미국 - 영어 - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate tablets, usp are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets, usp have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see ]. clinical studies (14) the clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema . [see warnings and precautions (5.3)] pregnancy category c there are no adequate and well-controlled studies of zolpidem tartrate tablets in pregnant women. studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respirator

미국 - 영어 - NLM (National Library of Medicine)

quality care products llc - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin is indicated for: •adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and visceral abnormalities, and increased embryofeta

미국 - 영어 - NLM (National Library of Medicine)

quality care products, llc - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine delayed-release capsules are indicated for the treatment of: - major depressive disorder [see clinical studies ( 14.1 )] . - generalized anxiety disorder [see clinical studies ( 14.2 )] . - diabetic peripheral neuropathy [see clinical studies ( 14.3 )] . - chronic musculoskeletal pain [see clinical studies ( 14.5 )] .          monoamine oxidase inhibitors (maois) - the use of maois intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)].          starting duloxetine in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration (2.9) and warnings and

미국 - 영어 - NLM (National Library of Medicine)

quality care products llc - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine delayed-release capsules are indicated for the treatment of: - major depressive disorder [see clinical studies ( 14.1 )] . - generalized anxiety disorder [see clinical studies ( 14.2 )] . - diabetic peripheral neuropathy [see clinical studies ( 14.3 )] . - chronic musculoskeletal pain [see clinical studies ( 14.5 )] .          monoamine oxidase inhibitors (maois) - the use of maois intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)].          starting duloxetine in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration (2.9) and warnings and precautions (5.4)]. pregnancy category c          risk summary — there are no adequate and well-controlled studies of duloxetine administration in pregnant women. in animal studies with duloxetine, fetal weights were decreased but there was no evidence of teratogenicity in pregnant rats and rabbits at oral doses administered during the period of organogenesis up to 4 and 7 times the maximum recommended human dose (mrhd) of 120 mg/day, respectively. when duloxetine was administered orally to pregnant rats throughout gestation and lactation, pup weights at birth and pup survival to 1 day postpartum were decreased at a dose 2 times the mrhd. at this dose, pup behaviors consistent with increased reactivity, such as increased startle response to noise and decreased habituation of locomotor activity were observed. post-weaning growth was not adversely affected. duloxetine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. clinical considerations          fetal/neonatal adverse reaction — neonates exposed during pregnancy to serotonin - norepinephrine reuptake inhibitors (snris) or selective serotonin reuptake inhibitors (ssris) have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding which can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. these features are consistent with either a direct toxic effect of the snris or ssris, or possibly, a drug discontinuation syndrome. it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see warnings and precautions (5.4)] . data          animal data — in animal reproduction studies, duloxetine has been shown to have adverse effects on embryo/fetal and postnatal development.          when duloxetine was administered orally to pregnant rats and rabbits during the period of organogenesis, there was no evidence of teratogenicity at doses up to 45 mg/kg/day (4 times the maximum recommended human dose (mrhd) of 120 mg/day on a mg/m2 basis, in rat; 7 times the mrhd in rabbit). however, fetal weights were decreased at this dose, with a no-effect dose of 10 mg/kg/day approximately equal to the mrhd in rats; 2 times the mrhd in rabbits).          when duloxetine was administered orally to pregnant rats throughout gestation and lactation, the survival of pups to 1 day postpartum and pup body weights at birth and during the lactation period were decreased at a dose of 30 mg/kg/day (2 times the mrhd); the no-effect dose was 10 mg/kg/day. furthermore, behaviors consistent with increased reactivity, such as increased startle response to noise and decreased habituation of locomotor activity, were observed in pups following maternal exposure to 30 mg/kg/day. post-weaning growth and reproductive performance of the progeny were not affected adversely by maternal duloxetine treatment.          risk summary          duloxetine is present in human milk. in a published study, lactating women who were weaning their infants were given duloxetine. at steady state, the concentration of duloxetine in breast milk was approximately 25% that of maternal plasma. the estimated daily infant dose was approximately 0.14% of the maternal dose. the developmental and health benefits of human milk feeding should be considered along with the mother’s clinical need for duloxetine and any potential adverse effects on the milk-fed child from the drug or from the underlying maternal condition. exercise caution when duloxetine is administered to a nursing woman.          