses equivalent to the hdd. administration of methadone to pregnant animals during organogenesis and through lactation resulted decreased litter size, increased pup mortality, decreased pup body weights, developmental delays, and long-term neurochemical changes in the brain of offspring which correlate with altered behavioral responses that persist through adulthood at exposures comparable to and less than the hdd. administration of methadone to male rodents prior to mating with untreated females resulted in increased neonatal mortality and significant differences in behavioral tests in the offspring at exposures comparable to and less than the hdd [see data]. based on animal data, advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations: disease-associated maternal and embryo-fetal risk: untreated opioid addiction in pregnancy is associated with adverse obstetrical outcomes such as low birth weight, preterm birth, and fetal death. in addition, untreated opioid addiction often results in continued or relapsing illicit opioid use. dosage adjustment during pregnancy: the disposition of oral methadone has been studied in approximately 30 pregnant patients in second and third trimesters. total body clearance of methadone was increased in pregnant patients compared to the same patients postpartum or to non-pregnant opioid-dependent women. the terminal half-life of methadone is decreased during second and third trimesters. the decrease in plasma half-life and increased clearance of methadone resulting in lower methadone trough levels during pregnancy can lead to withdrawal symptoms in some pregnant patients. the dosage may need to be increased or the dosing interval decreased in pregnant patients receiving methadone to achieve therapeutic effect [see dosage and administration (2.12)] . fetal/neonatal adverse reactions: neonatal opioid withdrawal syndrome may occur in newborn infants of mothers who are receiving treatment with methadone hydrochloride oral solution. neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and/or failure to gain weight. signs of neonatal withdrawal usually occur in the first days after birth. the duration and severity of neonatal opioid withdrawal syndrome may vary. observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly [see warnings and precautions (5.6)] . labor or delivery: opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. use of methadone hydrochloride oral solution as an analgesic is not recommended for pregnant women during or immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate. opioid analgesics, including methadone hydrochloride oral solution can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. however, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. data : human data: reported studies have generally compared the benefit of methadone to the risk of untreated addiction to illicit drugs; the relevance of these findings to pain patients prescribed methadone during pregnancy is unclear. pregnant women involved in methadone maintenance programs have been reported to have significantly improved prenatal care leading to significantly reduced incidence of obstetric and fetal complications and neonatal morbidity and mortality when compared to women using illicit drugs. several factors, including maternal use of illicit drugs, nutrition, infection and psychosocial circumstances, complicate the interpretation of investigations of the children of women who take methadone during pregnancy. information is limited regarding dose and duration of methadone use during pregnancy, and most maternal exposure appears to occur after the first trimester of pregnancy. a review of published data on experiences with methadone use during pregnancy by the teratogen information system (teris) concluded that maternal use of methadone during pregnancy as part of a supervised, therapeutic regimen is unlikely to pose a substantial teratogenic risk (quantity and quality of data assessed as "limited to fair"). however, the data are insufficient to state that there is no risk (teris, last reviewed october, 2002). a retrospective case series of 101 pregnant, opioid-dependent women who underwent inpatient opioid detoxification with methadone did not demonstrate any increased risk of miscarriage in the second trimester or premature delivery in the third trimester. recent studies suggest an increased risk of premature delivery in opioid-dependent women exposed to methadone during pregnancy, although the presence of confounding factors makes it difficult to determine a causal relationship. several studies have suggested that infants born to narcotic-addicted women treated with methadone during all or part of pregnancy have been found to have decreased fetal growth with reduced birth weight, length, and/or head circumference compared to controls. this growth deficit does not appear to persist into later childhood. children prenatally exposed to methadone have been reported to demonstrate mild but persistent deficits in performance on psychometric and behavioral tests. in addition, several studies suggest that children born to opioid-dependent women exposed to methadone during pregnancy may have an increased risk of visual development anomalies; however, a causal relationship has not been assigned. there are conflicting reports on whether sudden infant death syndrome occurs with an increased incidence in infants born to women treated with methadone during pregnancy. abnormal fetal non-stress tests have been reported to occur more frequently when the test is performed 1 to 2 hours after a maintenance dose of methadone in late pregnancy compared to controls. animal data: formal reproductive and developmental toxicology studies for methadone have not been conducted. exposure margins for the following published study reports are based on a human daily dose (hdd) of 120 mg methadone using a body surface area comparison. in a published study in pregnant hamsters, a single subcutaneous dose of methadone ranging from 31 mg/kg (2 times the hdd) to 185 mg/kg on gestation day 8 resulted in a decrease in the number of fetuses per litter and an increase in the percentage of fetuses exhibiting neural tube defects including exencephaly, cranioschisis, and "various other lesions." the majority of the doses tested also resulted in maternal death. in a study in pregnant mice, a single subcutaneous dose of 22 to 24 mg/kg methadone (approximately equivalent to the hdd) administered on gestation day 9 produced exencephaly in 11% of the embryos. in another study in pregnant mice, subcutaneous doses up to 28 mg/kg/day methadone (equivalent to the hdd) administered from gestation day 6 to 15 resulted in no malformations, but there were increased postimplantation loss and decreased live fetuses at 10 mg/kg/day or greater (0.4 times the hdd) and decreased ossification and fetal body weight at 20 mg/kg/day or greater (0.8 times the hdd). in a second study of pregnant mice dosed with subcutaneous doses up to 28 mg/kg/day methadone from gestation day 6 to 15, there was decreased pup viability, delayed onset of development of negative phototaxis and eye opening, increased righting reflexes at 5 mg/kg/day or greater (0.2 times the hdd), and decreased number of live pups at birth and decreased pup weight gain at 20 mg/kg/day or greater (0.8 times the hdd). no effects were reported in a study of pregnant rats and rabbits at oral doses up to 40 mg/kg (3 and 6 times, respectively, the hdd) administered from gestation days 6 to 15 and 6 to 18, respectively. when pregnant rats were treated with intraperitoneal doses of 2.5, 5, or 7.5 mg/kg methadone from one week prior to mating, through gestation until the end of lactation period, 5 mg/kg or greater (0.4 times the hdd) methadone resulted in decreases in litter size and live pups born and 7.5 mg/kg (0.6 times the hdd) resulted in decreased birth weights. furthermore, decreased pup viability and pup body weight gain at 2.5 mg/kg or greater (0.2 times the hdd) were noted during the preweaning period. additional animal data demonstrates evidence for neurochemical changes in the brains of offspring from methadone-treated pregnant rats, including changes to the cholinergic, dopaminergic, noradrenergic and serotonergic systems at doses below the hdd. other animal studies have reported that prenatal and/or postnatal exposure to opioids including methadone alters neuronal development and behavior in the offspring including alterations in learning ability, motor activity, thermal regulation, nociceptive responses, and sensitivity to drugs at doses below the hdd. treatment of pregnant rats subcutaneously with 5 mg/kg methadone from gestation day 14 to 19 (0.4 times the hdd) reduced fetal