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a-s medication solutions - enalapril maleate (unii: 9o25354epj) (enalaprilat anhydrous - unii:q508q118jm) - enalapril maleate is indicated for the treatment of hypertension. enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. the blood pressure lowering effects of enalapril maleate and thiazides are approximately additive. enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. in these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival trials). in clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival trials). in using enalapril maleate consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril maleate does not have a similar risk (see warnings, neutropenia/agranulocytosis ). in considering use of enalapril maleate, it should be noted that in controlled clinical trials ace inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. in addition, it should be noted that black patients receiving ace inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see warnings, head and neck angioedema ). enalapril maleate is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin-converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema. do not coadminister aliskiren with enalapril maleate in patients with diabetes (see precautions, drug interactions ). enalapril maleate is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer enalapril maleate within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see warnings, head and neck angioedema ).

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nucare pharmaceuticals, inc. - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 4 mg in 5 ml - ondansetron oral solution, usp is indicated for the prevention of nausea and vomiting associated with: - highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 . highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 . - initial and repeat courses of moderately emetogenic cancer chemotherapy. initial and repeat courses of moderately emetogenic cancer chemotherapy. - radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. ondansetron oral solution, usp is also indicated for the prevention of postoperative nausea and/or vomiting. ondansetron oral solution, usp is contraindicated in patients: - known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation

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remedyrepack inc. - hydrocortisone (unii: wi4x0x7bpj) (hydrocortisone - unii:wi4x0x7bpj) - cortef tablets are indicated in the following conditions. primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) congenital adrenal hyperplasia non suppurative thyroiditis hypercalcemia associated with cancer as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis acute nonspecific tenosynovitis acute gouty arthritis post-traumatic osteoarthritis synovitis of osteoarthritis epicondylitis during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus systemic dermatomyositis (polymyositis) acute rheumatic carditis pemphigus bullous dermatitis herpetiformis severe erythema multiforme (stevens-johnson syndrome) exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis serum sickness bronchial asthma contact dermatitis atopic dermatitis drug hypersensitivity reactions severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic conjunctivitis keratitis allergic corneal marginal ulcers herpes zoster ophthalmicus iritis and iridocyclitis chorioretinitis anterior segment inflammation diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia symptomatic sarcoidosis loeffler's syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy aspiration pneumonitis idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired (autoimmune) hemolytic anemia erythroblastopenia (rbc anemia) congenital (erythroid) hypoplastic anemia for palliative management of: leukemias and lymphomas in adults acute leukemia of childhood to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. to tide the patient over a critical period of the disease in: ulcerative colitis regional enteritis tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement systemic fungal infections and known hypersensitivity to components

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ceres pharma sa-nv - sildenafil citrate 140,45 mg - eq. sildenafil 100 mg - film-coated tablet - 100 mg - sildenafil citrate - sildenafil

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cardinal health - dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - dexamethasone 0.5 mg in 5 ml

