미국 - 영어 - NLM (National Library of Medicine)

specgx llc - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - mixed salts of a single-entity amphetamine product extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd) in patients 13 years and older [see clinical studies (14)] . limitations of use pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite [see use in specific populations (8.4)] . mixed salts of a single-entity amphetamine product extended-release capsules are contraindicated in patients with: - known hypersensitivity to amphetamine, or other components of mixed salts of a single-entity amphetamine product extended-release capsules. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see adverse reactions (6.2)] . - concomitant treatment with monoamine oxidase inhibitors (maois), and also within 14 days

미국 - 영어 - NLM (National Library of Medicine)

specgx llc - lubiprostone (unii: 7662kg2r6k) (lubiprostone - unii:7662kg2r6k) - amitiza® is indicated for the treatment of chronic idiopathic constipation (cic) in adults. amitiza is indicated for the treatment of opioid-induced constipation (oic) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. limitations of use: effectiveness of amitiza in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established. [see clinical studies (14.2)] amitiza is indicated for the treatment of irritable bowel syndrome with constipation (ibs-c) in women at least 18 years old. amitiza is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction [see warnings and precautions (5.5)] . risk summary following oral administration, concentrations of lubiprostone in plasma are below the level of quantitation; however, one of the metabolites, m3, has measurable systemic concentrations [see clinical pharmacology (12.3)] . limited available data with lubiprostone use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. animal reproduction studies did not show an increase in structural malformations. although a dose dependent increase in fetal loss was observed in pregnant guinea pigs that received lubiprostone (doses equivalent to 0.2 to 6 times the maximum recommended human dose (mrhd) based on body surface area (mg/m2 )), these effects were probably secondary to maternal toxicity and occurred after the period of organogenesis (see data) . the 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. data animal data in developmental toxicity studies, pregnant rats and rabbits received oral lubiprostone during organogenesis at doses up to approximately 338 times (rats) and approximately 34 times (rabbits) the maximum recommended human dose (mrhd) based on body surface area (mg/m2 ). maximal animal doses were 2000 mcg/kg/day (rats) and 100 mcg/kg/day (rabbits). in rats, there were increased incidences of early resorptions and soft tissue malformations (situs inversus , cleft palate) at the 2000 mcg/kg/day dose; however, these effects were probably secondary to maternal toxicity. a dose-dependent increase in fetal loss occurred when guinea pigs received lubiprostone after the period of organogenesis, on days 40 to 53 of gestation, at daily oral doses of 1, 10, and 25 mcg/kg/day (approximately 0.2, 2 and 6 times the mrhd based on body surface area (mg/m2 )); however, these effects were probably secondary to maternal toxicity. the potential of lubiprostone to cause fetal loss was also examined in pregnant rhesus monkeys. monkeys received lubiprostone post-organogenesis on gestation days 110 through 130 at daily oral doses of 10 and 30 mcg/kg/day (approximately 3 and 10 times the mrhd based on body surface area (mg/m2 )). fetal loss was noted in one monkey from the 10-mcg/kg dose group, which is within normal historical rates for this species. there was no drug-related adverse effect seen in monkeys. risk summary there are no data available on the presence of lubiprostone in human milk or the effect of lubiprostone on milk production. there are limited data available on the effect of lubiprostone on the breastfed infant. neither lubiprostone nor its active metabolite (m3) were present in the milk of lactating rats. when a drug is not present in animal milk, it is likely that the drug will not be present in human milk. if present, lubiprostone may cause diarrhea in the breastfed infant (see clinical considerations) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for amitiza and any potential adverse effects on the breastfed infant from amitiza or from the underlying maternal condition. clinical considerations infants of nursing mothers being treated with amitiza should be monitored for diarrhea. safety and effectiveness have not been established in pediatric patients with ibs-c, pediatric functional constipation (pfc), and oic. efficacy was not demonstrated for the treatment of pfc in patients 6 years of age and older in a 12 week, randomized, double-blind, placebo-controlled trial conducted in 606 patients 6 to 17 years with pfc comparing amitiza to placebo. the primary efficacy endpoint was an overall response based on spontaneous bowel movement frequency over the duration of the trial; the treatment difference from placebo was not statistically significant. in this age group, adverse reactions to amitiza were similar to those reported in adults. in a 36-week, long-term safety extension trial after approximately 9 months of treatment with amitiza, a single case of reversible elevation of alt (17-times upper limit of normal [uln]), ast (13-times uln), and ggt (9-times [uln]) was observed in a child with baseline elevated values (less than or equal to 2.5-times uln). juvenile animal toxicity data in a 13-week oral toxicity study in juvenile rats, a significant decrease in total bone mineral density was observed in female pups at 0.5 mg/kg/day; in male pups, a significantly lower cortical thickness at the tibial diaphysis was observed at 0.5 mg/kg. the 0.5 mg/kg/day dose is approximately 101 times the maximum recommended adult dose of 48 mcg/day, based on body surface area (mg/m2 ). chronic idiopathic constipation the efficacy of amitiza 24 mcg twice daily in the elderly (at least 65 years of age) subpopulation with cic was consistent with the efficacy in the overall study population. of the total number of patients treated in the dose-finding, efficacy, and long-term studies of amitiza, 16% were at least 65 years of age, and 4% were at least 75 years of age. elderly patients taking amitiza experienced a lower rate of associated nausea compared to the overall study population taking amitiza (19% vs. 29%, respectively). opioid-induced constipation the safety profile of amitiza in the elderly (at least 65 years of age) subpopulation with oic (9% were at least 65 years of age and 2% were at least 75 years of age) was consistent with the safety profile in the overall study population. clinical studies of amitiza did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. irritable bowel syndrome with constipation the safety profile of amitiza in the elderly (at least 65 years of age) subpopulation with ibs-c (8% were at least 65 years of age and 2% were at least 75 years of age) was consistent with the safety profile in the overall study population. clinical studies of amitiza did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. patients with moderate hepatic impairment (child-pugh class b) and severe hepatic impairment (child-pugh class c) experienced markedly higher systemic exposure of lubiprostone active metabolite m3, when compared to subjects with normal hepatic function [ see clinical pharmacology (12.3)] . clinical safety results demonstrated an increased incidence and severity of adverse events in subjects with greater severity of hepatic impairment. adjust the dosage of amitiza in patients with severe hepatic impairment for all indications. dosage adjustment is also needed for patients with moderate hepatic impairment treated for cic, and oic [ see dosage and administration (2.1)] . no dosing adjustment is required in patients with mild hepatic impairment (child-pugh class a).

