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hikma pharmaceuticals usa inc. - meperidine hydrochloride (unii: n8e7f7q170) (meperidine - unii:9e338qe28f) - meperidine hydrochloride 50 mg - meperidine hydrochloride tablets and oral solution are indicated for the management of acute 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, which can occur at any dosage or duration [see warnings and precautions (5.2)] , reserve meperidine hydrochloride tablets and oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products] : meperidine hydrochloride tablets or oral solution should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. meperidine hydrochloride tablets or oral solution should not be used for the treatment of chronic pain. use of meperidine hydrochloride tablets or oral solution for an extended period of time may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine . meperidine hydrochloride tablets and oral solution are contraindicated in patients with: risk summary use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.5)]. available data with meperidine is insufficient to inform a drug-associated risk for major birth defects and miscarriage. formal animal reproduction studies have not been conducted with meperidine. neural tube defects (exencephaly and cranioschisis) have been reported in hamsters administered a single bolus dose of meperidine during a critical period of organogenesis at 0.85 and 1.5 times the total human daily dose of 1,200 mg [see data]. adverse outcomes in pregnancy can occur regardless of the health of the mother or the use of medications. 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 fetal/neonatal adverse reactions : use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see warnings and precautions (5.5)]. labor and delivery : opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. resuscitation may be required [see overdose (10)]. an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. meperidine is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. opioid analgesics, including meperidine, 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 animal data : formal reproductive and developmental toxicology studies for meperidine have not been completed. in a published study, neural tube defects (exencephaly and cranioschisis) were noted following subcutaneous administration of meperidine hydrochloride (127 and 218 mg/kg, respectively) on gestation day 8 to pregnant hamsters (0.85 and 1.5 times the total daily dose of 1,200 mg/day based on body surface area). the findings cannot be clearly attributed to maternal toxicity. risk summary meperidine appears in the milk of nursing mothers receiving the drug. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for meperidine and any potential adverse effects on the breastfed infant from meperidine hydrochloride tablets or oral solution or from the underlying maternal condition. clinical considerations monitor infants exposed to meperidine through breast milk for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. infertility use of opioids for an extended period of time 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 toxicology (13.1)]. the safety and effectiveness of meperidine in pediatric patients has not been established. literature reports indicate that meperidine has a slower elimination rate in neonates and young infants compared to older children and adults. neonates and young infants may also be more susceptible to the effects, especially the respiratory depressant effects. if meperidine use is contemplated in neonates or young infants, any potential benefits of the drug need to be weighed against the relative risk of the patient. clinical studies of meperidine during product development did not include sufficient numbers of subjects aged 65 and over to evaluate age-related differences in safety or efficacy. literature reports indicate that geriatric patients have a slower elimination rate compared to young patients and they may be more susceptible to the effects of meperidine. reducing the total daily dose of meperidine is recommended in elderly patients, and the potential benefits of the drug should be weighed against the relative risk to a geriatric patient. 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 meperidine hydrochloride tablets or oral solution slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see warnings and precautions (5.4, 5.11)]. meperidine 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 regularly evaluate renal function. accumulation of meperidine and/or its active metabolite, normeperidine, can occur in patients with hepatic impairment. elevated serum levels have been reported to cause central nervous system excitatory effects. meperidine should therefore be used with caution in patients with hepatic impairment. titrate the dosage of meperidine hydrochloride tablets or oral solution slowly in patients with hepatic impairment and regularly evaluate for signs of central nervous system and respiratory depression. accumulation of meperidine and/or its active metabolite, normeperidine, can also occur in patients with renal impairment. meperidine should therefore be used with caution in patients with renal impairment. titrate the dosage of meperidine hydrochloride tablets or oral solution slowly in patients with renal impairment and regularly evaluate for signs of central nervous system and respiratory depression. meperidine hydrochloride tablets and oral solution contain meperidine, a schedule ii controlled substance. meperidine hydrochloride tablets and oral solution contain meperidine, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings and precautions (5.2)]. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of meperidine hydrochloride tablets and oral solution increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of meperidine hydrochloride tablets and/or oral solution with alcohol and other cns depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of meperidine hydrochloride tablets and oral solution abuse include those with a history of prolonged use of any opioid, including products containing meperidine, those with a history of drug or alcohol abuse, or those who use meperidine hydrochloride tablets and oral solution in combination with other abused drugs. “drug-seeking” behavior is very common in persons with substance use disorders. 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 healthcare provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. meperidine hydrochloride tablets and oral solution, like other opioids, can be diverted for nonmedical 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 of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of meperidine hydrochloride tablets and oral solution abuse of meperidine hydrochloride tablets and oral solution poses a risk of overdose and death. the risk is increased with concurrent use of meperidine hydrochloride tablets and oral solution with alcohol and/or other cns depressants. meperidine hydrochloride tablets and oral solution are approved for oral use only. meperidine hydrochloride tablets have been reported as being abused by crushing, chewing, snorting, or injecting the dissolved product. inappropriate intravenous, intramuscular, or subcutaneous use of meperidine hydrochloride tablets and oral solution can result in death, local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis, and valvular heart injury, and embolism. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), 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 use. do not abruptly discontinue meperidine hydrochloride tablets and oral solution in a patient physically dependent on opioids. rapid tapering of meperidine hydrochloride tablets and 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, gradually taper the dosage using a patient-specific plan that considers the following: the dose of meperidine hydrochloride tablets and 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 an extended period of time 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 (2.6), and warnings and precautions (5.17)]. 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)].

