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civica, inc. - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia. the use of phenylephrine hydrochloride is contraindicated in patients with: - hypersensitivity to it or any of its components pregnancy category c animal reproduction studies have not been conducted with intravenous phenylephrine. it is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed. the most common maternal adverse reactions reported in studies of phenylephrine use during neuraxial anesthesia during cesarean delivery include nausea and vomiting, which are commonly associated with hypotension, bradycardia, reactive hypertension, and transient arrhythmias.  phenylephrine does not appear to cause a de

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

civica, inc. - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine bitartrate injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. none. risk summary limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated (see clinical considerations ). in animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see data ). increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approxima

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

civica, inc. - tacrolimus (unii: wm0haq4wnm) (tacrolimus anhydrous - unii:y5l2157c4j) - tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult and pediatric patients receiving allogeneic kidney transplant [see clinical studies (14.1)], liver transplant [see clinical studies (14.2)] , heart transplant [see clinical studies (14.3)] , or lung transplant [see clinical studies (14.4)] in combination with other immunosuppressants . tacrolimus capsules are contraindicated in patients with a hypersensitivity to tacrolimus. hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome [see adverse reactions (6)] . pregnancy exposure registry there is a pregnancy registry that monitors pregnancy outcomes in women exposed to tacrolimus during pregnancy. the transplantation pregnancy registry international (tpri) is a voluntary pregnancy exposure registry that monitors outcomes of pregnancy in female transplant recipients and those fathered by male transplant recipients exposed to immunosuppressants including tacrolimus. healthcare

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

civica, inc. - ropivacaine hydrochloride (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - ropivacaine hydrochloride is indicated for the production of local or regional anesthesia for surgery and for acute pain management. surgical anesthesia : epidural block for surgery including cesarean section; major nerve block; local infiltration acute pain management : epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration ropivacaine hydrochloride is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. risk summary there are no available human data on use of ropivacaine hydrochloride injection in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. local anesthetics may cause varying degrees of toxicity to the mother and fetus and adverse reactions include alterations of the central nervous system, peripheral vascular tone, and cardiac function (see clinical considerations) . no teratogenicity was observed at dos

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

civica, inc. - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin hydrochloride for injection, usp is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. it is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. vancomycin hydrochloride for injection, usp is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. vancomycin hydrochloride for injection, usp is effective in the treatment of staphylococcal endocarditis. its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin-structure infections. when staphylococcal infecti

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

civica, inc. - vancomycin hydrochloride (unii: 71wo621tjd) (vancomycin - unii:6q205eh1vu) - vancomycin hydrochloride for injection, usp is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (ß-lactam-resistant) staphylococci. it is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. vancomycin hydrochloride for injection, usp is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. vancomycin hydrochloride for injection, usp is effective in the treatment of staphylococcal endocarditis. its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. when staphylococcal infecti

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civica, inc. - daptomycin (unii: nwq5n31vkk) (daptomycin - unii:nwq5n31vkk) - daptomycin for injection is indicated for the treatment of adult and pediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (csssi) caused by susceptible isolates of the following gram-positive bacteria: staphylococcus aureus (including methicillin-resistant isolates), streptococcus pyogenes, streptococcus agalactiae, streptococcus dysgalactiae subsp. equisimilis, and enterococcus faecalis (vancomycin-susceptible isolates only). daptomycin for injection is indicated for the treatment of adult patients with staphylococcus aureus bloodstream infections (bacteremia), including adult patients with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. daptomycin for injection is indicated for the treatment of pediatric patients (1 to 17 years of age) with staphylococcus aureus bloodstream infections (bacteremia). daptomycin for injection is not indicated for the treatment of pneumonia. daptomycin for injection is not i

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

civica, inc. - daptomycin (unii: nwq5n31vkk) (daptomycin - unii:nwq5n31vkk) - daptomycin for injection is indicated for the treatment of adult and pediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (csssi) caused by susceptible isolates of the following gram-positive bacteria: staphylococcus aureus (including methicillin-resistant isolates), streptococcus pyogenes, streptococcus agalactiae, streptococcus dysgalactiae subsp. equisimilis, and enterococcus faecalis (vancomycin-susceptible isolates only). daptomycin for injection is indicated for the treatment of adult patients with staphylococcus aureus bloodstream infections (bacteremia), including adult patients with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. daptomycin for injection is indicated for the treatment of pediatric patients (1 to 17 years of age) with staphylococcus aureus bloodstream infections (bacteremia). daptomycin for injection is not indicated for the treatment of pneumonia. daptomycin for injection is not i

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

civica, inc. - propofol (unii: yi7vu623sf) (propofol - unii:yi7vu623sf) - propofol injectable emulsion is an iv general anesthetic and sedation drug that can be used as described in the table below. indication approved patient population safety, effectiveness and dosing guidelines for propofol have not been established for mac sedation in the pediatric population; therefore, it is not recommended for this use. (see precautions - pediatric use . ) propofol is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations. in the intensive care unit (icu), propofol can be administered to intubated, mechanically ventilated adult patients to provide continuous sedation and control of stress responses, only by persons skilled in the medical management of critically ill patients and trained in cardiovascular resuscitation and airway management. propofol is not indicated for use in pediatric icu sedation since the safety of this regimen has

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

civica, inc - propofol (unii: yi7vu623sf) (propofol - unii:yi7vu623sf) - propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: limitations of use propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see pediatric use (8.4)] . safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for mac sedation in the pediatric population; therefore, it is not recommended for this use [see pediatric use (8.4)] . propofol injectable emulsion is not indicated for use in pediatric icu sedation since the safety of this regimen has not been established [see pediatric use (8.4)] . propofol injectable emulsion is contraindicated in patients with a known hypersensitivity to propofol or any of propofol injectable emulsion components. propofol injectable emulsion is contraindicated in patients with a history of anaphylaxis to