Verenigde Staten - Engels - NLM (National Library of Medicine)

ascend laboratories, llc - cholestyramine (unii: 4b33bgi082) (cholestyramine - unii:4b33bgi082) - 1) cholestyramine for oral suspension, usp powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [ldl] cholesterol) who do not respond adequately to diet. cholestyramine for oral suspension, usp powder may be useful to lower ldl cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight.

Verenigde Staten - Engels - NLM (National Library of Medicine)

ascend laboratories, llc - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron hydrochloride 1 mg - granisetron hcl is indicated for the prevention of :  - nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.  - nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation. granisetron hcl is contraindicated in patients with known hypersensitivity to the drug or any of its components.

Verenigde Staten - Engels - NLM (National Library of Medicine)

ascend laboratories, llc - olmesartan medoxomil (unii: 6m97xtv3hd) (olmesartan - unii:8w1iqp3u10) - olmesartan medoxomil 5 mg - olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, 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 the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with olmesartan medoxomil 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 join

Verenigde Staten - Engels - NLM (National Library of Medicine)

ascend laboratories, llc - valsartan (unii: 80m03yxj7i) (valsartan - unii:80m03yxj7i) - valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients one year of age and older. 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 the class to which valsartan principally belongs. there are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan 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 p

Verenigde Staten - Engels - NLM (National Library of Medicine)

ascend laboratories, llc - fosfomycin tromethamine (unii: 7fxw6u30gy) (fosfomycin - unii:2n81my12te) - fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of escherichia coli and enterococcus faecalis . fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. if persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (see precautions  and clinical studies  sections.) fosfomycin tromethamine is contraindicated in patients with known hypersensitivity to the drug.

Verenigde Staten - Engels - NLM (National Library of Medicine)

ascend laboratories, llc - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - riluzole is indicated for the treatment of amyotrophic lateral sclerosis (als).  riluzole is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions (6.1)] . risk summary there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk to the fetus associated wi

Verenigde Staten - Engels - NLM (National Library of Medicine)

ascend laboratories, llc - finasteride (unii: 57gno57u7g) (finasteride - unii:57gno57u7g) - finasteride 1 mg - finasteride tablets is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in men only . efficacy in bitemporal recession has not been established. finasteride tablets is not indicated for use in women. finasteride tablets is contraindicated in the following: - pregnancy. finasteride use is contraindicated in women when they are or may potentially be pregnant. because of the ability of type ii 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (dht), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. if this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus.  [ see  warnings  and  precautions   (5.1),  use  in  specific  populations  (8.1),  how  supplied / storage  and  handling  ( 16 )  and  patient   counseling  information  (17).]  in  female  rats,  low  doses

Verenigde Staten - Engels - NLM (National Library of Medicine)

ascend laboratories, llc - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide capsules, usp is indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules, usp is indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide is contraindicated in patients with a history of hypersensitivity reactions to: • temozolomide or any other ingredients in temozolomide; and • dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. reactions to temozolomide have included anaphylaxis [see adverse reactions ( 6.2 )]. risk summary based on its mechanism of action [see clinical pharmacology (12.1)] and findings from animal studies, temozolomide can cause fetal harm when administered to a pregnant woman. available postmarketing reports describ

Verenigde Staten - Engels - NLM (National Library of Medicine)

ascend laboratories, llc - cephalexin (unii: obn7uds42y) (cephalexin anhydrous - unii:5sff1w6677) - cephalexin anhydrous 500 mg - cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of streptococcus pneumoniae and streptococcus pyogenes. cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of streptococcus pneumoniae, haemophilus influenzae, staphylococcus aureus, streptococcus pyogenes, and moraxella catarrhalis. cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following gram-positive bacteria: staphylococcus aureus and streptococcus pyogenes. cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of staphylococcus aureus and proteus mirabilis. cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of escherichia coli, proteus mirabilis, and klebsiella pneumoniae. to reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin

Verenigde Staten - Engels - NLM (National Library of Medicine)

ascend laboratories, llc - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 137 ug - azelastine hcl nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. none. risk summary limited data from postmarketing experience over decades of use with azelastine hcl nasal spray in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (mrhdid) of 1.096 mg. how