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apotex corp. - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - olanzapine 5 mg - olanzapine orally disintegrating tablets are indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13 to 17), efficacy was established in one 6-week trial [see clinical studies (14.1)] . when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see warnings and precautions (5.5)] . monotherapy — olanzapine orally disintegrating tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder. efficacy was established in three clinical trials in adult patients with manic or mixed episodes of bipolar i disorder: two 3- to 4-week trials and one monotherapy maintenance trial. in adolescent patients with manic or mixed episodes associated with bipolar i disorder (ages 13 to 17), efficacy was established in one 3-week trial [see clinical studies (14.2)] . when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see warnings and precautions (5.5)] . adjunctive therapy to lithium or valproate — olanzapine orally disintegrating tablets are indicated for the treatment of manic or mixed episodes associated with bipolar i disorder as an adjunct to lithium or valproate. efficacy was established in two 6-week clinical trials in adults. the effectiveness of adjunctive therapy for longer-term use has not been systematically evaluated in controlled trials [see clinical studies (14.2)] . pediatric schizophrenia and bipolar i disorder are serious mental disorders; however, diagnosis can be challenging. for pediatric schizophrenia, symptom profiles can be variable, and for bipolar i disorder, pediatric patients may have variable patterns of periodicity of manic or mixed symptoms. it is recommended that medication therapy for pediatric schizophrenia and bipolar i disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. medication treatment for both pediatric schizophrenia and bipolar i disorder should be part of a total treatment program that often includes psychological, educational and social interventions. olanzapine orally disintegrating tablets and fluoxetine in combination is indicated for the treatment of depressive episodes associated with bipolar i disorder, based on clinical studies. when using olanzapine orally disintegrating tablets and fluoxetine in combination, refer to the clinical studies section of the package insert for symbyax. olanzapine orally disintegrating tablets monotherapy is not indicated for the treatment of depressive episodes associated with bipolar i disorder. oral olanzapine disintegrating tablets and fluoxetine in combination is indicated for the treatment of treatment resistant depression (major depressive disorder in patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode), based on clinical studies in adult patients. when using olanzapine orally disintegrating tablets and fluoxetine in combination, refer to the clinical studies section of the package insert for symbyax. olanzapine orally disintegrating tablets monotherapy is not indicated for the treatment of treatment resistant depression. - none with olanzapine orally disintegrating tablets monotherapy. - when using olanzapine orally disintegrating tablets and fluoxetine in combination, also refer to the contraindications section of the package insert for symbyax. - for specific information about the contraindications of lithium or valproate, refer to the contraindications section of the package inserts for these other products. when using olanzapine orally disintegrating tablets and fluoxetine in combination, also refer to the use in specific populations section of the package insert for symbyax. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including olanzapine, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs, including olanzapine, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see clinical considerations). overall available data from published epidemiologic studies of pregnant women exposed to olanzapine have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). there are risks to the mother associated with untreated schizophrenia or bipolar i disorder and with exposure to antipsychotics, including olanzapine, during pregnancy (see clinical considerations) . olanzapine was not teratogenic when administered orally to pregnant rats and rabbits at doses that are 9- and 30-times the daily oral maximum recommended human dose (mrhd), based on mg/m2 body surface area; some fetal toxicities were observed at these doses (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defects, 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 embryo/fetal risk there is a risk to the mother from untreated schizophrenia or bipolar i disorder, including increased risk of relapse, hospitalization, and suicide. schizophrenia and bipolar i disorder are associated with increased adverse perinatal outcomes, including preterm birth. it is not known if this is a direct result of the illness or other comorbid factors. fetal/neonatal adverse reactions extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including olanzapine, during the third trimester of pregnancy. these symptoms have varied in severity. monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization.   