الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

roxane laboratories, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 100 mg in 5 ml - oxycodone hydrochloride oral solution usp, 100 mg per 5 ml (20 mg/ml ) is an opioid analgesic indicated for the management of moderate to severe acute and chronic pain in opioid-tolerant patients. oxycodone hydrochloride oral solution usp, 100 mg per 5 ml (20 mg/ml) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. patients considered to be opioid tolerant are those who are taking at least 30 mg of oral oxycodone per day, or at least 60 mg oral morphine per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. oxycodone hydrochloride oral solution usp is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. oxycodone hydrochloride oral solution usp is contraindicated in any patient who has or is suspected of having paralytic ileus. oxycodone hydrochloride oral solution usp is contraindicated in patients with acute or severe bronchial asthma or hypercarbi

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

morton grove pharmaceuticals, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 5 mg in 5 ml - oxycodone hydrochloride oral solution, usp is 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 (5.2) ], reserve oxycodone hydrochloride oral solution, usp 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. oxycodone hydrochloride oral solution, usp is contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.4) ] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.4) ] - known or suspected gas

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

lannett company, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 100 mg in 5 ml - oxycodone hydrochloride oral solution (5 mg per ml) , an opioid agonist, is indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. oxycodone hydrochloride oral solution 100 mg per 5 ml (20 mg per ml) , an opioid agonist, is indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. oxycodone hydrochloride oral solution usp, 100 mg per 5 ml (20 mg per ml) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. patients considered to be opioid tolerant are those who are taking at least 30 mg of oral oxycodone per day, or at least 60 mg oral morphine per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. oxycodone hydrochloride is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. oxycodone hydrochloride is contraindicated in any patient who has or is sus

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

safecor health, llc - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 20 mg in 1 ml - morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. patients considered to be opioid tolerant are those who are taking at least 60 mg oral morphine per day, or at least 30 mg of oral oxycodone per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. morphine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. morphine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. morphine sulfate is contraindicated in any patient who has

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

atlantic biologicals corp. - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 20 mg in 5 ml - morphine sulfate oral solution (10 mg per 5 ml and 20 mg per 5 ml) are formulations of morphine, an opioid agonist, indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) is an opioid analgesic indicated for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients. morphine sulfate oral solution 100 mg per 5 ml (20 mg/ml) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. patients considered to be opioid tolerant are those who are taking at least 60 mg oral morphine per day, or at least 30 mg of oral oxycodone per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. morphine sulfate is contraindicated in patients

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

nostrum laboratories, inc. - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 10 mg in 5 ml - morphine sulfate oral solution (10 mg per 5 ml and 20 mg per 5 ml ) are formulations of morphine, an opioid agonist, indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. morphine sulfate is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. morphine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. morphine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. morphine sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus. no formal studies to assess the teratogenic effects of morphine in animals have been conducted.  it is also not known whether morphine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.  morphine should be given to a pregnant woman only if clearly needed. in humans, the frequency

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

mayne pharma commercial llc - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 5 mg - oxycodone hydrochloride capsules are an opioid agonist 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 oxycodone hydrochloride capsules 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 oxycodone hydrochloride capsules are 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 (5.7)] - known or suspected gast

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

safecor health, llc - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 20 mg in 1 ml - oxycodone hydrochloride oral solution 100 mg/5 ml (20 mg/ml ) is an opioid analgesic indicated for the management of moderate to severe acute and chronic pain in opioid-tolerant patients. oxycodone hydrochloride oral solution 100 mg/5 ml (20 mg/ml) may cause fatal respiratory depression when administered to patients not previously exposed to opioids. patients considered to be opioid tolerant are those who are taking at least 30 mg of oral oxycodone per day, or at least 60 mg oral morphine per day, or at least 12 mg hydromorphone per day, or an equianalgesic dose of another opioid, for a week or longer. oxycodone hydrochloride is contraindicated in patients with respiratory depression in the absence of resuscitative equipment. oxycodone hydrochloride is contraindicated in any patient who has or is suspected of having paralytic ileus. oxycodone hydrochloride is contraindicated in patients with acute or severe bronchial asthma or hypercarbia. oxycodone hydrochloride is contraindicated in patients with known