미국 - 영어 - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate 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 acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) - have not provided adequate analgesia, or are not expected to provide adequate analgesia, have not provided adequate analgesia, or are not expected to provide adequate analgesia, - have not been tolerated, or are not expected to be tolerated. acetaminophen and codeine phosphate tablets are contraindicated for: - all children younger than 12 years of age ( see  warnings ). - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy ( see  warnings

미국 - 영어 - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate 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 acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) - have not provided adequate analgesia, or are not expected to provide adequate analgesia, have not provided adequate analgesia, or are not expected to provide adequate analgesia, - have not been tolerated, or are not expected to be tolerated. acetaminophen and codeine phosphate tablets are contraindicated for: - all children younger than 12 years of age ( see  warnings ). - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy ( see  warnings

미국 - 영어 - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate 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 acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) - have not provided adequate analgesia, or are not expected to provide adequate analgesia, have not provided adequate analgesia, or are not expected to provide adequate analgesia, - have not been tolerated, or are not expected to be tolerated. acetaminophen and codeine phosphate tablets are contraindicated for: - all children younger than 12 years of age ( see  warnings ). - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy ( see  warnings

미국 - 영어 - NLM (National Library of Medicine)

proficient rx lp - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain. codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. this product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.  controlled substance acetaminophen and codeine phosphate tablets are classified as a schedule iii controlled substance. abuse and dependence codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.

미국 - 영어 - NLM (National Library of Medicine)

golden state medical supply, inc. - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen 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 been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia have not provided adequate analgesia, or are not expected to provide adequate analgesia hydrocodone bitartrate and acetaminophen 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. hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with: - significant respiratory depression ( see warnings ) significant respiratory depression ( see warnings ) - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment ( 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 ) known or suspected gastrointestinal obstruction, including paralytic ileus ( see warnings ) - hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) ( see warnings  and adverse reactions ) hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) ( see warnings  and adverse reactions ) hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a schedule ii controlled substance. hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, 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 hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen tablets abuse include those with a history of prolonged use of any opioid, including products containing hydrocodone, those with a history of drug or alcohol abuse, or those who use hydrocodone bitartrate and acetaminophen 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. hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen tablets abuse of hydrocodone bitartrate and acetaminophen tablets poses a risk of overdose and death. the risk is increased with concurrent use of hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen tablets in a patient physically dependent on opioids. rapid tapering of hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of hydrocodone bitartrate and acetaminophen 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, and warnings ) .   infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs ( see pregnancy ).

미국 - 영어 - NLM (National Library of Medicine)

direct_rx - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate 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 acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) have not provided adequate analgesia, or are not expected to provide adequate analgesia, have not been tolerated, or are not expected to be tolerated. acetaminophen and codeine phosphate tablets are contraindicated for: all children younger than 12 years of age (see warnings). postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see warnings). acetaminophen and codeine phosphate tablets are contraindicated in patients with: significant respiratory depression (see warnings). acut

미국 - 영어 - NLM (National Library of Medicine)

direct_rx - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate 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 acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) have not provided adequate analgesia, or are not expected to provide adequate analgesia, have not been tolerated, or are not expected to be tolerated. acetaminophen and codeine phosphate tablets are contraindicated for: all children younger than 12 years of age (see warnings). postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see warnings). acetaminophen and codeine phosphate tablets are contraindicated in patients with: significant respiratory depression (see warnings). acut

미국 - 영어 - NLM (National Library of Medicine)

direct_rx - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j) - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate 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 acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) have not provided adequate analgesia, or are not expected to provide adequate analgesia, have not been tolerated, or are not expected to be tolerated. acetaminophen and codeine phosphate tablets are contraindicated for: all children younger than 12 years of age (see warnings). postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (see warnings). acetaminophen and codeine phosphate tablets are contraindicated in patients with: significant respiratory depression (see warnings). acut