- phenylephrine hydrochloride
POM: Prescription only medicine
This information is intended for use by health professionals
Phenylephrine 10 mg/ml Solution for Injection or Infusion
Phenylephrine hydrochloride Ph Eur 1.0% w/v
Each 1 ml ampoule contains 10 mg phenylephrine.
For a full list of excipients, see section 6.1
Solution for injection, or concentrate for solution for injection or infusion.
Clear, colourless, sterile, solution.
For the treatment of hypotensive states, e.g. circulatory failure, during spinal anaesthesia or drug-induced hypotension.
For subcutaneous, intramuscular or slow intravenous injection or by intravenous infusion.
Whenever solution and container permit, parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
Phenylephrine injection may be administered subcutaneously or intramuscularly in a dosage of 2 to 5 mg with further doses of 1 to 10 mg if necessary according to response, or in a dose of 100 to 500 micrograms by slow intravenous injection as a 0.1% solution, repeated as necessary after at least 15 minutes.
Alternatively, 10 mg in 500 ml of glucose 5% injection or sodium chloride 0.9% injection may be infused intravenously, initially at a rate of up to 180 micrograms per minute, reduced according to response to 30-60 micrograms per minute.
100 micrograms/kg bodyweight subcutaneously or intramuscularly.
There is no need for dosage reduction in the elderly.
Hypersensitivity to phenylephrine or to any of the excipients listed in section 6.1.
Patients taking monoamine oxidase inhibitors, or within 14 days of ceasing such treatment.
Severe hypertension and hyperthyroidism.
Avoid in patients with prostatic enlargement.
Great care should be exercised in administering Phenylephrine Injection to patients with pre-existing cardiovascular disease such as ischaemic heart disease, arrhythmias, occlusive vascular disease including arteriosclerosis, hypertension or aneurysms. Anginal pain may be precipitated in patients with angina pectoris.
Care is also required when given to patients with diabetes mellitus or closed-angle glaucoma.
Keep all medicines out of the reach of children.
Phenylephrine may interact with cyclopropane and halothane and other halogenated inhalational anaesthetics, to induce ventricular fibrillation.
An increased risk of arrhythmias may also occur if phenylephrine injection is given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.
Phenylephrine may increase blood pressure and consequently reverse the action of many antihypertensive agents.
Interactions of phenylephrine with alpha and beta receptor blocking drugs may be complex. Drugs which have an effect on α1- adrenoreceptors could potentiate (such as ganisetron or clonidine) or inhibit (such as doxazosin or buspirone) the vasopressive action of phenylephrine.
Caution should be applied when administering atomoxetine concurrently, as there is potential for synergistic pharmacological effects.
Severe hypertension may occur following the use of phenylephrine and atropine or other antimuscarinics.
The pressor effects of phenylephrine may be slightly reduced by lithium carbonate.
The effects of phenylephrine may be potentiated by the use of monoamine oxidase inhibitors or reversible inhibitors of monoamine oxidase.
The safety of phenylephrine during pregnancy and lactation has not been established. Due to the vasoconstrictive properties of phenylephrine, the product should be used with caution in patients with a history of pre-eclampsia. Administration of phenylephrine in late pregnancy or labour may cause foetal hypoxia and bradycardia.
Excretion of phenylephrine in breast milk appears to be minimal.
No adverse effects known.
Immune system disorders
Metabolism and nutrition disorders
Nervous system disorders
Headache, cerebral haemorrhage, paraesthesia
Mydriasis, angle-closure glaucoma
Pulmonary oedema, bradycardia, tachycardia, arrhythmia, angina pectoris, palpitations, cardiac arrest
Hypotension, dizziness, syncope, flushing
Respiratory, thoracic and mediastinal disorders
Vomiting, salivary hypersecretion
Renal and urinary disorders
Dysuria, urinary retention
General disorders and administration site conditions
Extravasation, infusion site necrosis, hyperhidrosis
Increased blood pressure, abnormal blood glucose
Phenylephrine is without significant stimulating effects on the central nervous system at usual doses.
Reporting of suspected adverse reactions
Reporting 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms of overdosage include headache, vomiting, hypertension and reflex bradycardia and other cardiac arrhythmias. In severe cases confusion, hallucinations and seizures may occur.
Treatment should consist of symptomatic and supportive measures. The hypertensive effects may be treated with an alpha-adrenoceptor blocking drug, such as phentolamine, 5 to 60 mg i.v. over 10-30 minutes, repeated as necessary.
Pharmacotherapeutic group: Adrenergic and dopaminergic agents.
ATC code: C01C A06
Phenylephrine hydrochloride is a sympathomimetic agent with mainly direct effects on adrenergic receptors. It has predominantly alpha-adrenergic activity and is without significant stimulating effects on the central nervous system at usual doses. After injection it produces peripheral vasoconstriction and increased arterial pressure. It also causes reflex bradycardia.
When injected subcutaneously or intramuscularly, phenylephrine takes 10 to 15 minutes to act. Subcutaneous and intramuscular injections are effective for up to about one and up to two hours respectively. Intravenous injections are effective for up to about 20 minutes. Phenylephrine is metabolised in the liver by monoamine oxidase. The metabolites, their route and rate of excretion have not been identified.
Phenylephrine has been used to induce cardiac myocyte hypertrophy in cultures of rat neonatal mycocytes at doses of 100 µM and 10 µM. To the best of our knowledge there have been no human studies associating therapeutic phenylephrine use with the development of cardiac myocyte hypertrophy.
N/1 Sodium Hydroxide
N/1 Hydrochloric Acid
Water for Injections Ph Eur
Phenylephrine Injection has been stated to be incompatible with alkalis, ferric salts, phenytoin sodium and oxidising agents.
Keep out of sight and reach of children.
Store below 25°C. Store in the original package.
1 ml neutral glass ampoule with ceramic breakring.
Pack size: 10 ampoules
Beacon Pharmaceuticals Limited
DCC Vital, Westminster Industrial Estate
20th September 2018
85 High Street, Tunbridge Wells, TN1 1YG
0845 437 5567
0845 437 5565
+44 (0)1233 506 574
0800 220 280