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epic pharma, llc - meperidine hydrochloride (unii: n8e7f7q170) (meperidine - unii:9e338qe28f) - meperidine hydrochloride 50 mg - meperidine hydrochloride tablets are indicated for the management of acute 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 meperidine hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: meperidine hydrochloride tablets should not be used for treatment of chronic pain. prolonged meperidine hydrochloride tablets use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine. meperidine hydrochloride tablets are contraindicated in patients with: risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.4)]. available data with meperidine hydrochloride tablets are insufficie

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teva pharmaceuticals usa, inc. - meperidine hydrochloride (unii: n8e7f7q170) (meperidine - unii:9e338qe28f) - meperidine hydrochloride 50 mg - meperidine hydrochloride tablets are indicated for the management of acute 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 (5.2)] , reserve meperidine hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia. meperidine hydrochloride tablets should not be used for treatment of chronic pain. prolonged meperidine hydrochloride tablets use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine. meperidine hydrochloride tablets are contraindicated in patients with: - significant respiratory depression [see warnings and preca

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mikart, llc - meperidine hydrochloride (unii: n8e7f7q170) (meperidine - unii:9e338qe28f) - meperidine hydrochloride 50 mg - meperidine hydrochloride tablets are indicated for the management of acute 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 ( 5.2)] , reserve meperidine hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia. meperidine hydrochloride tablets should not be used for treatment of chronic pain. prolonged meperidine hydrochloride tablets use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine. meperidine hydrochloride tablets are contraindicated in patients with: - significant resp

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physicians total care, inc. - meperidine hydrochloride (unii: n8e7f7q170) (meperidine - unii:9e338qe28f) - meperidine hydrochloride 50 mg - meperidine hydrochloride tablets are indicated for the relief of moderate to severe pain. meperidine hydrochloride tablets are contraindicated in patients with hypersensitivity to meperidine or to any of its ingredients. meperidine is contraindicated in patients who are receiving monoamine oxidase (mao) inhibitors or those who have recently received such agents. therapeutic doses of meperidine have occasionally precipitated unpredictable, severe, and occasionally fatal reactions in patients who have received such agents within 14 days. the mechanism of these reactions is unclear, but may be related to a preexisting hyperphenylalaninemia. some have been characterized by coma, severe respiratory depression, cyanosis, and hypotension, and have resembled the syndrome of acute narcotic overdose. serotonin syndrome with agitation, hyperthermia, diarrhea, tachycardia, sweating, tremors and impaired consciousness may also occur. in other reactions the predominant manifestations have been hyperexcitability, convulsion

