Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK
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.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
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 is a hypertensive agent and may consequently reverse the action of many antihypertensive drugs. Interactions of phenylephrine with alpha and beta receptor blocking drugs may be complex.
Drugs which have an effect on α1 adrenoceptors could potentiate (such as clonidine) or inhibit (such as doxazosin) 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 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.
The safety of phenylephrine during lactation has not been established. Excretion of phenylephrine in breast milk appears to be minimal.
No adverse effects known.
A tabulated list of undesirable effects is outlined below:
The undesirable effects are listed according to organ systems and following frequency: Not known (cannot be estimated from the available data).
Not known: Hypersensitivity, Metabolism and nutrition disorders, Metabolic disorders
Not known: Nervousness, insomnia
Not known: Headache, cerebral haemorrhage, paraesthesia
Not known: Mydriasis, angle-closure glaucoma
Not known: Pulmonary oedema, bradycardia, tachycardia, arrhythmia, angina pectoris, palpitations, cardiac arrest
Not known: Hypotension, dizziness, syncope, flushing
Not known: Dyspnoea
Not known: Vomiting, salivary hypersecretion
Not known: Dysuria, urinary retention
Not known: Extravasation, infusion site necrosis, hyperhidrosis
Not known: Increased blood pressure, abnormal blood glucose
Phenylephrine is without significant stimulating effects on the central nervous system at usual doses.
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 website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Phenylephrine Injection has been stated to be incompatible with alkalies, ferric salts, phenytoin sodium and oxidising agents.
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