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teva pharmaceuticals usa, inc. - imatinib mesylate (unii: 8a1o1m485b) (imatinib - unii:bkj8m8g5hi) - imatinib 100 mg - newly diagnosed adult and pediatric patients with philadelphia chromosome positive chronic myeloid leukemia (ph+ cml) in chronic phase. patients with philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. adult patients with relapsed or refractory philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all). pediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) in combination with chemotherapy. adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with aggressive systemic mastocytosis without the d816v c-kit mutation or with c-kit mutational status unknown. adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the fip1l1-pdgfrα fusion kinase (mutational analysis or fluorescence in situ hybridiz

미국 - 영어 - NLM (National Library of Medicine)

american health packaging - imatinib mesylate (unii: 8a1o1m485b) (imatinib - unii:bkj8m8g5hi) - imatinib 100 mg - newly diagnosed adult and pediatric patients with philadelphia chromosome positive chronic myeloid leukemia (ph+ cml) in chronic phase. patients with philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. adult patients with relapsed or refractory philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all). pediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) in combination with chemotherapy. adult patients with myelodysplastic/myeloproliferative diseases associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with aggressive systemic mastocytosis without the d816v c-kit mutation or with c-kit mutational status unknown. adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who have the fip1l1-pdgfrα fusion kinase (mutational analysis or fluorescence in situ hybridization [fish] demonstration of chic2 allele deletion) and for patients with hes and/or cel who are fip1l1-pdgfrα fusion kinase negative or unknown. adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans. patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors. adjuvant treatment of adult patients following complete gross resection of kit (cd117) positive gist. none. risk summary imatinib mesylate can cause fetal harm when administered to a pregnant woman based on human and animal data. there are no clinical studies regarding use of imatinib mesylate in pregnant women. there have been postmarket reports of spontaneous abortions and congenital anomalies from women who have been exposed to imatinib mesylate during pregnancy. reproductive studies in rats have demonstrated that imatinib mesylate induced teratogenicity and increased incidence of congenital abnormalities following prenatal exposure to imatinib mesylate at doses equal to the highest recommended human dose of 800 mg/day based on bsa. advise women to avoid pregnancy when taking imatinib mesylate. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus. the background risk of major birth defects and miscarriage for the indicated population is not known; however, in the u.s. general population, the estimated background risk of major birth defects of clinically recognized pregnancies is 2% to 4% and of miscarriage is 15% to 20%. data animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of imatinib mesylate up to 100 mg/kg/day and 60 mg/kg/day, respectively, during the period of organogenesis. in rats, imatinib mesylate was teratogenic at 100 mg/kg/day (approximately equal to the maximum human dose of 800 mg/day based on bsa), the number of fetuses with encephalocoele and exencephaly was higher than historical control values and these findings were associated with missing or underdeveloped cranial bones. lower mean fetal body weights were associated with retarded skeletal ossifications. in rabbits, at doses 1.5 times higher than the maximum human dose of 800 mg/day based on bsa, no effects on the reproductive parameters with respect to implantation sites, number of live fetuses, sex ratio or fetal weight were observed. the examinations of the fetuses did not reveal any drug related morphological changes. in a pre- and postnatal development study in rats, pregnant rats received oral doses of imatinib mesylate during gestation (organogenesis) and lactation up to 45 mg/kg/day. five animals developed a red vaginal discharge in the 45 mg/kg/day group on days 14 or 15 of gestation, the significance of which is unknown since all females produced viable litters and none had increased post-implantation loss. other maternal effects noted only at the dose of 45 mg/kg/day (approximately one-half the maximum human dose of 800 mg/day based on bsa) included an increased number of stillborn pups and pups dying between postpartum days 0 and 4. in the f1 offspring at this same dose level, mean body weights were reduced from birth until terminal