Stati Uniti - inglese - NLM (National Library of Medicine)

redicare llc - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv), guaifenesin (unii: 495w7451vq) (guaifenesin - unii:495w7451vq), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - phenylephrine hydrochloride 5 mg - acetaminophen 325 mg ........................................................................................................pain reliever/fever reducer guaifenesin 200 mg .....................................................................................................................................expectorant phenylephrine hci 5 mg ...........................................................................................................................decongestant temporarily: ■ relieves nasal congestion associated with sinusitis ■ relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies ■ relieves sinus congestion and pressure, helps decongest sinus openings and passages ■ restores freer breathing ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive. temporarily relieves minor aches, pains, and fever associated with: ■ headache ■ common cold ■ toothac

Stati Uniti - inglese - NLM (National Library of Medicine)

ingenus pharmaceuticals, 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 defec

Stati Uniti - inglese - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (maoi). promethazine products are contraindicated for use in pediatric patients less than two years of age. caution should be exercised when administering promethazine products to pediatric p

Stati Uniti - inglese - NLM (National Library of Medicine)

remedyrepack 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

Stati Uniti - inglese - NLM (National Library of Medicine)

cipla 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 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

Stati Uniti - inglese - NLM (National Library of Medicine)

general injectables & vaccines, 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 dec

Stati Uniti - inglese - NLM (National Library of Medicine)

cardinal health - 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: 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

Stati Uniti - inglese - NLM (National Library of Medicine)

preferred pharmaceuticals, inc - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - promethazine hydrochloride 6.25 mg in 5 ml - promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds). phenylephrine should not be used in patients known to be hypersensitive to the drug or in those receiving a monoamine oxidase inhibitor (maoi). promethazine products are contraindicated for use in pediatric patients less than two years of age. caution should be exercised when administering promethazine products to pediatric p

Stati Uniti - inglese - NLM (National Library of Medicine)

aaa pharmaceutical, inc. - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride 10 mg - nasal decongestant - temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis - temporarily relieves sinus congestion and pressure

Stati Uniti - inglese - NLM (National Library of Medicine)

amneal pharmaceuticals 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 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 miscarriage for the indicated population are 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 disease-associated maternal and/or embryofetal risk untreated hypotension associated with spinal anesthesia for cesarean section is associated with an increase in maternal nausea and vomiting. a sustained decrease in uterine blood flow due to maternal hypotension may result in fetal bradycardia and acidosis. data human data published randomized controlled trials over several decades, which compared the use of phenylephrine hydrochloride injection to other similar agents in pregnant women during cesarean section, have not identified adverse maternal or infant outcomes. at recommended doses, phenylephrine does not appear to affect fetal heart rate or fetal heart rate variability to a significant degree. there are no studies on the safety of phenylephrine hydrochloride injection exposure during the period of organogenesis, and therefore, it is not possible to draw any conclusions on the risk of birth defects following exposure to phenylephrine hydrochloride injection during pregnancy. in addition, there are no data on the risk of miscarriage following fetal exposure to phenylephrine hydrochloride injection. animal data no clear malformations or fetal toxicity were reported when normotensive pregnant rabbits were treated with phenylephrine via continuous intravenous infusion over 1 hour (0.5 mg/kg/day; approximately equivalent to a hdd based on body surface area) from gestation day 7 to 19. at this dose, which demonstrated no maternal toxicity, there was evidence of developmental delay (altered ossification of sternebra). in a non-glp dose range-finding study in normotensive pregnant rabbits, fetal lethality and cranial, paw, and limb malformations were noted following treatment with 1.2 mg/kg/day of phenylephrine via continuous intravenous infusion over 1 hour (2.3-times the hdd). this dose was clearly maternally toxic (increased mortality and significant body weight loss). an increase in the incidence of limb malformation (hyperextension of the forepaw) coincident with high fetal mortality was noted in a single litter at 0.6 mg/kg/day (1.2-times the hdd) in the absence of maternal toxicity. no malformations or embryo-fetal toxicity were reported when normotensive pregnant rats were treated with up to 3 mg/kg/day phenylephrine via continuous intravenous infusion over 1 hour (2.9-times the hdd) from gestation day 6 to 17. this dose was associated with some maternal toxicity (decreased food consumption and body weights). decreased pup weights were reported in a pre-and postnatal development toxicity study in which normotensive pregnant rats were administered phenylephrine via continuous intravenous infusion over 1 hour (0.3, 1.0, or 3.0 mg/kg/day; 0.29, 1, or 2.9 times the hdd) from gestation day 6 through lactation day 21). no adverse effects on growth and development (learning and memory, sexual development, and fertility) were noted in the offspring of pregnant rats at any dose tested. maternal toxicities (mortality late in gestation and during lactation period, decreased food consumption and body weight) occurred at 1 and 3 mg/kg/day of phenylephrine (equivalent to and 2.9 times the hdd, respectively). risk summary there are no data on the presence of phenylephrine hydrochloride or its metabolite in human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for phenylephrine hydrochloride and any potential adverse effects on the breastfed infant from phenylephrine hydrochloride or from the underlying maternal condition. 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 b and class c], dose-response data indicate decreased responsiveness to phenylephrine. start dosing in the recommended dose range, but more phenylephrine may be needed in this population. in patients with end stage renal disease (esrd), dose-response data indicate increased responsiveness to phenylephrine. consider starting at the lower end of the recommended dose range, and adjusting dose based on the target blood pressure goal.