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

actavis pharma, inc. - pentazocine hydrochloride (unii: a36bxo4ppx) (pentazocine - unii:rp4a60d26l), naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - pentazocine 50 mg - pentazocine and naloxone tablets are 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, which can occur at any dosage or duration, reserve pentazocine and naloxone 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. pentazocine and naloxone tablets 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. pentazocine and naloxone tablets are 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 ] - patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] - patients with hypersensitivity to either pentazocine, naloxone, or any of the formulation excipients (e.g., anaphylaxis) [see warnings ]. pentazocine and naloxone tablets contain pentazocine, a schedule iv controlled substance. pentazocine and naloxone tablets contains pentazocine, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings] . 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 pentazocine and naloxone tablets 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 pentazocine and naloxone tablets 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 pentazocine and naloxone tablets abuse include those with a history of prolonged use of any opioid, including products containing pentazocine, those with a history of drug or alcohol abuse, or those who use pentazocine and naloxone tablets 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 health care 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. pentazocine and naloxone tablets, 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 pentazocine and naloxone tablets abuse of pentazocine and naloxone tablets poses a risk of overdose and death. the risk is increased with concurrent use of pentazocine and naloxone tablets with alcohol and/or other cns depressants. 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 pentazocine and naloxone tablets in a patient physically dependent on opioids. rapid tapering of pentazocine and naloxone tablets 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 pentazocine and naloxone tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of pentazocine and naloxone tablets 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 , warnings ] . infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see pregnancy ] .

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

lupin pharmaceuticals,inc. - pentazocine hydrochloride (unii: a36bxo4ppx) (pentazocine - unii:rp4a60d26l), naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - pentazocine 50 mg - pentazocine and naloxone tablets are 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, which can occur at any dosage or duration [see warnings], reserve pentazocine and naloxone 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 pentazocine and naloxone tablets 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. pentazocine and naloxone tablets are 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 ]. patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] - patients with hypersensitivity to either pentazocine, naloxone, or any of the formulation excipients (e.g., anaphylaxis) [see warnings ]. pentazocine and naloxone tablets contain pentazocine, a schedule iv controlled substance. controlled substance pentazocine and naloxone tablets contain pentazocine, a schedule iv controlled substance. abuse pentazocine and naloxone tablets contain pentazocine, a substance with a high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings]. 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 pentazocine and naloxone tablets increases a 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 pentazocine and naloxone tablets 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 pentazocine and naloxone tablets abuse include those with a history of prolonged use of any opioid, including products containing pentazocine, those with a history of drug or alcohol abuse, or those who use pentazocine and naloxone tablets 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. pentazocine and naloxone tablets, 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 pentazocine and naloxone tablets abuse of pentazocine and naloxone tablets poses a risk of overdose and death. the risk is increased with concurrent use of pentazocine and naloxone tablets with alcohol and/or other cns depressants. parental 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 pentazocine and naloxone tablets in a patient physically dependent on opioids. rapid tapering of pentazocine and naloxone tablets 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 pentazocine and naloxone tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of pentazocine and naloxone tablets 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, warnings ]. infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see pregnancy].

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

mylan pharmaceuticals inc. - perphenazine (unii: fta7xxy4ez) (perphenazine - unii:fta7xxy4ez), amitriptyline hydrochloride (unii: 26lud4jo9k) (amitriptyline - unii:1806d8d52k) - perphenazine 2 mg - perphenazine and amitriptyline hydrochloride tablets are recommended for treatment of (1) patients with moderate to severe anxiety and/or agitation and depressed mood, (2) patients with depression in whom anxiety and/or agitation are severe, and (3) patients with depression and anxiety in association with chronic physical disease. in many of these patients, anxiety masks the depressive state so that, although therapy with a tranquilizer appears to be indicated, the administration of a tranquilizer alone will not be adequate. schizophrenic patients who have associated depressive symptoms should be considered for therapy with perphenazine and amitriptyline hydrochloride tablets. perphenazine and amitriptyline hydrochloride tablets are contraindicated in depression of the central nervous system from drugs (barbiturates, alcohol, narcotics, analgesics, antihistamines); in the presence of evidence of bone marrow depression; and in patients known to be hypersensitive to phenothiazines or amitriptyline. it should not be given concomitantly with monoamine oxidase inhibitors. hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressants and monoamine oxidase inhibitors simultaneously. when it is desired to replace a monoamine oxidase inhibitor with perphenazine and amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. perphenazine and amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. amitriptyline hydrochloride is not recommended for use during the acute recovery phase following myocardial infarction.

