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

astrazeneca pharmaceuticals lp - roflumilast (unii: 0p6c6zop5u) (roflumilast - unii:0p6c6zop5u) - roflumilast 500 ug - daliresp® is indicated as a treatment to reduce the risk of copd exacerbations in patients with severe copd associated with chronic bronchitis and a history of exacerbations. limitations of use daliresp is not a bronchodilator and is not indicated for the relief of acute bronchospasm. daliresp 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. the use of daliresp is contraindicated in the following condition: moderate to severe liver impairment (child-pugh b or c) [see clinical pharmacology (12.3) and use in specific populations (8.6) ] . risk summary there are no randomized clinical studies of daliresp in pregnant women. in animal reproductive toxicity studies, daliresp administered to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities. the highest daliresp dose in these studies was approximately 30 and 26 times, respectively, the maximum recommended human dose (mrhd). daliresp induced post-im

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

astrazeneca pharmaceuticals lp - omeprazole magnesium (unii: 426qfe7xlk) (omeprazole - unii:kg60484qx9) - omeprazole 10 mg - prilosec is indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. triple therapy prilosec in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults. dual therapy prilosec in combination with clarithromycin is indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. among patients who fail therapy, prilosec with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. in patients who fail therapy, susceptibility testing should be done. if resistance to clarithromycin is demonstrated or susceptibility testing is not pos

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

astrazeneca pharmaceuticals lp - candesartan cilexetil (unii: r85m2x0d68) (candesartan - unii:s8q36md2xx), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - candesartan cilexetil 16 mg - atacand hct is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and non-fatal 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 the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with atacand hct. 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 blo

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

astrazeneca pharmaceuticals lp - vandetanib (unii: yo460oq37k) (vandetanib - unii:yo460oq37k) - vandetanib 100 mg - caprelsa is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. use caprelsa in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of caprelsa. do not use in patients with congenital long qt syndrome [see boxed warning ]. pregnancy category d [see warnings and precautions (5.14) ] risk summary based on its mechanism of action, caprelsa can cause fetal harm when administered to a pregnant woman. vandetanib is embryotoxic, fetotoxic, and teratogenic in rats, at exposures less than or equal to those expected at the recommended human dose of 300 mg/day. if caprelsa is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. animal data when vandetanib was administered to female rats prior to mating and through the first week of pregnancy at a do

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

astrazeneca pharmaceuticals lp - esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - esomeprazole 20 mg - adults nexium delayed-release capsules and nexium for delayed-release oral suspension are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed ee in adults. for those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8- week course of nexium may be considered. pediatric patients 12 years to 17 years of age nexium delayed-release capsules and nexium for delayed-release oral suspension are indicated for the short-term treatment (4 to 8 weeks) for the healing of ee in pediatric patients 12 years to 17 years of age. pediatric patients 1 year to 11 years of age nexium for delayed-release oral suspension is indicated for the short-term treatment (8 weeks) for the healing of ee in pediatric patients 1 year to 11 years of age. pediatric patients 1 month to less than 1 year of age nexium for delayed-release oral suspension is indicated for short-term treatment (up to 6 weeks) of ee due to acid-mediated gerd in pediat

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

astrazeneca pharmaceuticals lp - moxetumomab pasudotox (unii: 2ndx4b6n8f) (moxetumomab pasudotox - unii:2ndx4b6n8f) - lumoxiti is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (hcl) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (pna). limitations of use lumoxiti is not recommended in patients with severe renal impairment (crcl ≤ 29 ml/min) [see dosage and administration (2.3), warnings and precautions (5.3), and use in specific populations (8.5)] . none. risk summary based on its mechanism of action and findings in non-pregnant female animals, lumoxiti is expected to cause maternal and embryo-fetal toxicity when administered to a pregnant woman [see clinical pharmacology (12.1) and nonclinical toxicology (13.2)] . there are no available data on lumoxiti use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. animal reproduction or developmental toxicity studies have not been conducted with lumoxiti. advise pregnant women of the potential risk to a fetus. the estimated background ris

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

astrazeneca pharmaceuticals lp - exenatide (unii: 9p1872d4ol) (exenatide - unii:9p1872d4ol) - exenatide 2 mg in 0.65 ml - bydureon is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus [see clinical studies (14)]. limitations of use : bydureon is contraindicated in patients with: limited data with exenatide, the active ingredient in bydureon, in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . based on animal reproduction studies, there may be risks to the fetus from exposure to bydureon during pregnancy. bydureon should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. animal reproduction studies identified increased adverse fetal and neonatal outcomes from exposure to exenatide extended-release during pregnancy, or from exposure to exenatide, during pregnancy and lactation, in associatio

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

astrazeneca pharmaceuticals lp - pramlintide acetate (unii: 726i6te06g) (pramlintide - unii:d3fm8fa78t) - pramlintide 1000 ug in 1 ml - symlin is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. symlin is contraindicated in patients with any of the following: risk summary available data from a small number of reports in the manufacturer’s safety database on symlin use in pregnant women are not sufficient to determine a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). ex-vivo studies using term perfused human, rabbit, and rat placentas indicate that symlin has low potential to cross the maternal/fetal placental barrier. in animal reproduction studies, congenital abnormalities were observed in fetuses of pregnant rats but not in fetuses of pregnant rabbits exposed during organogenesis to pramlintide at 10 times the c

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

astrazeneca pharmaceuticals lp - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 50 mg - quetiapine fumarate extended-release tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine fumarate extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13-17 years) treated with quetiapine fumarate tablets [see clinical studies (14.1)]. quetiapine fumarate extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. the efficacy of quetiapine fumarate extended-release tablets in manic or mixed episodes of bipolar i disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar i disorder. efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes

European Union - English - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - carcinoma, non-small-cell lung - antineoplastic agents - tremelimumab astrazeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.