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caraco pharmaceutical laboratories, ltd. - meperidine hydrochloride (unii: n8e7f7q170) (meperidine - unii:9e338qe28f) - meperidine hydrochloride 50 mg - meperidine hydrochloride tablets are indicated for the relief of moderate to severe pain. meperidine hydrochloride tablet is contraindicated in patients with hypersensitivity to meperidine. meperidine is contraindicated in patients who are receiving monoamine oxidase (mao) inhibitors or those who have recently received such agents. therapeutic doses of meperidine have occasionally precipitated unpredictable, severe, and occasionally fatal reactions in patients who have received such agents within 14 days. the mechanism of these reactions is unclear, but may be related to a preexisting hyperphenylalaninemia. some have been characterized by coma, severe respiratory depression, cyanosis, and hypotension, and have resembled the syndrome of acute narcotic overdose. in other reactions the predominant manifestations have been hyperexcitability, convulsions, tachycardia, hyperpyrexia, and hypertension. although it is not known that other narcotics are free of the risk of such reactions, virtually all of the reported

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hikma pharmaceuticals usa inc. - meperidine hydrochloride (unii: n8e7f7q170) (meperidine - unii:9e338qe28f) - meperidine hydrochloride 25 mg in 1 ml - meperidine hydrochloride injection is indicated for preoperative medication, support of anesthesia, and obstetrical analgesia. meperidine hydrochloride injection is indicated 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 meperidine hydrochloride injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - have not been tolerated, or are not expected to be tolerated - have not provided adequate analgesia, or are not expected to provide adequate analgesia meperidine hydrochloride injection should not be used for treatment of chronic pain. prolonged meperidine hydrochloride injection use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine. meper

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physicians total care, inc. - meperidine hydrochloride (unii: n8e7f7q170) (meperidine - unii:9e338qe28f) - meperidine hydrochloride 50 mg in 1 ml - for the relief of moderate to severe pain. for preoperative medication. for support of anesthesia. for obstetrical analgesia. hypersensitivity to meperidine. meperidine is contraindicated in patients who are receiving monoamine oxidase (mao) inhibitors or those who have recently received such agents. therapeutic doses of meperidine have occasionally precipitated unpredictable, severe and occasionally fatal reactions in patients who have received such agents within 14 days. the mechanism of these reactions is unclear, but may be related to a preexisting hyperphenylalaninemia. some have been characterized by coma, severe respiratory depression, cyanosis and hypotension and have resembled the syndrome of acute narcotic overdose. in other reactions, the predominant manifestations have been hyperexcitability, convulsions, tachycardia, hyperpyrexia and hypertension. although it is not known that other narcotics are free of the risk of such reactions, virtually all of the reported reactions have occurred w

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watson laboratories, inc. - meperidine hydrochloride (unii: n8e7f7q170) (meperidine - unii:9e338qe28f) - tablet - 50 mg - meperidine hydrochloride tablets are indicated for the relief of moderate to severe pain. meperidine hydrochloride tablets are contraindicated in patients with hypersensitivity to meperidine. meperidine is contraindicated in patients who are receiving monoamine oxidase (mao) inhibitors or those who have recently received such agents. therapeutic doses of meperidine have occasionally precipitated unpredictable, severe, and occasionally fatal reactions in patients who have received such agents within 14 days. the mechanism of these reactions is unclear, but may be related to a preexisting hyperphenylalaninemia. some have been characterized by coma, severe respiratory depression, cyanosis, and hypotension, and have resembled the syndrome of acute narcotic overdose. in other reactions the predominant manifestations have been hyperexcitability, convulsions, tachycardia, hyperpyrexia, and hypertension. although it is not known that other narcotics are free of the risk of such reactions, virtually all of the reporte

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boehringer ingelheim - meperidine hydrochloride (unii: n8e7f7q170) (meperidine - unii:9e338qe28f) - solution - 50 mg in 5 ml - meperidine is indicated for the relief of moderate to severe pain. meperidine is contraindicated in patients with hypersensitivity to meperidine. meperidine is contraindicated in patients who are receiving monoamine oxidase (mao) inhibitors or those who have recently received such agents. therapeutic doses of meperidine have occasionally precipitated unpredictable, severe, and occasionally fatal reactions in patients who have received such agents within 14 days. the mechanism of these reactions is unclear, but may be related to a preexisting hyperphenylalaninemia. some have been characterized by coma, severe respiratory depression, cyanosis, and hypotension, and have resembled the syndrome of acute narcotic overdose. in other reactions the predominant manifestations have been hyperexcitability, convulsions, tachycardia, hyperpyrexia, and hypertension. although it is not known that other narcotics are free of the risk of such reactions, virtually all of the reported reactions have occurred with meperidine. if