data          the disposition of duloxetine was studied in 6 lactating women who were at least 12 weeks postpartum and had elected to wean their infants. the women were given 40 mg of duloxetine twice daily for 3.5 days. the peak concentration measured in breast milk occurred at a median of 3 hours after the dose. the amount of duloxetine in breast milk was approximately 7 mcg/day while on that dose; the estimated daily infant dose was approximately 2 mcg/kg/day. the presence of duloxetine metabolites in breast milk was not examined. generalized anxiety disorder — in pediatric patients aged 7 to 17 years, efficacy was demonstrated in one 10 week, placebo-controlled trial. the study included 272 pediatric patients with gad of which 47% were 7 to 11 years of age. duloxetine demonstrated superiority over placebo as measured by greater improvement in the pediatric anxiety rating scale (pars) for gad severity score [see clinical studies (14.2)]. the safety and effectiveness in pediatric patients less than 7 years of age have not been established. major depressive disorder — efficacy was not demonstrated in two 10-week, placebo-controlled trials with 800 pediatric patients with mdd, age 7-17. neither duloxetine nor an active control (indicated for treatment of pediatric depression) was superior to placebo. the safety and effectiveness in pediatric patients less than 7 years of age have not been established. the most frequently observed adverse reactions in the clinical trials included nausea, headache, decreased weight, and abdominal pain. decreased appetite and weight loss have been observed in association with the use of ssris and snris. perform regular monitoring of weight and growth in children and adolescents treated with an snri such as duloxetine [see adverse reactions (6.11)]. use of duloxetine in a child or adolescent must balance the potential risks with the clinical need [see boxed warning and warnings and precautions (5.1)]. animal data — duloxetine administration to young rats from post-natal day 21 (weaning) through post-natal day 90 (adult) resulted in decreased body weights that persisted into adulthood, but recovered when drug treatment was discontinued; slightly delayed (~1.5 days) sexual maturation in females, without any effect on fertility; and a delay in learning a complex task in adulthood, which was not observed after drug treatment was discontinued. these effects were observed at the high dose of 45 mg/kg/day (2 times the mrhd, for a child); the no-effect-level was 20 mg/kg/day (≈1 times the mrhd, for a child). of the 2,418 patients in premarketing clinical studies of duloxetine for mdd, 5.9% (143) were 65 years of age or over. of the 1041 patients in clbp premarketing studies, 21.2% (221) were 65 years of age or over. of the 487 patients in oa premarketing studies, 40.5% (197) were 65 years of age or over. of the 1,074 patients in the dpnp premarketing studies, 33% (357) were 65 years of age or over. in the mdd, gad, dpnp, oa, clbp, and other studies, no overall differences in safety or effectiveness were generally observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. ssris and snris, including duloxetine have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see warnings and precautions (5.13)] . in an analysis of data from all placebo-controlled-trials, patients treated with duloxetine reported a higher rate of falls compared to patients treated with placebo. the increased risk appears to be proportional to a patient’s underlying risk for falls. underlying risk appears to increase steadily with age. as elderly patients tend to have a higher prevalence of risk factors for falls such as medications, medical comorbidities and gait disturbances, the impact of increasing age by itself on falls during treatment with duloxetine is unclear. falls with serious consequences including bone fractures and hospitalizations have been reported [see warnings and precautions (5.3) and adverse reactions (6.10)] . the pharmacokinetics of duloxetine after a single dose of 40 mg were compared in healthy elderly females (65 to 77 years) and healthy middle-age females (32 to 50 years). there was no difference in the cmax, but the auc of duloxetine was somewhat (about 25%) higher and the half-life about 4 hours longer in the elderly females. population pharmacokinetic analyses suggest that the typical values for clearance decrease by approximately 1% for each year of age between 25 to 75 years of age; but age as a predictive factor only accounts for a small percentage of between-patient variability. dosage adjustment based on the age of the patient is not necessary.       duloxetine's half-life is similar in men and women. dosage adjustment based on gender is not necessary.          duloxetine bioavailability (auc) appears to be reduced by about one-third in smokers. dosage modifications are not recommended for smokers.          no specific pharmacokinetic study was conducted to investigate the effects of race.          patients with clinically evident hepatic impairment have decreased duloxetine metabolism and elimination. after a single 20 mg dose of duloxetine, 6 cirrhotic patients with moderate liver impairment (child-pugh class b) had a mean plasma duloxetine clearance about 15% that of age- and gender-matched healthy subjects, with a 5-fold increase in mean exposure (auc). although cmax was similar to normals in the cirrhotic patients, the half-life was about 3 times longer [see dosage and administration (2.6) and warnings and precautions (5.14)] .          limited data are available on the effects of duloxetine in patients with end-stage renal disease (esrd). after a single 60 mg dose of duloxetine, cmax and auc values were approximately 100% greater in patients with end-stage renal disease receiving chronic intermittent hemodialysis than in subjects with normal renal function. the elimination half-life, however, was similar in both groups. the aucs of the major circulating metabolites, 4-hydroxy duloxetine glucuronide and 5-hydroxy, 6-methoxy duloxetine sulfate, largely excreted in urine, were approximately 7- to 9-fold higher and would be expected to increase further with multiple dosing. population pk analyses suggest that mild to moderate degrees of renal impairment (estimated crcl 30 to 80 ml/min) have no significant effect on duloxetine apparent clearance [see dosage and administration (2.6) and warnings and precautions (5.14)] .          in animal studies, duloxetine did not demonstrate barbiturate-like (depressant) abuse potential.          while duloxetine has not been systematically studied in humans for its potential for abuse, there was no indication of drug-seeking behavior in the clinical trials. however, it is not possible to predict on the basis of premarketing experience the extent to which a cns active drug will be misused, diverted, and/or abused once marketed. consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of duloxetine (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).          in drug dependence studies, duloxetine did not demonstrate dependence-producing potential in rats.

