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

civica, inc. - cisatracurium besylate (unii: 80ys8o1mbs) (cisatracurium - unii:qx62kli41n) - cisatracurium besylate injection is indicated: limitations of use cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. risk summary the 10 ml cisatracurium besylate multiple-dose vials contain the preservative benzyl alcohol. therefore, if cisatracurium besylate is needed during pregnancy, consider using a benzyl alcohol-free formulation (i.e., 5 ml and 20 ml cisatracurium besylate single-dose vials). because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. however, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see contraindications (4), warnings and precautions (5.2), and use in specific populations (8.4)] . there are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug associated risk of major birth defects, miscarria

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

civica, inc. - cisatracurium besylate (unii: 80ys8o1mbs) (cisatracurium - unii:qx62kli41n) - cisatracurium besylate injection is indicated: limitations of use cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. risk summary there are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal studies conducted in rats administered cisatracurium besylate during organogenesis (gestational day 6 to 15) found no evidence of fetal harm at 0.8 times (ventilated rats) the exposure from a human starting iv bolus dose of 0.2 mg/kg (see data) . the estimated background risk for major birth defects and miscarriage in 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 2-4% and 15-20%, r

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

civica, inc. - voriconazole (unii: jfu09i87tr) (voriconazole - unii:jfu09i87tr) - voriconazole for injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (ia). in clinical trials, the majority of isolates recovered were aspergillus fumigatus . there was a small number of cases of culture-proven disease due to species of aspergillus other than a. fumigatus [see clinical studies (14.1, 14.5) and microbiology (12.4)]. voriconazole for injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see clinical studies (14.2, 14.5) and microbiology (12.4)]. voriconazole for injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (ec) in adults and pediatric patients 2 years of age and older [see clinical studies (14.3, 14.5) and microbiology (12

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

delpharm boucherville canada inc. - succinylcholine chloride (unii: i9l0ddd30i) (succinylcholine - unii:j2r869a8yf) - succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. anectine is contraindicated in patients with: • known or suspected genetic susceptibility to malignant hyperthermia (see  warnings; malignant hyperthermia, clinical pharmacology; pharmacogenomics ) • skeletal muscle myopathies • known hypersensitivity to succinylcholine (see warnings; anaphylaxis) • after the acute phase of injury following major burns, multiple trauma, extensive denervation of the skeletal muscle, or upper neuron injury because succinylcholine administered to such individuals may result in severe hyperkalemia, which may result in cardiac arrest (see warnings; hyperkalemia )

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

civicascript, llc - abiraterone acetate (unii: em5ocb9yj6) (abiraterone - unii:g819a456d0) - abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with none. risk summary the safety and efficacy of abiraterone acetate have not been established in females. based on findings from animal studies and the mechanism of action, abiraterone acetate can cause fetal harm and potential loss of pregnancy. there are no human data on the use of abiraterone acetate in pregnant women. in animal reproduction studies, oral administration of abiraterone acetate to pregnant rats during organogenesis caused adverse developmental effects at maternal exposures approximately ≥ 0.03 times the human exposure (auc) at the recommended dose (see data ). data animal data in an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogenesis (gestational days 6-17). findings included embryo-fetal lethality (increased post implantation loss and resorptions and decreased number of live fetuses), fetal developmental delay (skeletal effects) and urogenital effects (bilateral ureter dilation) at doses ≥10 mg/kg/day, decreased fetal ano-genital distance at ≥30 mg/kg/day, and decreased fetal body weight at 100 mg/kg/day. doses ≥10 mg/kg/day caused maternal toxicity. the doses tested in rats resulted in systemic exposures (auc) approximately 0.03, 0.1 and 0.3 times, respectively, the auc in patients. risk summary the safety and efficacy of abiraterone acetate have not been established in females. there is no information available on the presence of abiraterone acetate in human milk, or on the effects on the breastfed child or milk production. contraception males based on findings in animal reproduction studies and its mechanism of action, advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 weeks after the final dose of abiraterone acetate [see use in specific populations (8.1)]. infertility based on animal studies, abiraterone acetate may impair reproductive function and fertility in males of reproductive potential [see nonclinical toxicology (13.1)]. safety and effectiveness of abiraterone acetate in pediatric patients have not been established. of the total number of patients receiving abiraterone acetate in randomized clinical trials, 70% of patients were 65 years and over and 27% were 75 years and over. no overall differences in safety or effectiveness were observed between these elderly patients and younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. the pharmacokinetics of abiraterone were examined in subjects with baseline mild (n=8) or moderate (n=8) hepatic impairment (child-pugh class a and b, respectively) and in 8 healthy control subjects with normal hepatic function. the systemic exposure (auc) of abiraterone after a single oral 1,000 mg dose of abiraterone acetate increased by approximately 1.1-fold and 3.6-fold in subjects with mild and moderate baseline hepatic impairment, respectively compared to subjects with normal hepatic function. in another trial, the pharmacokinetics of abiraterone were examined in subjects with baseline severe (n=8) hepatic impairment (child-pugh class c) and in 8 healthy control subjects with normal hepatic function. the systemic exposure (auc) of abiraterone increased by approximately 7-fold and the fraction of free drug increased 2-fold in subjects with severe baseline hepatic impairment compared to subjects with normal hepatic function. no dosage adjustment is necessary for patients with baseline mild hepatic impairment. in patients with baseline moderate hepatic impairment (child-pugh class b), reduce the recommended dose of abiraterone acetate to 250 mg once daily. do not use abiraterone acetate in patients with baseline severe hepatic impairment (child-pugh class c). if elevations in alt or ast >5 x uln or total bilirubin >3 x uln occur in patients with baseline moderate hepatic impairment, discontinue abiraterone acetate treatment [see dosage and administration (2.4) and clinical pharmacology (12.3)] . for patients who develop hepatotoxicity during treatment, interruption of treatment and dosage adjustment may be required [see dosage and administration (2.4), warnings and precautions (5.3), and clinical pharmacology (12.3)]. no dosage adjustment is necessary for patients with renal impairment [see clinical pharmacology (12.3)].