Verenigde Staten - Engels - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 100 mg - tramadol hydrochloride extended-release 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: tramadol hydrochloride extended-release tablets are contraindicated for: all children younger than 12 years of age [see warnings and precautions (5.4) ] post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see warnings and precautions (5.4) ] . tramadol hydrochloride extended-release tablets are also contraindicated in patients with: significant respiratory depression [see warnings and precautions (5.3) ] acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.12) ] known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings and precautions (5.15) ] hypersensitivity to tramadol (e.g., anaphylaxis

Verenigde Staten - Engels - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 50 mg - tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use: because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): tramadol hydrochloride tablets are contraindicated for: tramadol hydrochloride tablets are also contraindicated in patients with: prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. available data with tramadol hydrochloride tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, tramadol administration during organogenesis decreased fetal weights and reduced ossification in mice, rats, and rabbits at 1.4, 0.6, and 3.

Verenigde Staten - Engels - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 50 mg - tramadol hcl tablets are indicated for the management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see warnings ), reserve tramadol hcl tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: - have not been tolerated, or are not expected to be tolerated. - have not provided adequate analgesia, or are not expected to provide adequate analgesia.   tramadol hcl tablets contraindicated in patients with: - significant respiratory depression (see warnings ). - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see warnings ). - known or suspected gastrointestinal obstruction, including paralytic ileus (see warnings ). - hypersensitivity to tramadol, any other componen

Verenigde Staten - Engels - NLM (National Library of Medicine)

virtus pharmaceuticals llc - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 50 mg - tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: tramadol hydrochloride tablets are contraindicated for: tramadol hydrochloride tablets are also contraindicated in patients with: risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. available data with tramadol hydrochloride in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, tramadol administration during organogenesis decreased fetal weights and reduced ossification in mice, rats, and rabbits at 1.4, 0.6, and

Verenigde Staten - Engels - NLM (National Library of Medicine)

avkare - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - tramadol hydrochloride 37.5 mg - tramadol hydrochloride and acetaminophen tablets, usp are indicated for the short-term (five days or less) management of acute pain. tramadol hydrochloride and acetaminophen tablets, usp should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, usp, acetaminophen, usp, any other component of this product or opioids. tramadol hydrochloride and acetaminophen tablets, usp are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. tramadol hydrochloride and acetaminophen tablets, usp may worsen central nervous system and respiratory depression in these patients. abuse tramadol has mu-opioid agonist activity. tramadol hydrochloride and acetaminophen tablets, a tramadol-containing product, can be abused and may be subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, p

Verenigde Staten - Engels - NLM (National Library of Medicine)

direct rx - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - tramadol hydrochloride 37.5 mg - tramadol hydrochloride and acetaminophen tablets, usp are indicated for the short-term (five days or less) management of acute pain. close tramadol hydrochloride and acetaminophen tablets, usp should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, usp, acetaminophen, usp, any other component of this product, or opioids. tramadol hydrochloride and acetaminophen tablets, usp are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids, or psychotropic drugs. tramadol hydrochloride and acetaminophen tablets, usp may worsen central nervous system and respiratory depression in these patients. close abuse tramadol has mu-opioid agonist activity. tramadol hydrochloride and acetaminophen tablets, a tramadol-containing product, can be abused and may be subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, w

Verenigde Staten - Engels - NLM (National Library of Medicine)

avpak - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - tramadol hydrochloride 37.5 mg - tramadol hydrochloride and acetaminophen tablets, usp are indicated for the short-term (five days or less) management of acute pain. tramadol hydrochloride and acetaminophen tablets, usp should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, usp, acetaminophen, usp, any other component of this product, or opioids. tramadol hydrochloride and acetaminophen tablets, usp are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids, or psychotropic drugs. tramadol hydrochloride and acetaminophen tablets, usp may worsen central nervous system and respiratory depression in these patients. abuse tramadol has mu-opioid agonist activity. tramadol hydrochloride and acetaminophen tablets, a tramadol-containing product, can be abused and may be subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. drug addiction is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, use for non-medical purposes, continued use despite harm or risk of harm, and craving. drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common. “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 “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating physician(s). “doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. abuse and addiction are separate and distinct from physical dependence and tolerance. physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. in addition, abuse of tramadol hydrochloride and acetaminophen tablets can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. concerns about abuse and addiction should not prevent the proper management of pain. however, all patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. proper assessment of the patient and periodic re-evaluation of therapy are appropriate measures that help to limit the potential abuse of this product. tramadol hydrochloride and acetaminophen tablets are intended for oral use only. dependence tolerance is the need for increasing doses of drugs 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 (see also warnings, withdrawal) . 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. generally, tolerance and/or withdrawal are more likely to occur the longer a patient is on continuous therapy with tramadol hydrochloride and acetaminophen tablets.

Verenigde Staten - Engels - NLM (National Library of Medicine)

proficient rx lp - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - tramadol hydrochloride 37.5 mg - tramadol hydrochloride and acetaminophen tablets, usp are indicated for the short-term (five days or less) management of acute pain. tramadol hydrochloride and acetaminophen tablets, usp should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, usp, acetaminophen, usp, any other component of this product or opioids. tramadol hydrochloride and acetaminophen tablets, usp are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. tramadol hydrochloride and acetaminophen tablets, usp may worsen central nervous system and respiratory depression in these patients. abuse tramadol has mu-opioid agonist activity. tramadol hydrochloride and acetaminophen tablets, a tramadol-containing product, can be abused and may be subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, p

Verenigde Staten - Engels - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - tramadol hydrochloride 37.5 mg - tramadol hydrochloride and acetaminophen tablets, usp are indicated for the short-term (five days or less) management of acute pain. tramadol hydrochloride and acetaminophen tablets, usp should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, usp, acetaminophen, usp, any other component of this product or opioids. tramadol hydrochloride and acetaminophen tablets, usp are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. tramadol hydrochloride and acetaminophen tablets, usp may worsen central nervous system and respiratory depression in these patients. abuse tramadol has mu-opioid agonist activity. tramadol hydrochloride and acetaminophen tablets, a tramadol-containing product, can be abused and may be subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, p

Verenigde Staten - Engels - NLM (National Library of Medicine)

rxchange co. - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - tramadol hydrochloride 37.5 mg - tramadol hydrochloride and acetaminophen tablets, usp are indicated for the short-term (five days or less) management of acute pain. tramadol hydrochloride and acetaminophen tablets, usp should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, usp, acetaminophen, usp, any other component of this product, or opioids. tramadol hydrochloride and acetaminophen tablets, usp are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids, or psychotropic drugs. tramadol hydrochloride and acetaminophen tablets, usp may worsen central nervous system and respiratory depression in these patients. abuse tramadol has mu-opioid agonist activity. tramadol hydrochloride and acetaminophen tablets, a tramadol-containing product, can be abused and may be subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic,