This information is intended for use by health professionals
Intravenous bolus injection:Normal dose is 50 to 100 micrograms, which can be repeated until the desired effect is attained. One bolus dose should not exceed 100 micrograms.
Continuous infusion:Initial dose is 25 to 50 micrograms/min. The doses may be increased or decreased to maintain the systolic blood pressure close to the normal value. Doses between 25 and 100 micrograms/min have been assessed to be effective.
Renal impairmentLower doses of phenylephrine may be needed in patients with impaired renal function.
Hepatic ImpairmentHigher doses of phenylephrine may be needed in patients with cirrhosis of the liver.
Older people:Treatment of the elderly should be carried out with care.
Paediatric populationThe safety and efficacy of phenylephrine in children have not been established. No data are available.
Method of administration:Parenteral administration. Intravenous bolus injection or intravenous infusion.Phenylephrine, 50 micrograms/ml, solution for injection should only be administered by healthcare professionals with appropriate training and relevant experience.
Contraindicated combinations (see section 4.3)• Non-selective monoamine oxidase inhibitors (MAOs) (iproniazid, nialamide)Paroxysmal hypertension, hyperthermia possibly fatal. Due to the long duration of action of MAOIs, this interaction is still possible 15 days after discontinuation of the MAOI.
Inadvisable combinations• Dopaminergic ergot alkaloids (bromocriptine, cabergoline, lisuride, pergolide): Risk of vasoconstriction and/or hypertensive crisis.• Vasoconstrictor ergot alkaloids (dihydroergotamine, ergotamine, methylergometrine, methylsergide): Risk of vasoconstriction and/or hypertensive crisis.• Tricyclic antidepressants (e.g. imipramine): Paroxysmal hypertension with possibility of arrhythmias (inhibition of adrenaline or noradrenaline entry in sympathetic fibers).• Noradrenergic-serotoninergic antidepressants (minalcipram, venlafaxine): Paroxysmal hypertension with possibility of arrhythmias (inhibition of adrenaline or noradrenaline entry in sympathetic fibers).• Selective type A monoamine oxidase inhibitors (MAOs) (moclobemide, toloxatone)Risk of vasoconstriction and/or hypertensive crisis.• Linezolid: Risk of vasoconstriction and/or hypertensive crisis.• Guanethidine and related products: Substantial increase in blood pressure (hyperreactivity linked to the reduction in sympathetic tone and /or to the inhibition of adrenaline or noradrenaline entry in sympathetic fibers). If the combination cannot be avoided, use with caution lower doses of sympathomimetic agents.• Cardiac glycosides, quinidine:Increased risk of arrhythmias.• Sibutramine: Paroxysmal hypertension with possibility of arrhythmias (inhibition of adrenaline or noradrenaline entry in sympathetic fibers).• Halogenated volatile anaesthetics (desflurane, enflurane, halothane, isoflurane, methoxyflurane, sevoflurane): Risk of perioperative hypertensive crisis and arrhythmia.
Combinations requiring precautions for use:• Oxytocic agents: The effect of presso-active sympathomimetic amines is potentiated. Thus, some oxytocic agents may cause severe persistent hypertension and strokes can occur during post-partum period.
PregnancyAnimal studies are insufficient with respect to reproductive toxicity and teratogenicity (see section 5.3). Administration of phenylephrine in late pregnancy or labour may potentially cause fetal hypoxia and bradycardia. Use of injectable phenylephrine is possible during pregnancy in accordance with the indications.The combination with some oxytocic agents can cause severe hypertension (see section 4.5).
Breast-feedingSmall quantities of phenylephrine are excreted in human breast milk and oral bioavailability may be low.Administering vasoconstrictors to the mother exposes the infant to a theoretical risk of cardiovascular and neurological effects. However, in the event of a single bolus administration during childbirth, breast-feeding is possible.
FertilityThere is no available data concerning fertility after exposure to phenylephrine (see section 5.3).
Summary of the safety profileThe most common adverse events of phenylephrine are bradycardia, hypertensive episodes, nausea and vomiting. Hypertension is more frequent with high doses. The most commonly reported cardiovascular adverse event appears to be bradycardia, likely due to baroreceptor-mediated vagal stimulation and consistent with the pharmacological effect of phenylephrine.
List of adverse reactionsFrequency: Not known (cannot be estimated from available data)
Immune system disorders:Not known: hypersensitivity
Psychiatric disorders:Not known: Anxiety, excitability, agitation, psychotic states, confusion.
Nervous system disordersNot known: Headache, nervousness, insomnia, paresthesia, tremor.
Eye disorders:Not known: Mydriasis, aggravation of pre-existing angle-closure glaucoma
Cardiac disorders:Not known: Reflex bradycardia, tachycardia, palpitations, hypertension, arrhythmia, angina pectoris, myocardial ischemia.
Vascular disorders:Not known: Cerebral haemorrhage, hypertensive crisis
Respiratory, thoracic and mediastinal disorders:Not known: Dyspnoea, pulmonary oedema
Gastrointestinal disorders:Not known: Nausea, vomiting
Skin and subcutaneous tissue disorders:Not known: Sweating, pallor or skin blanching, piloerection, skin necrosis with extravasation
Musculoskeletal and connective tissue disorders:Not known: muscular weakness
Renal and urinary disorders:Not known: Difficulty in micturition and urinary retention
Description of selected adverse reactionsAs phenylephrine has been frequently used in the critical care setting in patients with hypotension and shock, some of the reported serious adverse events and deaths are probably related to the underlying disease and not related to the use of phenylephrine.
Other special population(s)Elderly: risk for phenylephrine toxicity is increased in elderly patients (see section 4.4).
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card SchemeWebsite: www.mhra.gov.uk/yellowcard
Instructions for use:
Please prepare the syringe carefully as followsThe pre-filled syringe is for single patient only. Discard syringe after use. DO NOT REUSE.The content of un-opened and un-damaged blister is sterile, and must not be opened until use. The product should be inspected visually for particles and discoloration prior to administration. Only clear colourless solution free from particles or precipitates should be used. The product should not be used if the tamper evident seal on the syringe is broken.The external surface of syringe is sterile until blister is opened.When handled using an aseptic method, Phenylephrine 50 micrograms/ml, solution for injection in pre-filled syringe can be placed on a sterile field. 1) Withdraw the pre-filled syringe from the sterile blister.
|2) Push on the plunger to free the bung. The sterilisation process may have caused adhesion of the bung to the body of the syringe.|
|3) Twist off the end cap to break the seal. Do not touch the exposed luer connection in order to avoid contamination.|
|4) Check the syringe seal tip has been completely removed. If not, replace the cap and twist again|
|5) Expel the air by gently pushing the plunger.|