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)

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride injection 10 mg/ml is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock. the use of phenylephrine hydrochloride injection 10 mg/ml is contraindicated in patients with: - hypersensitivity to the products or any of their components risk summary in animal reproductive and developmental studies, decreased fetal body weights were noted at 0.4 times the human daily dose (hdd) of 10 mg. no malformations were reported, however, an increased incidence of agenesis of the intermediate lobe of the lung, a visceral variation, was reported at levels as low as 0.08 times the hdd. the estimated background risk of major birth defects and miscarriage for 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 i

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

armas pharmaceuticals 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 background risk of major birth defec

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

be pharmaceuticals inc. - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride injection 10 mg/ml is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock. the use of phenylephrine hydrochloride injection 10 mg/ml is contraindicated in patients with: - hypersensitivity to the products or any of their components risk summary in animal reproductive and developmental studies, decreased fetal body weights were noted at 0.4 times the human daily dose (hdd) of 10 mg. no malformations were reported, however, an increased incidence of agenesis of the intermediate lobe of the lung, a visceral variation, was reported at levels as low as 0.08 times the hdd. the estimated background risk of major birth defects and miscarriage for 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 miscarri

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 defec

Israel - English - Ministry of Health

raz pharmaceutics ltd, israel - phenylephrine hydrochloride - eye drops, solution - phenylephrine hydrochloride 100 mg / 1 ml - phenylephrine - phenylephrine vision 10 % is indicated for mydriasis and vasoconstriction.

Canada - English - Health Canada

odan laboratories ltd - phenylephrine hydrochloride - solution - 2.5% - phenylephrine hydrochloride 2.5% - mydriatics

Canada - English - Health Canada

sandoz canada incorporated - phenylephrine (phenylephrine hydrochloride) - liquid - 10mg - phenylephrine (phenylephrine hydrochloride) 10mg - alpha-adrenergic agonists

Canada - English - Health Canada

laboratoire aguettant - phenylephrine hydrochloride - solution - 50mcg - phenylephrine hydrochloride 50mcg - alpha-adrenergic agonists

Canada - English - Health Canada

marcan pharmaceuticals inc - phenylephrine hydrochloride - solution - 10mg - phenylephrine hydrochloride 10mg - alpha-adrenergic agonists