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

amneal pharmaceuticals llc - quinine sulfate (unii: kf7z0e0q2b) (quinine - unii:a7v27phc7a) - quinine sulfate 324 mg - quinine sulfate is an antimalarial drug indicated only for treatment of uncomplicated plasmodium falciparum malaria. quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see clinical studies (14)] . limitations of use: quinine sulfate capsules are not approved for: - treatment of severe or complicated p. falciparum malaria. - prevention of malaria. - treatment or prevention of nocturnal leg cramps [see warnings and precautions (5.1)] . quinine sulfate capsules are contraindicated in patients with the following: - prolonged qt interval. one case of a fatal ventricular arrhythmia was reported in an elderly patient with a prolonged qt interval at baseline, who received quinine sulfate intravenously for p. falciparum malaria [see warnings and precautions (5.4)] . - known hypersensitivity reactions to quinine. these include, but are not limited to, the following [see warnings and precautions (5.7)] : thrombocytopenia idiopathic thrombocytopenia purpura (itp) and thrombotic thrombocytopenic purpura (ttp) hemolytic uremic syndrome (hus) blackwater fever (acute intravascular hemolysis, hemoglobinuria, and hemoglobinemia) - thrombocytopenia - idiopathic thrombocytopenia purpura (itp) and thrombotic thrombocytopenic purpura (ttp) - hemolytic uremic syndrome (hus) - blackwater fever (acute intravascular hemolysis, hemoglobinuria, and hemoglobinemia) - known hypersensitivity to mefloquine or quinidine: cross-sensitivity to quinine has been documented [see warnings and precautions (5.7)] . - myasthenia gravis. quinine has neuromuscular blocking activity, and may exacerbate muscle weakness. - optic neuritis. quinine may exacerbate active optic neuritis [see adverse reactions (6.1)] . risk summary prolonged experience with quinine in pregnant women over several decades, based on published prospective and retrospective observational studies, surveys, safety and efficacy studies, review articles, case reports and case series have not identified a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see data) . in animal reproduction studies, administration of quinine by multiple routes of administration to pregnant rabbits, dogs, guinea pigs, rats, and monkeys during the period of organogenesis at doses of 0.25 to 2 times the maximum recommended human dose (mrhd) based on body surface area (bsa), produced embryo-fetal toxicity including malformations. offspring of pregnant rats administered oral quinine sulfate during mating, gestation, and lactation at a dose approximately equivalent to 0.1 times the mrhd based on bsa comparison experienced impaired growth and delayed physical development (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population are 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. clinical considerations disease-associated maternal and/or embryo/fetal risk malaria during and after pregnancy increases the risk for adverse pregnancy and neonatal outcomes, including maternal anemia, severe malaria, spontaneous abortion, stillbirths, preterm delivery, low birth weight, intrauterine growth retardation, congenital malaria, and maternal and neonatal mortality. maternal adverse reactions an increased incidence of hypoglycemia, due to increased pancreatic secretion of insulin, has been reported with quinine use, in pregnant women, especially during the third trimester1 . monitor glucose levels in pregnant woman taking quinine. tinnitus, vomiting, dizziness, and nausea are commonly reported adverse reactions in pregnant women taking quinine. pregnant women are also at risk for a rare triad of complications: massive hemolysis, hemoglobinemia, and hemoglobinuria2 . labor or delivery in doses several times higher than those used to treat malaria, quinine may cause uterine contractions; however, there is no evidence that quinine causes uterine contractions at the doses recommended for the treatment of malaria. data human data quinine crosses the placenta with measurable blood concentrations in the fetus. in 8 women who delivered live infants 1 to 6 days after starting quinine therapy, umbilical cord plasma quinine concentrations were between 1.0 and 4.6 mg/l (mean 2.4 mg/l) and the mean (±sd) ratio of cord plasma to maternal plasma quinine concentrations was 0.32 ± 0.14. quinine levels in the fetus may not be therapeutic. adverse outcomes have been identified in the post-marketing experience with quinine during pregnancy. because these outcomes are reported from varied data sources and have inconsistent findings and/or important methodological limitations, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. in studies in which more than 893 pregnant women were treated with quinine for malaria in the first trimester, no quinine-associated increases in the incidence of congenital anomalies were observed compared with other antimalarial drugs3 . a retrospective study of women with p. falciparum malaria who were treated with oral quinine sulfate 10 mg/kg 3 times daily for 7 days at any time in pregnancy reported no significant difference in the rate of stillbirths at > 28 weeks of gestation in women treated with quinine (10 of 633 women [1.6%]) as compared with a control group without malaria or exposure to antimalarial drugs during pregnancy (40 of 2201 women [1.8%]). the overall rate of congenital malformations (9 of 633 offspring [1.4%]) was not different for women who were treated with quinine sulfate compared with the