Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

american health packaging - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride 150 mg - trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd) in adults. trazodone hydrochloride tablets are contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2), drug interactions ( 7.1)]. teratogenic effects pregnancy category c trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 6 to 9 times the maximum recommended human dose (mrhd) of 400 mg/day on mg/m 2 in adolescents. there was also an increase in congenital anomalies in the rabbit at approximately 6 to 17 times the mrhd on mg/m 2 basis in adolescents . there are no adequate and well-controlled studies in pregnant women. trazodone hydrochloride should be used during pregnancy only if the po

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 100 mg - to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. doxycycline is indicated for the treatment of the following infections: doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacterio

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - azathioprine (unii: mrk240iy2l) (azathioprine - unii:mrk240iy2l) - azathioprine 50 mg

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

roxane laboratories, inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide capsules are contraindicated in patients who have a history of hypersensitivity reaction (such as urticaria, allergic reaction including anaphylaxis, toxic epidermal necrolysis, and stevens-johnson syndrome) to any of its components. temozolomide capsules are also contraindicated in patients who have a history of hypersensitivity to dacarbazine, since both drugs are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (mtic). pregnancy category d. see warnings and precautions section. temozolomide can cause fetal harm when administered to a pregnant woman. five consecutive days of o

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

janssen biotech, inc. - golimumab (unii: 91x1klu43e) (golimumab - unii:91x1klu43e) - golimumab 50 mg in 4 ml - simponi aria, in combination with methotrexate (mtx), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. simponi aria is indicated for the treatment of active psoriatic arthritis in patients 2 years of age and older. simponi aria is indicated for the treatment of adult patients with active ankylosing spondylitis. simponi aria is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pjia) in patients 2 years of age and older. none. risk summary there are no adequate and well-controlled trials of simponi aria in pregnant women. monoclonal antibodies, such as golimumab, are transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. there are clinical considerations for the use of simponi aria in pregnant women [see clinical considerations] . in an animal reproductive study, golimumab administered by the subcutaneous route to pregnant mo

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - furosemide (unii: 7lxu5n7zo5) (furosemide - unii:7lxu5n7zo5) - furosemide 40 mg - furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. furosemide is particularly useful when an agent with greater diuretic potential is desired. oral furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with furosemide alone. furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

roxane laboratories, inc. - cyclophosphamide (unii: 8n3dw7272p) (cyclophosphamide - unii:8n3dw7272p) - tablet - 25 mg - cyclophosphamide tablets, although effective alone in susceptible malignancies, are more frequently used concurrently or sequentially with other antineoplastic drugs. the following malignancies are often susceptible to cyclophosphamide treatment: - malignant lymphomas (stages iii and iv of the ann arbor staging system), hodgkin’s disease, lyphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, burkitt’s lymphoma. - multiple myeloma. - leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia; acute lymphoblastic (stem-cell) leukemia in children (cyclophosphamide given during remission is effective in prolonging its duration). - mycosis fungoides (advanced disease). - neuroblastoma (disseminated disease). - adenocarcinoma of the ovary. - retinoblastoma. - carcinoma of the breast. cyclophosphamide tablets are useful in carefully selected cases of biopsy proven “minimal c

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

nnodum pharmaceuticals - ferrous fumarate (unii: r5l488ry0q) (ferrous cation - unii:gw89581owr), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204) - ferrous cation 66 mg - for the treatment of all anemias responsive to oral iron therapy, such as hypochromic anemia associated with pregnancy, chronic or acute blood loss, dietary restriction, metabolic disease and post-surgical convalescence. hemochromatosis and hemosiderosis are contraindications to iron therapy. folic acid is contraindicated in patients with pernicious anemia (see precautions).

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hydrochloride 6.25 mg in 5 ml

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

american health packaging - meclizine hydrochloride (unii: hdp7w44cio) (meclizine - unii:3l5tq84570) - meclizine hydrochloride 12.5 mg - meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see adverse reactions (6) and description (11)]. risk summary data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy. however, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically. 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data human data epidemiological studies reporting on pregnancies exposed to meclizine have not identified an association between the use of meclizine during pregnancy and an increased risk of major birth defects. animal data in a published study, oral administration of meclizine (25 mg/kg to 250 mg/kg) to pregnant rats during the period of organogenesis resulted in a high incidence of fetal malformations. these effects occurred at doses as low as 25 mg/kg, which is approximately 2 times the maximum recommended human dose (100 mg) on a body surface area (mg/m 2 ) basis. risk summary there are no data on the presence of meclizine in human milk, the effects 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 meclizine hydrochloride and any potential adverse effects on the breastfed infant from meclizine hydrochloride or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. 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. the effect of hepatic impairment on the pharmacokinetics of meclizine has not been evaluated. as meclizine hydrochloride undergoes metabolism, hepatic impairment may result in increased systemic exposure of meclizine. treatment with meclizine hydrochloride should be administered with caution in patients with hepatic impairment. the effect of renal impairment on the pharmacokinetics of meclizine has not been evaluated. because of a potential for drug/metabolite accumulation, meclizine hydrochloride should be administered with caution in patients with renal impairment and in the elderly, as renal function generally declines with age. the genetic polymorphism of cyp2d6 that results in poor-, intermediate-, extensive-, and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure. therefore, when meclizine hydrochloride is administered to patients with cyp2d6 polymorphism, monitor for adverse reactions and clinical effect accordingly.