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contract pharmacy services-pa - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine hydrochloride 20 mg - fluoxetine is indicated for the treatment of major depressive disorder. adult - the efficacy of fluoxetine was established in 5 and 6 week trials with depressed adult and geriatric outpatients (≥18 years of age) whose diagnoses corresponded most closely to the dsm-iii (currently dsm-iv) category of major depressive disorder (see clinical trials ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. the effects of fluoxetine in hospitalized depressed patients have not been adequately studied. the efficacy of fluox

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zydus pharmaceuticals (usa) inc. - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - dextroamphetamine sulfate 5 mg - dextroamphetamine sulfate extended-release capsules are indicated in: narcolepsy attention deficit disorder with hyperactivity as an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organ

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mylan pharmaceuticals inc. - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - dextroamphetamine sulfate 5 mg - dextroamphetamine sulfate extended-release capsules are indicated in: narcolepsy as an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained ment

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proficient rx lp - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 150 mg - tramadol hydrochloride extended-release is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. tramadol hydrochloride extended-release is contraindicated in patients who have previously demonstrated hypersensitivity to tramadol, any other component of tramadol hydrochloride extended-release, or opioids. reactions range from pruritis to fatal anaphylactoid reactions [see warnings and precautions (5.4)]. tramadol hydrochloride extended-release is contraindicated in patients with significant respiratory depression in unmonitored settings or the absence of resuscitative equipment. tramadol hydrochloride extended-release is contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment. teratogenic effects: pregnancy category c there are no adequate and well-controlled studies in pregnant women. use tramadol hydroch

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medsource pharmaceuticals - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 150 mg - tramadol hydrochloride extended-release is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. tramadol hydrochloride extended-release is contraindicated in patients who have previously demonstrated hypersensitivity to tramadol, any other component of tramadol hydrochloride extended-release, or opioids. reactions range from pruritis to fatal anaphylactoid reactions [see warnings and precautions ( 5.4)]. tramadol hydrochloride extended-release is contraindicated in patients with significant respiratory depression in unmonitored settings or the absence of resuscitative equipment. tramadol hydrochloride extended-release is contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment. teratogenic effects: pregnancy category c there are no adequate and well-controlled studies in pregna

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h.j. harkins company, inc. - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 150 mg - tramadol hydrochloride extended-release is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. tramadol hydrochloride extended-release is contraindicated in patients who have previously demonstrated hypersensitivity to tramadol, any other component of tramadol hydrochloride extended-release, or opioids. reactions range from pruritis to fatal anaphylactoid reactions [see warnings and precautions (5.4)]. tramadol hydrochloride extended-release is contraindicated in patients with significant respiratory depression in unmonitored settings or the absence of resuscitative equipment. tramadol hydrochloride extended-release is contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment. teratogenic effects: pregnancy category c there are no adequate and well-controlled studies in pregnant women. use tramadol hydroc

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mylan institutional inc. - chlordiazepoxide hydrochloride (unii: mfm6k1xwdk) (chlordiazepoxide - unii:6rz6xez3cr) - chlordiazepoxide hydrochloride 5 mg - chlordiazepoxide hcl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the effectiveness of chlordiazepoxide hcl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodically reassess the usefulness of the drug for the individual patient. chlordiazepoxide hcl capsules are contraindicated in patients with known hypersensitivity to the drug. chlordiazepoxide is a schedule iv controlled substance. chlordiazepoxide is a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. 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. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication.  abuse and misuse may lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see warnings: abuse, misuse, and addiction). the following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. death is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol). physical dependence chlordiazepoxide may produce physical dependence from continued therapy. physical dependence is a state that develops as a result of 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. abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see warnings: dependence and withdrawal reactions). to reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide or reduce the dosage (see dosage and administration: discontinuation or dosage reduction of chlordiazepoxide and warnings: dependence and withdrawal reactions). acute withdrawal signs and symptoms acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality. protracted withdrawal syndrome protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more than 12 months. as a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. tolerance tolerance to chlordiazepoxide may develop from continued 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). tolerance to the therapeutic effect of chlordiazepoxide may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

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nucare pharmaceuticals, inc. - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 150 mg - tramadol hydrochloride extended-release is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. tramadol hydrochloride extended-release is contraindicated in patients who have previously demonstrated hypersensitivity to tramadol, any other component of tramadol hydrochloride extended-release, or opioids. reactions range from pruritis to fatal anaphylactoid reactions [see warnings and precautions ( 5.4 )]. tramadol hydrochloride extended-release is contraindicated in patients with significant respiratory depression in unmonitored settings or the absence of resuscitative equipment. tramadol hydrochloride extended-release is contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment. teratogenic effects: pregnancy category c there are no adequate and well-controlled studies in pregnant women.

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preferred pharmaceuticals inc. - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 150 mg - tramadol hydrochloride extended-release is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. tramadol hydrochloride extended-release is contraindicated in patients who have previously demonstrated hypersensitivity to tramadol, any other component of tramadol hydrochloride extended-release, or opioids. reactions range from pruritis to fatal anaphylactoid reactions [see warnings and precautions (5.4)]. tramadol hydrochloride extended-release is contraindicated in patients with significant respiratory depression in unmonitored settings or the absence of resuscitative equipment. tramadol hydrochloride extended-release is contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment. teratogenic effects: pregnancy category c there are no adequate and well-controlled studies in pregnant women. use tramadol hydroch

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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)] .