미국 - 영어 - NLM (National Library of Medicine)

cardinal health - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - adjunctive therapy lamotrigine tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: monotherapy lamotrigine tablets are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (aed). safety and effectiveness of lamotrigine tablets have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from aeds other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant aeds. lamotrigine tablets are indicated for the maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see clinical studies (14.2)] . limitations

미국 - 영어 - NLM (National Library of Medicine)

cardinal health 107, llc - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium tablets, usp are indicated for: limitations of use warfarin sodium has no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. warfarin sodium tablets, usp are contraindicated in: warfarin sodium tablets, usp are contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism [see warnings and precautions (5.7) and use in specific populations (8.1) ]. warfarin sodium can cause fetal harm when administered to a pregnant woman. warfarin sodium exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fet

미국 - 영어 - NLM (National Library of Medicine)

cardinal health 107, llc - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium tablets, usp are indicated for: limitations of use warfarin sodium has no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. warfarin sodium tablets, usp are contraindicated in: warfarin sodium tablets, usp are contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism [see warnings and precautions (5.7) and use in specific populations (8.1) ]. warfarin sodium can cause fetal harm when administered to a pregnant woman. warfarin sodium exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fet

미국 - 영어 - NLM (National Library of Medicine)

cardinal health 107, llc - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. risk summary available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. amiodarone and its metabolite, desethylamiodarone (dea), cross the placenta. untreated underlying arrhythmias, including ventricular arrhythmias, during pregnancy pose a risk to the mother and fetus (see clinical considerations) . in animal studies, administration of amiodarone to rabbits, rats, and mice during organogenesis resulted in embryo-fetal toxicity at doses less than the maximum recommended human maintenance dose (see data) . advise pregnant women of the potential risk to a fetus. 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. clinical considerations disease-associated maternal and or embryo/fetal risk the incidence of ventricular tachycardia is increased and may be more symptomatic during pregnancy. ventricular arrhythmias most often occur in pregnant women with underlying cardiomyopathy, congenital heart disease, valvular heart disease, or mitral valve prolapse. most tachycardia episodes are initiated by ectopic beats and the occurrence of arrhythmia episodes may therefore, increase during pregnancy due to the increased propensity to ectopic activity. breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to the increased volume of distribution and increased drug metabolism inherent in the pregnant state. fetal/neonatal adverse reactions amiodarone and its metabolite have been shown to cross the placenta. adverse fetal effects associated with maternal amiodarone use during pregnancy may include neonatal bradycardia, qt prolongation, and periodic ventricular extrasystoles, neonatal hypothyroidism (with or without goiter) detected antenatally or in the newborn and reported even after a few days of exposure, neonatal hyperthyroxinemia, neurodevelopmental abnormalities independent of thyroid function, including speech delay and difficulties with written language and arithmetic, delayed motor development, and ataxia, jerk nystagmus with synchronous head titubation, fetal growth restriction, and premature birth. monitor the newborn for signs and symptoms of thyroid disorder and cardiac arrhythmias. labor and delivery risk of arrhythmias may increase during labor and delivery. patients treated with amiodarone hydrochloride tablets should be monitored continuously during labor and delivery [see warnings and precautions (5.4)] . data animal data in pregnant rats and rabbits during the period of organogenesis, amiodarone hydrochloride in doses of 25 mg/kg/day (approximately 0.4 and 0.9 times, respectively, the maximum recommended human maintenance dose1) had no adverse effects on the fetus. in the rabbit, 75 mg/kg/day (approximately 2.7 times the maximum recommended human maintenance dose1) caused abortions in greater than 90% of the animals. in the rat, doses of 50 mg/kg/day or more were associated with slight displacement of the testes and an increased incidence of incomplete ossification of some skull and digital bones; at 100 mg/kg/day or more, fetal body weights were reduced; at 200 mg/kg/day, there was an increased incidence of fetal resorption. (these doses in the rat are approximately 0.8, 1.6 and 3.2 times the maximum recommended human maintenance dose1) adverse effects on fetal growth and survival also were noted in one of two strains of mice at a dose of 5 mg/kg/day (approximately 0.04 times the maximum recommended human maintenance dose1). risk summary amiodarone and one of its major metabolites, dea, are present in breastmilk at between 3.5% and 45% of the maternal weight-adjusted dosage of amiodarone. there are cases of hypothyroidism and bradycardia in breastfed infants, although it is unclear if these effects are due to amiodarone exposure in breastmilk. breastfeeding is not recommended during treatment with amiodarone hydrochloride tablets [see warnings and precautions (5.6, 5.7)] . infertility based on animal fertility studies, amiodarone hydrochloride tablets may reduce female and male fertility. it is not known if this effect is reversible [see nonclinical toxicology (13.1)] . the safety and effectiveness of amiodarone hydrochloride tablets in pediatric patients have not been established. normal subjects over 65 years of age show lower clearances and increased drug half-life than younger subjects [see clinical pharmacology (12.3)] . in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

미국 - 영어 - NLM (National Library of Medicine)

cardinal health 107, llc - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride tablets are indicated for the management of anxiety disorders or 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. the efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (gad). many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. generalized anxiety disorder (300.02) is described in the american psychiatric association’s diagnostic and statistical manual, iii1 as follows: generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1.      motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2.      autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3.      apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4.      vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience. the above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. however, mild depressive symptoms are common in gad. the effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. there is no body of evidence available that systematically addresses the appropriate duration of treatment for gad. however, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient. buspirone hydrochloride tablets are contraindicated in patients hypersensitive to buspirone hydrochloride. the use of monoamine oxidase inhibitors (maois) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. the use of buspirone within 14 days of stopping an maoi intended to treat depression is also contraindicated. starting buspirone in a patient who is being treated with reversible maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome. (see warnings , dosage and administration  and drug interactions ) controlled substance class: buspirone hydrochloride is not a controlled substance. physical and psychological dependence: in human and animal studies, buspirone has shown no potential for abuse or diversion and there is no evidence that it causes tolerance, or either physical or psychological dependence. human volunteers with a history of recreational drug or alcohol usage were studied in two double-blind clinical investigations. none of the subjects were able to distinguish between buspirone hydrochloride tablets and placebo. by contrast, subjects showed a statistically significant preference for methaqualone and diazepam. studies in monkeys, mice, and rats have indicated that buspirone lacks potential for abuse. following chronic administration in the rat, abrupt withdrawal of buspirone did not result in the loss of body weight commonly observed with substances that cause physical dependency. although there is no direct evidence that buspirone hydrochloride tablets causes physical dependence or drug-seeking behavior, it is difficult to predict from experiments 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 buspirone hydrochloride tablets misuse or abuse (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

미국 - 영어 - NLM (National Library of Medicine)

cardinal health 107, llc - divalproex sodium (unii: 644vl95ao6) (valproic acid - unii:614oi1z5wi) - divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. a manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. a mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). the efficacy of divalproex sodium extended-release tablets is based in part on studies of divalproex sodium delayed-release tablets in this indication, and was confirmed in a 3-week trial with patients meeting dsm-iv tr criteria for bipolar i disorder, manic or mixed type, who were hospitalized for acute mania [see clinical studies (

캐나다 - 영어 - Health Canada

septa pharmaceuticals inc - amlodipine (amlodipine besylate) - tablet - 10mg - amlodipine (amlodipine besylate) 10mg - dihydropyridines

캐나다 - 영어 - Health Canada

vanc pharmaceuticals inc - amlodipine (amlodipine besylate) - tablet - 10mg - amlodipine (amlodipine besylate) 10mg - dihydropyridines

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - pramipexole dihydrochloride monohydrate, quantity: 1 mg - tablet - excipient ingredients: pregelatinised maize starch; mannitol; microcrystalline cellulose; povidone; purified talc; magnesium stearate - the treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa. the symptomatic treatment of primary restless legs syndrome.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - pramipexole dihydrochloride monohydrate, quantity: 0.25 mg - tablet - excipient ingredients: pregelatinised maize starch; mannitol; microcrystalline cellulose; povidone; purified talc; magnesium stearate - the treatment of signs and symptoms of idiopathic parkinson's disease. it may be used as monotherapy or in combination with levodopa. the symptomatic treatment of primary restless legs syndrome.