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

sagent pharmaceuticals - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. none risk summary data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride use in pregnant women during cesarean section have not established a drug-associated risk of major birth defects and miscarriage. these studies have not identified an adverse effect on maternal outcomes or infant apgar scores [see data] . there are no data on the use of phenylephrine during the first or second trimester. in animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times the human daily dose (hdd) of 10 mg/60 kg/day. decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the hdd [see data]. the estimated background risk of major birth defects and mis

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

eugia us llc - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. none risk summary data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during cesarean section have not established a drug-associated risk of major birth defects and miscarriage. these studies have not identified an adverse effect on maternal outcomes or infant apgar scores [see data] . there are no data on the use of phenylephrine during the first or second trimester. in animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times the human daily dose (hdd) of 10 mg/60 kg/day. decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the hdd [see data] . the estimated background risk of major birt

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

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)

medical purchasing solutions, llc - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride injection, 10 mg/ml is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. none risk summary data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during cesarean section have not established a drug-associated risk of major birth defects and miscarriage. these studies have not identified an adverse effect on maternal outcomes or infant apgar scores [ see data ]. there are no data on the use of phenylephrine during the first or second trimester. in animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times the human daily dose (hdd) of 10 mg/60 kg/day. decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the hdd [ see data ]. the e

Australia - English - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - phenylephrine hydrochloride, quantity: 10 mg - injection, solution - excipient ingredients: hydrochloric acid; sodium hydroxide; sodium citrate dihydrate; water for injections; citric acid monohydrate; sodium metabisulfite; sodium chloride - for the maintenance of an adequate level of blood pressure during spinal and inhalation anaesthesia and for the treatment of vascular failure in shock, shock-like states, and drug-induced hypotension, or hypersensitivity. it is also employed to overcome paroxysmal supraventricular tachycardia, to prolong spinal anaesthesia, and as a vasoconstrictor in regional analgesia

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

eugia us llc - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride injection 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 injection 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 decrease in placental perfusion sufficient to alter either the neonate apgar scores or blood-gas status. it is not known whether this drug is excreted in human milk. safety and effectiveness in pediatric patients have not been established. clinical studies of phenylephrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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. in patients with liver cirrhosis [child pugh class a (n = 3), class b (n = 5) and class c (n = 1)], dose-response data indicate decreased responsiveness to phenylephrine. consider using larger doses than usual in hepatic impaired subjects. in patients with end stage renal disease (esrd) undergoing hemodialysis, dose-response data indicates increased responsiveness to phenylephrine. consider using lower doses of phenylephrine hydrochloride in esrd patients.

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

sandoz inc - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride injection, is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. none risk summary data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during cesarean section have not established a drug-associated risk of major birth defects and miscarriage. these studies have not identified an adverse effect on maternal outcomes or infant apgar scores [see data] . there are no data on the use of phenylephrine during the first or second trimester. in animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times the human daily dose (hdd) of 10 mg/60 kg/day. decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the hdd [see data]. the estimated backg

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

hf acquisition co llc, dba healthfirst - 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 8.1 pregnancy 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. 8.2 labor and delivery 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 decrease in placental perfusion sufficient to alter either the neonate apgar scores or blood-gas status. 8.3 nursing mothers it is not known whether this drug is excreted in human milk. 8.4 pediatric use safety and effectiveness in pediatric patients have not been established. 8.5 geriatric use clinical studies of phenylephrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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. 8.6 hepatic impairment in patients with liver cirrhosis [child pugh class a (n=3), class b (n=5) and class c (n=1)], dose-response data indicate decreased responsiveness to phenylephrine. consider using larger doses than usual in hepatic impaired subjects. 8.7 renal impairment in patients with end stage renal disease (esrd) undergoing hemodialysis, dose-response data indicates increased responsiveness to phenylephrine. consider using lower doses of phenylephrine hydrochloride in esrd patients.

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

provepharm inc. - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride injection, 10 mg/ml is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. none risk summary data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during cesarean section have not established a drug-associated risk of major birth defects and miscarriage. these studies have not identified an adverse effect on maternal outcomes or infant apgar scores [see data ]. there are no data on the use of phenylephrine during the first or second trimester. in animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times the human daily dose (hdd) of 10 mg/60 kg/day. decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the hdd [see data ]. the estimated background risk of ma

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

somerset therapeutics, llc - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. none risk summary data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during cesarean section have not established a drug-associated risk of major birth defects and miscarriage. these studies have not identified an adverse effect on maternal outcomes or infant apgar scores [see data]. there are no data on the use of phenylephrine during the first or second trimester. in animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times the human daily dose (hdd) of 10 mg/60 kg/day. decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the hdd [see data]. the estimated background risk of major birth defect