Združene države Amerike - angleščina - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - irbesartan (unii: j0e2756z7n) (irbesartan - unii:j0e2756z7n), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - irbesartan 150 mg - irbesartan and hydrochlorothiazide is indicated for the treatment of hypertension. irbesartan and hydrochlorothiazide may be used in patients whose blood pressure is not adequately controlled on monotherapy. irbesartan and hydrochlorothiazide may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. the choice of irbesartan and hydrochlorothiazide as initial therapy for hypertension should be based on an assessment of potential benefits and risks. patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. the decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy

Združene države Amerike - angleščina - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - cilostazol (unii: n7z035406b) (cilostazol - unii:n7z035406b) - cilostazol 50 mg - cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. cilostazol is contraindicated in patients with: hypersensitivity to cilostazol or any components of cilostazol (e.g., anaphylaxis, angioedema). teratogenic effects: pregnancy category c . cilostazol has been shown to be teratogenic in rats at doses that are greater than 5-times the human mrhd on a body surface area basis. there are no adequate and well-controlled studies in pregnant women. in a rat developmental toxicity study, oral administration of 1000 mg cilostazol/kg/day was associated with decreased fetal weights, and increased incidences of cardiovascular, renal, and skeletal anomalies (ventricular septal, aortic arch and subclavian artery abnormalities, renal pelvic dilation, 14th rib, and retarded ossification). at this dose, systemic exposure to unbound cilostazol in nonpregnant rats was about 5 times the exposure in humans given the mrhd. increased inciden

Združene države Amerike - angleščina - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - doxercalciferol (unii: 3diz9lf5y9) (doxercalciferol - unii:3diz9lf5y9) - doxercalciferol 0.5 ug - doxercalciferol capsules is contraindicated in patients with: risk summary: the limited available data with doxercalciferol in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus associated with chronic kidney disease in pregnancy [see clinical considerations ]. in reproduction studies in rats and rabbits administered doxercalciferol during organogenesis at up to 20 mcg/kg/day and 0.1 mcg/kg/day, respectively (approximately 25 times (rats) and less than (rabbits) the maximum recommended human oral dose of 60 mcg/week based on mcg/m2 body surface area), no adverse developmental effects were observed [see data ]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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

Združene države Amerike - angleščina - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - ritonavir 100 mg - ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. when co-administering ritonavir with other protease inhibitors, see the full prescribing information for the co-administered protease inhibitor including important information for use in special populations. pregnancy exposure registry: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ritonavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1–800–258–4263. risk summary: prospective pregnancy data from the antiretroviral pregnancy registry (apr) are not sufficient to adequately assess the risk of birth defects or miscarriage. available data from the apr show no difference in the rate of overall birth defects for ritonavir compared to the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp) [see data] . in animal reproduction studies, no evidence of adverse developmental outcomes was observed with oral administration of ritonavir to pregnant rats and rabbits. during organogenesis in the rat and rabbit, systemic exposure (auc) was approximately 1/3 lower than human exposure at the recommended daily dose. in the rat pre- and post-natal developmental study, maternal systemic exposure to ritonavir was approximately 1/2 of the exposure in humans at the recommended daily dose, based on a body surface area conversion factor [see data] . ritonavir oral solution is not recommended during pregnancy because there is no known safe level of ethanol exposure during pregnancy [see clinical considerations, dosage and administration (2.3) and warnings and precautions (5.2)] . the 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 to 4% and 15 to 20%, respectively. clinical considerations: dose adjustments during pregnancy and the postpartum period: ritonavir oral solution contains approx. 43% ethanol (v/v) and approx. 27% (w/v) propylene glycol and is not recommended during pregnancy because there is no known safe level of ethanol exposure during pregnancy [see dosage and administration (2.3) and warnings and precautions (5.2)] . data: human data: based on prospective reports to the apr of approximately 6,100 live births following exposure to ritonavir-containing regimens (including over 2,800 live births exposed in the first trimester and over 3,200 live births exposed in the second and third trimesters), there was no difference in the rate of overall birth defects for ritonavir compared with the background birth defect rate of 2.7% in the u.s. reference population of the macdp. the prevalence of birth defects in live births was 2.3% (95% ci: 1.7% to 2.9%) following first-trimester exposure to ritonavir-containing regimens and 2.9% (95% ci: 2.3% to 3.5%) following second and third trimester exposure to ritonavir-containing regimens. while placental transfer of ritonavir and fetal ritonavir concentrations are generally low, detectable levels have been observed in cord blood samples and neonate hair. animal data: ritonavir was administered orally to pregnant rats (at 0, 15, 35, and 75 mg/kg/day) and rabbits (at 0, 25, 50, and 110 mg/kg/day) during organogenesis (on gestation days 6 through 17 and 6 through 19, respectively). no evidence of teratogenicity due to ritonavir was observed in rats and rabbits at doses producing systemic exposures (auc) equivalent to approximately 1/3 lower than human exposure at the recommended daily dose. developmental toxicity observed in rats (early resorptions, decreased fetal body weight and ossification delays and developmental variations) occurred at a maternally toxic dose, at an exposure equivalent to approximately 1/3 lower than human exposure at the recommended daily dose. a slight increase in the incidence of cryptorchidism was also noted in rats (at a maternally toxic dose) at an exposure approximately 1/5 lower than human exposure at the recommended daily dose. developmental toxicity was observed in rabbits (resorptions, decreased litter size and decreased fetal weights) at maternally toxic doses approximately 1.8 times higher than the recommended daily dose, based on a body surface area conversion factor. in pre-and postnatal development study in rats, ritonavir was administered at doses of 0, 15, 35, and 60 mg/kg/day from gestation day 6 through postnatal day 20. at doses of 60 mg/kg/day, no developmental toxicity was noted with ritonavir dosage equivalent to 1/2 of the recommended daily dose, based on a body surface area conversion factor. risk summary: the centers for disease control and prevention recommend that hiv-infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv. limited published data reports that ritonavir is present in human milk. there is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production. because of the potential for (1) hiv transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive infants) and (3) serious adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving ritonavir. contraception: use of ritonavir may reduce the efficacy of combined hormonal contraceptives. advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception [see drug interactions (7.2)] . in hiv-infected patients age greater than 1 month to 21 years, the antiviral activity and adverse event profile seen during clinical trials and through postmarketing experience were similar to that for adult patients. clinical studies of ritonavir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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. no dose adjustment of ritonavir is necessary for patients with either mild (child-pugh class a) or moderate (child-pugh class b) hepatic impairment. no pharmacokinetic or safety data are available regarding the use of ritonavir in subjects with severe hepatic impairment (child-pugh class c), therefore, ritonavir is not recommended for use in patients with severe hepatic impairment [see warnings and precautions (5.3), clinical pharmacology (12.3)].

