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gland pharma limited - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride injection, 10 mg/ml, is an alpha-1 adrenergic receptor agonist 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]

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

paragon bioteck, inc. - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride ophthalmic solution, usp 2.5% and 10% is indicated to dilate the pupil. phenylephrine hydrochloride ophthalmic solution, usp 10% is contraindicated in patients with hypertension, or thyrotoxicosis. phenylephrine hydrochloride ophthalmic solution, usp 2.5% should be used in these patients. phenylephrine hydrochloride ophthalmic solution, usp 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. phenylephrine hydrochloride ophthalmic solution, usp 2.5% should be used in these patients [see dosage and administration ( 2.2)]. animal reproduction studies have not been conducted with topical 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 ophthalmic solution, usp 2.5% and 10% should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excrete

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

hikma pharmaceuticals usa 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)

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)

lifestar pharma llc - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride ophthalmic solution, usp 10%, is indicated to dilate the pupil. phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients. phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients [see dosage and administration (2.2)]. animal reproduction studies have not been conducted with topical 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. it is not known whether this drug is excreted in human breast milk. because many drugs are excreted in human milk, caution shoul

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)

lifestar pharma llc - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride ophthalmic solution 2.5%, is indicated to dilate the pupil. phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients. phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients [see dosage and administration (2.2)] . animal reproduction studies have not been conducted with topical 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. it is not known whether this drug is excreted in human breast milk. because many drugs are excreted in human milk, caution should b

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

gm pharmaceuticals, inc - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv), thonzylamine hydrochloride (unii: 6k9ykd48y4) (thonzylamine - unii:r79646h5z8) - phenylephrine hydrochloride 10 mg in 15 ml - nasal decongestant antihistamine temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: - nasal congestion - reduces swelling of the nasal passages - runny nose - sneezing - itching of the nose or throat - itchy, watery eyes

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p & l development, llc - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv), diphenhydramine hydrochloride (unii: tc2d6jad40) (diphenhydramine - unii:8gts82s83m) - phenylephrine hydrochloride 2.5 mg in 5 ml - antihistamine/cough suppressant nasal decongestant  - temporarily relieves: sneezing runny nose itchy nose or throat itchy, watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold - sneezing - runny nose - itchy nose or throat - itchy, watery eyes due to hay fever - nasal and sinus congestion - cough due to minor throat and bronchial irritation as may occur with a cold

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

genoma lab usa inc - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv), pramoxine hydrochloride (unii: 88ayb867l5) (pramoxine - unii:068x84e056) - phenylephrine hydrochloride 2.5 mg in 1 g - - for the temporary relief of anorectal itching, burning and discomfort associated with hemorrhoids, anorectal disorders, inflamed hemorrhoidal tissues, or piles.