data human data placental passage has been reported in published study reports; however, the placental passage ratio was highly variable ranging between 7% to 167% at birth following exposure during pregnancy. the clinical relevance of this finding is unknown. published data from observational studies, birth registries, and case reports that have evaluated the use of atypical antipsychotics during pregnancy do not establish an increased risk of major birth defects. a retrospective cohort study from a medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk for major birth defects. animal data in oral reproduction studies in rats at doses up to 18 mg/kg/day and in rabbits at doses up to 30 mg/kg/day (9 and 30 times the daily oral mrhd based on mg/m2 body surface area, respectively), no evidence of teratogenicity was observed. in an oral rat teratology study, early resorptions and increased numbers of nonviable fetuses were observed at a dose of 18 mg/kg/day (9 times the daily oral mrhd based on mg/m2 body surface area), and gestation was prolonged at 10 mg/kg/day (5 times the daily oral mrhd based on mg/m2 body surface area). in an oral rabbit teratology study, fetal toxicity manifested as increased resorptions and decreased fetal weight, occurred at a maternally toxic dose of 30 mg/kg/day (30 times the daily oral mrhd based on mg/m2 body surface area). risk summary olanzapine is present in human milk. there are reports of excess sedation, irritability, poor feeding and extrapyramidal symptoms (tremors and abnormal muscle movements) in infants exposed to olanzapine through breast milk (see clinical considerations). there is no information on the effects of olanzapine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for olanzapine and any potential adverse effects on the breastfed child from olanzapine or from the mother’s underlying condition. clinical considerations infants exposed to olanzapine should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements). infertility females based on the pharmacologic action of olanzapine (d2 receptor antagonism), treatment with olanzapine orally disintegrating tablets may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential [see warnings and precautions (5.15)] . the safety and effectiveness of oral olanzapine in the treatment of schizophrenia and manic or mixed episodes associated with bipolar i disorder were established in short-term studies in adolescents (ages 13 to 17 years). use of olanzapine in adolescents is supported by evidence from adequate and well-controlled studies of olanzapine in which 268 adolescents received olanzapine in a range of 2.5 to 20 mg/day [see clinical studies (14.1, 14.2)] . recommended starting dose for adolescents is lower than that for adults [see dosage and administration (2.1, 2.2)] . compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, ldl cholesterol, prolactin and hepatic aminotransferase levels [see warnings and precautions (5.5, 5.15, 5.17) and adverse reactions (6.1)]. when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see indications and usage (1.1, 1.2)] . safety and effectiveness of olanzapine in children <13 years of age have not been established [see patient counseling information (17)] . safety and efficacy of olanzapine and fluoxetine in combination in children and adolescents (10 to 17 years of age) have been established for the acute treatment of depressive episodes associated with bipolar i disorder. safety and effectiveness of olanzapine and fluoxetine in combination in children <10 years of age have not been established. of the 2,500 patients in premarketing clinical studies with oral olanzapine, 11% (263) were 65 years of age or over. in patients with schizophrenia, there was no indication of any different tolerability of olanzapine in the elderly compared to younger patients. studies in elderly patients with dementia-related psychosis have suggested that there may be a different tolerability profile in this population compared to younger patients with schizophrenia. elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death compared to placebo. in placebo-controlled studies of olanzapine in elderly patients with dementia-related psychosis, there was a higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) in patients treated with olanzapine compared to patients treated with placebo. in 5 placebo-controlled studies of olanzapine in elderly patients with dementia-related psychosis (n=1184), the following adverse reactions were reported in olanzapine-treated patients at an incidence of at least 2% and significantly greater than placebo-treated patients: falls, somnolence, peripheral edema, abnormal gait, urinary incontinence, lethargy, increased weight, asthenia, pyrexia, pneumonia, dry mouth and visual hallucinations. the rate of discontinuation due to adverse reactions was greater with olanzapine than placebo (13% vs 7%). elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death compared to placebo. olanzapine is not approved for the treatment of patients with dementia-related psychosis [see boxed warning, warnings and precautions (5.1), and patient counseling information (17)] . olanzapine is not approved for the treatment of patients with dementia-related psychosis. also, the presence of factors that might decrease pharmacokinetic clearance or increase the pharmacodynamic response to olanzapine should lead to consideration of a lower starting dose for any geriatric patient [see boxed warning, dosage and administration (2.1), and warnings and precautions (5.1)] . clinical studies of olanzapine and fluoxetine in combination did not include sufficient numbers of patients ≥65 years of age to determine whether they respond differently from younger patients. in studies prospectively designed to assess abuse and dependence potential, olanzapine was shown to have acute depressive cns effects but little or no potential of abuse or physical dependence in rats administered oral doses up to 15 times the daily oral mrhd (20 mg) and rhesus monkeys administered oral doses up to 8 times the daily oral mrhd based on mg/m2  body surface area. olanzapine has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. while the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic, and it is not possible to predict on the basis of this limited experience the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of olanzapine (e.g., development of tolerance, increases in dose, drug-seeking behavior).

United States - English - NLM (National Library of Medicine)

mary kay inc. - avobenzone (unii: g63qqf2nox) (avobenzone - unii:g63qqf2nox), homosalate (unii: v06sv4m95s) (homosalate - unii:v06sv4m95s), octisalate (unii: 4x49y0596w) (octisalate - unii:4x49y0596w), octocrylene (unii: 5a68wgf6wm) (octocrylene - unii:5a68wgf6wm), oxybenzone (unii: 95oos7ve0y) (oxybenzone - unii:95oos7ve0y) - uva/uvb protection helps to protect your skin from the damaging effects of the sun. protects from certain harmful uv rays of the sun to help prevent sunburn.

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teva pharmaceuticals, inc. - eltrombopag choline (unii: f9g8xe24ib) (eltrombopag - unii:s56d65xj9g) - alvaiz™ (eltrombopag tablets) are indicated for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (itp) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. alvaiz should be used only in patients with itp whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. alvaiz is indicated for the treatment of thrombocytopenia in adult patients with chronic hepatitis c to allow the initiation and maintenance of interferon-based therapy. alvaiz should be used only in patients with chronic hepatitis c whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. alvaiz is indicated for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. - alvaiz is not indicated for the treatment of patients with myelodysplastic syndromes (mds) [see warnings and precautions (5.3)] . - safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis c infection. none. risk summary available data from a small number of published case reports and postmarketing experience with eltrombopag use in pregnant women are insufficient to assess any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction and developmental toxicity studies, oral administration of eltrombopag to pregnant rats during organogenesis resulted in embryolethality and reduced fetal weights at maternally toxic doses. these effects were observed at doses resulting in exposures that were six times the human clinical exposure based on area under the curve (auc) in patients with persistent or chronic itp at 75 mg/day, and three times the auc in patients with chronic hepatitis c at 100 mg/day (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 of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in an early embryonic development study, female rats received oral eltrombopag at doses of 10, 20, or 60 mg/kg/day (0.8, 2, and 6 times, respectively, the human clinical exposure based on auc in patients with itp at 75 mg/day and 0.3, 1, and 3 times, respectively, the human clinical exposure based on auc in patients with chronic hepatitis c at 100 mg/day). increased pre- and post-implantation loss and reduced fetal weight were observed at the highest dose which also caused maternal toxicity. in an embryo-fetal development study eltrombopag was administered orally to pregnant rats during the period of organogenesis at doses of 10, 20, or 60 mg/kg/day (0.8, 2, and 6 times, respectively, the human clinical exposure based on auc in patients with itp at 75 mg/day and 0.3, 1, and 3 times, respectively, the human clinical exposure based on auc in patients with chronic hepatitis c at 100 mg/day). decreased fetal weights (6% to 7%) and a slight increase in the presence of cervical ribs were observed at the highest dose which also caused maternal toxicity. however, no evidence of major structural malformations was observed. in an embryo-fetal development study eltrombopag was administered orally to pregnant rabbits during the period of organogenesis at doses of 30, 80, or 150 mg/kg/day (0.04, 0.3, and 0.5 times, respectively, the human clinical exposure based on auc in patients with itp at 75 mg/day and 0.02, 0.1, and 0.3 times, respectively, the human clinical exposure based on auc in patients with chronic hepatitis c at 100 mg/day). no evidence of fetotoxicity, embryolethality, or teratogenicity was observed. in a pre- and post-natal developmental toxicity study in pregnant rats (f0), oral eltrombopag was administered from gestation day 6 through lactation day 20. no adverse effects on maternal reproductive function or on the development of the offspring (f1) were observed at doses up to 20 mg/kg/day (2 times the human clinical exposure based on auc in patients with itp at 75 mg/day and similar to the human clinical exposure based on auc in patients with chronic hepatitis c at 100 mg/day). eltrombopag was detected in the plasma of offspring (f1). the plasma concentrations in pups increased with dose following administration of drug to the f0 dams. risk summary there are no data regarding the presence of eltrombopag or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. however, eltrombopag was detected in the pups of lactating rats 10 days postpartum suggesting the potential for transfer during lactation. due to the potential for serious adverse reactions in a breastfed child from eltrombopag, breastfeeding is not recommended during treatment.   