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west-ward pharmaceuticals corp. - granisetron hydrochloride (unii: 318f6l70j8) (granisetron - unii:wzg3j2mcol) - granisetron 1 mg - granisetron hydrochloride tablets are indicated for the prevention of: granisetron hydrochloride is contraindicated in patients with known hypersensitivity to the drug or any of its components.

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

west-ward pharmaceuticals corp - nicardipine hydrochloride (unii: k5bc5011k3) (nicardipine - unii:cz5312222s) - nicardipine hydrochloride 2.5 mg in 1 ml - nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. for prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see dosage and administration (2.6)]. do not use nicardipine in patients with advanced aortic stenosis because of the afterload reduction effect of nicardipine. reduction of diastolic pressure in these patients may worsen rather than improve myocardial oxygen balance. pregnancy category c. there are no adequate and well-controlled studies of nicardipine use in pregnant women. there are limited human data in pregnant women with pre-eclampsia and preterm labor. in animal reproduction and developmental toxicity studies, evidence of fetal harm was observed. therefore use nicardipine during pregnancy only if the potential benefit justifies the potential risk to the fetus. in reproduction studies conducted in rats and rabbits, increased embryolethality oc

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

west-ward pharmaceuticals corp - fosphenytoin sodium (unii: 7vlr55452z) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 50 mg in 1 ml - fosphenytoin sodium injection, usp is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. fosphenytoin sodium injection, usp can also be substituted, short-term, for oral phenytoin. fosphenytoin sodium injection, usp should be used only when oral phenytoin administration is not possible [see dosage and administration (2.4) and warnings and precautions (5.2) ]. fosphenytoin sodium injection is contraindicated in patients with: - a history of hypersensitivity to fosphenytoin sodium injection or its inactive ingredients, or to phenytoin or other hydantoins [see warnings and precautions (5.6)] . - sinus bradycardia, sino-atrial block, second and third degree a-v block, or adams-stokes syndrome because of the effect of parenteral phenytoin or fosphenytoin sodium injection on ventricular automaticity. - a history of prior acute hepatotoxicity attributable to fosphenytoin sodium injection or phenytoin [see warnings and pr

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

west-ward pharmaceuticals corp. - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 0.25 mg - ropinirole is indicated for the treatment of parkinson’s disease. ropinirole is indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). ropinirole tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. risk summary there are no adequate data on the developmental risk associated with the use of ropinirole in pregnant women. in animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the maximum recommended human dose (mrhd) for parkinson’s disease. ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity. in pregnant rabbits, ropinirole potentiated the teratogenic effects of l-dopa when these drugs were administered in combination [se

United States - English - 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

United States - English - 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

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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

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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)].

United States - English - 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

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west-ward pharmaceuticals corp - cefotaxime sodium (unii: 258j72s7tz) (cefotaxime - unii:n2gi8b1gk7) - cefotaxime 10 g - cefotaxime for injection, usp is indicated for the treatment of patients with serious infections caused by susceptible strains of the designated microorganisms in the diseases listed below. (1) lower respiratory tract infections, including pneumonia, caused by streptococcus pneumoniae (formerly diplococcus pneumoniae ), streptococcus pyogenes* (group a streptococci) and other streptococci (excluding enterococci, e.g., enterococcus faecalis ), staphylococcus aureus (penicillinase and non-penicillinase producing), escherichia coli , klebsiella species, haemophilus influenzae (including ampicillin resistant strains), haemophilus parainfluenzae , proteus mirabilis , serratia marcescens* , enterobacter species, indole positive proteus and pseudomonas species (including p. aeruginosa ). (2) genitourinary infections . urinary tract infections caused by enterococcus species, staphylococcus epidermidis , staphylococcus aureus* , (penicillinase and non-penicillinase producing), citrobacter species, enterobac