İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

athlone pharmaceuticals limited - phenylephrine hydrochloride - solution for injection/infusion - phenylephrine

ABD - İngilizce - NLM (National Library of Medicine)

granules india limited - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), dextromethorphan hydrobromide (unii: 9d2rti9kyh) (dextromethorphan - unii:7355x3rots) - phenylephrine hydrochloride 5 mg - pain reliever/fever reducer cough suppressant nasal decongestant • temporarily relieves these symptoms due to cold and flu: sneezing itching of the nose, throat or watery eyes due to hay fever cough nasal congestion sinus congestion and pressure sore throat head ache minor aches and pains • helps clear nasal passages and shrinks swollen membranes • temporarily reduces fever • with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson’s disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. • if you ever had an allergic reaction to this

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

bausch & lomb australia pty ltd - phenylephrine hydrochloride, quantity: 100 mg/ml - eye drops, solution - excipient ingredients: sodium metabisulfite; disodium edetate; purified water - phenylephrine is a directly acting sympathomimetic agent used topically in the eye as a mydriatic. minims phenylephrine hydrochloride eye drops are indicated to dilate the pupil for diagnostic or therapeutic procedures.

Avustralya - İngilizce - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - phenylephrine hydrochloride, quantity: 10 mg - injection - excipient ingredients: water for injections; sodium chloride; sodium citrate dihydrate; citric acid monohydrate; sodium metabisulfite; hydrochloric acid; sodium hydroxide - phenylephrine hydrochloride is intended 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.

Yeni Zelanda - İngilizce - Medsafe (Medicines Safety Authority)

bausch & lomb (nz) ltd - phenylephrine hydrochloride 10%;  ;   - eye drops, solution - 10 % - active: phenylephrine hydrochloride 10%     excipient: disodium edetate dihydrate sodium metabisulfite water for injection

ABD - İngilizce - NLM (National Library of Medicine)

hainan poly pharm. co., ltd. - 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 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 2-4% and 15-20%, 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 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 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 injection during pregnancy. in addition, there are no data on the risk of miscarriage following fetal exposure to phenylephrine 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 injection 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.

ABD - İngilizce - NLM (National Library of Medicine)

bausch & lomb americas 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 excreted in human breas

ABD - İngilizce - NLM (National Library of Medicine)

medical purhasing 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 estimated background

Birleşik Krallık - İngilizce - MHRA (Medicines & Healthcare Products Regulatory Agency)

imported (germany) - phenylephrine hydrochloride - powder - 1mg/1mg

İrlanda - İngilizce - HPRA (Health Products Regulatory Authority)

bausch & lomb uk limited - phenylephrine hydrochloride - eye drops solution - 10 %w/v - phenylephrine