contraception based on animal reproduction studies, eltrombopag can cause fetal harm when administered to a pregnant woman. sexually-active females of reproductive potential should use effective contraception (methods that result in less than 1% pregnancy rates) when using alvaiz during treatment and for at least 7 days after stopping treatment with alvaiz. the safety and effectiveness of alvaiz have been established in pediatric patients 6 years and older with persistent or chronic itp.  the safety and effectiveness of eltrombopag in pediatric patients 6 years and older with persistent or chronic itp were evaluated in two double-blind, placebo-controlled trials [see adverse reactions (6.1), clinical studies (14.1)] . the pharmacokinetics of eltrombopag have been established in 130 pediatric patients 6 years and older with itp dosed once daily [see clinical pharmacology (12.3)] . see dosage and administration (2.1) for dosing recommendations for pediatric patients 6 years and older. the safety and effectiveness of alvaiz have not been established in pediatric patients less than 6 years of age with persistent or chronic itp. pediatric patients must be able to swallow alvaiz tablets whole [see dosage and administration (2.5)]. the safety and effectiveness in pediatric patients with thrombocytopenia associated with chronic hepatitis c and refractory severe aplastic anemia have not been established. of the 106 patients in two randomized clinical trials of eltrombopag 50 mg in persistent or chronic itp, 22% were 65 years of age and over, while 9% were 75 years of age and over. of the 1439 patients in two randomized clinical trials of eltrombopag in patients with chronic hepatitis c and thrombocytopenia, 7% were 65 years of age and over, while < 1% were 75 years of age and over. of the 196 patients who received eltrombopag for the treatment of severe aplastic anemia, 18% were 65 years of age and over, while 3% were 75 years of age and over. no overall differences in safety or effectiveness were observed between these patients and younger patients. patients with persistent or chronic itp and severe aplastic anemia reduce the initial dose of eltrombopag in patients with persistent or chronic itp (adult and pediatric patients 6 years and older only) or refractory severe aplastic anemia who also have hepatic impairment (child-pugh class a, b, c) [see dosage and administration (2.1, 2.3), warnings and precautions (5.2), clinical pharmacology (12.3)] . in a clinical trial in patients with severe aplastic anemia who had not received prior definitive immunosuppressive therapy, patients with baseline alt or ast > 5 x uln were ineligible to participate [see dosage and administration (2.3), warnings and precautions (5.2), clinical pharmacology (12.3)] . patients with chronic hepatitis c no dosage adjustment is recommended in patients with chronic hepatitis c and hepatic impairment [see clinical pharmacology (12.3)] . reduce the initial dose of alvaiz for patients of east- /southeast-asian ancestry with itp (adult and pediatric patients 6 years and older only) or adults with severe aplastic anemia [see dosage and administration (2.1, 2.3), clinical pharmacology (12.3)] . no reduction in the initial dose of alvaiz is recommended in patients of east-/southeast-asian ancestry with chronic hepatitis c [see clinical pharmacology (12.3)] .

United States - English - NLM (National Library of Medicine)

abbvie inc. - niacin (unii: 2679mf687a) (niacin - unii:2679mf687a) - niacin 500 mg - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. - niaspan is indicated to reduce elevated tc, ldl-c, apo b and tg levels, and to increase hdl-c in patients with primary hyperlipidemia and mixed dyslipidemia. - in patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction. - in patients with a history of coronary artery disease (cad) and hyperlipidemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease. - niaspan in combination with a bile acid binding resin is indicated to reduce elevated tc an

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nelco laboratories, inc. - taraxacum officinale pollen (unii: wq3s5294xy) (taraxacum officinale pollen - unii:wq3s5294xy) - allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. the use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again. allergenic extracts should not be used if the patient has asthma, cardiovascular disease, emphysema, diabetes, bleeding diathesis or pregnancy, unless a specific diagnosis of t