アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

mylan institutional inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 75 mg - bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of bupropion hydrochloride tablets 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)] . - bupropion hydrochloride tablets are contraindicated in patients with a seizure disorder. - bupropion hydrochloride tablets are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrochloride tablets [see warnings and precautions (5.3)]

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

mylan institutional inc. - zonisamide (unii: 459384h98v) (zonisamide - unii:459384h98v) - zonisamide 100 mg - zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. zonisamide capsules are contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide. the abuse and dependence potential of zonisamide capsules have not been evaluated in human studies (see warnings: cognitive/neuropsychiatric adverse events). in a series of animal studies, zonisamide did not demonstrate abuse liability and dependence potential. monkeys did not self-administer zonisamide in a standard reinforcing paradigm. rats exposed to zonisamide did not exhibit signs of physical dependence of the cns-depressant type. rats did not generalize the effects of diazepam to zonisamide in a standard discrimination paradigm after training, suggesting that zonisamide does not have abuse potential of the benzodiazepine-cns depressant type.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

mylan institutional inc. - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - - clopidogrel tablets are indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non-st-segment elevation acs [unstable angina (ua)/non-st-elevation myocardial infarction (nstemi)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel tablets should be administered in conjunction with aspirin . clopidogrel . clopidogrel tablets are indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non-st-segment elevation acs [unstable angina (ua)/non-st-elevation myocardial infarction (nstemi)], including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel tablets should be administered in conjunction with aspirin . clopidogrel . - clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

mylan institutional inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 250 mg - levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. levetiracetam tablets are contraindicated in patients with a hypersensitivity to levetiracetam . reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4)] . there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam tablets, during pregnancy. encourage women who are taking levetiracetam tablets during pregnancy to enroll in the north american antiepileptic drug (naaed