Združene države Amerike - angleščina - NLM (National Library of Medicine)

west-ward pharmaceuticals corp - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron 2 mg in 1 ml - ondansetron injection, usp is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. ondansetron is approved for patients aged 6 months and older. ondansetron injection, usp is indicated for the prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/‌or vomiting will occur postoperatively. in patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection, usp is recommended even when the incidence of postoperative nausea and/or vomiting is low. for patients who do not receive prophylactic ondansetron injection, usp and experience nausea and/or vomiting postoperatively, ondansetron injection, usp may be given to prevent further episodes. ondansetron injection, usp is approved for patients aged 1 month and older. ondansetron injection is contraindica

Združene države Amerike - angleščina - NLM (National Library of Medicine)

west-ward pharmaceuticals corp - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol 2 ug in 1 ml - paricalcitol injection is an active vitamin d2 analogue indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stage 5. paricalcitol injection is contraindicated in patients with evidence of: - hypercalcemia [see warnings and precautions (5.1) ] - vitamin d toxicity [see warnings and precautions (5.1) ] or - hypersensitivity to paricalcitol or any inactive ingredient in this product [see adverse reactions (6.2) ] pregnancy category c paricalcitol has been shown to cause minimal decreases in fetal viability (5%) when administered daily to rabbits at a dose 0.5 times the 0.24 mcg/kg human dose (based on surface area, mg/m2 ) and when administered to rats at a dose 2 times the 0.24 mcg/kg human dose (based on plasma levels of exposure). at the highest dose tested (20 mcg/kg 3 times per week in rats, 13 times the 0.24 mcg/kg human dose based on surface area), there was a significant increase of the mortality of newborn rats at doses that were mate

Združene države Amerike - angleščina - NLM (National Library of Medicine)

west-ward pharmaceuticals corp - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 5 mg - roxicet is indicated for the relief of moderate to moderately severe pain. roxicet should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product. oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. oxycodone is contraindicated in the setting of suspected or known paralytic ileus. roxicet is a schedule ii controlled substance. oxycodone is a mu-agonist opioid with an abuse liability similar to morphine. oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion. drug addiction is defined as an abnormal, compulsive use, use for non-medical purposes of a substance despite physical, psychological, occupational or interpersonal difficulties resulting from such use, and co

Združene države Amerike - angleščina - NLM (National Library of Medicine)

west-ward pharmaceuticals corp. - telmisartan (unii: u5syw473rq) (telmisartan - unii:u5syw473rq) - telmisartan 20 mg - telmisartan 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 the class to which this drug principally belongs. 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 o

Združene države Amerike - angleščina - NLM (National Library of Medicine)

west-ward pharmaceutical corp - gemfibrozil (unii: q8x02027x3) (gemfibrozil - unii:q8x02027x3) - gemfibrozil 600 mg - gemfibrozil tablets, usp are indicated as adjunctive therapy to diet for: 1.  treatment of adult patients with very high elevations of serum triglyceride levels (types iv and v hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. patients who present such risk typically have serum triglycerides over 2000 mg/dl and have elevations of vldl-cholesterol as well as fasting chylomicrons (type v hyperlipidemia). subjects who consistently have total serum or plasma triglycerides below 1000 mg/dl are unlikely to present a risk of pancreatitis. gemfibrozil tablets, usp therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dl who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. it is recognized that some type iv patients with triglycerides under 1000 mg/dl may, through dietary or alcoholic indiscretion, convert to a type v pattern with massive triglyceride ele

Združene države Amerike - angleščina - NLM (National Library of Medicine)

west-ward pharmaceutical corp. - milrinone lactate (unii: 9k8xr81mo8) (milrinone - unii:ju9yax04c7) - milrinone 1 mg in 1 ml - milrinone lactate injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. patients receiving milrinone should be observed closely with appropriate electrocardiographic equipment. the facility for immediate treatment of potential cardiac events, which may include life-threatening ventricular arrhythmias, must be available. the majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. there is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours. milrinone lactate injection is contraindicated in patients who are hypersensitive to it.