미국 - 영어 - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - citalopram hydrobromide (unii: i1e9d14f36) (citalopram - unii:0dhu5b8d6v) - citalopram tablets, usp are indicated for the treatment of depression. the efficacy of citalopram tablets, usp in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the dsm-iii and dsm-iii-r category of major depressive disorder (see clinical pharmacology ). 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 antidepressant action of citalopram tablets, usp in hospitalized depressed patients has not been adequately

미국 - 영어 - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine fumarate tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1) ]. quetiapine fumarate tablets are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical studies (14.2) ]. quetiapine fumarate tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week mo

미국 - 영어 - NLM (National Library of Medicine)

aurolife pharma, llc - amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - amphetamine sulfate tablets usp are indicated for: - narcolepsy - attention deficit disorder with hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or not be warranted. - exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patient’s refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs. the limited usefulness of amphetamines (see clinical pharmacology ) should be weighed against possible risks inherent in use of the drug, such as those described below. ·         known hypersensitivity to amphetamine products. ·         during or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result) (see warnings). controlled substance amphetamine sulfate tablets contains amphetamine, a schedule ii controlled substance. abuse amphetamine sulfate tablets has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see warnings). amphetamine sulfate tablets can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. 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. misuse and abuse of amphetamines may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with cns stimulants abuse and/or misuse. misuse and abuse of cns stimulants, including amphetamine sulfate, can result in overdose and death (see overdosage), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.   dependence physical dependence amphetamine sulfate tablets may produce physical dependence. 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. withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of cns stimulants including amphetamine sulfate tablets include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation. tolerance amphetamine sulfate tablets may produce tolerance. 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).

미국 - 영어 - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see clinical studies (14.1) ]. triple therapy: lansoprazole/amoxicillin/clarithromycin lansoprazole in combination with amoxicillin plus clarithromycin as triple therapy is indicated i adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate h. pylori. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.2) ]. please refer to the full prescribing information for amoxicillin and clarithromycin. dual therapy: lansoprazole/amoxicillin lansoprazole in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithrom

미국 - 영어 - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride extended-release (sr) tablets are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies (14)] . the efficacy of bupropion hydrochloride extended-release (sr) tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see clinical studies (14)] . pregnancy category c risk summary: data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. all pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. no clear evidence of teratogen

미국 - 영어 - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine hydrochloride extended-release capsules, usp are indicated for the treatment of major depressive disorder (mdd). efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. venlafaxine hydrochloride extended-release capsules, usp are indicated for the treatment of social anxiety disorder (sad), also known as social phobia. efficacy was established in four 12-week and one 26-week, placebo-controlled trials. venlafaxine hydrochloride extended-release capsules, usp are indicated for the treatment of panic disorder (pd), with or without agoraphobia. efficacy was established in two 12-week placebo-controlled trials. hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation the use of maois (intended to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride or within 7 days of discontinuing treatment with venlafaxine hydrochloride is contraindicated because of an increased risk of seroto