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

mylan institutional inc. - colchicine (unii: sml2y3j35t) (colchicine - unii:sml2y3j35t) - colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. - prophylaxis of gout flares:   colchicine tablets are indicated for prophylaxis of gout flares. - treatment of gout flares:   colchicine tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. colchicine tablets are indicated in adults and children four years or older for treatment of familial mediterranean fever (fmf). patients with renal or hepatic impairment should not be given colchicine tablets in conjunction with p-gp or strong cyp3a4 inhibitors (this includes all protease inhibitors except fosamprenavir). in these patients, life-threatening and fatal colchicine toxicity has been reported with colchicine taken in therapeutic doses. available data from published literature on colchicine use in pregnancy over several decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). colchicine crosses the human placenta. although animal reproductive and developmental studies were not conducted with colchicine tablets, published animal reproduction and development studies indicate that colchicine causes embryofetal toxicity, teratogenicity and altered postnatal development at exposures within or above the clinical therapeutic range. the estimated 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. available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects or miscarriage in pregnant women with rheumatic diseases (such as rheumatoid arthritis, behcet’s disease, or familial mediterranean fever (fmf) treated with colchicine at therapeutic doses during pregnancy. limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications. colchicine is present in human milk (see data) . adverse events in breastfed infants have not been reported in the published literature after administration of colchicine to lactating women. there are no data on the effects of colchicine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for colchicine tablets and any potential adverse effects on the breastfed child from colchicine tablets or from the underlying maternal condition. limited published data from case reports and a small lactation study demonstrate that colchicine is present in breastmilk. a systematic review of literature reported no adverse effects in 149 breastfed children. in a prospective observational cohort study, no gastrointestinal or other symptoms were reported in 38 colchicine-exposed breastfed infants. case reports and epidemiology studies in human male subjects on colchicine therapy indicated that infertility from colchicine is rare and may be reversible. a case report indicated that azoospermia was reversed when therapy was stopped. case reports and epidemiology studies in female subjects on colchicine therapy have not established a clear relationship between colchicine use and female infertility. however, since the progression of fmf without treatment may result in infertility, the use of colchicine needs to be weighed against the potential risks [see nonclinical toxicology (13.1)] . the safety and efficacy of colchicine in children of all ages with fmf has been evaluated in uncontrolled studies. there does not appear to be an adverse effect on growth in children with fmf treated long-term with colchicine. safety and effectiveness of colchicine in pediatric patients with gout has not been established. clinical studies with colchicine for prophylaxis and treatment of gout flares and for treatment of fmf did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. in general, dose selection for an elderly patient with gout should be cautious, reflecting the greater frequency of decreased renal function, concomitant disease or other drug therapy [see dosage and administration (2.4), clinical pharmacology (12.3)] . colchicine is significantly excreted in urine in healthy subjects. clearance of colchicine is decreased in patients with impaired renal function. total body clearance of colchicine was reduced by 75% in patients with end-stage renal disease undergoing dialysis. for prophylaxis of gout flares in patients with mild (estimated creatinine clearance cl cr 50 to 80 ml/min) to moderate (cl cr 30 to 50 ml/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. however, in patients with severe impairment, the starting dose should be 0.3 mg per day and any increase in dose should be done with close monitoring. for the prophylaxis of gout flares in patients undergoing dialysis, the starting doses should be 0.3 mg given twice a week with close monitoring [see dosage and administration (2.5)] . for treatment of gout flares in patients with mild (cl cr 50 to 80 ml/min) to moderate (cl cr 30 to 50 ml/min) renal function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine tablets. however, in patients with severe impairment, while the dose does not need to be adjusted for the treatment of gout flares, a treatment course should be repeated no more than once every two weeks. for patients with gout flares requiring repeated courses, consideration should be given to alternate therapy. for patients undergoing dialysis, the total recommended dose for the treatment of gout flares should be reduced to a single dose of 0.6 mg (one tablet). for these patients, the treatment course should not be repeated more than once every two weeks [see dosage and administration (2.5)] . although pharmacokinetics of colchicine in patients with mild (cl cr 50 to 80 ml/min) and moderate (cl cr 30 to 50 ml/min) renal impairment is not known, these patients should be monitored closely for adverse effects of colchicine. dose reduction may be necessary. in patients with severe renal failure (cl cr less than 30 ml/min) and end-stage renal disease requiring dialysis, colchicine tablets may be started at the dose of 0.3 mg/day. any increase in dose should be done with adequate monitoring of the patient for adverse effects of colchicine tablets [see clinical pharmacology (12.3), dosage and administration (2.5)] . the clearance of colchicine may be significantly reduced and plasma half-life prolonged in patients with chronic hepatic impairment compared to healthy subjects [see clinical pharmacology (12.3)] . for prophylaxis of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended dose is not required, but patients should be monitored closely for adverse effects of colchicine. dose reduction should be considered for the prophylaxis of gout flares in patients with severe hepatic impairment [see dosage and administration (2.6)] . for treatment of gout flares in patients with mild to moderate hepatic function impairment, adjustment of the recommended colchicine tablets dose is not required, but patients should be monitored closely for adverse effects of colchicine tablets. however, for the treatment of gout flares in patients with severe impairment, while the dose does not need to be adjusted, the treatment course should be repeated no more than once every two weeks. for these patients, requiring repeated courses for the treatment of gout flares, consideration should be given to alternate therapy [see dosage and administration (2.6)] . in patients with severe hepatic disease, dose reduction should be considered with careful monitoring [see clinical pharmacology (12.3), dosage and administration (2.6)] . tolerance, abuse or dependence with colchicine has not been reported.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

mylan institutional inc. - celecoxib (unii: jcx84q7j1l) (celecoxib - unii:jcx84q7j1l) - celecoxib 100 mg - celecoxib capsules are indicated for the management of the signs and symptoms of oa [see clinical studies (14.1)] for the management of the signs and symptoms of ra [see clinical studies (14.2)] for the management of the signs and symptoms of jra in patients 2 years and older [see clinical studies (14.3)] for the management of the signs and symptoms of as [see clinical studies (14.4)] for the management of acute pain in adults [see clinical studies (14.5)] for the management of primary dysmenorrhea [see clinical studies (14.5)] celecoxib capsules are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product [see warnings and precautions (5.7, 5.9)

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

mylan institutional inc. - diazepam (unii: q3jtx2q7tu) (diazepam - unii:q3jtx2q7tu) - diazepam 5 mg - diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. in acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. diazepam tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. oral diazepam tablets may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. the effectiveness of diazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. the physician should periodi

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

mylan institutional inc. - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole 30 mg - 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)] . lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy are 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) 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. lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy are indicated in adults for the treatment of patients with h. pylor

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

mylan institutional inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 20 mg - 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 delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine delayed-release capsules 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 delayed-release capsules 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

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

mylan institutional inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine 20 mg - paroxetine tablets are indicated for the treatment of major depressive disorder. the efficacy of paroxetine tablets in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology: clinical trials). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the effects of paroxetine tablets in hospitalized depressed patients have not been ade