Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratoires sterop sa-nv - methadone hydrochloride 10 mg/ml - solution for injection - 10 mg/1 ml - methadone hydrochloride 10 mg/ml - methadone

New Zealand - English - Medsafe (Medicines Safety Authority)

aft pharmaceuticals ltd - methadone hydrochloride 10mg - tablet - 10 mg - active: methadone hydrochloride 10mg excipient: lactose monohydrate magnesium stearate starch - methadone is indicated for relief of severe pain. methadone is sometimes used as an antitussive when severe pain is present, and coughing cannot be relieved by other means. methadone is not recommended for obstetric analgesia because its long duration of action increases the risk of neonatal respiratory depression.

Malta - English - Medicines Authority

rosemont pharmaceuticals limited rosemont house, yorkdale industrial park, braithwaite street, leeds ls11 9xe, united kingdom - methadone hydrochloride - oral solution - methadone hydrochloride 1 mg/ml - other nervous system drugs

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

atlantic biologicals corp. - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride oral solution is indicated for the: 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: 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 hydroc

Australia - English - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - methadone hydrochloride, quantity: 10 mg/ml - injection, solution - excipient ingredients: water for injections - aspen methadone injection is indicated for the management of severe pain where: (i) other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and (ii) the pain is opioid-responsive, and (iii) requires daily, continuous, long-term treatment. ,aspen methadone injection is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,aspen methadone injection is not indicated as an as-needed (prn) analgesia.,aspen methadone injection is not recommended for use in ambulant patients.

Israel - English - Ministry of Health

rafa laboratories ltd - methadone hydrochloride - solution - methadone hydrochloride 50 mg/ml - methadone, comb. excl. psycholeptics - methadone, comb. excl. psycholeptics - relief of severe pain. detoxification and withdrawal treatment in narcotic addiction.

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

american health packaging - 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 [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. - 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

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

epic pharma, llc - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride tablets, usp are indicated for the:        limitations of use methadone hydrochloride tablets are contraindicated in patients with: risk summary the majority of available data from clinical trials, observational studies, case series, and case reports on methadone use in pregnancy do not indicate an increased risk of major malformations specifically due to methadone. pregnant women involved in methadone maintenance programs have been reported to have improved prenatal care leading to 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 in these studies appears to occur after th

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

camber pharmaceuticals, inc - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride tablets are indicated for the: 1. management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [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 opioid combination products) 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 appropriate social and medical services. limitations of use methad

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

bryant ranch prepack - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - methadone hydrochloride tablets, usp 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, usp 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. 2. detoxification treatment of opioid addiction (heroin or other morphine-like drugs). 3. maintenance treatment of opioid addiction (heroin or other morph