control group (38 of 2201 offspring [1.7%]). the spontaneous abortion rate was higher in the control group (10.9%) than in women treated with quinine sulfate (3.5%) [or = 3.1; 95% ci 2.1 to 4.7]. an epidemiologic survey that included 104 mother-child pairs exposed to quinine during the first 4 months of pregnancy, found no increased risk of structural birth defects was seen (2 fetal malformations [1.9%]). case reports describe deafness and optic nerve hypoplasia in children exposed in utero due to maternal ingestion of high doses of quinine. animal data in animal developmental studies conducted in multiple animal species4 , pregnant animals received quinine by the subcutaneous, intramuscular, and oral routes at doses 0.25 to 2 times the maximum recommended human dose (mrhd) based on body surface area (bsa). increases in fetal death were observed in utero in pregnant rabbits at maternal doses ≥ 100 mg/kg/day and in pregnant dogs at ≥ 15 mg/kg/day corresponding to dose levels approximately 0.5 and 0.25 times the mrhd respectively based on bsa comparisons. rabbit offspring had increased rates of degenerated auditory nerve and spiral ganglion and increased rates of cns anomalies such as anencephaly and microcephaly at a dose of 130 mg/kg/day corresponding to a maternal dose approximately 1.3 times the mrhd based on bsa comparison. guinea pig offspring had increased rates of cochlear hemorrhage at maternal doses of 200 mg/kg corresponding to a dose level of approximately 1.4 times the mrhd based on bsa comparison. no fetal malformations were observed in rats at maternal doses up to 300 mg/kg/day and in monkeys at maternal doses up to 200 mg/kg/day corresponding to doses approximately 1 and 2 times the mrhd respectively based on bsa comparisons. in a pre-postnatal study, pregnant rats received quinine sulfate in feed beginning two weeks prior to mating, through gestation, and lactation. an estimated oral dose of quinine sulfate of 20 mg/kg/day corresponding to approximately 0.1 times the mrhd based on bsa comparison resulted in offspring with impaired growth, lower body weights at birth and during the lactation period, and delayed physical development of teeth eruption and eye opening during the lactation period. risk summary quinine is present in human milk. it is estimated that breastfed infants would receive less than 2 to 3 mg per day of quinine base (< 0.4% of the maternal dose) via breast milk (see data) . there are no data on the effects of quinine on the breastfed infant or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for quinine sulfate and any potential adverse effects on the breastfed child from quinine sulfate or from the underlying maternal condition. data no toxicity was reported in infants in a single study where oral quinine sulfate (10 mg/kg every 8 hours for 1 to 10 days) was administered to 25 lactating women. quinine concentrations in breast milk are approximately 31% of quinine concentrations in maternal plasma. infertility in a published study5 in 5 men receiving oral tablets of 600 mg quinine three times a day for one week, sperm motility was decreased and percent sperm with abnormal morphology was increased, but sperm count and serum testosterone were unaffected. based on findings from animal studies, quinine sulfate may impair fertility [see nonclinical toxicology (13.1)] . the safety and efficacy of quinine sulfate in pediatric patients under the age of 16 has not been established. clinical studies of quinine sulfate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond to treatment differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. clearance of quinine is decreased in patients with severe chronic renal failure. the dosage and dosing frequency should be reduced [see dosage and administration (2.2) and clinical pharmacology (12.3)] . in patients with severe hepatic impairment (child-pugh c), quinine oral clearance (cl/f) is decreased, volume of distribution (vd /f) is increased, and half-life is prolonged, relative to subjects with normal liver function. therefore, quinine is not indicated in patients with severe hepatic impairment and alternate therapy should be administered [see dosage and administration (2.3) and clinical pharmacology (12.3)] . close monitoring is recommended for patients with mild (child-pugh a) or moderate (child-pugh b) hepatic impairment, as exposure to quinine may be increased relative to subjects with normal liver function [see clinical pharmacology (12.3)] .

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - quinine sulfate (unii: kf7z0e0q2b) (quinine - unii:a7v27phc7a) - quinine sulfate 324 mg - quinine sulfate capsules are an antimalarial drug indicated only for treatment of uncomplicated plasmodium falciparum malaria. quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see clinical studies (14) ]. limitations of use: quinine sulfate capsules are not approved for: - treatment of severe or complicated p. falciparum malaria. - prevention of malaria. - treatment or prevention of nocturnal leg cramps [see warnings and precautions (5.1) ]. quinine sulfate capsules are contraindicated in patients with the following: - prolonged qt interval. one case of a fatal ventricular arrhythmia was reported in an elderly patient with a prolonged qt interval at baseline, who received quinine sulfate intravenously for p. falciparum malaria [see warnings and precautions (5.4) ]. - known hypersensitivity reactions to quinine. these include, but are not limited to, the following [see warnings and precautions (5.7) ]: thrombocytopenia idiopathic