PHENYLEPHRINE

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.

1% solution, repeated as necessary after at least 15 minutes. 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. Children 100 micrograms/kg bodyweight subcutaneously or intramuscularly.

Elderly There is no need for dosage reduction in the elderly.

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) Immune system disorders Hypersensitivity Metabolism and nutrition disorders Metabolic disorders Psychiatric disorders Nervousness, insomnia Nervous system disorders Headache, cerebral haemorrhage, paraesthesia Eye disorders Mydriasis, angle-closure glaucoma Cardiac disorders Pulmonary oedema, bradycardia, tachycardia, arrhythmia, angina pectoris, palpitations, cardiac arrest Vascular disorders Hypotension, dizziness, syncope, flushing Respiratory, thoracic and mediastinal disorders Dyspnoea Gastrointestinal disorders Vomiting, salivary hypersecretion Renal and urinary disorders Dysuria, urinary retention General disorders and administration site conditions Extravasation, infusion site necrosis, hyperhidrosis Investigations Increased blood pressure, abnormal blood glucose Phenylephrine is without significant stimulating effects on the central nervoussystem 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 balanceof the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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. Phenylephrine is not recommended in subjects with a shallow anterior chamber or a history of acute narrow angle glaucoma.

Use of Phenylephrine 10 mg/ml Injection in patients with shallow anterior chamber, a history of acute narrow angle glaucoma and/or insufficient pupil dilation can increase the risk of both iridocele and floppy iris syndrome. Keep all medicines out of the reach of children.

This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially 'sodium-free'.

1. Patients taking monoamine oxidase inhibitors, or within 14 days of ceasing such treatment. Severe hypertension and hyperthyroidism. Avoid in patients with prostatic enlargement.