blood testosterone and androstenedione in males. published animal data have reported increased neonatal mortality in the offspring of male rodents that were treated with methadone at doses comparable to and less than the hdd for 1 to 12 days before and/or during mating (with more pronounced effects in the first 4 days). in these studies, the female rodents were not treated with methadone, indicating paternally-mediated developmental toxicity. specifically, methadone administered to the male rat prior to mating with methadone-naïve females resulted in decreased weight gain in progeny after weaning. the male progeny demonstrated reduced thymus weights, whereas the female progeny demonstrated increased adrenal weights. behavioral testing of these male and female progeny revealed significant differences in behavioral tests compared to control animals, suggesting that paternal methadone exposure can produce physiological and behavioral changes in progeny in this model. examination of uterine contents of methadone-naïve female mice bred to methadone-treated male mice (once a day for three consecutive days) indicated that methadone treatment produced an increase in the rate of preimplantation deaths in all post-meiotic states at 1 mg/kg/day or greater (0.04 times the hdd). chromosome analysis revealed a dose-dependent increase in the frequency of chromosomal abnormalities at 1 mg/kg/day or greater. studies demonstrated that methadone treatment of male rats for 21 to 32 days prior to mating with methadone-naïve females did not produce any adverse effects, suggesting that prolonged methadone treatment of the male rat resulted in tolerance to the developmental toxicities noted in the progeny. mechanistic studies in this rat model suggest that the developmental effects of "paternal" methadone on the progeny appear to be due to decreased testosterone production. these animal data mirror the reported clinical findings of decreased testosterone levels in human males on methadone maintenance therapy for opioid addiction and in males receiving chronic intraspinal opioids. risk summary: based on two studies in 22 breastfeeding women maintained on methadone treatment, methadone was present in low levels in human milk, and did not show adverse reactions in breastfed infants. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for methadone and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. clinical considerations: advise breastfeeding women taking methadone to monitor the infant for increased drowsiness and breathing difficulties. data: in a study of ten breastfeeding women maintained on oral methadone doses of 10 to 80 mg/day, methadone concentrations from 50 to 570 mcg/l in milk were reported, which, in the majority of samples, were lower than maternal serum drug concentrations at steady state. in a study of twelve breastfeeding women maintained on oral methadone doses of 20 to 80 mg/day, methadone concentrations from 39 to 232 mcg/l in milk were reported. based on an average milk consumption of 150 ml/kg/day, an infant would consume approximately 17.4 mcg/kg/day which is approximately 2 to 3% of the oral maternal dose. methadone has been detected in very low plasma concentrations in some infants whose mothers were taking methadone. there have been rare cases of sedation and respiratory depression in infants exposed to methadone through breast milk. infertility: chronic use of opioids may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see adverse reactions (6), clinical pharmacology (12.2), nonclinical pharmacology (13.1)] . reproductive function in human males may be decreased by methadone treatment. reductions in ejaculate volume and seminal vesicle and prostate secretions have been reported in methadone-treated individuals. in addition, reductions in serum testosterone levels and sperm motility, and abnormalities in sperm morphology have been reported. in published animal studies, methadone produces a significant regression of sex accessory organs and testes of male mice and rats and administration of methadone to pregnant rats reduced fetal blood testosterone and androstenedione in male offspring [see nonclinical toxicology (13)] . the safety, effectiveness, and pharmacokinetics of methadone in pediatric patients below the age of 18 years have not been established. clinical studies of methadone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently compared to younger subjects. other reported clinical experience has not identified differences in responses between elderly and younger patients. elderly patients (aged 65 years or older) may have increased sensitivity to methadone. in general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. titrate the dosage of methadone hydrochloride oral solution slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression [see warnings and precautions (5.9)] . methadone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. methadone pharmacokinetics have not been extensively evaluated in patients with hepatic insufficiency. methadone is metabolized by hepatic pathways; therefore, patients with liver impairment may be at risk of increased systemic exposure to methadone after multiple dosing. start these patients on lower doses and titrate slowly while carefully monitoring for signs of respiratory and central nervous system depression. methadone pharmacokinetics have not been extensively evaluated in patients with renal insufficiency. since unmetabolized methadone and its metabolites are excreted in urine to a variable degree, start these patients on lower doses and with longer dosing intervals and titrate slowly while carefully monitoring for signs of respiratory and central nervous system depression. methadone hydrochloride oral solution contains methadone, a schedule ii controlled substance. methadone hydrochloride oral solution contains methadone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, morphine, oxycodone, oxymorphone, and tapentadol. methadone hydrochloride oral solution can be abused and is subject to misuse, addiction, and criminal diversion [see warnings and precautions (5.2)] . all patients treated with opioids for pain management require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and include: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. "drug-seeking" behavior is very common in addicts and drug abusers. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated claims of lost prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). "doctor shopping" (visiting multiple prescribers) to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. abuse and addiction are separate and distinct from physical dependence and tolerance. healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. in addition, abuse of opioids can occur in the absence of true addiction. methadone hydrochloride oral solution, like other opioids, can be diverted for non-medical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests as required by state and federal law, is strongly advised. proper assessment and selection 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. risks specific to abuse of methadone hydrochloride oral solution: abuse of methadone hydrochloride oral solution poses a risk of overdose and death. this risk is increased with concurrent abuse of methadone and other substances. methadone hydrochloride oral solution is for oral use only and must not be injected. with intravenous abuse the inactive ingredients in methadone hydrochloride oral solution can result in local tissue necrosis, infection, pulmonary granulomas, embolism and death, and increased risk of endocarditis and valvular heart injury. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during chronic opioid therapy. 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). tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity, (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage. do not abruptly discontinue methadone hydrochloride oral solution in a patient physically dependent on opioids. rapid tapering of methadone hydrochloride oral solution in a patient physically dependent on opioids may lead to 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. when discontinuing methadone hydrochloride oral solution, gradually taper the dosage using a patient-specific plan that considers the following: the dose of methadone hydrochloride oral solution the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. to improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. in patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see dosage and administration (2.5) and warnings (5.16)] . infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see use in specific populations (8.1)] .