sacrifice and the number of litters achieving criterion for preputial separation was slightly decreased. there were no other significant effects in developmental parameters or behavioral testing. f1 fertility was not affected but reproductive effects were noted at 45 mg/kg/day, including an increased number of resorptions and a decreased number of viable fetuses. the no-observed-effect level (noel) for both maternal animals and the f1 generation was 15 mg/kg/day. risk summary imatinib and its active metabolite are excreted into human milk. because of the potential for serious adverse reactions in breastfed infants from imatinib mesylate, advise a lactating woman not to breastfeed during treatment and for 1 month after the last dose. human data based on data from 3 breastfeeding women taking imatinib mesylate, the milk:plasma ratio is about 0.5 for imatinib and about 0.9 for the active metabolite. considering the combined concentration of imatinib and active metabolite, a breastfed infant could receive up to 10% of the maternal therapeutic dose based on body weight. human postmarketing reports and animal studies have shown imatinib mesylate to be harmful to the developing fetus [see use in specific populations (8.1)]. pregnancy testing test pregnancy status in females with reproductive potential prior to the initiation of treatment with imatinib mesylate. contraception females advise female patients of reproductive potential to use effective contraception (methods that result in less than 1 % pregnancy rates) when using imatinib mesylate during treatment and for fourteen days after stopping treatment with imatinib mesylate [see use in specific populations (8.1)]. infertility the risk of infertility in females or males of reproductive potential has not been studied in humans. in a rat study, the fertility in males and females was not affected [see nonclinical toxicology (13) ]. the safety and effectiveness of imatinib mesylate have been demonstrated in pediatric patients with newly diagnosed ph+ chronic phase cml and ph+ all [see clinical studies (14.2, 14.4)]. there are no data in children under 1 year of age. in the cml clinical studies, approximately 20% of patients were older than 65 years. in the study of patients with newly diagnosed cml, 6% of patients were older than 65 years. the frequency of edema was higher in patients older than 65 years as compared to younger patients; no other difference in the safety profile was observed [see warnings and precautions (5.1) ]. the efficacy of imatinib mesylate was similar in older and younger patients. in the unresectable or metastatic gist study, 16% of patients were older than 65 years. no obvious differences in the safety or efficacy profile were noted in patients older than 65 years as compared to younger patients, but the small number of patients does not allow a formal analysis. in the adjuvant gist study, 221 patients (31%) were older than 65 years. no difference was observed in the safety profile in patients older than 65 years as compared to younger patients, with the exception of a higher frequency of edema. the efficacy of imatinib mesylate was similar in patients older than 65 years and younger patients. the effect of hepatic impairment on the pharmacokinetics of both imatinib and its major metabolite, cgp74588, was assessed in 84 patients with cancer with varying degrees of hepatic impairment at imatinib doses ranging from 100 mg to 800 mg. mild and moderate hepatic impairment do not influence exposure to imatinib and cgp74588. in patients with severe hepatic impairment, the imatinib c max and area under curve (auc) increased by 63% and 45% and the cgp74588 c max and auc increased by 56% and 55%, relative to patients with normal hepatic function [see clinical pharmacology (12.3)]. reduce the dose by 25% for patients with severe hepatic impairment [see dosage and administration (2.12)]. abbreviation: sgot, serum glutamic-oxaloacetic transaminase is now referred to as aspartate aminotransferase (ast); uln, upper limit of normal for the institution. the effect of renal impairment on the pharmacokinetics of imatinib was assessed in 59 patients with cancer and varying degrees of renal impairment at single and steady state imatinib doses ranging from 100 to 800 mg/day. the mean exposure to imatinib (dose normalized auc) in patients with mild and moderate renal impairment increased 1.5- to 2- fold compared to patients with normal renal function. there are not sufficient data in patients with severe renal impairment [see clinical pharmacology (12.3)]. dose reductions are necessary for patients with moderate and severe renal impairment [see dosage and administration (2.12)]. renal dysfunction renal function tests mild crcl = 40 to 59 ml/min moderate crcl = 20 to 39 ml/min severe crcl = less than 20 ml/min abbreviation: crcl, creatinine clearance.