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

stat rx usa llc - pentazocine hydrochloride (unii: a36bxo4ppx) (pentazocine - unii:rp4a60d26l), naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - pentazocine hydrochloride 50 mg - pentazocine and naloxone hydrochlorides tablets are indicated for the relief of moderate to severe pain. pentazocine and naloxone hydrochlorides tablets are indicated for oral use only. pentazocine and naloxone hydrochlorides tablets should not be administered to patients who are hypersensitive to either pentazocine or naloxone. controlled substance. pentazocine and naloxone hydrochlorides tablets are a schedule iv controlled substance. there have been some reports of dependence and of withdrawal symptoms with orally administered pentazocine. patients with a history of drug dependence should be under close supervision while receiving pentazocine orally. there have been rare reports of possible abstinence syndromes in newborns after prolonged use of pentazocine during pregnancy. there have been instances of psychological and physical dependence on parenteral pentazocine in patients with a history of drug abuse and rarely, in patients without such a history. abrupt discontinuance following the exten

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

mylan pharmaceuticals inc. - perphenazine (unii: fta7xxy4ez) (perphenazine - unii:fta7xxy4ez) - perphenazine 2 mg - perphenazine tablets are indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. perphenazine tablets have not been shown effective for the management of behavioral complications in patients with mental retardation. perphenazine products are contraindicated in comatose or greatly obtunded patients and in patients receiving large doses of central nervous system depressants (barbiturates, alcohol, narcotics, analgesics, or antihistamines); in the presence of existing blood dyscrasias, bone marrow depression, or liver damage; and in patients who have shown hypersensitivity to perphenazine products, their components, or related compounds. perphenazine products are also contraindicated in patients with suspected or established subcortical brain damage, with or without hypothalamic damage, since a hyperthermic reaction with temperatures in excess of 104°f may occur in such patients, sometimes not until 14 to 16 hours after drug administration. total body ice-

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

wilshire pharmaceuticals, inc. - perphenazine (unii: fta7xxy4ez) (perphenazine - unii:fta7xxy4ez) - perphenazine 2 mg - perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation. perphenazine products are contraindicated in comatose or greatly obtunded patients and in patients receiving large doses of central nervous system depressants (barbiturates, alcohol, narcotics, analgesics, or antihistamines); in the presence of existing blood dyscrasias, bone marrow depression, or liver damage; and in patients who have shown hypersensitivity to perphenazine products, their components, or related compounds. perphenazine products are also contraindicated in patients with suspected or established subcortical brain damage, with or without hypothalamic damage, since a hyperthermic reaction with temperatures in excess of 104°f may occur in such patients, sometimes not until 14 to 16 hours after drug administration. total body ice-packing is recomme

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

remedyrepack inc. - perphenazine (unii: fta7xxy4ez) (perphenazine - unii:fta7xxy4ez) - perphenazine 8 mg - perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation. perphenazine products are contraindicated in comatose or greatly obtunded patients and in patients receiving large doses of central nervous system depressants (barbiturates, alcohol, narcotics, analgesics, or antihistamines); in the presence of existing blood dyscrasias, bone marrow depression, or liver damage; and in patients who have shown hypersensitivity to perphenazine products, their components, or related compounds. perphenazine products are also contraindicated in patients with suspected or established subcortical brain damage, with or without hypothalamic damage, since a hyperthermic reaction with temperatures in excess of 104°f may occur in such patients, sometimes not until 14 to 16 hours after drug administration. total body ice-packing is recommended for such a reaction; antipyretics may also be useful.

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

par pharmaceutical, inc. - perphenazine (unii: fta7xxy4ez) (perphenazine - unii:fta7xxy4ez) - perphenazine 2 mg - perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation. perphenazine products are contraindicated in comatose or greatly obtunded patients and in patients receiving large doses of central nervous system depressants (barbiturates, alcohol, narcotics, analgesics, or antihistamines); in the presence of existing blood dyscrasias, bone marrow depression, or liver damage; and in patients who have shown hypersensitivity to perphenazine products, their components, or related compounds. perphenazine products are also contraindicated in patients with suspected or established subcortical brain damage, with or without hypothalamic damage, since a hyperthermic reaction with temperatures in excess of 104°f may occur in such patients, sometimes not until 14 to 16 hours after drug administration. total body ice-packing is recomme

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

rebel distributors corp - perphenazine (unii: fta7xxy4ez) (perphenazine - unii:fta7xxy4ez) - perphenazine 4 mg - perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation. perphenazine products are contraindicated in comatose or greatly obtunded patients and in patients receiving large doses of central nervous system depressants (barbiturates, alcohol, narcotics, analgesics, or antihistamines); in the presence of existing blood dyscrasias, bone marrow depression, or liver damage; and in patients who have shown hypersensitivity to perphenazine tablets, their components, or related compounds. perphenazine products are also contraindicated in patients with suspected or established subcortical brain damage, with or without hypothalamic damage, since a hyperthermic reaction with temperatures in excess of 104°f may occur in such patients, sometimes not until 14 to 16 hours after drug administration. total body ice-packing is recommen

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

ncs healthcare of ky, inc dba vangard labs - perphenazine (unii: fta7xxy4ez) (perphenazine - unii:fta7xxy4ez) - perphenazine 2 mg - perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation. perphenazine products are contraindicated in comatose or greatly obtunded patients and in patients receiving large doses of central nervous system depressants (barbiturates, alcohol, narcotics, analgesics, or antihistamines); in the presence of existing blood dyscrasias, bone marrow depression, or liver damage; and in patients who have shown hypersensitivity to perphenazine tablets, their components, or related compounds. perphenazine products are also contraindicated in patients with suspected or established subcortical brain damage, with or without hypothalamic damage, since a hyperthermic reaction with temperatures in excess of 104°f may occur in such patients, sometimes not until 14 to 16 hours after drug administration. total body ice-packing is recommen