United States - English - NLM (National Library of Medicine)

specgx llc - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride oral solution 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 [ see warnings and precautions (5.2) ] , reserve methadone hydrochloride oral solution for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. methadone hydrochloride oral solution is not indicated as an as-needed (prn) analgesic. 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

United States - English - NLM (National Library of Medicine)

ascend laboratories, llc - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride tablets are indicated for the: 1. 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 [see warnings and precautions (5.1)] , reserve methadone hydrochloride tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.          • methadone hydrochloride tablets are not indicated as an as-needed (prn) analgesic. 2. detoxification treatment of opioid addiction (heroin or other morphine-like drugs). 3. maintenance treatment of opioid addiction (heroin or other morphine-like drugs)

United States - English - NLM (National Library of Medicine)

cebert pharmaceuticals, inc. - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - concentrate - - 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. outpatient maintenance and outpatient detoxification treatment may be provided only by opioid treatment programs (otps) certified by the federal substance abuse and mental health services administration (samhsa) and registered by the drug enforcement administration (dea). this does not preclude 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 his/her stay, or of a patient whose enrollment has been verified in a program which has been certified for maintenance treatment with methadone. methadone hydrochloride oral concentrate is contraindicated in patients with a known hypersensitivity to methadone hydrochloride or any other ingred

United States - English - NLM (National Library of Medicine)

direct_rx - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride tablets are 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 methadone hydrochloride tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. • methadone hydrochloride tablets usp are 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

United States - English - NLM (National Library of Medicine)

direct_rx - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride tablets are 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 methadone hydrochloride tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. • methadone hydrochloride tablets usp are 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