미국 - 영어 - NLM (National Library of Medicine)

avpak - imatinib mesylate (unii: 8a1o1m485b) (imatinib - unii:bkj8m8g5hi) - imatinib 100 mg - newly diagnosed adult and pediatric patients with philadelphia chromosome positive chronic myeloid leukemia in chronic phase. patients with philadelphia chromosome positive chronic myeloid leukemia in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. adult patients with relapsed or refractory philadelphia chromosome positive acute lymphoblastic leukemia. adult patients with myelodysplastic/myeloproliferative diseases associated with pdgfr (platelet-derived growth factor receptor) gene re-arrangements as determined with an fda-approved test [ see dosage and administration ( 2.6) ]. adult patients with aggressive systemic mastocytosis without the d816v c-kit mutation as determined with an fda-approved test [ see dosage and administration ( 2.7) ] or with c-kit mutational status unknown. adult patients with hypereosinophilic syndrome and/or chronic eosinophilic leukemia who ha

미국 - 영어 - NLM (National Library of Medicine)

legacy pharmaceutical packaging, llc - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 5 mg - amlodipine besylate tablets, usp are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. amlodipine besylate tablets may be used alone or in combination with other antihypertensive agents. chronic stable angina amlodipine besylate tablets, usp are indicated for the symptomatic treatment of chronic stable angina. amlodipine besylate tablets, usp may be used alone or in combination with other antianginal agents. vasospastic angina (prinzmetal's or variant angina) amlodipine besylate tablets, usp are indicated for the treatment of confirmed or suspected vasospastic angina. amlodipine besylate tablets, usp may be used as monotherapy or in combination with other antianginal agents. angiographically documented cad in patients with recently documented cad by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets, usp are indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine. risk summary the limited available data based on post-marketing reports with amlodipine use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy [see clinical considerations] . in animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20-times the maximum recommended human dose (mrhd), respectively. however, for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold). amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose [see data]. 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%-4% and 15%-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. pregnant women with hypertension should be carefully monitored and managed accordingly. data animal data no evidence of teratogenicity or other embryo/fetal toxicity was found when pregnant rats and rabbits were treated orally with amlodipine maleate at doses up to 10 mg amlodipine/kg/day (approximately 10 and 20 times the mrhd based on body surface area, respectively) during their respective periods of major organogenesis. however for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold) in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation. amlodipine maleate has been shown to prolong both the gestation period and the duration of labor in rats at this dose. risk summary limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%. no adverse effects of amlodipine on the breastfed infant have been observed. there is no available information on the effects of amlodipine on milk production. amlodipine besylate tablets (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see clinical studies ( 14.1)]. effect of amlodipine on blood pressure in patients less than 6 years of age is not known. clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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. elderly patients have decreased clearance of amlodipine with a resulting increase of auc of approximately 40 to 60%, and a lower initial dose may be required [see dosage and administration ( 2.1)] .

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unichem pharmaceuticals (usa), inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 2.5 mg - amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic

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ascend laboratories, llc - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 2.5 mg - amlodipine besylate tablets is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic

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marlex pharmaceuticals inc - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 2.5 mg - amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic clas

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wockhardt usa llc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 2.5 mg - amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic

미국 - 영어 - NLM (National Library of Medicine)

hikma pharmaceutical - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine besylate 2.5 mg - amlodipine is indicated for the treatment of hypertension. it may be used alone or in combination with other antihypertensive agents. -  chronic stable angina amlodipine is indicated for the treatment of chronic stable angina. amlodipine may be used alone or in combination with other antianginal agents.   -  vasospastic angina (prinzmetal's or variant angina) amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. amlodipine may be used as monotherapy or in combination with other antianginal agents.   -  angiographically documented cad in patients with recently documented cad by angiography and without heart failure or an ejection fraction <40%, amlodipine is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure. amlodipine is contraindicated in patients with known sensitivity to amlodipine. there are no adequate and well-controlled studies in pregnant women. amlodipine should be used during pre

미국 - 영어 - NLM (National Library of Medicine)

exelan pharmaceuticals, inc. - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine 2.5 mg - amlodipine besylate tablets, usp are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmaco